Clinical trial NCT02762981
Conditions: Solid Tumors
Keywords: CORT125134 nab-paclitaxel Triple-Negative Breast Cancer Ovarian Epithelial Cancer GR Antagonist Glucocorticoid Receptor Antagonist Pancreatic Cancer Solid Tumors Relacorilant Abraxane
Sponsor: Corcept Therapeutics
Start date: 2016-05-23; Completion date: 2020-09-12
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. The structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.

Detailed description:
The study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. Segment I was to evaluate a continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II were mutually exclusive, and the two segments enrolled participants concurrently.

In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a total of 64 participants.

In Segment II intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.

Arms: arm 1: Participants will be treated with relacorilant in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen.
Interventions: intervention 1: Relacorilant with nab-paclitaxel
Intervention descriptions: intervention 1: Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.

Protocol documents:
Prot_000.pdf: 
 
Title: Phase 1/2 Study of CORT125134 in Combination with Nab-
paclitaxel in Patients with Solid Tumors 
 
 
NCT Number: NCT02762981 
 
 
Date: 13 January 2020 






Protocol CORT125134-550
Corcept Therapeutics  
Amendment 6  |  13 January 2020 
Confidential  
 Page 3 
INVESTIGATOR SIGNATURE PAGE 
Protocol Title 
Phase 1/2 Study of CORT125134 in 
Combination with Nab-paclitaxel in 
Patients with Solid Tumors 
Protocol Number 
CORT125134-550 
Version 
Amendment 6 
Date  
13 January 2020 
 
INVESTIGATOR AGREEMENT 
By my signature below, I attest to the following:  
1. I have read the attached protocol.  
2. I agree to conduct the study as outlined in the protocol and in accordance with all 
applicable regulations and guidelines, including the Declaration of Helsinki (version as 
currently endorsed by the European Medicines Evaluation Agency and the United States 
Food and Drug Administration [FDA]); the principles of Good Clinical Practice (GCP) as 
described in the United States Code of Federal Regulations (CFR) – 21 CFR parts 50, 54, 
56, and 312 and the ICH document “E6(R2) Good Clinical Practice: Integrated 
Addendum to ICH E6(R1),” dated 9 Nov 2016. Further, I will conduct the study in 
keeping with local legal and regulatory requirements. 
3. I will initiate this study only with written and dated approval from the appropriate 
Institutional Review Board (IRB). I understand that any changes in the protocol must be 
approved in writing by the Sponsor, the IRB, and, in certain cases the FDA or other 
applicable regulatory agencies, before they can be implemented. 
4. I agree to maintain the confidentiality of all information received or developed in 
connection with this protocol. 
 
Signed:   
 
 
 
 
 
Signature 
 
 
 
Date 
 
Name 
 
Institution 


Protocol CORT125134-550
Corcept Therapeutics  
Amendment 6  |  13 January 2020 
Confidential  
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SYNOPSIS 
Name of Sponsor 
Corcept Therapeutics  
Name of Active Ingredient 
CORT125134  
Study number: 
CORT125134-550 
Title of Study  
Phase 1/2 Study of CORT125134 in Combination with Nab-paclitaxel in Patients with Solid Tumors 
Rationale  
Some solid tumors develop chemotherapy resistance in part via stimulation or upregulation of the 
glucocorticoid receptor (GR) with subsequent expression of cell survival gene products. GR 
antagonists enhance the efficacy of taxanes in GR-positive solid tumor mouse xenograft studies. Nab-
paclitaxel is an effective form of paclitaxel that does not require pretreating patients with intravenous 
(IV) steroids. This study will evaluate the combination of CORT125134, a novel GR antagonist, and 
nab-paclitaxel in patients with solid tumors with the goal of developing a treatment regimen that 
bypasses the GR-mediated chemotherapy resistance pathway. 
Study Centers:  Approximately 12 centers in the United States  
Study Period:  Approximately 
36 months 
Phase of Development:  Phase 1/2 
Objectives 
These objectives will apply to all regimens evaluated during the study. 
Primary Objective 
• 
To determine the maximum tolerated dose (MTD) and the development regimen of the 
combination of CORT125134 and nab-paclitaxel in patients with solid tumors.  
Secondary Objectives 
• 
To characterize the safety profile of the combination of CORT125134 and nab-paclitaxel.  
• 
To characterize the preliminary anticancer activity (objective response rate [ORR], 
progression-free survival [PFS], and overall survival [OS]) of the combination of 
CORT125134 and nab-paclitaxel in patients with solid tumors in a dose-finding phase and 
in patients with specific tumor types.  
• 
To characterize the preliminary anticancer activity (ORR, PFS, and OS) of the combination 
of CORT125134 and nab-paclitaxel in patients with GR-positive or GR-negative solid 
tumors enrolled in any part of the study.  
• 
To characterize the pharmacokinetics (PK) and exposure-response of the combination of 
CORT125134 and nab-paclitaxel in patients with solid tumors in a dose-finding phase and 
in patients with specific tumor types. 
• 
To characterize the pharmacodynamics (PD) of the combination of CORT125134 and nab-
paclitaxel indicative of modulation of GR function, including hormonal changes and 
FKBP5. 
Exploratory Objectives 
• 
To evaluate molecular, cellular, and soluble markers in peripheral blood and/or tumor 
tissue that may be relevant to the mechanism of action of or response/resistance to 
CORT125134. 
• 
To evaluate pharmacogenomic (PG) markers to assess genetic factors affecting drug 
metabolism and transporters. 


Protocol CORT125134-550
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Confidential  
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Overview of Study Design  
This is a Phase 1/2 single-arm, open-label, multicenter study to determine the MTD and to assess 
safety, PK, PD, and preliminary anticancer activity of the combination of CORT125134 and 
nab-paclitaxel in patients with solid tumors.  
The study will consist of two segments to evaluate alternative dosing schedules of CORT125134: 
Segment I will evaluate a continuous-dosing regimen and Segment II will evaluate an intermittent-
dosing regimen. As shown in Figure S1, in Segment I, dose-escalation cohorts will be enrolled to 
determine the maximum tolerated dose (MTD) and the development regimen for the continuous-dosing 
regimen; thereafter, expansion cohorts will be enrolled and treated with the continuous-dosing 
development regimen to better characterize the antitumor activity in patients with specific tumor types 
and to better define the safety profile. In Segment II, dose-escalation cohorts will be enrolled to 
determine the MTD and the development regimen for the intermittent-dosing regimen; thereafter, 
expansion cohort(s) will be enrolled and treated with the intermittent-dosing development regimen to 
better characterize the antitumor activity of that regimen in patients with specific tumor types and to 
better define the safety profile for that regimen.  
Enrollment in Segment I and Segment II will be mutually exclusive, and the two segments will enroll 
patients concurrently. 
 
Figure S1  Overview of Study Design Showing Segment I and Segment II Regimens 
 
 
 
Design of Segment I and Segment II 
The treatment cycle in each segment will consist of 28 days, and PK, PD, and safety evaluations will be 
performed throughout the study along with preliminary evaluations of antitumor activity as shown in 
the Schedule of Visits and Procedures (Table 9 for Segment I and Table 11 for Segment II).  
Segment I Continuous-Dosing Regimen 
The dosing and PK sampling schedule for the Segment I Continuous-Dosing Regimen is shown 
schematically in Figure S2. 


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Figure S2 Segment I Continuous-Dosing Regimen:  Schematic of Study Drug Dosing and PK 
Sampling Schedule 
 
Abbreviations:  Nab-Pac, nab-paclitaxel; PK, pharmacokinetic. 
 
Segment I, Part 1: Dose-Finding Phase 
• 
Patients with any solid tumor, for whom nab-paclitaxel is an appropriate therapy in the 
opinion of the Investigator, will be enrolled according to a standard 3+3 cohort design. 
• 
The starting dose level will be 100 mg CORT125134, administered once daily (QD), in 
combination with 80 mg/m2 nab-paclitaxel, administered on Days 1, 8, and 15 of a 
28-day cycle. 
• 
In Part 1 there will be a 1-week nab-paclitaxel lead-in (1 dose of nab-paclitaxel on Day 1) 
and a 1-week CORT125134 lead-in (CORT125134 daily for 7 days) before the start of 
Cycle 1, and then 28 day cycles consisting of CORT125134 daily for 28 days plus nab-
paclitaxel weekly for 3 weeks (Figure S2). 
• 
PK will be characterized after dosing with nab-paclitaxel alone, after 7 days of dosing with 
CORT125134 alone, and after dosing with the combination of nab-paclitaxel and 
CORT125134, in Cycle 1 only (Figure S2).  
• 
After a minimum of two dose levels are observed in Part 1, the nab-paclitaxel lead-in may 
be discontinued per DRC recommendation. If the nab-paclitaxel lead-in is discontinued, 
the first dose of study drug will be the CORT125134 dose on Day 1 of the CORT125134 
lead-in. 
• 
The Data Review Committee (DRC) will review safety, laboratory, and any available PK 
data from each cohort before selecting the dose for the next cohort. Dosing will follow the 
dose-finding Table S1 (see Dose-Finding Procedures below). Dose-limiting toxicities 
(DLTs) will be identified at each dose level. The MTD and development regimen to be 
used in Part 2 will be determined.  
• 
A given dose level may be expanded to further evaluate safety, tolerability, PK, or 
preliminary efficacy at that dose level or in a more restricted patient population.  
 


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• 
A dose of CORT125134 100 mg continuous dosing and nab-paclitaxel 60 mg/m2 with 
prophylactic G-CSF support will be explored in patients with pancreatic cancer. Initially, 
approximately 6–8 patients will be enrolled in this cohort. The DRC will review the safety 
and tolerability after 6 DLT-evaluable patients complete 1 cycle of therapy. If the dose-
limiting toxicity (DLT) rate exceeds 33%, the dose will be declared non-tolerable for this 
population (tumor type and similar line of therapy) and no additional patients will be 
enrolled to that cohort. Alternatively, a higher or lower dose level may be evaluated, per 
the recommendation of the DRC based on safety and PK data. Once the dose level is 
declared tolerable, the cohort will be expanded to include approximately 12–15 additional 
patients to further assess the safety and efficacy of this dose level. Safety and efficacy data 
from all pancreatic cancer patients receiving this dose level will be summarized. The DRC 
will take into consideration the overall tolerability and toxicities observed in this cohort(s) 
to inform dose escalation decisions and the recommended Phase 2 dose. 
 
Segment I, Part 2: Dose-Expansion Phase 
• 
Preliminary anticancer activity will be assessed in patients treated with the development 
regimen.  
• 
Patients in Part 2 will have the same dose schedule as patients in Part 1, but without the 
nab-paclitaxel lead-in (Figure S2).  
• 
Expansion cohorts will include approximately 20 patients in each, with a plan to evaluate 
the following tumor types:  (1) platinum-resistant ovarian, fallopian tube, or primary 
peritoneal cancer and, (2) triple-negative breast cancer (TNBC). Additional tumor types 
may be identified by data from Part 1, in which case additional expansion cohorts may be 
added by amendment. 
• 
PK will be characterized in Part 2 Cycle 1 only during treatment with combination 
nab-paclitaxel and CORT125134.  
 
Segment II, Intermittent-Dosing Regimen 
The dosing and PK sampling schedule for the Segment II Intermittent-Dosing Regimen is shown 
schematically in Figure S3. 
Figure S3 Segment II Intermittent-Dosing Regimen:  Schematic of Study Drug Dosing and PK 
Sampling Schedule 
 
Abbreviations:  PK, pharmacokinetic. 
 


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Segment II, Part 1: Dose-Finding Phase 
• 
Patients with any solid tumor, for whom nab-paclitaxel is an appropriate therapy in the 
opinion of the Investigator, will be enrolled according to a standard 3+3 cohort design. 
• 
The starting dose level will be 200 mg CORT125134 in combination with 100 mg/m2 
nab-paclitaxel. CORT125134 will be administered once daily on the day before, the day of, 
and the day after the nab-paclitaxel infusions that will be administered on Days 1, 8, and 
15 of the 28-day cycle. 
• 
PK will be characterized in Cycle 1 only, during treatment with combination nab-paclitaxel 
and CORT125134 (Figure S3).  
• 
The DRC will review safety, laboratory, and any available PK data from each cohort 
before selecting the dose for the next cohort. Dosing will follow the dose-finding Table S2 
(see Dose-Finding Procedures below). DLTs will be identified at each dose level. The 
MTD and development regimen to be used in Part 2 will be determined. 
 
Segment II, Part 2: Dose-Expansion Phase 
• 
Preliminary anticancer activity will be assessed in patients treated with the development 
regimen.  
• 
Patients in Part 2 will have the same dose schedule as patients in Part 1. 
• 
Expansion cohort(s) will include approximately 20 patients in each, with a plan to evaluate 
triple-negative breast cancer (TNBC). Expansion cohorts of 20 patients with platinum-
resistant ovarian, fallopian tube, or primary peritoneal cancer may be evaluated with the 
intermittent regimen, per the same selection criteria as provided for Segment I. Additional 
tumor types may be identified by data from Part 1, in which case additional expansion 
cohorts may be added by amendment. 
• 
PK will be characterized in Cycle 1 only, during treatment with combination nab-paclitaxel 
and CORT125134 
Dose-Finding Procedures 
Enrollment in the Part 1 Dose-Finding Phases of Segment I and Segment II will proceed in parallel and 
independently. 
Dose Levels 
Segment I Continuous-Dosing Regimen—Example target dose levels for evaluation in Part 1 are 
shown in Table S1.  
• 
CORT125134 dose escalation will proceed by a maximum of 50 mg per dose level, per 
DRC recommendation. The starting dose of 100 mg CORT125134 is at the low end of the 
anticipated range of doses, yet retains the potential for PD effect.  
• 
Nab-paclitaxel will start at the low end of the standard dose range (80 mg/m2) since 
CORT125134 inhibits both cytochrome P450(CYP) 3A4 and CYP2C8 (the primary routes 
of metabolism of nab-paclitaxel) in nonclinical studies. With the starting dose level set in a 
conservative manner, the plan is to escalate the investigational product, CORT125134, 
sequentially through the dose-finding phase of the study as outlined in Table S1. However, 
taking PK and safety data into account, the DRC could recommend modifying the 
nab-paclitaxel dose with an increase to 100 mg/m2 or a decrease to 60 mg/m2.  


Protocol CORT125134-550
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Table S1 
Segment I Continuous-Dosing Regimen:  Example Dose-Finding  
Table of CORT125134 / Nab-paclitaxel Dose Levels for Part 1 
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose a 
(mg/m2) 
−1 
50 
80 
1 – Starting dose 
100 
80 
2 
150 
80 
3 
200 
80 
4 
250 b 
80 
a Taking the nab-paclitaxel exposure and safety data into account, the nab-paclitaxel dose  
may be increased to 100 mg/m2 or decreased to 60 mg/m2. Nab-paclitaxel and CORT125134 will  
not be escalated simultaneously; therefore, a change in dose for nab-paclitaxel would constitute a  
separate dose level. 
b Doses may exceed 250 mg CORT125134 based on safety and PK data and DRC recommendation.  
 
Segment II Intermittent-Dosing Regimen—Example target dose levels for evaluation in Part 1 are 
shown in Table S2. 
The starting dose in Part 1 is 200 mg CORT125134 in combination with 100 mg/m2 nab-paclitaxel. 
CORT125134 dose escalation is expected to proceed by 100 mg per dose level. The DRC may 
recommend modifying the nab-paclitaxel dose to 80 mg/m2 based on the nab-paclitaxel exposure and 
safety data.  
 
Table S2 
Segment II Intermittent-Dosing Regimen: Example Dose-Finding  
Table of CORT125134 / Nab-paclitaxel Dose Levels for Part 1 
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose  
(mg/m2) 
−1 
150 
100 
1 – Starting dose 
200 
100 
2 
300 
100 
3 
400 a 
100 
a Doses may exceed 400 mg CORT125134 based on safety and PK data and DRC recommendation. 
 
Dose-finding Process 
Dose-finding decisions, including selection of dose levels for cohorts, determination of the MTD and 
development regimen, and stopping enrollment, as applicable, will be performed by the DRC. The key 
principles guiding DRC recommendations for dose levels in dose-finding are to ensure that patients 
receive nab-paclitaxel at therapeutic exposures and to sequentially increase the dose of CORT125134 
as tolerated. Dose escalation will be guided by safety and PK profiles. 
The DRC will recommend dose escalation or de-escalation after review of data from the current cohort. 
For dose escalation, either CORT125134 or nab-paclitaxel, but not both, will be changed in the next 
dose level, based on recommendations by the DRC. If a lower dose level is explored and is well 
tolerated, the DRC may recommend re-escalating either CORT125134 or nab-paclitaxel. 


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All patients in the Part 1 cohorts will be treated with the CORT125134/nab-paclitaxel combination and 
assessed for 1 cycle. Approximately 5 patients may be initially enrolled to a cohort, and non-DLT 
evaluable patients may be replaced to allow for a minimum of 3 evaluable patients for each cohort. 
Depending on the number of patients with DLTs, additional patients will be enrolled in the same cohort 
or additional cohorts will be enrolled following the criteria described in Table S3.  
 
Table S3 
Rules for Dose-Finding to Define Maximum Tolerated Dose in Part 1  
Dose-Finding Phase of Segments I and II 
No. of Evaluable Patients with 
DLT at a Dose Level (cohort 
of <6 evaluable patients) 
Dose-Finding Decision Rule for Dosing in Subsequent Cohort 
0  
• Enroll cohort at next higher dose level. 
1  
• Expand current dose level to 6 patients. a 
• If 1 of 6 patients (<33%) experiences DLT, enroll cohort at next 
higher dose level. 
• If ≥2 of 6 patients (≥33%) experience DLT: 
– Enroll cohort at next lower dose level, if available. 
OR 
– Declare next lower dose level as the MTD. 
≥2  
• If ≥2 patients experience DLT: 
– Enroll cohort at next lower dose level, if available. 
OR 
– Declare next lower dose level as the MTD. 
 a The DRC may make the recommendation to adjust the size of a cohort to more than 6 patients to further the 
evaluation of a given dose level, such as further evaluation of PK data or tolerability. If cohorts are >6 patients, 
the decision rule will be based on the percentage of patients experiencing DLT within that cohort. 
 
The MTD is defined as the highest dose at which <33% (eg, 0 of 3 or 1 of 6 patients, with a minimum 
of 6 patients if 1 DLT is observed) experiences a DLT during Cycle 1. Alternatively, a different (lower) 
dose level may be declared the MTD depending on the nature, severity, and frequency of toxicities to 
date. Safety data that become available for patients remaining on-study after Cycle 1 will be taken into 
consideration when making decisions about dose escalation.  
The dose level selected for the development regimen may be equal to or lower than the MTD and its 
selection will take into account other issues such as safety data occurring after the first cycle.  
A sufficient number of DLT-evaluable patients will be enrolled in each cohort to ensure that there are 
DLT-evaluable patients available for determination of the MTD and identification of the development 
regimen. The number of DLT-evaluable patients may be inclusive of all cohorts at that dose level and 
schedule (such as advanced solid tumor and pancreatic cancer cohorts in Segment I) for determination 
of the MTD or dose-finding decisions, per DRC recommendation. If two distinct DLTs, such as events 
occurring in different MedDRA system organ classes, are observed within a dose level, the DRC may 
recommend expanding the cohort to >6 patients to further evaluate the tolerability of that dose level. 
• 
DLT-evaluable patients will include those who complete one cycle of treatment or those 
who withdraw from the study due to toxicity during Cycle 1.  
Non-evaluable patients will include patients who withdraw from the study prior to completion of 
Cycle 1 for reasons other than toxicity (eg, lost to follow-up, withdrawal of consent, or disease 


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progression, or received ≤80% of CORT125134 dosing due to reasons other than toxicity). These 
patients may be replaced.  
PK for patients with a history of GI resection or gastric bypass surgery will be considered separately 
from the remainder of the cohort. The safety data for these patients will be taken into consideration in 
the assessment of the overall tolerability of a given cohort. A minimum number of patients evaluable 
for DLT will be enrolled to a cohort to consider the tolerability at this dose level who don’t have a 
history of GI resection/gastric bypass surgery. 
For non-hematological events, a DLT is defined as any TEAE not attributable to disease or disease-
related processes that occurs during the observation period (Cycle 1) and that: 
• 
Is Grade 3 or higher according to National Cancer Institute Common Terminology Criteria 
for Adverse Events (NCI-CTCAE) v4.03, excluding the exceptions listed below.  
or  
• 
Results in a dose omission or > 1-week delay of nab-paclitaxel. 
Note: if a >1-week delay of nab-paclitaxel occurs for logistical reasons, it will not be 
considered a DLT. 
Exceptions include the following non-hematological AEs that are not considered DLTs: 
• 
Grade 3 fatigue lasting <7 days 
• 
Rigors lasting <24 hours 
• 
Grade ≥3 nausea or vomiting that has resolved to Grade ≤2 within 48 hours after standard 
antiemetic therapies 
• 
Grade 3 diarrhea that has resolved to Grade ≤2 within 48 hours after standard antidiarrheal 
therapies 
and/or 
• 
Isolated laboratory findings not associated with signs or symptoms, including Grade 3/4 
alkaline phosphatase, uric acid, amylase, and lipase elevations, and Grade 3 hyponatremia 
lasting <72 hours. 
The following non-hematological AEs are considered DLTs: 
• 
Any elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 
≥10 × upper limit of normal (ULN) lasting more than 3 days with discontinuation of 
therapy  
• 
Any elevation of AST or ALT >20 × ULN  
• 
Any elevation of AST and ALT >3 × ULN associated with serum bilirubin >2 × ULN 
without evidence of another cause for the hyperbilirubinemia is a DLT requiring 
immediate discontinuation of all study therapy. 
 
For hematologic events: a DLT is defined as follows: 
• 
Grade 4 neutropenia lasting >7 days. 
• 
Grade ≥3 febrile neutropenia (ANC <1000 cells/mm3 with a single temperature of >38.3°C 
or a sustained temperature of ≥38°C for more than 1 hour). 
• 
Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia lasting >7 days or associated 
with Grade ≥2 bleeding.  
• 
Dose delay >7 days of scheduled chemotherapy secondary to myelosuppression. 


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Data Review Committee 
A DRC consisting of at least one Investigator from each site experienced in evaluating oncology 
treatments, a clinical pharmacologist, and the Medical Monitor will perform safety monitoring of the 
study drugs in accordance with procedures detailed in a DRC Charter.  
The DRC will convene prior to each planned dose escalation during the dose-finding phase (Part 1), at 
least every 6 months during the dose-expansion phase of the study (Part 2), and on an ad hoc basis as 
necessary throughout study conduct. The DRC will perform the following tasks:  
• 
Evaluate suspected DLTs, using criteria defined above for adjudication of treatment-
related AEs.  
• 
Determine the appropriateness of dose escalation or dose de-escalation and cohort 
expansion based on all available data, leading to a specific recommendation for the next 
dose to be evaluated during the dose-finding phase. 
• 
Make recommendations to hold dosing or enrollment, or to adjust the size of any cohort as 
needed to further evaluate safety, tolerability, PK, or preliminary efficacy at a given dose 
level or in a more restricted patient population. 
• 
Make recommendations to adjust the size of any cohort as needed to obtain more PK data 
(eg, at the development regimen). 
• 
Make recommendations to end dosing or enrollment.  
• 
Make recommendations to enroll specific cohort(s) in dose-finding to investigate the use of 
G-CSF at a dose level associated with high rates of neutropenia. Once a cohort is defined 
as a G-CSF cohort, the rules for G-CSF usage may be carried forward to additional cohorts 
at the recommendation of the DRC.  
• 
Monitor emerging PD, PK, and clinical activity data throughout the course of dose-finding 
(Part 1) to form basis of recommendation for subsequent dose according to Table S2, and 
make recommendations regarding the dose and schedule of CORT125134 and nab-
paclitaxel (ie, the development regimen) to be evaluated in the dose-expansion phase of the 
study (Part 2).  
• 
If supported by data, the DRC may recommend changes to schedule of dosing with nab-
paclitaxel (ie, every other week schedule or two out of three week schedule) in a 
subsequent cohort. 
• 
The DRC may recommend dose titration of either CORT125134 or nab-paclitaxel to 
optimize exposure and tolerability. If dose titration is instituted, feasibility of that dose 
level will be assessed over the number of cycles during which titration occurs. 
In the event that a decision is made by the Sponsor to reject a safety recommendation by the DRC, the 
decision and rationale will be communicated to the Food and Drug Administration (FDA) and site 
Institutional Review Boards (IRBs) before enrolling additional patients. 
Number of Patients  
• 
Segment I Continuous-Dosing Regimen—Part 1, approximately 62 patients;  
Part 2, approximately 20 patients in each expansion cohort  
• 
Segment II Intermittent-Dosing Regimen—Part 1, approximately 24 patients; Part 2, 
approximately 20 patients in each expansion cohort  


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Inclusion and Exclusion Criteria 
The following study entry criteria apply to both Segment I and Segment II. 
Inclusion Criteria 
For all patients 
1. Signed and dated IRB-approved informed consent form (ICF) prior to study-specific screening 
procedures. Note: standard-of-care assessments completed before the ICF is signed can be used 
for eligibility if done within the 28-day screening period. 
2. Consent to provide archived tumor tissue (primary or metastatic) or pretreatment tumor biopsy if 
available for the purpose of staining for GR status. Note: Neither tissue sample nor 
immunohistochemistry (IHC) results are required prior to starting study treatment due to 
potential delays in obtaining tumor block or results from GR assay. Tumor biopsy sample 
proximal to study entry in addition to archived tumor tissue is preferred. 
3. Age ≥18 years old. 
4. Patients with advanced or metastatic solid tumors who have disease progression after treatment 
with available therapies that are known to confer clinical benefit, or who are intolerant to 
treatment and for whom nab-paclitaxel treatment is appropriate. 
5. Up to 3 prior cytotoxic chemotherapeutic regimens or myelosuppressive therapies in the 
advanced setting. (Hormonal or non-myelosuppressive biologic, targeted, or immune therapies 
will not be counted toward the maximum lines of prior therapy.) 
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 
7. Organ and marrow function meeting the following criteria at the Screening Visit: 
• 
Absolute neutrophil count (ANC) ≥1,500 cells/mm3 
• 
Platelet count ≥100,000/mm3 
• 
Hemoglobin ≥9 g/dL 
• 
AST or ALT ≤2.5 × ULN (or ≤5 × ULN in the context of liver metastasis) 
• 
Total bilirubin ≤1.5 × ULN 
• 
Serum creatinine ≤1.5 × ULN  
or 
• 
Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above 
institutional normal. 
8. For female patients of childbearing potential, a negative pregnancy test. Female study patients of 
childbearing potential and male study patients with female partners of childbearing potential 
must be willing to use two effective methods of contraception (one of which is a barrier method) 
during the treatment period and for at least 3 months after the last dose of the study drug. 
Hormonal contraceptives are not permitted (hormonal intrauterine device [IUD] is acceptable).  
9. Ability to take oral medications. 
10. Albumin ≥3.0 g/dL (≥30 g/L) 
11. If patient has undergone gastric bypass surgery and/or surgery of GI or hepatobiliary tract, the 
patient must demonstrate adequate absorption as evidenced by: albumin ≥3.0 g/dL, controlled 
pancreatic insufficiency (if present), lack of evidence of malabsorption.  
 
For patients in Dose-Finding Part 1 
12. Measurable or evaluable disease. 
 


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For patients enrolled in a specific dose-finding cohort in Part 1 limited to diagnosis of pancreatic 
cancer. 
13. Histologically confirmed diagnosis of pancreatic adenocarcinoma. Patients with pancreatic 
neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.  
14. CA19-9 (or CEA, CA-125 in non-CA 19-9 elevated tumors) measured within 14 days prior to 
first dose of study drug 
15. Metastatic (non-irradiated) lesion that is measurable by RECIST 1.1 
 
For patients in Dose-Expansion Part 2 
For all patients in Part 2 
16. Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer or TNBC that, in the 
opinion of the Investigator, is appropriate to treat with nab-paclitaxel.  
 
For patients in Part 2 with ovarian, fallopian tube, or primary peritoneal cancer only 
17. Must have a histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube 
cancer or ovarian carcinosarcoma. Note: Mucinous and borderline histologic subtypes are 
excluded.  
18. Treatment-free interval after platinum-based therapy of less than 12 months, or disease 
progression during platinum-based therapy.  
19. Measurable or nonmeasurable disease. Previously irradiated lesions are not allowed as 
measurable disease, unless there is documented evidence of progression in the lesions. To be 
eligible with nonmeasurable disease, patients must have evaluable disease with cancer antigen 
125 (CA-125) levels of ≥100 U/mL along with radiographically evaluable disease by computed 
tomography (CT) or magnetic resonance imaging (MRI). A minimum of 10 patients with 
measurable disease will be enrolled. 
 
For patients in Part 2 with TNBC only 
20. Histologically confirmed diagnosis of TNBC: Triple-negative for ER and PR (<1% cells positive 
for ER/PR) and HER2 per the American Society of Clinical Oncology/College of American 
Pathologists (ASCO/CAP) Guidelines (Wolff et al. 2013) (HER2 test results show [a] IHC 1+ 
negative or IHC 0 negative or [b] in situ hybridization [ISH]-negative using single-probe ISH or 
dual-probe ISH). 
21. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 
in at least one lesion. Previously irradiated lesions are not allowed as measurable disease, unless 
there is documented evidence of progression in the lesions. 
 
Exclusion Criteria 
1. Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in the 
opinion of the Investigator has not resolved to Grade 1 or less prior to the first dose of study drug 
(ie, Day 1 of the first scheduled 1-week lead-in). 
2. Clinically significant uncontrolled condition(s) or any medical condition which in the opinion of 
the study investigator places the subject at an unacceptably high risk for toxicities, or puts the 
patient at high risk for not completing the DLT evaluation period of the study. 
3. Any major surgery within 4 weeks prior to the first dose of study drug (ie, Day 1 of the first 
scheduled 1-week lead-in). 




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Criteria for Evaluation  
Safety  
Safety will be assessed by AEs including DLTs, clinical laboratory tests, vital signs, ECOG 
performance status, physical examinations, and electrocardiograms (ECGs). Laboratory testing will 
include hematology, serum biochemistry, urinalysis, coagulation (international normalized ratio [INR]) 
for patients taking warfarin, pregnancy testing as applicable, hormone levels, and thyroid function 
testing. In the event of a serious adverse event (SAE) or DLT, ACTH and cortisol should be assessed 
as close to the time of the event as possible, and a PK sample may be drawn at the discretion of the 
Investigator. Additional safety assessments may be made at any time if clinically indicated. 
Anticancer Activity  
Tumor assessments: In both segments, assessments of the chest, abdomen, and pelvis (CAP) using 
computed tomography (CT) scans or magnetic resonance imaging (MRI) will be performed at 
Screening, at the end of Cycle 2 (Cycle 3 Day 1 ±7 days), and thereafter every 6 to 8 weeks (no more 
than 8 weeks between scans) and at time of clinical suspicion of disease progression. The same method 
(radiological or physical) should be employed and assessed by the same individual on each occasion, if 
possible. Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine 
response (Eisenhauer et al. 2009). Confirmation of objective responses is defined as responses that 
persist on repeat imaging for two assessments with a time period of at least 4 weeks between two 
assessments (if possible, 4–6 weeks). In the event of a confirmed response, the timing of subsequent 
tumor assessment will be reset at the 6–8 week interval from confirmatory scan. At the 
Posttreatment/Early Termination Visit, tumor assessment will be done if ≥4 weeks have elapsed since 
the last tumor assessment, unless there is documented progressive disease. If progressive disease is 
documented, an additional tumor assessment is not required as part of the final visit. 
In patients with ovarian, fallopian tube, or primary peritoneal cancer, CA-125 will be assessed at the 
time of radiologic tumor assessments (baseline and every 6–8 weeks) and response reported per GCIG 
criteria (Rustin et al. 2011) in addition to RECIST v1.1.  
Patients will be followed for survival quarterly for 1 year following the last dose of study drug in the 
final patient enrolled. 
Pharmacokinetics  
Blood samples will be collected for determination of plasma concentrations of CORT125134 and its 
metabolites and nab-paclitaxel. In Segment I, serial PK data for Part 1 and for Part 2 will be obtained as 
shown in Figure S2. In Segment II, serial PK data will be obtained during Cycle 1 as shown in 
Figure S3. Should a patient require a dose reduction on study, a PK profile at the new dose level may 
be obtained with patient consent. 
Standard PK parameters will be included in the characterization and evaluation of the dose-exposure 
relationship and related analyses. An assessment of the correlation of anticancer activity, AEs, and 
plasma drug concentrations will be undertaken. An optional PG sample will be collected to assess 
genetic factors affecting drug metabolism, transporters, and other PK parameters. 
Pharmacodynamics and Biomarkers  
Consent for tumor biopsy specimens is mandatory in Parts 1 and 2, and the tissue will be used for 
analysis of GR expression by IHC, in addition to other exploratory correlative biomarkers. Tumor 
tissue most proximal to study entry is preferred; historical tumor tissue is acceptable as an alternative 
and may be submitted in addition to tissue most proximal to study entry to assess for changes in GR 
expression over time and line of therapy. Tumor biopsy specimens may be collected at disease 
progression or during procedures required for patient management and are optional; these will be 
assessed for GR expression along with other exploratory biomarkers. 


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Pharmacodynamics will be assessed by measuring blood levels of insulin, C-peptide, 
adrenocorticotropic hormone (ACTH), morning cortisol, tumor characterization, and mRNA 
expression tests, including FKBP5 and glucocorticoid-induced genes or biomarkers of GR activity. 
Cytokines and T-cell profiles will be assessed to explore the effect of CORT125134 when given alone 
and in combination with nab-paclitaxel. Additional exploratory correlative biomarkers may be 
evaluated to correlate with disease status, target engagement, or response. 
General Statistical Methods 
Statistical Analyses 
The primary analyses will include determination of the MTD/development regimen and the incidence 
and duration of toxicities according to the NCI-CTCAE, version 4.03.  
Secondary analyses will characterize anticancer activity for the following endpoints: 
• 
Objective response rate consisting of the percentage of patients with measurable disease 
who achieve an objective tumor response.  
• 
Response rate for ovarian, fallopian tube, and primary peritoneal cancer will include 
measures by GCIC and by RECIST v1.1. 
• 
Best response defined as the best response recorded from the date of the first dose of 
CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period. 
• 
Clinical benefit rate (CBR) defined as the percentage of patients who have achieved CR or 
PR, or SD for 6 months or greater. 
• 
Progression-free survival defined as the time from the date the patient receives the first 
dose of CORT125134 or nab-paclitaxel, whichever is earliest, to the date the patient 
experiences unequivocal disease progression per RECIST v1.1 or death (all causes of 
mortality). 
• 
Duration of response as measured from the date that the criteria are met for complete 
response (CR) or partial response (PR) until the first date that progressive disease is 
objectively documented. 
• 
Overall survival defined as the time from date of the first dose of CORT125134 or 
nab-paclitaxel, whichever is earliest, until the date of death from any cause. 
Pharmacokinetic parameters of nab-paclitaxel and CORT125134 and its metabolites will be calculated 
and analyte concentration-versus-time plots will be provided. PD parameters and biomarker results will 
be listed and summarized as appropriate. 
All analyses of safety and anticancer activity for this open-label Phase 1/2 study will be descriptive and 
presented by dose group, tumor type, GR status, and overall, as appropriate. Patient listings will also be 
provided. The incidence and duration of TEAEs, defined as AEs occurring after the first dose of study 
treatment through 28 days after the last dose of either CORT125134 or nab-paclitaxel, will be tabulated 
by Medical Dictionary for Regulatory Activities (MedDRA) preferred term and system organ class, 
and by severity and relationship to study drug. 
Sample Size 
An adequate number of DLT-evaluable patients will be enrolled in Part 1 of both segments to 
determine the MTD and development regimen.  
Approximately 20 patients will be enrolled in each expansion cohort in Part 2 of the study, with two 
expansion cohorts planned in Segment I and one planned in Segment II to provide a preliminary 
estimate of activity.  


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CONTENTS 
CLINICAL STUDY PROTOCOL CORT125134-550 .................................................................. 1 
SPONSOR SIGNATURE PAGE ................................................................................................... 2 
INVESTIGATOR SIGNATURE PAGE ........................................................................................ 3 
SYNOPSIS ...................................................................................................................................... 4 
CONTENTS .................................................................................................................................. 18 
List of Tables ................................................................................................................................ 23 
List of Figures ............................................................................................................................... 24 
List of Abbreviations and Definitions........................................................................................... 25 
1 
INTRODUCTION AND BACKGROUND ..................................................................... 28 
1.1 
CORT125134 .................................................................................................................... 28 
1.1.1 Nonclinical Data ................................................................................................... 28 
1.1.1.1 Pharmacology ........................................................................................ 28 
1.1.1.2 Safety ..................................................................................................... 28 
1.1.1.3 Other In Vitro Studies ............................................................................ 31 
1.1.2 Clinical Data on CORT125134 Monotherapy ...................................................... 31 
1.1.2.1 Safety ..................................................................................................... 31 
1.1.2.2 Pharmacokinetics ................................................................................... 32 
1.1.2.3 Pharmacodynamics ................................................................................ 33 
1.1.2.4 Pharmacodynamic Interactions - QTc Effects ....................................... 34 
1.2 
Nab-paclitaxel ................................................................................................................... 34 
1.3 
Rationale for Combination of CORT125134 and Nab-paclitaxel in Chemotherapy-
Resistant Tumor Types ..................................................................................................... 36 
1.3.1 Rationale for Use of CORT125134 in Chemotherapy-Resistant Tumor Types ... 36 
1.3.1.1 Nonclinical Data .................................................................................... 36 
1.3.1.2 Clinical Data for Combination of a Glucocorticoid Receptor Antagonist 
and Nab-paclitaxel ................................................................................. 38 
1.3.2 Rationale for Use of Nab-paclitaxel in Conjunction with CORT125134 ............. 38 
1.3.2.1 ADME Characteristics of Nab-paclitaxel .............................................. 39 
1.3.2.2 Drug-Drug Interactions with Paclitaxel and Nab-paclitaxel .................. 39 
1.4 
Rationale for Selection of Specific Tumor Types ............................................................. 40 
1.4.1 Ovarian Cancer ..................................................................................................... 41 


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1.4.2 Triple-Negative Breast Cancer ............................................................................. 42 
1.4.3 Pancreatic Cancer .................................................................................................. 42 
1.5 
Rationale for the Dosing Regimens .................................................................................. 44 
1.6 
Rationale for Starting Doses ............................................................................................. 44 
2 
STUDY OBJECTIVES ..................................................................................................... 48 
3 
STUDY DESIGN.............................................................................................................. 49 
3.1 
Overview of Study Design ................................................................................................ 49 
3.1.1 Overview of Design:  Segment I Continuous-Dosing Regimen ........................... 50 
3.1.2 Overview of Design:  Segment II Intermittent-Dosing Regimen ......................... 51 
3.2 
Overview of Methodology ................................................................................................ 52 
3.2.1 Segment I, Continuous-Dosing Regimen ............................................................. 52 
3.2.2 Segment II, Intermittent-Dosing Regimen ............................................................ 53 
3.2.3 Segments I and II:  Assessments ........................................................................... 54 
3.3 
Dose-Finding Phase (Part 1) ............................................................................................. 54 
3.3.1 Dose Levels ........................................................................................................... 54 
3.3.1.1 Dose Levels in Segment I ...................................................................... 54 
3.3.1.2 Dose Levels in Segment II ..................................................................... 55 
3.3.2 Dose-Finding Process ........................................................................................... 56 
3.3.3 Dose-limiting Toxicity .......................................................................................... 58 
3.4 
Dose-Expansion Phase (Part 2) ......................................................................................... 59 
3.5 
Data Review Committee (DRC) ....................................................................................... 60 
4 
STUDY POPULATION AND ENTRY CRITERIA ........................................................ 61 
4.1 
Number of Patients ........................................................................................................... 61 
4.2 
Inclusion Criteria .............................................................................................................. 61 
4.3 
Exclusion Criteria ............................................................................................................. 63 
4.4 
Concomitant Medications/Treatments .............................................................................. 64 
4.4.1 Supportive Care with Granulocyte–Colony-Stimulating Factor........................... 64 
4.4.2 Permissible Medications/Treatments .................................................................... 64 
4.4.3 Prohibited and Restricted Medications/Treatments .............................................. 65 
4.4.4 Medications Having Potential Drug-Drug Interactions ........................................ 65 
4.4.5 Management of Signs of Excessive GR Antagonism ........................................... 66 


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5 
STUDY DRUG ................................................................................................................. 67 
5.1 
Study Drug and Formulations ........................................................................................... 67 
5.2 
Treatment Regimen and Dosing ....................................................................................... 67 
5.2.1 Segment I, Continuous-Dosing Regimen ............................................................. 68 
5.2.2 Segment II, Intermittent-Dosing Regimen ............................................................ 68 
5.3 
Duration of Patient Participation ...................................................................................... 68 
5.4 
Intrapatient Dose Modifications and Delays ..................................................................... 68 
5.4.1 Dose Modifications/Dose Delays for Nab-paclitaxel ........................................... 69 
5.4.2 Dose Modifications/Dose Delays for CORT125134 ............................................ 70 
5.4.3 Intra-patient Dose Escalation ................................................................................ 70 
5.5 
Storage of Study Drug ...................................................................................................... 70 
5.6 
Treatment Assignment ...................................................................................................... 71 
6 
STUDY VISIT SCHEDULE AND PROCEDURES ....................................................... 72 
6.1 
Patient Entry Procedures for Both Segments .................................................................... 72 
6.2 
Segment I: Visits and Associated Procedures ................................................................... 72 
6.2.1 Segment I:  Screening Visit (Days −28 to −1) ...................................................... 72 
6.2.2 Segment I:  Baseline Visit, if Needed (Days −7 to −1) ........................................ 73 
6.2.3 Segment I, Part 1 Patients Only: 1-Week Nab-paclitaxel Lead-in (before 
CORT125134 Lead-in) ......................................................................................... 74 
6.2.4 Segment I:  1-Week CORT125134 Lead-in (before Cycle 1) .............................. 74 
6.2.5 Segment I:  Cycle 1 ............................................................................................... 75 
6.2.6 Segment I:  Cycles 2+ ........................................................................................... 78 
6.3 
Segment II:  Visits and Associated Procedures ................................................................ 79 
6.3.1 Segment II:  Screening Visit (Days −28 to −2) .................................................... 79 
6.3.2 Segment II:  Baseline/CORT125134 Lead-in Visit (Day −1) .............................. 80 
6.3.3 Segment II:  Cycle 1 ............................................................................................. 81 
6.3.4 Cycles 2+ .............................................................................................................. 82 
6.4 
Segments I and II:  Posttreatment Visit/Early Termination Visit (In-clinic Visit) (28 Days 
After Last Dose of Study Drug) ........................................................................................ 83 
6.5 
Telephone Follow-up for Survival .................................................................................... 84 
6.6 
Unscheduled Visits ........................................................................................................... 84 


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6.7 
Study Drug Compliance Procedures ................................................................................. 84 
6.8 
Patient Discontinuation and Withdrawal .......................................................................... 84 
6.8.1 Discontinuation of Study Treatment ..................................................................... 85 
6.8.2 Withdrawal from Study......................................................................................... 85 
6.9 
Early Termination of the Study......................................................................................... 86 
6.10 
Replacement of Patients .................................................................................................... 86 
6.11 
Dose Diary ........................................................................................................................ 86 
7 
RESPONSE MEASURES AND SUMMARY OF DATA COLLECTION METHODS 87 
7.1 
Safety Measures ................................................................................................................ 87 
7.1.1 Adverse Events ..................................................................................................... 87 
7.1.2 Clinical Laboratory Assessments .......................................................................... 87 
7.1.3 Vital Signs ............................................................................................................. 89 
7.1.4 ECOG Performance Status ................................................................................... 89 
7.1.5 Physical Examinations .......................................................................................... 89 
7.1.6 Electrocardiogram ................................................................................................. 90 
7.2 
Measures of Anticancer Activity ...................................................................................... 90 
7.3 
Pharmacokinetic Measures ............................................................................................... 91 
7.4 
Pharmacodynamic and Biomarker Measures.................................................................... 91 
7.5 
Pharmacogenomic Testing ................................................................................................ 92 
7.6 
Tumor Tissue Collection................................................................................................... 92 
7.7 
Summary of Methods of Data Collection ......................................................................... 92 
8 
STATISTICAL PROCEDURES ...................................................................................... 94 
8.1 
Analysis Populations ......................................................................................................... 94 
8.2 
General Statistical Considerations .................................................................................... 94 
8.2.1 Summary of Demographics and Study Conduct ................................................... 94 
8.2.2 Safety Analyses ..................................................................................................... 94 
8.2.3 Analyses of Anticancer Activity ........................................................................... 95 
8.2.4 Pharmacokinetic Analyses .................................................................................... 96 
8.2.5 Pharmacodynamic Analyses ................................................................................. 97 
8.3 
Sample Size Calculation ................................................................................................... 97 


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9 
SAFETY EVENT DOCUMENTATION AND REPORTING ........................................ 98 
9.1 
Investigator’s Responsibilities .......................................................................................... 98 
9.2 
Monitoring Safety Data during Study ............................................................................... 98 
9.3 
Definition of an Adverse Event ........................................................................................ 98 
9.4 
Definition of a Serious Adverse Event ............................................................................. 98 
9.5 
Clinical Laboratory Adverse Events ................................................................................. 99 
9.6 
Documentation of Adverse Events ................................................................................... 99 
9.7 
Adverse Event Classification ............................................................................................ 99 
9.7.1 Severity (Intensity) Grades of Adverse Events ..................................................... 99 
9.7.2 Relationship of Adverse Event to Study Drug or Study Procedure .................... 100 
9.8 
Procedures for Reporting Adverse Events ...................................................................... 101 
9.9 
Procedures for Reporting a Serious Adverse Event ........................................................ 101 
9.10 
Adverse Event Follow-up ............................................................................................... 101 
9.11 
Pregnancy ........................................................................................................................ 102 
9.12 
Emergency Sponsor Contact ........................................................................................... 102 
10 
ADMINISTRATIVE ITEMS ......................................................................................... 103 
10.1 
Protection of Human Patients ......................................................................................... 103 
10.1.1 Compliance with Informed Consent Regulations (21 CFR Part 50) and Relevant 
Country Regulations ........................................................................................... 103 
10.1.2 Compliance with IRB Regulations ..................................................................... 103 
10.2 
Patient Confidentiality .................................................................................................... 103 
10.2.1 Patient Privacy .................................................................................................... 104 
10.3 
Changes to the Protocol .................................................................................................. 104 
10.4 
Documentation ................................................................................................................ 104 
10.4.1 Source Documents .............................................................................................. 104 
10.4.2 Case Report Form Completion ........................................................................... 104 
10.4.3 Retention of Documentation ............................................................................... 105 
10.5 
Inventory, Reconciliation, Return, and Disposition of Clinical Supplies ....................... 105 
10.5.1 Clinical Supply Inventory ................................................................................... 105 
10.5.2 Return or Disposal of Study Drug and/or Supplies ............................................ 105 
10.6 
Monitoring, Audit, and Inspection .................................................................................. 106 


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10.7 
Handling of Biological Specimens ................................................................................. 106 
10.8 
Publications ..................................................................................................................... 106 
11 
REFERENCES ............................................................................................................... 107 
12 
ATTACHMENTS ........................................................................................................... 110 
12.1 
Segment I:  Schedules of Visits and Procedures ............................................................. 111 
12.2 
Segment II: Schedules of Visits and Procedures ............................................................ 116 
12.3 
Investigator’s Brochure and Package Insert ................................................................... 121 
12.4 
Summary of Changes in Protocol CORT125134-550 Amendment 6 ............................ 122 
 
List of Tables 
Table 1 
Predicted Systemic Exposure (AUCinf) to CORT125134 Following Multiple-Dose 
Oral Administration to Patients in Study CORT125134-550 from the Current 
Formulation ............................................................................................................46 
Table 2 
Segment I Continuous Dosing: Example Dose-Finding Table  of CORT125134 / 
Nab-paclitaxel Dose Levels for Part 1 ...................................................................55 
Table 3 
Segment II Intermittent-Dosing Regimen: Example Dose-Finding Table  of 
CORT125134 / Nab-paclitaxel Dose Levels for Part 1 .........................................55 
Table 4 
Rules for Dose-Finding to Define Maximum Tolerated Dose in Part 1 of 
Segments I and II ...................................................................................................57 
Table 5 
Clinical Laboratory Tests .......................................................................................88 
Table 6 
ECOG Performance Status ....................................................................................89 
Table 7 
Adverse Event Grades Based on the Common Terminology Criteria for Adverse 
Events ...................................................................................................................100 
Table 8 
Causal Attribution Guidance for Adverse Events ................................................100 
Table 9 
Segment I:  Study Visits and Procedures .............................................................111 
Table 10 
Segment I:  Study Pharmacokinetic Sampling Times ..........................................114 
Table 11 
Segment II:  Study Visits and Procedures............................................................116 
Table 12 
Segment II:  Study Dosing Schedule ...................................................................119 
Table 13 
Segment II:  Study Pharmacokinetic Sampling Times ........................................120 
Table 14 
Summary of Changes in Protocol CORT125134-550 Amendment 6 .................122 
 


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List of Figures 
Figure 1 
Effect of CORT125134 in combination with paclitaxel in a pancreatic cancer 
xenograft model (MIAPaCa-2 model) ...................................................................43 
Figure 2 
Comparison of Day 13 AM Serum Cortisol Values (nmol/L) by Dose Level for 
50, 150, and 250 mg/day and Combined Placebos – Part 2 of Phase 1 Study 
CORT125134-120..................................................................................................45 
Figure 3 
Overview of Study Design Showing Segment I and Segment II Regimens ..........49 
Figure 4 
Segment I Continuous-Dosing Regimen:  Schematic of Study Drug Dosing and 
Pharmacokinetic Sampling Schedule .....................................................................53 
Figure 5 
Segment II Intermittent-Dosing Regimen:  Schematic of Study Drug Dosing and 
Pharmacokinetic Sampling Schedule .....................................................................54 
 


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List of Abbreviations and Definitions 
Term/Abbreviation 
Definition 
ACTH 
adrenocorticotropic hormone 
ADME 
absorption, distribution, metabolism, and excretion 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
AR 
androgen receptor 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
AUC 
area under the plasma concentration-time curve  
AUC0–24 
AUC values from time 0 to 24 hours postdose 
AUClast 
area under the plasma concentration-time curve from time 0 to time of last 
measurable concentration 
AUCinf 
area under the plasma concentration-time curve from time 0 to infinity 
BCRP 
breast cancer resistance protein 
BRCA1 
breast cancer 1 (gene) 
BUN 
blood urea nitrogen 
CA 15-3 
cancer antigen 15-3 
CA 19-9 
cancer antigen 19-9 
CA-125 
cancer antigen 125 
CAP 
chest, abdomen, and pelvis 
CAP 
College of American Pathologists 
CEA 
carcinoembryonic antigen 
CFR 
Code of Federal Regulations 
CL 
systemic plasma clearance  
CLIA 
Clinical Laboratory Improvement Amendments 
Cmax 
maximum plasma concentration 
Cmin 
predose plasma concentration 
CRA 
clinical research associate 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
cytochrome P450 
DHEA-S 
dehydroepiandrosterone sulfate 
DLT 
dose-limiting toxicity 
DRC 
Data Review Committee 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
ER 
estrogen receptor 
FDA 
Food and Drug Administration 
FKBP5 
mRNA expression test for FK506 binding protein 5 


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Term/Abbreviation 
Definition 
FSH 
follicle-stimulating hormone 
GCIG 
Gynecological Cancer Intergroup 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony-stimulating factor 
GLP 
Good Laboratory Practice 
GR 
glucocorticoid receptor 
HER2 
human epithelial receptor-2 
HIPAA 
Health Insurance Portability and Accountability Act 
HPA 
hypothalamic-pituitary-adrenal  
HR 
hazard ratio 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IHC 
immunohistochemistry 
IL-2, 4, 10, 12, 13 
interleukins 2, 4, 10, 12, 13 
INR 
international normalized ratio 
IRB 
Institutional Review Board 
IUD 
intrauterine device 
IV 
intravenous(ly) 
Ki 
binding affinity constant 
LC/MS/MS 
liquid chromatography-tandem mass spectrometry method 
LDH 
lactic dehydrogenase 
LH 
luteinizing hormone 
MCV 
mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
myocardial infarction 
MKP1/DUSP1 
mitogen-activated protein kinase phosphatase/dual-specificity phosphatase 1 
MRI 
magnetic resonance imaging 
MTD 
maximum tolerated dose 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events (v4.03) 
NOAEL 
no-observed-adverse-effects level 
NYHA 
New York Heart Association 
ORR 
objective response rate  
OS 
overall survival 
PD 
pharmacodynamic(s) 
PFS 
progression-free survival 
P-gp 
permeability glycoprotein  
PK 
pharmacokinetic(s) 
PG 
pharmacogenomic 
PoPE 
proof of pharmaceutical effect 
PR 
progesterone receptor 
PSA 
prostate-specific antigen 


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Term/Abbreviation 
Definition 
QTc 
corrected QT (interval) 
RBC 
red blood cell 
REB 
Research Ethics Board 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse event 
SGK1 
serum glucocorticoid regulated kinase 1 
shRNA 
short hairpin RNA 
t1/2 
apparent terminal elimination half-life 
TA 
tumor assessment 
TAT 
tyrosine amino transferase  
TEAE 
treatment-emergent adverse event 
Th1, Th2, Th17 
type 1, 2, and 17 T helper (cells) 
Tmax 
time to reach maximum plasma concentration  
TNBC 
triple-negative breast cancer 
Treg 
regulatory T (cells) 
TSH 
thyroid-stimulating hormone 
ULN 
upper limit of normal 
Vss 
volume of distribution at steady state 
WBC 
white blood cell 
WNL 
within normal limits 
 


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1 
INTRODUCTION AND BACKGROUND  
CORT125134 is a small molecule being developed by Corcept Therapeutics (Corcept) for 
indications that may benefit from the modulation and/or antagonism of the glucocorticoid 
receptor (GR). GR mediates many biological processes, including inflammation, 
gluconeogenesis, immunity, cardiovascular system processes, bone metabolism, brain function, 
and homeostasis/development, predominantly through transcriptional mechanisms. Binding of 
the hormone cortisol to GR is responsible for regulating many of these processes. In preclinical 
models, GR was shown to be involved in chemotherapy resistance developed in tumor cells, with 
stimulation of GR shown to reduce chemotherapy sensitivity and blockade of GR shown to 
enhance chemotherapy sensitivity (Skor et al. 2013, Isikbay et al. 2014).  
As a selective and potent GR antagonist, CORT125134 has the potential to provide a clinical 
benefit in oncologic indications in combination with appropriate chemotherapeutic agents by 
reversing the GR-mediated chemotherapy resistance mechanism and potentially restoring tumor 
sensitivity to the chemotherapeutic agent. This study was designed to evaluate the combination 
of CORT125134 and the commercially available chemotherapeutic agent nab-paclitaxel 
(Abraxane) in patients with solid tumors for whom nab-paclitaxel is an appropriate therapy. The 
goals of the study are to identify the maximum tolerated dose (MTD) and development regimens 
of this combination in patients with solid tumors appropriate for treatment with nab-paclitaxel 
and to evaluate the preliminary activity of the combination using the development regimens in 
expansion cohorts of patients with specific solid tumors (eg, platinum-resistant ovarian, fallopian 
tube, and primary peritoneal cancer or triple-negative breast cancer [TNBC]). Two 
CORT125134 dosing schedules will be evaluated (continuous dosing in Segment I and 
intermittent dosing in Segment II). Additional goals include characterizing the safety, 
pharmacokinetic (PK), and pharmacodynamic (PD) profile of the development regimens selected 
for further evaluation in this and other studies.  
1.1 
CORT125134 
1.1.1 Nonclinical Data 
Details of all nonclinical studies are provided in the Investigator’s Brochure (IB). 
1.1.1.1 
Pharmacology 
CORT125134 is a selective GR antagonist with a high binding affinity (Ki) of 0.15 nM in the 
human GR binding assay. CORT125134 has high selectivity for the GR relative to the 
progesterone receptor (PR), estrogen receptor (ER), and androgen receptor (AR), showing 100%, 
7%, −1%, and 6% inhibition, respectively, in radioligand binding assays at a 1 µM concentration. 
Functional GR antagonism was demonstrated in vitro by the ability of CORT125134 to block the 
effects of dexamethasone (a potent GR agonist) on tyrosine amino transferase (TAT) activity in a 
human liver carcinoma cell line (Ki of 7.2 nM) and a rat hepatoma cell line (Ki of 1.2 nM).  
1.1.1.2 
Safety 
To characterize the nonclinical safety of CORT125134, preliminary ascending single-dose, 
repeat-dose, and Good Laboratory Practice (GLP) 14-day repeat-dose toxicology studies were 


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conducted in rats and cynomolgus monkeys. The results of the general toxicology studies 
indicated that CORT125134 produced many anticipated effects related to the antagonism of GR 
and compensatory perturbations of the hypothalamic-pituitary-adrenal (HPA) axis. In these 
studies, safety pharmacology assessments included cardiovascular effects in monkeys, 
respiratory function in rats, and neurobehavioral effects in rats. In general, there were no 
remarkable central nervous, respiratory, or cardiovascular system effects in rats or monkeys 
following single oral doses up to 200 mg/kg (highest dose tested). In cynomolgus monkeys, 
administration of 200 mg/kg, and to a lesser extent, 100 mg/kg was associated with slight 
increases in QT interval and corrected QT (QTc) interval (<10%) in only a single animal. Given 
the magnitude of change in these parameters seen in this animal, the alterations noted were not 
judged to be adverse in nature. 
During a 14-day GLP toxicology study in rats, three rats administered the highest dose 
(200 mg/kg) either died or were euthanized prior to the end of the study. The macroscopic and 
microscopic findings in these animals were generally similar and included a generalized 
depletion in body fat, and microscopic observations in the liver (mild panlobular hypertrophy 
and mild periportal vacuolation), bone marrow of the femur (minimal decrease in cellularity), 
spleen (minimal generalized lymphoid depletion), thymus (mild generalized lymphoid 
depletion), mandibular and parotid salivary glands (mild secretory depletion and mild atrophy, 
respectively), lymph nodes and gut-associated lymphoid tissue (mild generalized lymphoid 
depletion), and/or larynx (mild subacute/chronic inflammation). These findings suggest that 
death was a combination of direct test article effects, some of which were related to a 
compensatory response to the GR antagonistic properties of the test article and/or GR agonism, 
inappetence, and generalized lymphoid depletion. The no-observed-adverse-effect-level 
(NOAEL) is this study was 80 mg/kg/day.  
In a 90-day GLP toxicology study in rats, a dose of 10 mg/kg was well tolerated. Dose dependent 
effects associated with the intended pharmacological activity of the test article were observed. 
The only effect considered adverse was an effect on body weight/body weight gain in male and 
female rats at 40 mg/kg/day. The NOAEL was considered to be 10 mg/kg/day in male and 
female rats.  
In a chronic toxicology study in rats, doses of 2.5, 10, and 30 mg/kg/day were administered 
daily for 6 months. The only effect considered adverse was a reduction in body weight or body 
weight gain at the highest dose. The NOAEL was considered to be 10 mg/kg/day in male and 
female rats. 
During a 14-day GLP toxicology study in monkeys, 1 animal died unexpectedly and 5 animals 
were euthanized prior to completion of the study. Although a definitive cause of death could 
not be determined microscopically, changes in the adrenal gland (degeneration of the medulla) 
may have contributed to the moribundity/death of these monkeys. The high dose was reduced 
from 200 mg/kg to 80 mg/kg partway through the study, and the mid dose was reduced from 
100 mg/kg to 40 mg/kg. Adverse clinical findings observed prior to the unexpected death/early 
euthanasias included decreased activity, ataxia, watery feces, inappetence, hunched posture, 
tremors/convulsions, swollen eyes, and vomiting. Of these, soft or water feces (which was also 
seen in vehicle control and other test article treatment groups), inactivity, and inappetence 
typically preceded more pronounced neurobehavioral observations and morbidity or death. The 


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clinical observations along with the morbidity/mortality were instrumental in the lowering of the 
mid and high dose levels midway through the study. The NOAEL in this study was 
20 mg/kg/day.  
In a 90-day GLP toxicology study in monkeys, once-daily oral gavage doses of CORT125134 at 
dose levels of 3, 10, and 30 mg/kg/day were well tolerated. Non-adverse CORT125134-related 
effects were noted in clinical observations, clinical pathology, and anatomic pathology 
parameters. The predominant effects seen in this study were reversible, expected, and consistent 
with the anticipated pharmacology of the test article. Therefore, the NOAEL was 30 mg/kg/day. 
In a chronic toxicology study in monkeys, doses of 3, 10, and 30 mg/kg/day were administered 
daily for 9 months. No adverse effects were noted at any dose, and the NOAEL was 
30 mg/kg/day. 
Effects seen in rats and/or monkeys upon the adrenal gland, thymus, bone marrow, and pituitary 
were considered likely direct and/or secondary effects resulting from GR antagonism. The liver 
and kidney (rats) were also affected, though the noted changes were largely adaptive responses 
or, in the case of the kidney, an effect unlikely to be of clinical relevance. 
Two pilot embryo-fetal-development (EFD), DRF studies–one in the rat and one in the rabbit–
were undertaken to determine the dose levels for subsequent definitive developmental studies. 
The results of the definitive studies are described below: 
• A definitive GLP embryo-fetal-development study was conducted in pregnant rabbits at 
doses of 1, 3, and 10 mg/kg/day. Doses of 3 and 10 mg/kg/day revealed evidence of 
developmental toxicity in the form of fetal malformations (eg, whole body edema, 
abnormal forepaw flexure, hind limb malrotation, microencephaly, cleft palate and 
exencephaly, skeletal malformations, and pathological visceral findings), and at a dose of 
10 mg/kg/day, post-implantation loss and early and late resorptions were statistically 
increased, while statistically significant decreases were observed in litter size and viable 
fetuses. Maternal toxicity occurred in the 10 mg/kg/day group as evidenced by reduced 
body weight gain or body weight loss, and reduced food consumption. Based on these 
results in pregnant rabbits, the NOAEL for maternal toxicity was 3 mg/kg, and the 
NOAEL for developmental toxicity was 1 mg/kg. 
• A definitive GLP embryo-fetal development study was also performed in pregnant rats, at 
doses of 1, 2.5, and 10 mg/kg/day. No CORT125134-related fetal malformations or total 
litter resorptions were observed at any of the dose levels evaluated in the study. Maternal 
toxicity occurred in the 10 mg/kg dose group as evidenced by reduced body weight gain 
or body weight loss, and reduced food consumption. Based on these results in pregnant 
rats, the NOAEL for maternal toxicity was 2.5 mg/kg, and the NOAEL for developmental 
toxicity was 10 mg/kg.  
• A study of fertility and early embryonic development to implantation in rats showed that 
CORT125134 had no effect on male or female fertility up to doses of 40 mg/kg/day, the 
highest dose tested. There were the expected effects on body weight in both sexes 
 
CORT125134 was not genotoxic in in vitro bacterial and mammalian cell assays or in vivo in the 
rat micronucleus assay. 


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1.1.1.3 
Other In Vitro Studies 
CORT125134 is not a substrate for permeability glycoprotein (P-gp) or breast cancer resistance 
protein (BCRP). It appears to be eliminated via multiple metabolic pathways including 
cytochrome P450 (CYP) 2C8, CYP3A4 and CYP3A5 and a non-CYP pathway but not via renal 
elimination. This is reassuring with respect to the risk of drug-drug interactions affecting 
exposure to CORT125134. Based on in vitro studies, CORT125134 appears to be a potent 
inhibitor of CYP3A4 and CYP2C8 and a modest inhibitor of CYP2C9, CYP2C19, CYP2D6, and 
CYP3A5. No significant induction of CYP1A2, CYP2B6, or CYP3A4 was noted in a study 
carried out in human hepatocytes. Limited data are available concerning the potential of 
CORT125134 to affect transporter function. Additional details are provided in Section 1.3.2.2. 
1.1.2 Clinical Data on CORT125134 Monotherapy 
Clinical experience with CORT125134 is derived from two studies conducted in healthy 
subjects: Study CORT125134-120, which evaluated single ascending and multiple ascending 
doses of the Phase 1 formulation in healthy subjects, and Study CORT125134-122, which 
evaluated a single dose of 150 mg of the Phase 2 formulation in healthy subjects.  
Study CORT125134-120:  The clinical phase of Part 1 and Part 2, in which the safety, 
tolerability, and PK of single and multiple-ascending-doses, respectively, in healthy volunteers 
were assessed, is complete; final unblinded data are available, data analysis is complete. In total 
across all single dose groups, 69 subjects received CORT125134 and 12 received placebo. By 
dose level, 8 subjects received each of 5, 15, and 50 mg fasted; 7 received 150 mg fasted; 
6 received 300 mg fasted and 24 received 500 mg fasted, and a further 8 received 150 mg fed. 
Across all multiple-dose groups, 25 subjects received up to 14 days treatment with CORT125134 
and 9 received placebo. By dose level, 9 subjects received each of 50 and 150 mg, and 7 subjects 
received 250 mg once daily after an overnight fast. Dosing in Part 3 of the study, in which the 
safety, tolerability and PK of a higher multiple dose (500 mg) daily in healthy volunteers were 
assessed, was terminated prematurely due to lack of tolerability (principally musculoskeletal 
complaints).  
Study CORT125134-122: This study evaluated the safety, tolerability, and PK of a single 
150 mg dose of the CORT125134 Phase 2 formulation in 8 healthy male volunteers. The PK data 
analysis is complete and the clinical study report is in preparation. All 8 subjects completed the 
study without important protocol deviations or tolerability issues. There were no serious adverse 
events (SAEs) reported. 
More information is provided in the Investigator’s Brochure. 
1.1.2.1 
Safety 
Study CORT125134-120:  Overall, CORT125134 appeared to be safe and well tolerated 
following single doses up to 500 mg or repeated doses up to 250 mg once daily in Study 
CORT125134-120.  
In the single-ascending-dose portion (Part 1), the overall incidence of treatment-emergent 
adverse events (TEAEs) was low after administration of CORT125134, with no notable 
difference in the percentage of subjects reporting TEAEs after dosing with active drug compared 


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with placebo. In the multiple-ascending-dose study (Part 2), TEAEs in the musculoskeletal and 
connective tissue disorders system organ class were reported more frequently by subjects treated 
with CORT125134, and with increasing frequency with increasing dose. The proportions of 
subjects with reports of musculoskeletal and connective tissue disorder TEAEs by daily dose 
were Placebo:  0 subjects; 50 mg:  2 subjects (22.2%); 150 mg:  4 subjects (44.4%); and 250 mg:  
4 subjects (57.1%). The events reported were coded as back pain, pain in extremity, myalgia, 
arthralgia, musculoskeletal pain, spinal osteoarthritis, and tendon discomfort. However, back 
pain (0% [0/9] placebo, 22.2% [2/9] 50 mg, 11.1% [1/9] 150 mg, and 28.6% [2/7] 250 mg), pain 
in extremity (0% [0/9] placebo, 0% [0/9] 50 mg, 11.1% [1/9] 150 mg, and 28.6% [2/7] 250 mg), 
and myalgia (0% [0/9] placebo, 0% [0/9] 50 mg, 22.2% [2/9] 150 mg, and 0% [0/7] 250 mg) 
were the only TEAEs reported for at least 2 subjects in any of the three multiple ascending dose 
cohorts. Two subjects in Part 2 withdrew from the study due to a TEAE (severe back pain in a 
subject in the 150 mg group and moderate constipation and upper abdominal pain in a subject in 
the 250 mg group). 
There was also some evidence that gastrointestinal TEAEs such as abdominal pain upper, 
epigastric pain, nausea, vomiting and constipation were reported with increasing frequency with 
dose of CORT125134, with the majority assessed as treatment-related following both single and 
multiple doses. Most events were mild, but moderate abdominal pain and constipation in one 
subject treated with CORT125134, 250 mg daily, resulted in withdrawal of treatment.  
Findings in Part 3, the multiple-ascending-dose extension cohort, show that CORT125134 
500 mg once daily exceeds the maximum well-tolerated dose in healthy volunteers, with 
musculoskeletal symptoms and earache being the most frequently reported limiting symptoms. 
One SAE has been reported in this Phase 1 study. A subject treated with CORT125134, 50 mg 
daily was admitted to hospital overnight due to a head injury during the follow-up period. The 
subject declared this was due to an accidental fall; however, the hospital record states that the 
subject was assaulted. The event was considered unrelated to study treatment and the subject 
made a full recovery.  
There were no clinically significant findings in any laboratory assessments, vital signs, 12-lead 
electrocardiograms (ECGs), Holter ECGs, or body weight. Five CORT125134-treated subjects in 
the multiple-dose part of the study had substantial reductions in platelet count during the 
treatment period, with prompt recovery subsequently. The average of the absolute platelet counts 
decreased in the CORT125134 treated groups when compared with placebo. None of the 
individual values was considered clinically significant, and an independent review did not 
consider these findings a safety concern. 
Based on the mechanism of action of CORT125134, there is a theoretical risk of excessive 
GR blockade, which could manifest with findings such as weakness, tiredness, dizziness, 
hypoglycemia, dehydration, weight loss, nausea, vomiting, diarrhea and muscle aches. Since 
CORT125134 does not block the mineralocorticoid receptor, it is unlikely that hypotension 
would be seen in the absence of anti-hypertensive medication.  
1.1.2.2 
Pharmacokinetics 
In Study CORT125134-120, PK analysis demonstrated that plasma CORT125134 concentrations 
declined in a multiphasic manner. In Part 2 of Study 120, plasma concentrations appeared to 


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plateau by Day 7 with little accumulation from Day 7 to Day 14, indicating that concentrations 
were likely at or near steady state by Day 7. Concentrations declined to unmeasurable levels 
prior to or by the last sampling time point, indicating that the concentration-time profile was 
completely captured within the planned sampling time window. The half-life for CORT125134 
in Part 2 after the last dose on Day 14 averaged 11.99, 19.09, and 14.71 hours at 50, 150, and 
250 mg/day, respectively. Approximately 20% increase in exposure was observed in the fasted 
state relative to following a United States Food and Drug Administration (FDA) high-fat 
breakfast. This mild food effect was observed in the extreme case of fasted vs high-fat diet and, 
hence, is likely less pronounced with a normal diet. Nutrition is of utmost importance to patients 
with cancer, and for that reason this protocol puts no restrictions around timing of meals. 
Dose proportionality analysis from Study CORT125134-120 showed that for both maximum 
plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC), 
exposure increased in a greater than proportional manner with dose increment for both single and 
daily dosing.  
In Part 1 there were no subjects with AUC values from time 0 to 24 hours postdose (AUC0-24) 
values greater than the animal data stopping rule limit of 22,944 ng∙h/mL. Based on AUCinf, 
there were 5 subjects with values higher than the limit, all at a dose of 500 mg. In Part 2 there 
were 3 subjects with AUC0-24 values greater than this limit, all at a dose of 250 mg/day. 
Metabolite (CORT125201) exposure was small compared to parent drug. At presumed steady 
state, metabolite AUC0-24 was less than 5% that of parent drug. 
In Study CORT125134-122, which evaluated single, 150-mg doses of the Phase 2 capsule 
formulation in 8 healthy volunteers, CORT125134 was absorbed rapidly (median time to reach 
maximum plasma concentration [Tmax] 1 hour, range 1–2 hours) to a mean Cmax of 200.5 ng/mL. 
Thereafter, elimination was rapid (median Tlast 24 hours; mean t½ 7.7 hours), giving a mean 
AUCinf of 801 ng•h/mL.  
In comparison of the Phase 2 capsule formulation with historical data for the Phase 1 capsule 
formulation, exposure from the Phase 2 formulation was substantially lower, with Cmax being 
approximately 30 to 52% and AUCinf 22% to 36% that of the Phase 1 formulation. 
1.1.2.3 
Pharmacodynamics 
In Study CORT125134-120, the PD effects of CORT125134 were assessed by evaluating the 
ability of CORT125134 to prevent selected effects of the GR agonist prednisone. This evaluation 
was conducted after the administration of a single dose of CORT125134 (500 mg) in Part 1 of 
the study, and 14 days repeat dosing of CORT125134 (250 mg/day) in Part 2 of the study. In 
Part 1, a single dose of mifepristone (600 mg) was used as a comparator. 
Administration of a single dose of prednisone (25 mg) resulted in a rapid drop in eosinophils, 
lymphocytes, and osteocalcin, and an increase in neutrophils. After administration of 600 mg 
mifepristone with 25 mg prednisone, the effect of prednisone on these parameters was 
ameliorated to a large extent. Similarly, after administration of 500 mg CORT125134 the effect 
of prednisone was also ameliorated. The 24-hour AUC on time point deltas for proof of 
pharmaceutical effect (PoPE) parameters for both mifepristone and CORT125134 were 
significantly different from those for prednisone alone on Day −19 (p <0.05) for eosinophils and 
neutrophils but not plasma osteocalcin. For lymphocyte 24 h AUC, CORT125134 with 


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prednisone (but not mifepristone with prednisone) was significantly different to 
prednisone alone.  
In Part 2 of the study, the 24-hour AUC on time point deltas for PoPE parameters for 
CORT125134 on Day 14 were significantly different from those for prednisone alone on Day −5 
(p <0.05) for eosinophils, neutrophils, and osteocalcin but not lymphocytes. Because there were 
only 3 placebo-treated subjects, no statistical comparison was done between placebo- and 
CORT125134-treated subjects. However, it was evident from plotting the data that active 
treatment on Day 14 resulted in an amelioration of the prednisone effect whereas placebo 
treatment did not. 
The administration of prednisone increased FK506 binding protein 5 (FKBP5) mRNA 
expression, and this increase was prevented by co-administration of either mifepristone (600 mg) 
or CORT125134 (500 mg) with the prednisone in Part 1 of the study. After dosing with 
CORT125134 (250 mg) for 14 days in Part 2 of the study, prednisone did not induce FKBP5 
mRNA expression. Administration of placebo for 14 days did not prevent prednisone-induced 
FKBP5 mRNA expression. 
Due to inhibition of the negative feedback mechanism, the administration of a GR antagonist 
causes an increase in morning serum plasma cortisol levels. After administration of 
CORT125134 for 14 days, there appeared to be a dose-related effect, with increased cortisol 
levels at the higher doses. A comparison between morning cortisol levels on Day 13 for 
CORT125134-treated subjects with placebo-treated subjects showed that 50 mg CORT125134 
did not have a statistically significant effect (p = 0.2634), whereas 150 mg and 250 mg 
CORT125134 did have a statistically significant effect (p = 0.0025 and 0.0006, respectively). 
1.1.2.4 
Pharmacodynamic Interactions - QTc Effects 
Analysis of ECG safety data from Study CORT125134-120, showed that CORT125134 at doses 
up to 500 mg, which resulted in plasma concentrations up to approximately 4 µg/mL, did not 
have a clinically relevant effect on ECG parameters (cardiac safety report, data on file). Based on 
the exposure-response analysis of the QT effect, the data demonstrated that CORT125134 does 
not have a clinically relevant effect on the QTc interval. An effect on ∆∆QTcF above 10 ms 
could clearly be excluded within the studied range of plasma concentrations up to approximately 
4 µg/mL, which corresponded to single doses up to 500 mg or repeated doses up to 250 mg 
once daily. 
1.2 
Nab-paclitaxel 
Nab-paclitaxel (Abraxane) is paclitaxel formulated as albumin-bound nanoparticles. Paclitaxel is 
a microtubule inhibitor that stabilizes microtubules by preventing depolymerization, which 
results in the inhibition of the normal dynamic reorganization of the microtubule network that is 
essential for vital interphase and mitotic cellular functions. As a result, cells become blocked in 
the G2/M phase of the cell cycle, which disrupts the mitotic spindles and causes cell death due to 
prolonged mitotic blockage (Abraxane Prescribing Information 2015; Horwitz 1994).  
Nab-paclitaxel is indicated for the treatment of the following: metastatic breast cancer after 
failure of combination chemotherapy for metastatic disease or relapse within 6 months of 
adjuvant chemotherapy, with prior therapy including an anthracycline unless clinically 


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contraindicated; locally advanced or metastatic non-small cell lung cancer as first-line treatment 
in combination with carboplatin in patients who are not candidates for curative surgery or 
radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment in 
combination with gemcitabine. In the current study, nab-paclitaxel will be administered in a 
dose-finding part to patients with solid tumors for whom nab-paclitaxel is considered appropriate 
by the Investigator, and followed by expansion cohorts of patients with platinum-resistant 
ovarian, fallopian tube, or primary peritoneal cancer or with TNBC. 
The recommended dosage of nab-paclitaxel in the metastatic breast cancer setting is 260 mg/m2 
administered intravenously (IV) over 30 minutes every 3 weeks. The approval of nab-paclitaxel 
for use in metastatic breast cancer was based on results from two single-arm, open-label studies 
and one randomized comparative study. In the open-label studies, objective responses were 
observed in patients with metastatic breast cancer administered nab-paclitaxel as 30-minute 
infusions at a dose of 175 mg/m2 (n = 43) or 300 mg/m2 (n = 63) at 3-week intervals.  
In the randomized comparative study, 460 patients with metastatic breast cancer were 
randomized to receive either nab-paclitaxel at 260 mg/m2 as a 30-minute infusion or paclitaxel 
injection at 175 mg/m2 as a 3-hour infusion. In the primary analysis, patients in the nab-
paclitaxel treatment arm had a statistically significantly higher reconciled target lesion response 
rate of 21.5% compared to 11.1% for patients in the paclitaxel injection treatment arm. There 
was no statistically significant difference in overall survival (OS) between the two study arms. 
In the randomized comparative study, the most common adverse reactions (in at least 20% of 
patients) associated with single-agent nab-paclitaxel in metastatic breast cancer were alopecia, 
neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, aspartate 
aminotransferase (AST) elevation, alkaline phosphatase (ALP) elevation, anemia, nausea, 
infections, and diarrhea. Grade 3–4 neutropenia occurred in 34% of patients. The incidence of 
Grade 4 neutropenia was lower in patients treated with nab-paclitaxel (9%) than in patients 
treated with paclitaxel injection (22%). The frequency and severity of sensory neuropathy 
increased with cumulative dose. Sensory neuropathy led to nab-paclitaxel discontinuation in 3% 
of patients. Twenty-four patients (10%) treated with nab-paclitaxel developed Grade 3 peripheral 
neuropathy, of whom 14 had documented improvement after a median of 22 days. Of the 
10 patients without documented improvement, 4 discontinued the study due to peripheral 
neuropathy. No Grade 4 sensory neuropathies were reported.  
Warnings and precautions include bone marrow suppression (primarily neutropenia), sensory 
neuropathy, sepsis, hypersensitivity, use in patients with hepatic impairment, and use in 
pregnancy. The prescribing information indicates that nab-paclitaxel should not be used in 
patients who have baseline neutrophil counts of <1,500 cells/mm3 and that patients who 
experience a severe hypersensitivity reaction to nab-paclitaxel should not be rechallenged with 
the drug. The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be 
exercised when administering nab-paclitaxel concomitantly with medicines known to inhibit or 
induce either CYP2C8 or CYP3A4 (see Section 1.3.2.2 for data concerning CORT125134). 
The nab-paclitaxel dose for Segment I selected for this study starts at 80 mg/m2 (range from 
60 mg/m2 to 100 mg/m2 dependent on tolerability) administered in 28-day cycles by IV infusion 
over 30 minutes weekly for 3 weeks followed by 1 week of no treatment. A weekly dose 
schedule was reported to improve tolerability and reduce side effects of the therapy and was 


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associated with greater efficacy (Gradishar et al. 2009). Because of the potential of 
CORT125134 to inhibit metabolism of nab-paclitaxel, a conservative starting dose of 
nab-paclitaxel 80 mg/m2 is selected in combination with CORT125134 100 mg for Segment I. 
Segment II intermittent dosing will start with a nab-paclitaxel dose of 100 mg/m2 based on the 
lower CORT125134 exposures expected with intermittent dosing (see rationale for dose 
regimens, Section 1.5, and starting doses, Section 1.6) 
1.3 
Rationale for Combination of CORT125134 and Nab-paclitaxel in Chemotherapy-
Resistant Tumor Types 
1.3.1 Rationale for Use of CORT125134 in Chemotherapy-Resistant Tumor Types  
1.3.1.1 
Nonclinical Data 
Preclinical studies have demonstrated that stimulation with a GR agonist triggers tumor cells to 
promote the expression of cell survival (anti-apoptotic) genes, enhancing their ability to escape 
chemotherapy that would otherwise induce cell death via apoptosis. In vitro studies have shown 
that the mechanism of chemotherapy resistance induced by the GR agonist dexamethasone is 
reproducible across several tumor cell line models (Zhang et al. 2006, Stringer-Reasor et al. 
2015). Several in vitro xenograft studies have demonstrated that the addition of GR antagonists 
to a tumor cell line treated with chemotherapeutic agents, including taxanes, enhances the effects 
of chemotherapy. The addition of a GR agonist such as dexamethasone reduced the efficacy of 
the chemotherapeutic agent. In vivo models of mouse xenografts have shown that across several 
human tumor cell line models including ovarian cancer, TNBC, and castration-resistant prostate 
cancer, GR antagonists enhance the efficacy of chemotherapeutic agents, including taxanes, in 
the presence of circulating endogenous glucocorticoids (Stringer-Reasor et al. 2015, Szmulewitz 
et al. 2012; Skor et al. 2013, data on file). 
There are several lines of evidence suggesting that activation of GR in cancer cell leads to an 
activation of tumor survival signals and consequent reduction in the effect of chemotherapy. 
This is important because increase of adrenal glucocorticoid production and up-regulation of 
its receptor (GR) during acute or chronic stressors (including diagnosis of cancer and related 
medical treatment) has the theoretical ability to promote tumor growth (Conzen 2008). In 
addition, dexamethasone, a potent GR agonist, is given as routine prophylaxis for emesis and 
side effects associated with many cancer chemotherapies (Basch et al. 2011). Specifically, 
dexamethasone is a standard prophylactic pretreatment given prior to administration of 
paclitaxel, a widely used chemotherapeutic agent, in order to prevent allergic reactions to a key 
excipient in the formulation of paclitaxel known as cremophor. Nab-paclitaxel, an effective and 
well-tolerated form of paclitaxel, does not require pretreatment with dexamethasone and hence is 
an ideal candidate for this line of research inquiry. 
The concept of GR-mediated tumor survival is supported by the following:  (a) high levels of 
GR expression are associated with poor prognosis in ER-negative breast cancer patients 
(Pan et al. 2011); (b) apoptosis is reduced when dexamethasone is added to in vitro cancer cell 
lines or to mouse xenografts treated with cytotoxic drugs such as paclitaxel; (c) up-regulation of 
GR by dexamethasone induces expression of a number of genes including those involved in 
anti-apoptosis such as the serum glucocorticoid regulated kinase 1 gene (SGK1) and 


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MKP1/DUSP1 (mitogen-activated protein kinase phosphatase/dual-specificity phosphatase 1) 
gene (Pan et al. 2011); and (d) in prostate cancer potent inhibition of the AR pathway by agents 
such as enzalutamide leads to a compensatory increase in GR expression that facilitates tumor 
survival signals and leads to the development of resistance (Balbas et al. 2013).  
The hypothesis that a GR antagonist such as CORT125134 would potentiate the effects of 
chemotherapy is supported by several lines of evidence. GR is highly expressed in TNBC tumors 
(>10% of tumor cells stain positive by immunohistochemistry [IHC]) and/or having significantly 
increased tumor NR3C1 (GR) mRNA levels compared with normal breast tissue (Skor et al. 
2013). High expression of GR appears to correlate with adverse outcomes in patients with 
ER-negative breast cancer (Pan et al. 2011). However, this effect does not occur in patients with 
ER-positive disease, and in fact the presence of GR expression in ER-positive disease is a 
positive prognostic marker. In a meta-analysis of 1,378 early-stage breast cancer patients, those 
patients with ER-negative tumors and high levels of GR expression had a significantly increased 
risk of early relapse compared to tumors with low GR expression (ie, GR-negative). In contrast, 
in patients with ER-positive disease high GR expression was associated with a better outcome 
(Pan et al. 2011). 
Withdrawal of glucocorticoid from defined media triggers apoptosis of the immortalized human 
mammary epithelial cell line MCF10A, despite the presence of epidermal growth factor and 
insulin (Moran et al. 2000), suggesting that glucocorticoids mediate a potent survival pathway in 
these cells. Subsequent experiments showed that dexamethasone decreases response to paclitaxel 
in xenografts of the ER/PR/human epithelial receptor-2 (HER2)/neu-negative human breast 
cancer MDA-MB-231 through an inhibition of apoptosis (Pang et al. 2006).  
Glucocorticoids initiate anti-apoptotic signaling through GR, which in turn regulates the 
transcription of genes that initiate signaling cascades. Induction of SGK1 and MKP-1 is required 
for anti-apoptotic signaling following GR activation in epithelial cells and breast cancer cell lines 
such as MDA-MB-231 (Mikosz et al. 2001, Wu et al. 2004, Engelbrecht et al. 2003). Following 
induction, the serine/threonine kinase SGK-1 is phosphorylated and activated downstream of the 
phosphatidylinositol 3-kinase pathway by phosphoinositide-dependent kinases 1 and 2. In 
addition to SGK-1, GR-induced MKP-1 expression is also required for glucocorticoid mediated 
cell survival in breast cancer cell lines (Wu et al. 2005). Following GR activation, induction of 
MKP-1 activity is associated with the dephosphorylation and inactivation of extracellular 
regulated kinases 1,2 and c-Jun NH2-terminal kinases 1 (Amsterdam et al. 2002, Engelbrecht et 
al. 2003). Inhibition of either endogenous SGK-1 or MKP-1 expression by short hairpin RNA 
(shRNA) in dexamethasone-treated breast cancer cells reverses GR-induced protection from 
chemotherapy suggesting that induction of both genes is required for cell survival signaling 
downstream of GR activation (Wu et al. 2004). 
In vitro studies in ER-negative human breast tumor cell lines have shown that GR activation by 
the glucocorticoid agonist dexamethasone initiated an anti-apoptotic effect that increased cell 
survival, and that a GR antagonist could reverse this effect (Mikosz et al. 2001). Similarly, 
Skor et al. (2013) demonstrated that when added to dexamethasone and paclitaxel treatment, 
the GR antagonist mifepristone significantly increased cytotoxicity in vitro and inhibited 
MDA-MB-231 xenograft tumor growth. These effects were accompanied by an antagonism of 


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GR-induced SGK1 and MKP1/DUSP1 gene expression. CORT125134 treatment alone had no 
significant effect on TNBC cell viability or clonogenicity in the absence of chemotherapy  
Overall, these results suggest that co-administration of CORT125134 with a chemotherapeutic 
agent may help overcome the resistance resulting from increased activation of GR that occurs as 
a result of a stimulation of GR by either endogenous or exogenous glucocorticoids.  
1.3.1.2 
Clinical Data for Combination of a Glucocorticoid Receptor Antagonist and 
Nab-paclitaxel 
A recent Phase 1 dose-ranging study evaluated the combination of nab-paclitaxel and 
mifepristone (Korlym®), a GR antagonist similar to CORT125134, in patients with metastatic 
breast cancer (Nanda et al. 2016). In Cycle 1, patients received nab-paclitaxel on Days 1, 8, and 
15 and either oral mifepristone (300 mg once daily) or matching placebo on the day before and 
the day of nab-paclitaxel administration. In Cycle 2 and later, patients received the combination 
of mifepristone and nab-paclitaxel. In the first cohort (100 mg/m2 nab-paclitaxel, n = 4), 
2 patients received placebo and 2 received mifepristone; both mifepristone-treated patients had 
dose-limiting neutropenia in the first cycle. In the second cohort (80 mg/m2 nab-paclitaxel, 
n = 5), 2 patients received placebo and 3 patients received mifepristone; 2 of the mifepristone-
treated patients had dose-limiting neutropenia in the first cycle. Of the 9 treated patients, 2 had 
complete response, 3 had partial response, 1 had stable disease, and 3 had disease progression. 
The 6 patients with best responses of complete response, partial response, or stable disease 
received between 4 and 10 cycles of treatment. Five of these 6 patients were GR-positive and 
1 patient who achieved partial response was GR-negative. Of the 3 patients with a best response 
of disease progression, 1 was weakly GR-positive and 2 were GR-negative. The study provided 
evidence of anticancer activity but was stopped early due to dose-limiting toxicity (DLT, 
neutropenia). 
1.3.2 Rationale for Use of Nab-paclitaxel in Conjunction with CORT125134 
The current study sets out to evaluate the combination of CORT125134 with nab-paclitaxel, to 
enable the added potential benefits associated with selective GR antagonism. Nab-paclitaxel was 
selected in the current study for the following reasons: 
1. The mechanism of reversal of chemotherapy resistance with GR antagonists has been 
reproducibly demonstrated in several preclinical models across several tumor cells lines, 
with taxanes as the chemotherapy agent.  
2. Taxanes are a widely used and efficacious chemotherapy, with applicability to many 
tumor types. 
3. Data from a small study evaluating nab-paclitaxel in conjunction with the GR antagonist 
mifepristone in patients with metastatic breast cancer revealed data suggestive of durable 
response (Nanda et al. 2016; see Section 1.3.1.2). 
4. Nab-paclitaxel has a similar safety and efficacy profile to paclitaxel; however, it does not 
require pretreatment with steroids to avoid allergic reaction and hence is an ideal 
candidate to evaluate further in the model of GR antagonism to reduce chemotherapy.  
In selecting the combination of CORT125134 and nab-paclitaxel for evaluation in this study, the 
potential for drug-drug interactions has been considered. Data on absorption, distribution, 


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metabolism, and excretion (ADME) characteristics of nab-paclitaxel and interactions of 
nab-paclitaxel with other drugs is described below. 
1.3.2.1 
ADME Characteristics of Nab-paclitaxel 
In vitro studies with human liver microsomes and tissue slices show that paclitaxel is 
metabolized primarily to 6α-hydroxypaclitaxel and to two minor metabolites, 
3'-p-hydroxypaclitaxel and 6α-3'-p-dihydroxypaclitaxel. The formation of these hydroxylated 
metabolites is catalyzed by CYP2C8, CYP3A4, and both CYP2C8 and CYP3A4 isoenzymes, 
respectively. 
Paclitaxel exposure (AUC) increased from 2653 to 16736 ng∙h/mL in a dose-proportional 
manner following doses in the clinical dose range, 80 to 300 mg/m2. The mean plasma clearance 
of paclitaxel ranges from 13 to 30 L/h/m2, and the mean apparent terminal half-life ranges from 
13 to 27 hours. The mean cumulative urinary excretion of unchanged active substance accounted 
for 4% of the total administered dose, with less than 1% as the metabolites 6α-hydroxypaclitaxel 
and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance. Paclitaxel is principally 
eliminated by hepatic metabolism and biliary excretion. 
Based on population PK analysis, the total volume of distribution is approximately 1741 L, 
indicating extensive extravascular distribution and/or tissue binding of paclitaxel. 
Intrapatient variability in AUC was 19% (range = 3.21% to 27.70%). There was no evidence for 
accumulation of paclitaxel with multiple treatment courses. 
Nab-paclitaxel comprises paclitaxel formulated as albumin-bound nanoparticles. The 
characteristics of paclitaxel administered as nab-paclitaxel have been compared with those 
following administration as a solvent-based paclitaxel formulation. The fraction of free paclitaxel 
(and, therefore, exposure to unbound paclitaxel) was significantly higher with Abraxane (nab-
paclitaxel; 6.2%) than with solvent-based paclitaxel (2.3%), possibly due to paclitaxel not being 
trapped in Cremophor EL micelles as with solvent-based paclitaxel. The plasma clearance and 
volume of distribution of paclitaxel with nab-paclitaxel were larger (43% and 53%, respectively) 
than following a solvent-based paclitaxel injection. Terminal half-lives were comparable. 
1.3.2.2 
Drug-Drug Interactions with Paclitaxel and Nab-paclitaxel 
Few if any formal PK drug-drug interaction studies have been performed with nab-paclitaxel; 
most of the label guidance appears to be from studies with paclitaxel.  
The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. In vitro, the metabolism of 
paclitaxel to 6α-hydroxypaclitaxel was inhibited by a number of agents (ketoconazole, 
verapamil, diazepam, quinidine, dexamethasone, cyclosporin, teniposide, etoposide, and 
vincristine), but the concentrations used exceeded those found in vivo following therapeutic 
doses. Testosterone, 17α-ethinyl estradiol, retinoic acid, and quercetin, a specific inhibitor of 
CYP2C8, also inhibited the formation of 6α-hydroxy-paclitaxel in vitro.  
The PK of paclitaxel may also be altered in vivo as a result of interactions with compounds that 
are substrates, inducers, or inhibitors of CYP2C8 and/or CYP3A4. Caution should be exercised 
when administering Abraxane (nab-paclitaxel) concomitantly with medicines known to inhibit 
(eg, ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, 


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cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or induce (eg, rifampicin, 
carbamazepine, phenytoin, efavirenz, and nevirapine) either CYP2C8 or CYP3A4. 
A PK interaction between CORT125134 and nab-paclitaxel following administration of 
nab-paclitaxel is likely. In in vitro testing, CORT125134 showed potent inhibition of CYP2C8 
(IC50 <1 µM) and substantial inhibition of CYP3A4 (IC50 ∼1 µM). Modest inhibition of 
CYP3A5, CYP2C19 and CYP2D6 (IC50 4.9 µM, 8 µM and 9 µM, respectively) and partial 
inhibition of CYP2C9 were also noted. CORT125134 did not inhibit CYP1A2 or CYP2B6 
(IC50 ≥10 µM). Pending further investigation as to the clinical relevance of these findings, 
concomitant administration of CORT125134 with drugs metabolized by CYP2C8, CYP3A4, 
CYP3A5, CYP2C9, CYP2C19 or CYP2D6, particularly drugs with a narrow therapeutic ratio, 
should be performed with caution. 
In this study, patients will initially receive nab-paclitaxel in cycles of 3 doses at weekly intervals 
followed by 1 week off treatment, in combination with continuous CORT125134 dosing in 
Segment I and intermittent CORT125134 dosing in Segment II. The initial cohort of patients will 
be treated in Segment I with a unit dose of nab-paclitaxel of 80 mg/m2. Exposure to nab-
paclitaxel will be evaluated with PK sampling, and patients will be monitored closely for 
evidence of toxicity. If there is evidence of nab-paclitaxel toxicity, individual patients will 
receive appropriate supportive treatment and adjustment of subsequent nab-paclitaxel dose(s) 
in accordance with the prescribing information. The Data Review Committee (DRC; see 
Section 3.5) will review safety and PK data and, if appropriate, recommend dose-adjustment for 
nab-paclitaxel and/or CORT125134 for subsequent patients. The DRC may recommend that 
CORT125134 be administered intermittently (eg, if there is evidence of clinically significant 
enzyme induction associated with treatment with CORT125134). The rationale for the treatment 
regimens and starting doses is provided in Sections 1.5 and 1.6, respectively.  
1.4 
Rationale for Selection of Specific Tumor Types  
The specific tumor types planned to be evaluated under this protocol are: 
• Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer  
• TNBC 
• Pancreatic Cancer 
Additional expansion cohorts may be added by amendment. Expansion cohorts will include 
approximately 20 patients each.  
The selection of additional tumor types for the expansion cohorts will be based on data from 
Part 1, as well as the current knowledge base and emerging data on GR-mediated chemotherapy 
resistance in tumor cells. The factors listed below will be used to select additional tumor types 
for evaluation in the dose-expansion phases of the study. 
• Rate of GR expression in various tumor types (data on file). 
A recently completed evaluation of rates of GR expression by IHC across 20 solid tumor 
types showed that high rates of GR expression are present in several tumor types 
including melanoma, sarcoma, lung, and pancreatic cancer, as well as previously reported 
tumor types of TNBC and ovarian cancer.  
• In vitro evidence of GR-mediated chemotherapy resistance (Zhang et al. 2006). 


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• In vivo (xenograft) evidence of GR-mediated chemotherapy resistance  
(Pang et al. 2006). 
Ongoing mouse xenograft studies with tumor cell lines from breast, ovarian, pancreatic, 
cervical, and other cancer types will continue to inform the development program and 
will likely contribute to choice in expansion cohorts. 
• Clinical evidence of benefits of GR antagonism in GR-positive tumors. 
Ongoing Investigator-sponsored trials are evaluating the use of the GR antagonist 
mifepristone in castration-resistant prostate cancer, breast and ovarian cancer, and lung 
cancer. Corcept has an ongoing sponsored trial exploring the use of eribulin in 
combination with mifepristone in TNBC, which will inform the utility of that treatment 
regimen. Data from the dose-finding portion of Study CORT125134-550 may also 
provide clinical evidence of benefit. 
Candidates for treatment in additional tumor-specific cohorts in either dose finding or dose 
expansion phases may include patients with pancreatic cancer, cervical cancer, lung cancer, 
and other solid tumors of epithelial origin that have high expression of GR or documented 
GR-mediated chemotherapy resistance. Details on the rationale for the initial selection of 
platinum-resistant ovarian, fallopian tube, and primary peritoneal cancer, TNBC, and pancreatic 
cancer are provided below.  
1.4.1 Ovarian Cancer 
Ovarian cancer, including fallopian tube, and primary peritoneal cancer, accounts for 3% of 
cancers in women and is the fifth most common cancer death in women. Women with early stage 
ovarian cancer have the best prognosis with cure rates of 70–90%. However, most patients are 
asymptomatic until advanced stages of the disease, and women with late stage ovarian cancer 
have a much worse prognosis with only a 15–30% cure rate. The limited treatment options for 
late stage ovarian cancer include tumor debulking and administration of a combination of 
nonplatinum- and platinum-based chemotherapy. Recurrence rates are high and most patients 
succumb to the disease. First line chemotherapeutic treatment of advanced ovarian cancer is 
combination therapy with carboplatin and paclitaxel. Patients who develop a recurrence within 
6 months of the original platinum-based therapy are deemed platinum resistant. Standard of care 
for platinum-resistant ovarian cancer is treatment with single agent chemotherapy, often 
paclitaxel, with or without the addition of bevacizumab.  
A research group at the University of Chicago has published data from a small proof-of-principle 
study with 10 ovarian cancer patients who received 20 mg of dexamethasone or placebo 
30 minutes before surgery for ovarian cancer (Melhem et al. 2009). All human ovarian tumors 
from the enrolled patients expressed GR via IHC. The dexamethasone-treated patients 
experienced an average 6.1-fold increase in the GR target genes SGK1 and an average 8.2-fold 
increase in MKP1/DUSP1 tumor gene expression, while placebo-treated patients had no 
significant GR-mediated gene expression changes. Therefore, GR activation appears to result in 
increased anti-apoptotic gene expression in patients with ovarian tumors. Recently, the group has 
found that several high-grade serous ovarian cancer cell lines HeyA8, SKOV3, CAOV3, and 
Monty-1 expressed detectable amounts of the GR by Western analysis and quantitative reverse-
transcription polymerase chain reaction. Seventy-nine percent of high-grade ovarian epithelial 
cancers (n = 52 total) had strong GR expression in most cells (Stringer et al. 2013). 


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Xenograft studies in ovarian cancer cell lines demonstrated that the addition of the GR antagonist 
mifepristone to combination therapy gemcitabine-carboplatin significantly reduced tumor burden 
over the gemcitabine-carboplatin arm alone (Stringer-Reasor et al. 2015).  
Taken together, the nonclinical and clinical data indicate that GR antagonism may play a role in 
enhancing or restoring chemotherapy sensitivity in the treatment of patients with ovarian cancer. 
The data therefore support the planned evaluation of the combination of CORT125134 and 
nab-paclitaxel in this indication.  
1.4.2 Triple-Negative Breast Cancer 
Breast cancer, the most frequent cancer in women, is generally classified into ER-positive and 
ER-negative subtypes. TNBC lacks expression of the ER, PR, and HER2. TNBC is molecularly 
complex and increasingly recognized as heterogeneous with several gene expression pattern 
subtypes or clusters (Shah et al. 2012). TNBC represents 15 to 20% of newly diagnosed breast 
cancer (Bauer 2007), and is more common in younger, premenopausal, and African American 
women as well as women with breast cancer 1 (BRCA1) mutations (Morris et al. 2007). 
TNBC has high sensitivity to chemotherapy, but there is a higher rate of relapse and 
worse prognosis compared to other types of breast cancer. In a study of 12,902 women 
(Lin et al. 2012), there was worse breast-cancer-specific survival (hazard ratio [HR] 2.99, 95% 
CI 2.59–3.45), worse overall survival (HR 2.72, 95% CI 2.39–3.10), and increased risk of death 
within 2 years of diagnosis (HR 6.10, 95% CI 4.81–7.74) for TNBC compared with ER- and 
PR-positive/HER2-negative breast tumors. In the locally advanced/metastatic setting, there are 
currently no drugs licensed specifically for the treatment of patients with TNBC. The median 
survival in this patient population is reported as approximately 6 months based on a retrospective 
review of over 3,700 patients (Kennecke et al. 2010). There is no standard of care, but common 
treatment practices in metastatic disease include, but are not limited to, a taxane-based regimen 
or gemcitabine plus platinum (cisplatin or carboplatin) as first-line treatment. The treatment of 
patients with TNBC represents an unmet medical need largely because of the molecular 
heterogeneity of the disease.  
The following findings have led to the hypothesis that a GR antagonist such as CORT125134 
would potentiate the effects of chemotherapy, including paclitaxel, in the treatment of TNBC:  
(a) high levels of the GR are associated with poor prognosis in ER-negative breast cancer 
patients; (b) apoptosis is reduced when dexamethasone is added to TNBC cancer cells or 
xenografts treated with cytotoxic drugs such as paclitaxel; and (c) up-regulation of the GR by 
dexamethasone in TNBC cell lines induces expression of a number of genes including those 
involved in anti-apoptosis such as SGK1 and MKP1/DUSP1 (Pan et al. 2011). These lines of 
evidence support the planned evaluation of the combination of CORT125134 and nab-paclitaxel 
in patients with TNBC. 
1.4.3 Pancreatic Cancer 
Pancreatic cancer is the third leading cause of cancer-related death in the United States, and is 
characterized as a highly lethal form of cancer. Typically, patients present with a later stage of 
cancer when a surgical cure is no longer an option. Five-year survival for node positive disease is 
10%, even after surgical resection of disease. Once first and second line treatments are exhausted 


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for patients with advanced pancreatic cancer, options are limited and patients often move to 
palliation and pain control.  
The role of GR in chemotherapy resistance in pancreatic cancer is of interest. Evaluation and 
staining for GR in 16 samples of pancreatic cancer from a tumor bank demonstrated a mean 
H score of 131 with a range of 30–280 using a validated IHC assay for GR (Block et al. 2017), 
demonstrating a significant GR expression in the tumor samples studied. 
A xenograft model in pancreatic cancer with GR + cell line shown below demonstrated that 
while the model responded to paclitaxel alone, the tumor cells continued to grow despite addition 
of chemotherapy. The arm with the same dose of paclitaxel plus GR antagonism with 
CORT125134 showed a reversal of tumor growth and suggests that GR antagonism in this model 
improved the efficacy of paclitaxel. 
Figure 1 
Effect of CORT125134 in combination with paclitaxel in a pancreatic cancer 
xenograft model (MIAPaCa-2 model) 
 
 
Clinical data from this study (CORT125134-550) in a patient with advanced pancreatic cancer 
receiving CORT125134 100 mg daily (continuous) and nab-paclitaxel 80 mg/m2 is promising 
and merits further exploration. In total, the patient’s cancer had progressed on four different prior 
lines of therapy before entering this study. This includes progression of disease after 4 cycles of 
nab-paclitaxel/gemcitabine 7 months prior to entry into this study. Since enrollment on the trial, 
this patient has tolerated treatment well, with a partial response by Cycle 3. The patient continues 
to do well clinically and is now on cycle 10 of the protocol with a sustained PR. In addition, the 
patient’s tumor tissue was found to stain strongly for GR with the IHC assay for GR. 
Based on the combination of preclinical and clinical data in pancreatic cancer to date, the 
protocol is amended to further explore pancreatic cancer. 


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1.5 
Rationale for the Dosing Regimens 
This study will assess the safety and efficacy of two dosing regimens of CORT125134 
(continuous dosing in Segment I and intermittent dosing in Segment II) in combination with 
weekly nab-paclitaxel infusions.  
The rationale for assessing two different dosing regimens (continuous and intermittent) is to 
evaluate and optimize the dose and schedule selection. Continuous dosing confers the potential 
advantages of (1) allowing continuous coverage of GR chemotherapy resistance pathways and 
(2) improving immune function through suppression of activity of endogenous glucocorticoids. 
Intermittent dosing confers the potential advantages of (1) optimizing GR blockade around times 
of greatest chemotherapy exposure and (2) improving tolerability. 
1.6 
Rationale for Starting Doses 
CORT125134 is a selective GR antagonist, with high affinity for the GR. The compound was 
studied in a Phase 1, healthy volunteer study (CORT125134-120) evaluating doses ranging from 
5 mg to 500 mg in a single-ascending-dose portion of the study, followed by evaluation of 
50 mg, 150 mg, and 250 mg for 14 days in a multiple-ascending-dose portion of the study. 
Additional details of the clinical data summarized below are found in Section 1.1.2 and in the IB. 
The Phase 1 healthy volunteer data, PK modeling, PD, and assessment for potential of drug-drug 
interactions support the starting doses of 100 mg CORT125134 for continuous dosing 
(Segment I) and 200 mg CORT125134 for intermittent dosing (Segment II), with additional 
rational provided. 
In the Phase 1 Study CORT125134-120, single doses of CORT125134 were safe and well 
tolerated in the dosing range of 5 mg to 500 mg. In the same study, continuous daily dosing with 
CORT125134 for 14 days was also safe and well tolerated at the doses of 50 mg, 150 mg, and 
250 mg. Mild to moderate musculoskeletal adverse events (AEs) were reported with repeat doses 
up to 250 mg. A transient reduction in platelet count was observed in a non-dose-dependent 
manner, which resolved at study end. An additional, 500 mg cohort was added by amendment to 
the protocol and was discontinued early, principally due to musculoskeletal AEs, and a decision 
by the investigator that this dose level was generally not well tolerated in this group of healthy 
volunteers. There were no SAEs in this dose group. Doses between 250 mg and 500 mg were 
not studied. PK analysis in human volunteers supports daily dosing of the compound (see 
Section 1.1.2.2). Repeat daily dosing resulted in achievement of steady state by Day 7. 
PD studies demonstrated that CORT125134, and mifepristone as a positive control, were able to 
reverse the effect of prednisone on white blood cell (WBC) count, osteocalcin, glucose, and 
FKBP5, thereby indicating GR blockade. After repeat dosing of CORT125134, Day 13 morning 
cortisol levels increased in a dose-dependent manner (indicative of GR antagonism), with a 
numeric but not significant increase over placebo in the 50 mg dose group, and significant 
increases over placebo in both the 150 mg and 250 mg dose groups (Figure 2). 


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Taken as a whole, the PD, PK, and safety profile of the Phase 1 formulation of CORT125134 
justified a daily dosing range from 50 mg to 250 mg. Based on PK, PD, safety and tolerability 
data, the DRC in Study CORT125134-550 may recommend doses higher than 250 mg once data 
are collected through the 250 mg dose groups. 
A small Phase 1 study (Study CORT125134-122) was conducted to characterize the current 
formulation of CORT125134 in healthy volunteers. A single 150-mg oral dose was administered 
to 8 healthy male subjects. The 150-mg dose of the current formulation of CORT125134 
provided lower exposures in Study CORT125134-122 when compared with the 150-mg dose of 
the earlier, just-in-time formulation used in Study CORT125134-120. At the 150-mg dose level, 
the mean AUCinf of the current formulation (800 ng•h/mL) is 27.5% of that of the earlier 
formulation (2912 ng•h/mL) used in Study CORT125134-120. 
Based on results from Study CORT125134-120, the clinical PK of CORT125134 are nonlinear, 
with greater than dose-proportional increases in exposure observed over a dose range of 5 to 
150 mg. Over the range of 50 mg to 150 mg of the earlier formulation, a 3-fold increase in dose 
resulted in a 6.3-fold increase in exposure (AUCinf) to CORT125134 (exposure ratio:dose ratio 
[ER/DR] ratio = 2.1). The nonlinearity was greater at lower concentrations (namely, a ≥ 3.5 
ER/DR from 15 mg to 50 mg); thus, lower absorbed doses of the current formulation would 
result in greater relative differences in exposure at 50 mg compared with 150 mg. The 
anticipated AUCinf for a 50 mg dose of the current formulation is 92.2 ng•h/mL compared with 
an AUCinf of 566 ng•h/mL for the 50 mg dose of the earlier formulation. 


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Starting Dose for Segment I Continuous-Dosing Regimen—This reduction in CORT125134 
exposure at the lower dose range of the current formulation is likely to yield BLQ values when 
tested at 50 mg and is likely to be subtherapeutic. A reasonable correction of the exposure of the 
current formulation can be achieved with a shift of the starting dose from 50 mg/day to 
100 mg/day. The anticipated AUCinf with 100 mg of the current formulation is 645 ng•h/mL. 
This is comparable to that of 50 mg of the earlier formulation (AUCinf = 566 ng•h/mL) and 
therefore supports the increase in starting dose from 50 mg/day to 100 mg/day in the Segment I 
Continuous-Dosing Regimen.  
Starting Dose for Segment II Intermittent-Dosing Regimen—The Segment II intermittent-
dosing schedule of CORT125134 will provide Day 3 AUC that is 54% of the steady-state 
exposure expected in the Segment I continuous-dosing cohorts. The anticipated exposures 
(AUC0–24) to CORT125134 at steady-state and exposures (AUC0–24) on Day 3 of intermittent 
daily dosing are presented in Table 1. The calculated mean steady state and Day 3 exposures, 
even at a dose of 500 mg, all fall below the mean exposure levels (22,390 ng•h/mL) achieved for 
the 250-mg daily doses of the earlier formulation for 14 days that were well tolerated. A starting 
dose of 200 mg intermittent dosing yields an anticipated exposure of 2457 ng•h/mL, comparable 
to the 100 mg continuous-dosing regimen starting dose that yields an exposure of 2000 ng•h/mL. 
CORT125134 and Nab-paclitaxel—CORT125134 is an inhibitor of CYP3A4 and CYP2C8, 
the two CYP isoforms that are involved in the metabolic elimination of nab-paclitaxel (see 
Section 1.3.2.2). Pharmacokinetic modeling of the possible drug-drug interaction between 
CORT125134 and nab-paclitaxel suggests that the starting dose level of 100 mg CORT125134 
(the current formulation) could cause up to a 1.7-fold increase in systemic exposure to 
nab-paclitaxel. Therefore, caution will be used in the dose escalation/de-escalation of 
CORT125134, and patients will be monitored carefully for signs of nab-paclitaxel toxicity. The 
starting dose of nab-paclitaxel in the Segment I Continuous-Dosing Regimen will be 80 mg/m2, 
and the doses of nab-paclitaxel in subsequent cohorts may be increased or decreased based on 


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safety, PK, and tolerability data. Based on PK and safety data collected during the dose-finding 
phase of the study and reviewed by the DRC, careful dose escalation/de-escalation of 
CORT125134 is planned to ensure optimal antagonism of cortisol’s activity at the GR 
(see Section 3.3 for details), as CORT125134 is expected to increase paclitaxel concentration 
due to its CYP inhibition profile. 


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2 
STUDY OBJECTIVES 
These objectives will apply to all regimens evaluated during the study. 
Primary Objective 
• To determine the MTD and the development regimen of the combination of 
CORT125134 and nab-paclitaxel in patients with solid tumors.  
Secondary Objectives  
• To characterize the safety profile of the combination of CORT125134 and nab-paclitaxel.  
• To characterize the preliminary anticancer activity (objective response rate [ORR], 
progression-free survival [PFS], and OS) of the combination of CORT125134 and 
nab-paclitaxel in patients with solid tumors in a dose-finding phase and in patients with 
specific tumor types.  
• To characterize the preliminary anticancer activity (ORR, PFS, and OS) of the 
combination of CORT125134 and nab-paclitaxel in patients with GR-positive or 
GR-negative solid tumors enrolled in any part of the study. 
• To characterize the PK and exposure-response of the combination of CORT125134 and 
nab-paclitaxel in patients with solid tumors in a dose-finding phase and in patients with 
specific tumor types.  
• To characterize the PD of the combination of CORT125134 and nab-paclitaxel indicative 
of modulation of GR function, including hormonal changes and FKBP5. 
Exploratory Objectives 
• To evaluate molecular, cellular, and soluble markers in peripheral blood and/or tumor 
tissue that may be relevant to the mechanism of action of or response/resistance to 
CORT125134. 
• To evaluate pharmacogenomic (PG) markers to assess genetic factors affecting drug 
metabolism and transporters. 
 


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3 
STUDY DESIGN 
3.1 
Overview of Study Design 
This is a Phase 1/2 single-arm, open-label, multicenter study to determine the MTD and to assess 
safety, PK, PD, and preliminary anticancer activity of the combination of CORT125134 and 
nab-paclitaxel in patients with solid tumors. 
The study will consist of two segments to evaluate alternative dosing schedules of 
CORT125134: Segment I will evaluate a continuous-dosing regimen and Segment II will 
evaluate an intermittent-dosing regimen (Figure 3). In Segment I, dose-escalation cohorts will be 
enrolled to determine the maximum tolerated dose (MTD) and the development regimen for the 
continuous-dosing regimen; thereafter, dose-expansion cohorts will be enrolled and treated with 
the continuous-dosing development regimen to better characterize the antitumor activity in 
patients with specific tumor types and to better define the safety profile. In Segment II, dose-
escalation cohorts will be enrolled to determine the MTD and the development regimen for the 
intermittent-dosing regimen; thereafter, dose-expansion cohorts will be enrolled and treated with 
the intermittent-dosing development regimen to better characterize the antitumor activity of that 
regimen in patients with specific tumor types and to better define the safety profile for that 
regimen. Enrollment in Segment I and Segment II will be mutually exclusive, and the two 
segments will enroll patients concurrently.  
Figure 3 
Overview of Study Design Showing Segment I and Segment II Regimens 
 
 
The treatment cycle in each segment will consist of 28 days, and PK, PD, and safety evaluations 
will be performed throughout along with preliminary evaluations of antitumor activity as shown 
in the Schedule of Visits and Procedures (Table 9 for Segment I and Table 11 for Segment II). 
However, the doses and treatment schedules will be different in each segment of the study.  


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Dose escalation will be guided by safety and PK profiles. Safety will be assessed by review of 
AEs, including DLTs; clinical laboratory tests, vital signs, Eastern Cooperative Oncology Group 
(ECOG) performance status, physical examinations, and electrocardiograms (ECGs). Anticancer 
activity will be evaluated using radiographic assessments.  
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine response 
(Eisenhauer et al. 2009). Objective responses will be confirmed no less than 4 weeks after the 
criteria for response are first met (if possible, 4–6 weeks). In patients with ovarian, fallopian 
tube, or primary peritoneal cancer, CA-125 will be assessed at the time of radiologic tumor 
assessments (baseline and every 6–8 weeks) and response reported per Gynecological Cancer 
Intergroup (GCIG) criteria (Rustin et al. 2011) in addition to RECIST v1.1. Levels of other 
tumor markers collected as standard practice (such as cancer antigens 15-3 and 19-9 [CA15-3 
and CA19-9], prostate-specific antigen [PSA], and carcinoembryonic antigen [CEA]) will be 
documented. Patients will be followed for survival for a year after the last dose of study drug is 
administered in the final patient enrolled.  
3.1.1 Overview of Design:  Segment I Continuous-Dosing Regimen 
• Part 1, Dose-Finding Phase:  
– Patients with any solid tumor for whom nab-paclitaxel is an appropriate therapy in the 
opinion of the Investigator, will be enrolled according to a standard 3+3 cohort 
design. 
– The starting dose level will be 100 mg CORT125134, administered once daily (QD), 
in combination with 80 mg/m2 nab-paclitaxel administered on Days 1, 8, and 15 of a 
28-day cycle.  
– In Part 1 there will be a 1-week nab-paclitaxel lead-in (1 dose of nab-paclitaxel on 
Day 1) and a 1-week CORT125134 lead-in (CORT125134 daily for 7 days) before 
the start of Cycle 1, and then 28-day cycles consisting of CORT125134 daily for 
28 days plus nab-paclitaxel weekly for 3 weeks. 
– PK will be characterized after dosing with nab-paclitaxel alone, after 7 days of dosing 
with CORT125134 alone, and after dosing with the combination of nab-paclitaxel and 
CORT125134, in Cycle 1 only.  
– After a minimum of two dose levels are observed in Part 1, the nab-paclitaxel lead-in 
may be discontinued per DRC recommendation. If the nab-paclitaxel lead-in is 
discontinued, the first dose of study drug will be the CORT125134 dose on Day 1 of 
the CORT125134 lead-in. 
– The DRC will review safety, laboratory, and any available PK data from each cohort 
before selecting the dose for the next cohort. Dosing will follow the dose-finding 
Table 2 (see Section 3.3.1.1). DLTs will be identified at each dose level. The MTD 
and development regimen to be used in Part 2 will be determined. 
– A given dose level may be expanded to further evaluate safety, tolerability, PK, or 
preliminary efficacy at that dose level or in a more restricted patient population (ie 
see pancreatic cancer specific cohort). 
 


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• Part 2 Dose-Expansion Phase 
– Preliminary anticancer activity will be assessed in patients treated with the 
development regimen.  
– Patients in Part 2 will have the same dose schedule as patients in Part 1, but without 
the nab-paclitaxel lead-in.  
– Expansion cohorts will include approximately 20 patients in each, with a plan to 
evaluate the following tumor types: (1) platinum-resistant ovarian, fallopian tube, or 
primary peritoneal cancer and (2) triple-negative breast cancer (TNBC). Additional 
tumor types may be identified by data from Part 1, in which case additional expansion 
cohorts may be added by amendment. 
– PK will be characterized in Part 2 Cycle 1 only during treatment with combination 
nab-paclitaxel and CORT125134.  
 
3.1.2 Overview of Design:  Segment II Intermittent-Dosing Regimen 
• Part 1, Dose-Finding Phase: 
– Patients with any solid tumor, for whom nab-paclitaxel is an appropriate therapy in 
the opinion of the Investigator, will be enrolled according to a standard 3+3 cohort 
design. 
– The starting dose level will be 200 mg CORT125134 in combination with 100 mg/m2 
nab-paclitaxel. CORT125134 will be administered once daily on the day before, the 
day of, and the day after the nab-paclitaxel infusions that will be administered on 
Days 1, 8, and 15 of the 28-day cycle. 
– PK will be characterized in Cycle 1 only, during treatment with combination nab-
paclitaxel and CORT125134.  
– The DRC will review safety, laboratory, and any available PK data from each cohort 
before selecting the dose for the next cohort. Dosing will follow the dose-finding 
Table 3 (see Section 3.3.1.2). DLTs will be identified at each dose level. The MTD 
and development regimen to be used in Part 2 will be determined. 
 
• Part 2, Dose-Expansion Phase: 
– Preliminary anticancer activity will be assessed in patients treated with the 
development regimen.  
– Patients in Part 2 will have the same dose schedule as patients in Part 1. 
– Expansion cohort(s) will include approximately 20 patients in each, with a plan to 
evaluate triple negative breast cancer (TNBC). An expansion cohort of 20 patients 
with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer may be 
evaluated with the intermittent regimen, per the same selection criteria as provided 
for Segment I. Additional tumor types may be identified by data from Part 1, in which 
case additional expansion cohorts may be added by amendment. 
– PK will be characterized in Cycle 1 only, during treatment with combination nab-
paclitaxel and CORT125134. 
 


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3.2 
Overview of Methodology 
3.2.1 Segment I, Continuous-Dosing Regimen 
During Segment I, patients will have the following in-clinic visits: Screening; Baseline (if 
needed, see below); Days 1 and 2 of a 1-week nab-paclitaxel lead-in and Days 1 and 7 of a 
1-week CORT125134 lead-in before Cycle 1 (patients in Part 1); Cycle 1 Days 1, 8, and 15 (all 
patients) and Day 9 (patients in Part 1); Cycle ≥2 Days 1, 8, and 15; and a Posttreatment or Early 
Termination Visit. Study assessments are summarized below and provided in the Schedule of 
Visits and Procedures (Table 9). 
After signing the Institutional Review Board (IRB)-approved informed consent form (ICF) at a 
Screening Visit within 28 days before the first dose of study drug, patients will undergo 
screening procedures including review of inclusion and exclusion criteria, medical/oncologic 
history, safety assessments (AEs, physical examination, vital signs, ECOG performance status, 
ECG, and clinical laboratory tests), assessment of levels of PD biomarkers (ie, C-peptide, 
adrenocorticotropic hormone [ACTH], morning cortisol, and FKBP5), a tumor assessment per 
Response Evaluation Criteria in Solid Tumors (RECIST), and archival tumor tissue collection or 
tumor biopsy for determination of GR status. If the Screening Visit is >7 days before the first 
scheduled dose of study drug, selected screening procedures will be repeated at a Baseline Visit 
within 7 days before the first dose of study drug. Eligible patients will enroll in the study and 
will begin dosing with CORT125134 and nab-paclitaxel as described below. 
After completing Screening/Baseline assessments, patients in Part 1 of Segment I will return 
to the clinic to receive nab-paclitaxel as their first dose of study drug on Day 1 of a 1-week 
nab-paclitaxel lead-in. These patients will not receive study drug for the remainder of the nab-
paclitaxel lead-in. On the day after Day 7 of the nab-paclitaxel lead-in, they will receive the first 
dose of CORT125134 as part of a 1-week CORT125134 lead-in prior to Cycle 1 (CORT125134 
daily for 7 days) followed by 28-day cycles of the combination regimen (CORT125134 daily for 
28 days plus nab-paclitaxel weekly for 3 weeks). After a minimum of two dose levels are 
observed, the nab-paclitaxel lead-in may be discontinued per the DRC recommendation. 
Patients in Part 2 of Segment I will not have the 1-week nab-paclitaxel lead-in and will receive 
CORT125134 as their first dose of study drug. After Screening/Baseline, these patients will 
return to the clinic to receive CORT125134 during a 1-week lead-in prior to Cycle 1 
(CORT125134 daily for 7 days) followed by 28-day cycles of the combination regimen 
(CORT125134 daily for 28 days plus nab-paclitaxel weekly for 3 weeks).  
Patients will have safety assessments performed at all scheduled in-clinic visits, PK assessments 
during the 1-week lead-ins for patients in Part 1 only and during Cycle 1 for all patients, and PD 
assessments during Cycle 1. Serial PK sampling will be performed for patients in Part 1 and in 
Part 2.  
The study design scheme showing the dose schedule and planned PK sampling for patients in 
both parts of Segment I is shown in Figure 4.  


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Figure 4 
Segment I Continuous-Dosing Regimen:  
Schematic of Study Drug Dosing and Pharmacokinetic Sampling Schedule  
 
Abbreviations: Nab-Pac, nab-paclitaxel; PK, pharmacokinetic. 
3.2.2 Segment II, Intermittent-Dosing Regimen 
During Segment II, patients will have the following in-clinic visits: Screening; Baseline/ 
CORT125134 Lead-in (Day −1); Cycle 1 Days 1, 2, 8, and 15 (all patients); Cycle ≥2 Days 1, 8, 
and 15; and a Posttreatment or Early Termination Visit. Study assessments are summarized 
below and provided in the Schedule of Visits and Procedures (Table 11). 
After signing the IRB-approved ICF at a Screening Visit within 28 days before the first dose of 
study drug, patients will undergo the same screening procedures as outlined for Segment I. If the 
Screening Visit is >7 days before the first scheduled dose of study drug, selected screening 
procedures will be repeated at the Baseline Visit before the first dose of CORT125134. Eligible 
patients will enroll in the study and will begin dosing with CORT125134 and nab-paclitaxel as 
described below. 
Patients in Parts 1 and 2 of Segment II will follow the same schedule. After completing 
Screening assessments, patients will visit the clinic on Day −1 to complete their Baseline 
assessments then take their first dose of CORT125134. They will return to the clinic on Day 1 of 
Cycle 1 to receive their first infusion of nab-paclitaxel in combination with CORT125134, which 
is the start of the 28-day regimen of CORT125134 and nab-paclitaxel. 
Patients will have safety assessments performed at all scheduled in-clinic visits, and serial PK 
assessments during the first 24 hours (ie, Day 1 predose through predose on Day 2) and on Day 
15 of Cycle 1 only. The study design scheme showing the dose schedule and planned PK 
sampling for patients in both parts of the Segment II is presented in Figure 5.  


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Figure 5 
Segment II Intermittent-Dosing Regimen:  
Schematic of Study Drug Dosing and Pharmacokinetic Sampling Schedule 
 
 
3.2.3 Segments I and II:  Assessments 
Tumor assessments will occur at Screening (and Baseline if >28 days elapse between Screening 
and Cycle 1 Day 1), at the end of Cycle 2, and thereafter every 6–8 weeks and at time of 
suspicion of disease progression. Confirmation of response will be done as needed as per 
RECIST (see Section 7.2). In patients with ovarian, fallopian tube, or primary peritoneal cancer, 
CA-125 will be assessed at the time of radiologic tumor assessments (baseline and every 6–8 
weeks) and response reported per GCIG criteria (Rustin et al. 2011) in addition to RECIST v1.1.  
Patients will continue treatment in 28-day cycles until unacceptable toxicity, disease progression, 
or another withdrawal criterion is met (see Section 6.7). For patients with ovarian, fallopian tube, 
or primary peritoneal cancer, PFS will be based on RECIST 1.1 and progression should not be 
determined early based on increased CA-125 alone. 
A Posttreatment Visit for safety will be scheduled within 28 ±7 days after the last dose of study 
drug. Tumor assessment will be done at this visit if ≥4 weeks have elapsed since the prior tumor 
assessment and progressive disease has not been documented.  
Patients will be contacted by telephone to monitor for survival on a quarterly basis for 1 year 
after the last dose of study drug (CORT125134 or nab-paclitaxel, whichever is latest) in the last 
patient on treatment.  
3.3 
Dose-Finding Phase (Part 1) 
Approximately 62 patients with solid tumors for whom nab-paclitaxel is appropriate therapy will 
be enrolled in Segment I, Part 1 and approximately 24 in Segment II, Part 1. The number of 
patients will depend on the number of dose levels assessed and the DLTs observed.  
3.3.1 Dose Levels 
3.3.1.1 
Dose Levels in Segment I 
In Segment I, the starting dose in Part 1 is 100 mg CORT125134 in combination with 80 mg/m2 
nab-paclitaxel. CORT125134 dose escalation will proceed by a maximum of 50 mg per dose 
level. Example target dose levels for evaluation in Segment I, Part 1 are shown in Table 2. The 


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starting dose of 100 mg CORT125134 is at the low end of the anticipated range of doses, yet 
retains the potential for PD effect. The starting dose of 80 mg/m2 nab-paclitaxel is at the lower 
end of the range for a standard dose of nab-paclitaxel. With the starting dose level set in a 
conservative manner, the plan is to escalate the investigational product, CORT125134, 
sequentially in 50 mg increments through the dose-finding phase of the study. 
Table 2 
Segment I Continuous Dosing: Example Dose-Finding Table  
of CORT125134 / Nab-paclitaxel Dose Levels for Part 1  
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose a 
(mg/m2) 
−1  
50 
80 
1 Starting dose 
100 
80 
2 
150 
80 
3 
200 
80 
4 
250 b 
80 
a Taking the nab-paclitaxel exposure and safety data into account, the nab-paclitaxel dose may be increased to 100 
mg/m2 or decreased to 60 mg/m2. Nab-paclitaxel and CORT125134 will not be escalated simultaneously; 
therefore, an increase in dose for nab-paclitaxel would constitute a separate dose level. 
b Doses may exceed 250 mg CORT125134 based on safety and PK data and DRC recommendation. 
 
3.3.1.2 
Dose Levels in Segment II 
In Segment II, the starting dose level in Part 1 is 200 mg CORT125134 in combination with 
100 mg/m2 nab-paclitaxel. CORT125134 dose escalation is expected to proceed by 100 mg per 
dose level (Table 3). However, CORT125134 doses may be escalated in 50 mg increments if 
recommended by the DRC. In Segment II, the DRC may recommend modifying the 
nab-paclitaxel dose to 80 mg/m2 based on the nab-paclitaxel exposure and safety data. As noted 
above, enrollment in Segment I and Segment II will be mutually exclusive, and the two segments 
will enroll patients concurrently. 
Table 3 
Segment II Intermittent-Dosing Regimen: Example Dose-Finding Table  
of CORT125134 / Nab-paclitaxel Dose Levels for Part 1 
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose  
(mg/m2) 
−1 
150 
100 
1 – Starting dose 
200 
100 
2 
300 
100 
3 
400 a 
100 
a Doses may exceed 400 mg CORT125134 based on DRC recommendation. 
Nab-paclitaxel may be dose reduced or dosed increased based on PK and DDI findings. 
CORT125134 doses may change in 50, or 100 mg increments based on DRC recommendations. 
 


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3.3.2 Dose-Finding Process 
Dose-finding decisions including selection of dose levels for cohorts, determination of the MTD 
and development regimen, and stopping enrollment, as applicable, will be performed by a DRC 
(Section 3.5). The key principles guiding DRC recommendations for dose levels in dose-finding 
are to ensure that patients receive nab-paclitaxel at therapeutic exposures and to sequentially 
increase the dose of CORT125134 as tolerated.  
Dose escalation or de-escalation will occur only after review of data from the first cohort by the 
DRC. If a lower dose level is explored and is well tolerated, the DRC may recommend re-
escalating either CORT125134 or nab-paclitaxel. 
During the Part 1 Dose-Escalation Phase, on review of safety, laboratory, and available PK data 
from each cohort, the DRC may recommend proceeding to the next dose level per Table 2 for 
Segment I and per Table 3 for Segment II. Alternatively, taking PK and safety data into account, 
the DRC could recommend modifying the nab-paclitaxel dose (eg, with an increase to 
100 mg/m2 or a decrease to 60 mg/m2 in Segment I) for reasons including: 
• Dose finding requires greater resolution to the titration of nab-paclitaxel exposure than 
may be induced by changes in dose of CORT125134 due to significant metabolic 
interaction (eg, increasing nab-paclitaxel dose by one step would increase nab-paclitaxel 
exposure to a lesser degree than increasing CORT125134 dose by one step). 
• There is no significant metabolic interaction between CORT125134 and nab-paclitaxel. 
• An AE profile is encountered that is not suggestive of a nab-paclitaxel effect and hence 
may be attributed to CORT125134. 
For dose escalation, either CORT125134 or nab-paclitaxel, but not both, will be changed in the 
next dose level, based on recommendations by the DRC. If a lower dose level is explored and is 
well tolerated, the DRC may recommend re-escalating either CORT125134 or nab-paclitaxel. 
All patients in the Part 1 Dose-Escalation cohorts in Segment I and Segment II will be treated 
with CORT125134 plus nab-paclitaxel and assessed for 1 cycle. Approximately 5 patients may 
be initially enrolled in a cohort, and non-DLT evaluable patients may be replaced to allow for a 
minimum of 3 evaluable patients for each cohort. Depending on the number of patients with 
DLTs, additional patients will be enrolled in the same cohort or additional cohorts will be 
enrolled following the criteria described in Table 4.  


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Table 4 
Rules for Dose-Finding to Define Maximum Tolerated Dose in Part 1 of 
Segments I and II 
No. of Evaluable Patients with DLT  
at a Dose Level (cohort of 
<6 evaluable patients) 
Dose-Escalation Decision Rule in Cycle 1 
0  
• Enroll cohort at next higher dose level.  
1  
• Expand current dose level to 6 patientsa 
• If 1 of 6 patients (<33%) experiences DLT, enroll cohort at next 
higher dose level.  
• If ≥2 of 6 patients ( ≥33%) experience DLT: 
– Enroll cohort at next lower dose level, if available.  
OR 
– Declare next lower dose level as the MTD. 
≥2  
• If ≥2 patients experience DLT: 
– Enroll cohort at next lower dose level, if available.  
OR 
– Declare next lower dose level as the MTD. 
Abbreviations: DLT, dose-limiting toxicity; MTD, maximum tolerated dose 
a The DRC may make the recommendation to adjust the size of a cohort to more than 6 patients to further 
the evaluation of a given dose level, such as further evaluation of PK data or tolerability. If cohorts are 
>6 patients, the decision rule will be based on the percentage of patients experiencing DLT within that cohort. 
 
The MTD is defined as the highest dose at which <33% (eg, 0 of 3 or 1 of 6 patients, with a 
minimum of 6 patients if 1 DLT is observed) experiences a DLT during Cycle 1. Alternatively, a 
different (lower) dose level may be declared the MTD depending on the nature, severity, and 
frequency of toxicities to date. Safety data that become available for patients remaining on-study 
after Cycle 1 will be taken into consideration when making decisions about dose escalation.  
The dose level selected for the development regimen may be equal to or lower than the MTD and 
its selection will take into account other issues such as safety data occurring after the first cycle.  
A sufficient number of patients will be enrolled in each cohort to ensure that there are 
DLT-evaluable patients available for determination of the MTD and identification of the 
development regimen. The number of DLT-evaluable patients may be inclusive of all cohorts at 
that dose level and schedule (such as advanced solid tumor and pancreatic cancer cohorts in 
Segment I) for determination of the MTD or dose-finding decisions, per DRC recommendation. 
If two distinct DLTs, such as events occurring in different MedDRA system organ classes, are 
observed within a dose level, the DRC may recommend expanding the cohort to >6 patients to 
further evaluate the tolerability of that dose level. 
• DLT-evaluable patients will include those who complete one cycle of treatment or those 
who withdraw from the study due to toxicity during Cycle 1.  
• Non-evaluable patients will include patients who withdraw from the study prior to 
completion of Cycle 1 for reasons other than toxicity (eg, lost to follow-up, withdrawal of 


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consent, disease progression, or receipt of ≤80% of CORT125134 dosing due to reasons 
other than toxicity); these patients may be replaced.  
• PK for patients with a history of GI resection or gastric bypass surgery will be considered 
separately from the remainder of the cohort. The safety data for these patients will be 
taken into consideration in the assessment of the overall tolerability of a given cohort. A 
minimum number of patients evaluable for DLT will be enrolled to a cohort to consider 
the tolerability at this dose level who don’t have a history of GI resection/gastric bypass 
surgery. 
 
Based on safety data from the initial dose-finding cohorts, the DRC may recommend following 
an alternative dose-finding strategy that evaluates any of the dose levels in the planned Part 1 
phases with inclusion of granulocyte colony-stimulating factor (G-CSF). 
• A given dose level may be expanded to further evaluate safety, tolerability, PK, or 
preliminary efficacy at that dose level or in a more restricted patient population.  
• A dose of CORT125134 100 mg continuous dosing and nab-paclitaxel 60 mg/m2 with 
prophylactic G-CSF support will be explored in patients with pancreatic cancer. Initially, 
approximately 6–8 patients will be enrolled in this cohort. The DRC will review the 
safety and tolerability after 6 DLT-evaluable patients complete 1 cycle of therapy. If the 
dose-limiting toxicity (DLT) rate exceeds 33%, the dose will be declared non-tolerable 
for this population (tumor type and similar line of therapy) and no additional patients will 
be enrolled to that cohort. Alternatively, a higher or lower dose level may be evaluated, 
per the recommendation of the DRC based on safety and PK data. Once the dose level is 
declared tolerable, the cohort will be expanded to include approximately 12–15 additional 
patients to further assess the safety and efficacy of this dose level. Safety and efficacy 
data from all pancreatic cancer patients receiving this dose level will be summarized. The 
DRC will take into consideration the overall tolerability and toxicities observed in this 
cohort(s) to inform dose escalation decisions and the recommended Phase 2 dose. 
 
3.3.3 Dose-limiting Toxicity 
The DLT evaluation period is from the first dose of CORT125134 through the completion 
of Cycle 1 during Part 1 of Segment I (Figure 4) and Segment II (Figure 5) of the study. 
Dose-limiting toxicities are defined below and dose-modification guidelines are provided in 
Section 5.4. 
For non-hematological events, a DLT is defined as any TEAE not attributable to disease or 
disease-related processes that occurs during the observation period (Cycle 1) and that: 
• Is Grade 3 or higher according to National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI-CTCAE) v4.03, excluding the exceptions listed below.  
or  
• Results in a dose omission or > 1-week delay of nab-paclitaxel. 
Note: if a >1-week delay of nab-paclitaxel occurs for logistical reasons, it will not be 
considered a DLT. 
 


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Exceptions include the following non-hematological AEs that are not considered DLTs: 
• Grade 3 fatigue lasting <7 days. 
• Rigors lasting <24 hours. 
• Grade ≥3 nausea or vomiting that has resolved to Grade ≤2 within 48 hours after standard 
antiemetic therapies. 
• Grade 3 diarrhea that has resolved to Grade ≤2 within 48 hours after standard 
antidiarrheal therapies  
and/or 
• Isolated laboratory findings not associated with signs or symptoms including Grade 3/4 
ALP, uric acid, amylase, and lipase elevations, and Grade 3 hyponatremia lasting 
<72 hours. 
 
The following non-hematological AEs are considered DLTs: 
• Any elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 
≥10 × upper limit of normal (ULN) lasting more than 3 days with discontinuation of 
therapy. 
• Any elevation of AST or ALT >20 × ULN. 
• Any elevation of AST and ALT >3 × ULN associated with serum bilirubin >2 × ULN 
without evidence of another cause for the hyperbilirubinemia is a DLT requiring 
immediate discontinuation of all study therapy. 
 
For hematologic events, a DLT is defined as follows: 
• Grade 4 neutropenia lasting >7 days. 
• Grade ≥3 febrile neutropenia (ANC <1000 cells/mm3 with a single temperature of 
>38.3°C or a sustained temperature of ≥38°C for more than 1 hour). 
• Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia lasting >7 days or associated 
with Grade ≥2 bleeding 
and/or  
• Dose delay >7 days of scheduled chemotherapy secondary to myelosuppression.  
 
3.4 
Dose-Expansion Phase (Part 2) 
In both Segment I and Segment II, enrollment in Part 2 (dose-expansion) will occur once the 
development regimen has been identified in Part 1. Approximately 20 patients will be enrolled in 
each cohort in Part 2. Expansion cohorts of patients are planned with the following tumor types:  
(1) platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer or (2) TNBC.  
In both Segment I and Segment II, based on data obtained from Part 1, additional expansion 
cohorts may be enrolled (by amendment), each with approximately 20 patients with specific 
advanced or metastatic cancer tumor types. In each dose-expansion cohort, patients will be 
treated with CORT125134 and nab-paclitaxel at the development regimen selected for either 
continuous or intermittent dosing in repeated 28-day cycles until progression or another 
withdrawal criterion is met.  


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3.5 
Data Review Committee (DRC) 
A DRC consisting of at least one Investigator from each site experienced in evaluating oncology 
treatments, a clinical pharmacologist, and the Medical Monitor will perform safety monitoring of 
the study treatment in accordance with procedures detailed in a DRC Charter.  
During both Segment I and Segment II, the DRC will convene before each planned dose 
escalation during the dose-finding phase (Part 1), at least every 6 months during the dose-
expansion phase of the study (Part 2), and on an ad hoc basis as necessary throughout study 
conduct. The DRC will perform the following tasks:  
• Evaluate suspected DLTs, using defined criteria (see Section 3.3.3) for adjudication of 
treatment-related AEs; 
• Determine the appropriateness of dose escalation or dose de-escalation and cohort 
expansion based on all available data leading to a specific recommendation for the next 
dose to be evaluated during the dose finding phase;  
• Make recommendations to hold dosing or enrollment, or to adjust the size of any cohort 
as needed to further evaluate safety, tolerability, PK, or preliminary efficacy at a given 
dose level or in a more restricted patient population; 
• Make recommendations to adjust the size of any cohort as needed to obtain more PK data 
(eg, at the development regimen); 
• Make recommendations to end dosing or enrollment; 
• Make recommendations to enroll specific cohort(s) in dose-finding to investigate the use 
of G-CSF at a dose level associated with high rates of neutropenia. Once a cohort is 
defined as a G-CSF cohort, the rules for G-CSF usage may be carried forward to 
additional cohorts at the recommendation of the DRC. 
• Monitor emerging PD, PK, and clinical activity data throughout the dose-finding phase 
(Part 1) and make recommendations regarding the dose and schedule of CORT125134, 
the schedule of CORT125134 and nab-paclitaxel (ie, the development regimen) to be 
evaluated in the dose-expansion phase of the study (Part 2).  
• If supported by data, the DRC may recommend changes to schedule of dosing with nab-
paclitaxel (ie every other week schedule or two out of three week schedule) in a 
subsequent cohort. 
• The DRC may recommend dose titration of either CORT125134 or nab-paclitaxel to 
optimize exposure and tolerability. If dose titration is instituted, feasibility of that dose 
level will be assessed over the number of cycles during which titration occurs. 
 
In the event that a decision is made by the Sponsor to reject a safety recommendation by the 
DRC, the decision and rationale will be communicated to the FDA and site IRBs before enrolling 
additional patients.  


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4 
STUDY POPULATION AND ENTRY CRITERIA 
4.1 
Number of Patients  
Approximately 146 patients are planned; estimates are as follows:  
• Segment I Continuous-Dosing Regimen—Part 1, approximately 62 patients; In addition 
to the standard dose finding process, approximately 6–8 patients with pancreatic cancer 
will be enrolled in Part 1 at a dose level of CORT125134 100 mg continuous dosing and 
nab-paclitaxel 60 mg/m2 with prophylactic G-CSF. The DRC will review the safety and 
tolerability after 6 DLT-evaluable patients complete 1 cycle of therapy. If the dose-
limiting toxicity (DLT) rate exceeds 33%, the dose will be declared non-tolerable for this 
population (tumor type and similar line of therapy) and no additional patients will be 
enrolled to that cohort. Alternatively, a higher or lower dose level may be evaluated, per 
the recommendation of the DRC based on safety and PK data. Once the dose level is 
declared tolerable, the cohort will be expanded to include approximately 12–15 additional 
patients to further assess the safety and efficacy of this dose level. 
Part 2, approximately 20 patients in each expansion cohort (eg, 20 TNBC patients, 
20 patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer) 
• Segment II Intermittent-Dosing Regimen—Part 1, approximately 24 patients; Part 2, 
approximately 20 patients in the expansion cohort (eg, 20 TNBC patients) 
 
The following study entry criteria apply to both Segment I and Segment II. 
4.2 
Inclusion Criteria 
Each patient must meet the following criteria to be enrolled in the study: 
For All Patients 
1. Signed and dated IRB-approved informed consent form (ICF) prior to study-specific 
screening procedures. Note: standard-of-care assessments completed before the ICF is 
signed can be used for eligibility if done within the 28-day screening period. 
2. Consent to provide archived tumor tissue (primary or metastatic) or pretreatment tumor 
biopsy if available for the purpose of staining for GR status. Note: Neither tissue sample 
nor immunohistochemistry (IHC) results are required prior to starting study treatment due 
to potential delays in obtaining tumor block or results from GR assay. Tumor biopsy 
sample proximal to study entry in addition to archived tumor tissue is preferred. 
3. Age ≥18 years old. 
4. Patients with advanced or metastatic solid tumors who have disease progression after 
treatment with available therapies that are known to confer clinical benefit, or who are 
intolerant to treatment and for whom nab-paclitaxel treatment is appropriate. 
5. Up to 3 prior cytotoxic chemotherapeutic regimens or myelosuppressive therapies in the 
advanced setting. (Hormonal or nonmyelosuppressive biologic, targeted, or immune 
therapies will not be counted toward the maximum lines of prior therapy.) 
6. ECOG performance status 0 or 1. 
7. Organ and marrow function meeting the following criteria at the Screening Visit: 
– Absolute neutrophil count (ANC) ≥1,500 cells/mm3 


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– Platelet count ≥100,000/mm3 
– Hemoglobin ≥9 g/dL 
– AST or ALT ≤2.5 × ULN (or ≤5 × ULN in the context of liver metastasis) 
– Total bilirubin ≤1.5 × ULN 
– Serum creatinine ≤1.5 × ULN 
– or 
– Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above 
institutional normal. 
8. For female patients of childbearing potential, a negative pregnancy test. Female study 
patients of childbearing potential and male study patients with female partners of 
childbearing potential must be willing to use two effective methods of contraception (one 
of which is a barrier method) during the treatment period and for at least 3 months after 
the last dose of the study drug. Hormonal contraceptives are not permitted (hormonal 
intrauterine device [IUD] is acceptable). 
9. Ability to take oral medications. 
10. Albumin ≥3.0 g/dL (≥30 g/L) 
11. If patient has undergone gastric bypass surgery and/or surgery of GI or hepatobiliary 
tract, the patient must demonstrate adequate absorption as evidenced by: albumin ≥3.0 
g/dL, controlled pancreatic insufficiency (if present), lack of evidence of malabsorption,  
 
For Patients in Dose-Finding Part 1 
12. Measurable or evaluable disease. 
 
For patients enrolled in a specific dose-finding cohort in Part 1 limited to diagnosis of pancreatic 
cancer. 
13. Histologically confirmed diagnosis of pancreatic adenocarcinoma. Patients with 
pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are 
not eligible.  
14. CA19-9 (or CEA, CA-125 in non-CA 19-9 elevated tumors) measured within 14 days 
prior to first dose of study drug 
15. Metastatic (non-irradiated) lesion that is measurable by RECIST 1.1 
 
For Patients in Dose-Expansion Part 2 
For all patients in Part 2  
16. Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer or TNBC that, in 
the opinion of the Investigator, is appropriate to treat with nab-paclitaxel. 
 
For patients in Part 2 with ovarian, fallopian tube, or primary peritoneal cancer only 
17. Must have a histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian 
tube cancer or ovarian carcinosarcoma. Note: mucinous and borderline histologic 
subtypes are excluded. 


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18. Treatment-free interval after platinum-based therapy of less than 12 months, or disease 
progression during platinum-based therapy. 
19. Measurable or nonmeasurable disease. Previously irradiated lesions are not allowed as 
measurable disease, unless there is documented evidence of progression in the lesions. To 
be eligible with nonmeasurable disease, patients must have evaluable disease with cancer 
antigen 125 (CA-125) levels of ≥100 U/mL along with radiographically evaluable disease 
by computed tomography (CT) or magnetic resonance imaging (MRI). A minimum of 
10 patients with measurable disease will be enrolled. 
 
For patients in Part 2 with TNBC only 
20. Histologically confirmed diagnosis of TNBC: Triple-negative for ER and PR (<1% cells 
positive for ER/PR) and HER2 per the American Society of Clinical Oncology/College of 
American Pathologists (ASCO/CAP) Guidelines (Wolff et al. 2013) (HER2 test results 
show [a] IHC 1+ negative or IHC 0 negative or [b] in situ hybridization [ISH]-negative 
using single-probe ISH or dual-probe ISH)  
21. Measurable disease as defined by RECIST v1.1 in at least one lesion. Previously 
irradiated lesions are not allowed as measurable disease, unless there is documented 
evidence of progression in the lesions. 
 
4.3 
Exclusion Criteria 
Patients who meet any of the following criteria will not be permitted entry to the study: 
1. Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in 
the opinion of the Investigator has not resolved to Grade 1 or less prior to the first dose of 
study drug (ie, Day 1 of the first scheduled 1-week lead-in). 
2. Clinically significant uncontrolled condition(s) or any medical condition which in the 
opinion of the study investigator places the subject at an unacceptably high risk for 
toxicities, or puts the patient at high risk for not completing the DLT evaluation period of 
the study. 
3. Any major surgery within 4 weeks prior to the first dose of study drug (ie, Day 1 of the 
first scheduled 1-week lead-in). 
4. Treatment with the following prior to the first dose of study drug (ie, Day 1 of the first 
scheduled 1-week lead-in): 
– An investigational product within 21 days or 5 half-lives, whichever is longer. 
– Systemic, inhaled, or prescription strength topical corticosteroids for the purposes of 
treating a chronic non-oncologic indication within 21 days. 
– Systemic cytotoxic agents within 21 days. 
– Monoclonal antibodies (eg, pembrolizumab, nivolumab) or anticancer vaccines 
within 60 days. 
– Hormonal anticancer therapies within 7 days. 
5. Requirement for treatment with chronic or frequently used oral corticosteroids for 
medical conditions or illnesses (eg, rheumatoid arthritis, immunosuppression after organ 
transplantation). 


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6. History of significant cardiac disease defined as New York Heart Association (NYHA) 
class III or IV, myocardial infarction (MI) within 6 months of first dose of study drug, or 
unstable angina within 6 months of first dose of study drug.  
7. Pregnancy or breast feeding. 
8. History of hypersensitivity or severe reaction to either study drug or to similar classes of 
either study drug. 
9. Any intercurrent medical condition that in the opinion of the Investigator would confound 
study analysis or impair study participation or cooperation. 
10. Any patient requiring chronic maintenance of white blood cell counts or granulocyte 
counts through the use of growth factor support (eg, Neulasta, Neupogen) or transfusion 
for red blood cell (RBC) or platelet support. 
 
4.4 
Concomitant Medications/Treatments 
4.4.1 Supportive Care with Granulocyte–Colony-Stimulating Factor 
Dosing with filgrastim 5 µg/kg/day (subcutaneous administration) is allowed per protocol after 
Cycle 1 of both study segments. It may be used to provide G-CSF support for a patient with 
clinically meaningful neutropenia (ANC <1500 cells/µL) on study. The use of G-CSF during 
Part 1 Cycle 1 of Segment I or II should be avoided because G-CSF can confound the assessment 
of DLTs.  
Additionally, G-CSF may be used as therapy in a specific G-CSF cohort, but only if the DRC 
recommends evaluation of a G-CSF cohort based on data from earlier cohorts. In this case, use of 
G-CSF in cycle 1 does not interfere with a patient’s DLT evaluable status. 
Filgrastim will be administered, when clinically appropriate, at least 24 hours after completion of 
dosing with nab-paclitaxel, and greater than or equal to 24 hours prior to the next treatment with 
nab-paclitaxel. In the case of a G-CSF cohort, the filgrastim would be administered according to 
above prescribing information within Cycle 1 or administered within a cohort prophylactically.  
4.4.2 Permissible Medications/Treatments 
Permitted treatments include palliative and supportive care for disease-related symptoms and 
standard therapies for concurrent medical conditions. Prophylactic anti-emetics may include 
ondansetron and/or other therapies as appropriate.  
The Investigator may prescribe treatment at his/her discretion in the interests of patient safety 
and acceptable standards of medical care. However, at this stage in the drug development 
program, available data relating to the possibility of drug-drug interactions are limited (see 
Section 4.4.4). In prescribing new medication or changing the dose of an existing concomitant 
medication, the Investigator must consider the general guidance provided herein, specific 
guidance provided in the IB, and the balance of risk to benefit for the individual patient. If a 
prohibited medication is required (see Section 4.4.3), the patient should be withdrawn from the 
study, unless the Investigator, in agreement with the Medical Monitor, considers the benefits of 
remaining in the study outweigh the risks. 


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4.4.3 Prohibited and Restricted Medications/Treatments 
Prohibited Medications—The following treatments are not allowed: 
• Treatment for cancer: any concurrent chemotherapy, radiotherapy, hormonal therapy, 
immunotherapy, or other systemic therapy other than the study drugs. (Hormonal therapy 
with GnRH agonists or surgical castration >3 months before study entry is not 
exclusionary). 
• Other investigational products. 
• Hormonal contraception (hormonal intrauterine device [IUD] is acceptable). 
Restricted Medications—The following treatments are allowed within limits: 
• The use of G-CSF during Part 1, Cycle 1, of any segment should be avoided because 
G-CSF can confound the assessment of DLTs. If G-CSF is used during the DLT 
evaluation period in absence of a protocol-defined DLT and in the absence of being 
prespecified as a G-CSF-cohort, the patient will be non-evaluable for the DLT 
assessment. The patient may continue on the study and will be included in the overall 
assessment of tolerability and response. 
• Transfusional support (packed RBC or platelets) during Part 1, Cycle 1, of any segment 
should be avoided unless clinically required. If transfusional support is used in absence of 
a protocol-defined DLT, the patient will be non-evaluable for the DLT assessment.  
• Corticosteroids: 
– Systemic corticosteroids. Short courses of prednisone (<100 mg per day for ≤14 days) 
for rash or non–cancer-related reasons are permitted if clinically required. 
CORT125134 treatment should be withheld during corticosteroid administration, and 
the Medical Monitor should be notified.  
– For patients requiring IV corticosteroids for treatment of intractable nausea and 
vomiting, the Medical Monitor should be contacted to discuss whether the patient 
should be continued in the study. 
– In addition, potent (Group III) topical corticosteroids should be used with caution due 
to the potential for systemic absorption, and the Medical Monitor should be contacted 
to discuss the treatment approach. 
4.4.4 Medications Having Potential Drug-Drug Interactions 
The following treatments should be used with caution due to potential drug-drug interactions: 
• CORT125134 has been shown to inhibit the activity of CYP3A4 and CYP2C8 (see 
Section 1.3.2.2) and may inhibit CYP3A5, CYP2C9, CYP2C19, and CYP2D6. Drugs 
metabolized by these isozymes, particularly drugs with a narrow therapeutic ratio, should 
be used with caution.  
• The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be 
exercised when administering nab-paclitaxel concomitantly with medicines/food known 
to inhibit (eg, ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, 
gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir, and grapefruit, 
grapefruit juice, or grapefruit-containing products) or induce (eg, rifampicin, 
carbamazepine, phenytoin, efavirenz, and nevirapine) either CYP2C8 or CYP3A4. 


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4.4.5 Management of Signs of Excessive GR Antagonism 
As noted in Section 1.1.2.3, there is the possibility that patients could experience signs or 
symptoms related to excessive GR antagonism. If signs and/or symptoms of excessive GR 
antagonism such as malaise, fatigue, lethargy, weakness, anorexia, nausea, vomiting, 
abdominal pain, altered mental status, or hypoglycemia are present, particularly if co-existent, 
treatment with CORT125134 should be interrupted and the Medical Monitor should be consulted 
to assist in evaluating whether treatment should continue. If excessive GR antagonism is 
suspected, standard supportive care (including fluid resuscitation as indicated) and medical 
therapy should be administered without delay. Systemic administration of corticosteroids should 
be considered (eg, dexamethasone 4 mg daily for 3 days and then tapered by 1 mg per day, or as 
indicated based on clinical response). Full clearance of CORT125134 is expected in 3–5 days 
(5 half-lives). In the event of significant trauma or surgery through 28 days after the last dose of 
CORT125134, supplemental glucocorticoids and appropriate medical care may be needed to 
prevent excessive GR antagonism that may arise due to increased cortisol requirements in the 
perioperative period. 




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5.2.1 Segment I, Continuous-Dosing Regimen 
• CORT125134 is administered orally once daily in the morning for 7 days in a 1-week 
lead-in prior to Cycle 1 and once daily in the morning for 28 days during each 28-day 
cycle, preferably at the same time each day.  
– On the days nab-paclitaxel is administered, CORT125134 should be taken within 
15 minutes before the start of nab-paclitaxel infusion.  
– On in-clinic visit days, CORT125134 should not be taken at home but brought to the 
clinic and taken after any scheduled predose PK samples are drawn. 
• Nab-paclitaxel is administered by IV infusion over 30 minutes (±5 minutes) on Day 1 of 
a 1-week nab-paclitaxel lead-in for patients in Part 1 and on Days 1, 8, and 15 of each 
28-day cycle for all patients. Nab-paclitaxel infusions must be no less than 7 days apart. 
After a minimum of two dose levels are observed, the nab-paclitaxel lead-in may be 
discontinued per the DRC recommendation. 
5.2.2 Segment II, Intermittent-Dosing Regimen 
• CORT125134 is administered orally once daily in the morning the day before, the day of, 
and the day after nab-paclitaxel infusion.  
– On the days nab-paclitaxel is administered, CORT125134 should be taken within 
15 minutes before the start of nab-paclitaxel infusion.  
– On in-clinic visit days, CORT125134 should not be taken at home but brought to the 
clinic and taken after any scheduled predose PK samples are drawn. 
• Nab-paclitaxel is administered by IV infusion over 30 minutes (±5 minutes) on Days 1, 8, 
and 15 of each 28-day cycle for all patients. Nab-paclitaxel infusions must be no less 
than 7 days apart.  
5.3 
Duration of Patient Participation 
Patients completing Cycle 1 will receive subsequent treatment in repeated 28-day cycles. 
Patients may remain on treatment until they experience disease progression or unacceptable 
toxicity, until they meet any of the withdrawal criteria (Section 6.7), or until the study is 
terminated by the Sponsor. 
5.4 
Intrapatient Dose Modifications and Delays 
The following are guidelines for dose reduction and delay of CORT125134 in combination with 
nab-paclitaxel.  
If in the Investigator’s opinion a DLT (see Section 3.3.3) or Grade 3 or 4 toxicity occurs that is 
not disease-related, the Investigator should interrupt or modify administration of only the drug 
responsible for the toxicity following the guidelines below. If the toxicity does not resolve to 
Grade 1 or baseline severity, if Grade 2 toxicity was present at baseline, after interruption of only 
one study treatment, then both CORT125134 and nab-paclitaxel could be interrupted until the 
toxicity resolves to Grade 1 or baseline, if Grade 2 toxicity was present at baseline. 


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5.4.1 Dose Modifications/Dose Delays for Nab-paclitaxel 
After Cycle 1 Day 1, if there is a delay in nab-paclitaxel administration for any reason, the 
following apply:  
• If delayed by 3 days or less, all subsequent doses for this course will be delayed to keep 
weekly spacing between doses.  
If an infusion is delayed by more than 3 days, that dose may be skipped, and the patient may 
resume treatment with the next scheduled infusion if appropriate in the judgment of the PI. If 
treatment with nab-paclitaxel is delayed for more than 4 weeks (omission of nab-paclitaxel for > 
28 days), the Medical Monitor should be notified.  
Intrapatient nab-paclitaxel dose reductions should be made based on observed toxicities 
secondary to treatment. Sequential dose reductions may be made at the discretion of the 
Investigator. A maximum of two dose reductions are allowed. 
Neutropenia 
Cycle Day 1 
• Delay Day 1 for ANC <1500 cells/µL. 
• If chemotherapy is delayed for ANC <1000 cells/µL, decrease nab-paclitaxel by 
20 mg/m2 for all subsequent cycles. 
 
Cycle Day 8, 15 
• Skip or Delay Day 8 or Day 15 for ANC <1000 cells/µL. 
• If chemotherapy is delayed for ANC <1000 cells/µL, decrease nab-paclitaxel by 
20 mg/m2 for all subsequent cycles. 
• If chemotherapy is delayed for ANC < 1000 cell/ µL, CBC with differential must be 
checked on at least a weekly basis until the counts recover to Grade 2 or less 
 
Patients who experience severe neutropenia (neutrophil count less than 500 cells/mm3 for a week 
or longer) during nab-paclitaxel therapy should have dosage reduced by 20 mg/m2 for 
subsequent courses of nab-paclitaxel. For recurrence of severe neutropenia, additional dose 
reduction should be made by an additional 20 mg/m2.  
Peripheral Neuropathy 
For intolerable Grade 2 peripheral neuropathy, nab-paclitaxel should be dose reduced by 
20 mg/m2 for all subsequent doses.  
For Grade 3 peripheral neuropathy that has persisted since the last dose, nab-paclitaxel should be 
skipped. If peripheral neuropathy improves to less than Grade 2 before the next scheduled cycle, 
treatment may resume with dose reduction of 20 mg/m2 for all subsequent doses. 
In those patients who experience Grade 4 peripheral neuropathy, nab-paclitaxel should be 
discontinued. 


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5.4.2 Dose Modifications/Dose Delays for CORT125134  
If the patient misses a daily dose of CORT125134 and it is within 12 hours of the next scheduled 
dose, the patient should skip that dose and take the next scheduled dose. 
For any patient who experiences Grade 3 or 4 toxicity that is attributable to CORT125134 but 
not nab-paclitaxel or the underlying disease, CORT125134 will be interrupted until the toxicity 
resolves to Grade ≤1 or to baseline if Grade 2 toxicity was present at study entry. After recovery 
to Grade ≤1 toxicity, CORT125134 will be resumed at 1 dose level lower than the current level. 
A maximum of two dose reductions of CORT125134 will be allowed. If a third dose reduction 
is required, CORT125134 will be discontinued and the patient will continue on nab-paclitaxel 
alone. 
5.4.3 Intra-patient Dose Escalation 
In order to maximize the collection of information at relevant doses and to minimize the 
exposure of individuals to sub-optimal doses, intra-patient dose escalation will be allowed for 
patients with stable disease or response who may benefit from escalating the dose in the opinion 
of the investigator. Patients who have not experienced a Grade 3 or greater toxicity or SAE 
attributed to CORT125134 or nab-paclitaxel may, upon discussion with the Medical Monitor, 
increase the dose of CORT125134 or nab-paclitaxel to a dose that has been shown to be safe and 
well-tolerated after studying data from later cohorts.  
To be eligible for intra-patient dose escalation, an individual will need to complete at least 
2 cycles of therapy without any dose reductions or experiencing any DLT, grade 3 or 4 
drug-related toxicities, or SAE attributed to CORT125134 or nab-paclitaxel and have a tumor 
assessment within the past 4 weeks. The maximum dose level to which a patient may escalate 
will be to the dose most recently declared safe within the context of a dose escalation decision. 
CORT125134 and nab-paclitaxel will not be escalated simultaneously. Only one intra-patient 
dose escalation will be allowed per patient. Patients who receive intra-patient escalated dosing 
will have a new radiographic baseline established. The most recent tumor assessment (within 
4 weeks prior to escalation) will be considered the new baseline. 
If a patient meets the above criteria and the investigator recommends dose escalation, a 
discussion between the site and the Medical Monitor is required prior to escalation the dose. 
All procedures will be performed according to the schedule of assessments as outlined for the 
patient's cumulative cycle. In addition, CORT125134 and nab-paclitaxel PK samples will be 
drawn prior to CORT125134 and nab-paclitaxel dosing and 0.5 hr after nab-paclitaxel infusion 
on Day 15 following dose escalation. 
5.5 
Storage of Study Drug 
The study drug must be stored in a secure area and administered only to patients entered into the 
clinical study in accordance with the conditions specified in this protocol. 
• The investigational product CORT125134 should be stored at 25°C (77°F); excursions 
are permitted to 2–30°C (36–86°F). CORT125134 will be dispensed to patients according 
to their visit schedule. CORT125134 capsules should be at room temperature when 
administered, and taken with room temperature liquid. 


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• Un-reconstituted nab-paclitaxel should be stored at 20–25°C  
(68–77°F) in its carton. Vials should be stored in their original cartons. Reconstituted 
nab-paclitaxel should be used immediately. If not used immediately, the vial must be 
placed in its carton and stored at 2–8°C (36–46°F) for a maximum of 8 hours. Both forms 
should be stored in an area free of environmental extremes and must be accessible only to 
study personnel. Partially and completely used vials should be discarded according to the 
site’s guidelines and their disposition should be recorded on the Study Drug 
Accountability Record Form.  
Procedures for inventory, reconciliation, and destruction or return of study drug are provided in 
Section 10.5.2. 
5.6 
Treatment Assignment 
Enrollment in Segment I and Segment II will be mutually exclusive, and the two segments will 
enroll patients concurrently. Subjects will be assigned to a dose level in the order of study entry. 
If escalation in both schedules occurs at the same time, enrollment of the first 3–5 patients to the 
intermittent schedule will be completed before enrollment in the continuous schedule. If both the 
continuous-dosing and intermittent-dosing expansion cohorts are open simultaneously, patients 
will be assigned sequentially (in alternating fashion) to one of the two dosing schedules in the 
order of study entry. The study site will contact the Sponsor for treatment assignment once a 
patient is determined to be eligible for enrollment. Patients who meet all eligibility requirements 
will be assigned to a treatment group as determined by the Sponsor before Screening.  
Once assigned, patient numbers for any patients who fail screening, do not receive study 
treatment, are non-evaluable or who discontinue treatment or withdraw from study will not 
be reused. 


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6 
STUDY VISIT SCHEDULE AND PROCEDURES 
The schedule of visits and timing of procedures for all patients is provided in Table 9 for 
Segment I and Table 11 for Segment II, and the dosing schedule for Segment II is provided in 
Table 12. The acceptable visit window is ±3 days for Day 1 of each Cycle after Cycle 1. 
Nab-paclitaxel infusions must be no less than 7 days apart, and the recommended window for 
Day 8 and Day 15 is no more than +24 hours. Posttreatment/Early Termination Visit should 
occur 28 (±7) days after the last dose of study drug. No visit window is allowed due to the 
planned collection of the 24-hour PK sample for the following visits: 
• Segment I, Part 1: Nab-paclitaxel Lead-in Day 2, Cycle 1 Day 1, and Cycle 1 Day 9.  
• Segment II, Part 1 and Part 2: Cycle 1 Day 2.  
A detailed schedule of PK sampling times is provided in Table 10 for Segment I and in  
Table 13 for Segment II. 
6.1 
Patient Entry Procedures for Both Segments 
Prospective patients as defined by the criteria in Sections 4.2 and 4.3 (inclusion/exclusion 
criteria) will be considered for entry into this study. The study will be discussed with the patient, 
and a patient wishing to participate must give written informed consent prior to any study-related 
procedures or change in treatment. The patient must also give written authorization regarding 
privacy requirements prior to any study-related procedures or change in treatment. 
Each patient who receives study treatment will be assigned a patient number that will be used on 
patient documentation throughout the study.  
Procedures conducted as part of the patient’s routine clinical management (eg, blood count) and 
obtained before signing of the ICF may be used for Screening or Baseline purposes provided the 
procedures met the protocol-specified criteria and were performed within the time frame defined 
in Table 9, Segment I: Study Visits and Procedures and in Table 11, Segment II: Study Visits 
and Procedures. 
6.2 
Segment I: Visits and Associated Procedures 
6.2.1 Segment I:  Screening Visit (Days −28 to −1) 
At the Screening Visit, to be done within 28 days before the first scheduled dose of study drug, 
the following assessments are required: 
• Informed consent 
• Inclusion/exclusion criteria 
• Medical/oncologic history 
• Physical examination 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs (beginning after signing the ICF) 
• Collect prior and concomitant medications 
• ECOG performance status 
• ECGs (performed in triplicate) 


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• Local laboratory tests (see Table 5 for details) 
– Serum or urine pregnancy test for female patients of childbearing potential 
(optionally, can be performed at site or serum test can be performed by central 
laboratory) 
– Hematology 
– Chemistry 
– Urinalysis 
– Coagulation (international normalized ratio [INR]) for patients taking warfarin 
• Tumor assessment:  
– Chest, abdomen and pelvis (CAP) computed tomography (CT) scan with contrast. 
Tumor assessment documented per RECIST v1.1  
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: serum CA-125 
• Consent for archival tumor tissue collection and tumor biopsy if possible for GR-IHC. 
 
6.2.2 Segment I:  Baseline Visit, if Needed (Days −7 to −1) 
If the Screening Visit was >7 days before the first scheduled dose of study treatment, the 
following screening assessments must be repeated at a Baseline Visit within 7 days before the 
first scheduled dose of study treatment: 
• Inclusion/exclusion criteria 
• Physical examination 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• ECOG performance status 
• Local laboratory tests (see Table 5 for details) 
– Serum or urine pregnancy test for female patients of childbearing potential 
(optionally, can be performed at site or serum test can be performed by central 
laboratory) 
– Hematology 
– Chemistry with fasting glucose and fasting insulin 
– Urinalysis 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory tests (samples can be obtained on first day of treatment if obtained 
predose) (see Table 5 for details) 
– Hormone levels 
– Thyroid function test 
– PD/biomarker tests: C-peptide (obtain at the same time point as fasting glucose and 
insulin), ACTH, morning cortisol, and FKBP5 
– Optional collection of pharmacogenomic sample  


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• Tumor assessments (only need to be repeated if done >28 days before the first dose of 
study drug):  
– CAP CT scan with contrast. Tumor assessment documented per RECIST v1.1. 
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: serum CA-125 
 
6.2.3 Segment I, Part 1 Patients Only: 1-Week Nab-paclitaxel Lead-in (before 
CORT125134 Lead-in) 
Note:  After a minimum of two dose levels are observed, the nab-paclitaxel lead-in may be 
discontinued per the DRC recommendation. If the nab-paclitaxel lead-in is discontinued, the first 
dose of study drug will be the CORT125134 dose on Day 1 of the CORT125134 Lead-in (see 
Section 6.2.4 below) and central laboratory samples will be collected at that visit before 
administration of study drug. 
Nab-paclitaxel Lead-in Day 1 (Morning in-clinic infusion visit) 
• Patients in Part 1 (see Table 10) will have a morning in-clinic visit for serial PK draws 
starting within 1 hour before the start of nab-paclitaxel infusion through 6 hours after 
start of infusion.  
• Hematology (obtain predose if drawn >7 days prior) 
• Central laboratory tests (obtain predose) (see Table 5 for details) 
– Cytokines and T cells (predose and 4 hours postdose for patients in Part 1) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. 
 
Nab-paclitaxel Lead-in Day 2 (Morning in-clinic visit) 
• Patients in Part 1 (see Table 10) will have a morning in-clinic visit for a PK draw 
24 hours after start of nab-paclitaxel infusion. 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
 
Note: No study treatment will be administered on Days 2 through 7 of the nab-paclitaxel lead-in; 
patients in Part 1 will be asked to return to the clinic on the day after nab-paclitaxel lead-in 
Day 7 to begin the 1-week CORT125134 lead-in. 
6.2.4 Segment I:  1-Week CORT125134 Lead-in (before Cycle 1) 
All patients in the study will have a 1-week CORT125134 lead-in before Cycle 1. For patients in 
Part 2, the first dose of study drug will be the CORT125134 dose on Day 1 of the CORT125134 
lead-in. 


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CORT125134 Lead-in Day 1 (Morning in-clinic visit) 
• Patients in Part 1 (see Table 10) will have a morning in-clinic visit for a predose (within 
1 hour before dose) PK draw. 
• Hematology 
• Self-administration of oral dose of CORT125134 in the morning  
• Assess for AEs  
• Review concomitant medications for changes or addition of new medications 
• Dispense CORT125134 study drug to patient  
 
CORT125134 Lead-in Days 2 through 6 (at home)  
• Self-administration of oral dose of CORT125134 in the morning  
 
CORT125134 Lead-in Day 7 (Morning in-clinic visit) 
• Patients in Part 1 (see Table 10) will have a morning in-clinic visit for serial PK draws 
starting within 1 hour before the CORT125134 dose through 6 hours postdose. 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECGs (in duplicate) 
– Pre-CORT125134 dose 
– Postdose (2.5 hours ± 30 minutes) 
• Central laboratory tests:  
– Cytokines and T cells (collect predose and at 4 hours postdose only for patients 
in Part 1) 
• Self-administration of oral dose of CORT125134 in the morning  
6.2.5 Segment I:  Cycle 1 
Cycle 1 will begin the day after CORT125134 lead-in Day 7.  
Study-related activities to be performed at in-clinic visits and at home during Cycle 1 are 
listed below. 
Cycle 1 Day 1 (Morning in-clinic infusion visit) 
• Review of inclusion/exclusion criteria to confirm continued eligibility 
• Physical examination (complete exam including weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 


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• Local laboratory tests, predose. Samples may be obtained up to 24 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry 
– Urinalysis 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory tests, before CORT125134 and nab-paclitaxel doses: 
– PK blood sample collection predose (within 1 hour before CORT125134 dose) Note: 
for patients in Part 1, this is the 24-hour postdose sample for the CORT125134 
lead-in Day 7 serial PK; see Table 10.  
• Self-administration of oral dose of CORT125134 in the morning  
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after CORT125134 dose 
• Central laboratory samples (after nab-paclitaxel dose) 
– PK blood sample collection 0.5 hours after start of nab-paclitaxel infusion  
(see Table 10). 
 
Cycle 1 Days 2 through 7 (at home) 
• Self-administration of oral dose of CORT125134 in the morning  
 
Cycle 1 Day 8 (Morning in-clinic infusion visit) 
• Physical examination (focused based on patient’s clinical presentation; weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 
• Local laboratory tests, predose. Samples may be obtained within 48 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory sample, predose 
– Patients in Part 1 (see Table 10): PK blood sample collection predose (within 1 hour 
before CORT125134 dose)  
– Cytokines and T cells (predose and 4 hours postdose) 
• Self-administration of oral dose of CORT125134 in the morning  
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  


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• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after CORT125134 dose 
• Central laboratory samples postdose (after start of the nab-paclitaxel infusion) 
– PK blood sample collection at time points from 0.5 to 6 hours after start of the 
nab-paclitaxel infusion (see Table 10) 
Cycle 1 Day 9 (Morning in-clinic visit) 
• Patients in Part 1 (see Table 10) will have a 24-hour post-nab-paclitaxel infusion, 
pre-CORT125134 dose PK draw visit. 
– PK blood sample collection predose (24 hours ±30 minutes from start of 
nab-paclitaxel infusion and within 1 hour before CORT125134 dose)  
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Self-administration of oral dose of CORT125134 in the morning  
 
Cycle 1 Days 10 through 14 (at home) 
• Self-administration of oral dose of CORT125134 in the morning  
 
Cycle 1 Day 15 (Morning in-clinic infusion visit) 
• Physical examination (focused based on patient’s clinical presentation; weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 
• Local laboratory tests, predose. Samples may be obtained within 48 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry with fasting glucose and fasting insulin 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory tests, predose (before CORT125134 and nab-paclitaxel doses) 
– PK blood sample collection predose (within 1 hour before CORT125134 dose) 
– PD/biomarker tests: C-peptide (obtain at the same time point as fasting glucose and 
fasting insulin), ACTH, fasting morning cortisol, and FKBP5  
– Hormone levels (fasting, between 7–9 AM) 
• Self-administration of oral dose of CORT125134 in the morning  
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after CORT125134 dose 


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• Central laboratory tests, postdose (after nab-paclitaxel infusion) 
– PK blood sample collection at 30 minutes after start of nab-paclitaxel infusion  
– Patients in Part 1 only (see Table 10): PK blood sample collection at 45 minutes 
post-start of nab-paclitaxel infusion 
 
Cycle 1 Days 16 through 28 (at home) 
• Self-administration of oral dose of CORT125134 in the morning  
 
6.2.6 Segment I:  Cycles 2+ 
Cycle 2 will begin the day after Cycle 1 Day 28, and subsequent 28-day cycles will be done until 
the patient meets withdrawal or discontinuation criteria (Section 6.8).  
Study-related activities to be performed at in-clinic visits and at home during Cycles 2 and 
greater are listed below.  
Day 1, Day 8, and Day 15 (Morning in-clinic visits) 
• Physical examination (complete examination at Day 1, focused Days 8 and 15; weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 
• ECG if clinically indicated 
• Local laboratory tests, predose. Samples may be obtained within 48 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry 
– Urinalysis (only on Cycle 2 Day 1, Cycle 3 Day 1, and then every 12 weeks ±14 days) 
– Coagulation (INR) for patients taking warfarin 
– Serum or urine pregnancy test for female patients of childbearing potential every 
12 weeks ±7 days  
• Central laboratory tests, before CORT125134 and nab-paclitaxel doses, every 12 weeks 
(±14 days) starting from Cycle 1 Day 15:   
– PD/biomarker tests: ACTH, fasting morning cortisol, FKBP5 
– Thyroid function test (thyroid-stimulating hormone [TSH] with reflex total T3 and 
free T4 if abnormal TSH values are observed) 
• Self-administration of oral dose of CORT125134 in the morning  
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after CORT125134 dose 


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• Tumor assessments: at Cycle 3 Day 1 (±7 days), thereafter every 6 to 8 weeks, and at 
time of clinical suspicion of disease progression: 
– CAP CT scan with contrast. Tumor assessments will be documented per 
RECIST v1.1. 
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: 
serum CA-125. 
 
Days 2 through 7, 9 through 14, and 16 through 28 (at home) 
• Self-administration of oral dose of CORT125134 in the morning  
 
6.3 
Segment II:  Visits and Associated Procedures 
In Segment II, patients will take CORT125134 on the day before, the day of, and the day after 
nab-paclitaxel infusions. For this reason, CORT125134 treatments are on Day −1 (the day before 
the start of Cycle 1) and Days 1–2, 7–9, 14–16, and 28, and the nab-paclitaxel infusions are on 
Days 1, 8, and 15 of the 28-day cycles (Figure 5).  
6.3.1 Segment II:  Screening Visit (Days −28 to −2) 
At the Screening Visit, to be done within 28 days before the first scheduled dose of study 
drug, the following assessments are required: 
• Informed consent 
• Inclusion/exclusion criteria 
• Medical/oncologic history 
• Physical examination 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs (beginning after signing the ICF) 
• Collect prior and concomitant medications 
• ECOG performance status 
• ECGs (in triplicate) 
• Local laboratory tests (see Table 5 for details) 
– Serum or urine pregnancy test for female patients of childbearing potential 
(optionally, can be performed at site or serum test can be performed by central 
laboratory) 
– Hematology 
– Chemistry 
– Urinalysis 
– Coagulation (INR) for patients taking warfarin 


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• Tumor assessments: 
– CAP CT scan with contrast. Tumor assessment documented per RECIST v1.1. 
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: 
serum CA-125. 
• Consent for archival tumor tissue collection and tumor biopsy if possible for GR-IHC. 
 
6.3.2 Segment II:  Baseline/CORT125134 Lead-in Visit (Day −1) 
If the Screening Visit was >7 days before the first scheduled dose of study treatment, the 
following screening assessments must be repeated at a Baseline Visit within 7 days before the 
first scheduled dose of study treatment:  
• Inclusion/exclusion criteria 
• Physical examination 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• ECOG performance status 
• Serum or urine pregnancy test for female patients of childbearing potential (optionally, 
can be performed at site or serum test can be performed by central laboratory) 
 
The following assessments must be completed at the Baseline/CORT125134 Lead-in Day −1: 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Local laboratory testing (see Table 5 for details) 
– Hematology 
– Chemistry with fasting glucose and fasting insulin 
– Urinalysis 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory tests, predose samples (see Table 5 for details) 
– Hormone levels  
– Thyroid function test (thyroid-stimulating hormone [TSH] with reflex total T3 and 
free T4 if abnormal TSH values are observed) 
– PD/biomarker tests: C-peptide, ACTH, fasting morning cortisol, and FKBP5 
– Cytokines and T cells 
– Optional collection of pharmacogenomic sample 
• Tumor assessments (only need to be repeated if done >28 days before the first dose of 
study drug): 
– Tumor assessment RECIST v1.1  
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: serum CA-125 
• Provide and observe self-administration of morning oral dose of CORT125134 
 


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6.3.3 Segment II:  Cycle 1 
Study-related activities to be performed at in-clinic visits and at home during Cycle 1 are 
listed below. 
Cycle 1 Day 1 (Morning in-clinic infusion visit) 
• Patients in Cycle 1 (see Table 13) will have a morning in-clinic visit for serial PK draws 
starting within 1 hour before the start of nab-paclitaxel infusion through 6 hours after the 
start of infusion.  
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Dispense CORT125134 
• ECGs (in duplicate) 
– Before CORT125134 dose 
– After start of nab-paclitaxel infusion (2.5 hours ±30 minutes) 
• Local laboratory tests, predose - samples may be obtained up to 1 hour before dosing (see 
Table 5 for details) 
– Hematology 
• Central laboratory tests 
– Cytokines and T cells (collected predose and at 4 hours postdose) 
• Self-administration of oral dose of CORT125134 in the morning  
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping the 
nab-paclitaxel infusion)  
• PK blood sample collection at time points from 0.5 hours to 6 hours after start of 
nab-paclitaxel infusion (see Table 13) 
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after CORT125134 dose 
 
Cycle 1 Day 2 (Morning in-clinic visit) 
• Patients will have a 24-hour post-nab-paclitaxel infusion, pre-CORT125134 morning 
dose PK draw visit (see Table 13) 
– PK blood sample collection predose (24 hours ±30 minutes from start of Day 1 
nab-paclitaxel infusion and within 1 hour before Day 2 CORT125134 dose)  
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Self-administration of oral dose of CORT125134 in the morning 
 
Cycle 1 Days 7 and 9, 14 and 16, and 28 (at home) 
• Self-administration of oral doses of CORT125134 in the morning  
 


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Cycle 1 Day 8 and Day 15 (Morning in-clinic infusion visit) 
• Physical examination (focused based on patient’s clinical presentation; weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 
• Local laboratory tests, predose – samples may be obtained within 48 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry without glucose and insulin on Cycle 1 Day 8  
– Chemistry with fasting glucose and fasting insulin on Cycle 1 Day 15 
– Coagulation (INR) for patients taking warfarin 
• Central laboratory tests, predose (before CORT125134 and nab-paclitaxel doses)  
Cycle 1 Day 15 only: 
– Hormone levels (see Table 5 for details) 
– PD/biomarker tests: C-peptide, ACTH, fasting morning cortisol, FKBP5  
– PK blood sample collection at time points from 0.5 to 4 hours after start of nab 
paclitaxel infusion (see Table 13) 
• Self-administration of oral dose of CORT125134 before the nab-paclitaxel infusion 
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after morning CORT125134 dose 
 
6.3.4 Cycles 2+ 
Cycle 2 will begin the day after Cycle 1 Day 28, and subsequent 28-day cycles will be continued 
until the patient meets withdrawal criteria.  
Study-related activities to be performed at in-clinic visits and at home during Cycles 2 and 
greater are listed below.  
Day 1, Day 8, and Day 15 (Morning in-clinic visits) 
• Physical examination (complete examination at Day 1, focused Days 8 and 15; weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and dispense CORT125134 
• ECOG performance status 
• ECG if clinically indicated 


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• Local laboratory tests, predose samples may be obtained within 48 hours before dosing 
(see Table 5 for details) 
– Hematology 
– Chemistry 
– Urinalysis (only at Cycle 2 Day 1, Cycle 3 Day 1, then every 12 weeks ±14 days 
thereafter) 
– Coagulation (INR) for patients taking warfarin 
– Serum or urine pregnancy test for female patients of childbearing potential every 
12 weeks ±7 days  
• Central laboratory tests, before CORT125134 and nab-paclitaxel doses, starting at Cycle 
4 Day 1 and every 12 weeks (±14 days) thereafter:   
– PD/biomarker tests: ACTH, fasting morning cortisol, FKBP5 
– Thyroid function test (thyroid-stimulating hormone [TSH] with reflex total T3 and 
free T4 if abnormal TSH values are observed) 
• Self-administration of oral dose of CORT125134 before nab-paclitaxel infusion 
• Vital signs (before nab-paclitaxel infusion and within 5 minutes after stopping 
nab-paclitaxel infusion)  
• Administration of nab-paclitaxel over 30 minutes (±5 minutes) by IV infusion. Start of 
infusion must be within 15 minutes after the morning CORT125134 dose 
• Tumor assessments at Cycle 3 Day 1 (±7 days), thereafter every 6 to 8 weeks, and at time 
of clinical suspicion of disease progression:  
– CAP CT scan with contrast. Tumor assessments will be documented per 
RECIST v1.1 
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: serum CA-125 
 
Days 2, 7 and 9, 14 and 16, and 28 (at home) 
• Self-administration of oral doses of CORT125134 in the morning  
 
6.4 
Segments I and II:  Posttreatment Visit/Early Termination Visit (In-clinic Visit) 
(28 Days After Last Dose of Study Drug) 
For the Posttreatment Visit, the following assessments are required: 
• Physical examination (complete examination including weight) 
• Vital signs (blood pressure, heart rate, respiration rate, temperature) 
• Assess for AEs through 28 days after the last dose of study drug 
• Review concomitant medications for changes or addition of new medications 
• Assess CORT125134 study drug compliance and collect all unused study drug and 
remaining empty foil pouches. 
• ECOG performance status 
• ECG if clinically indicated 


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• Local laboratory tests (see Table 5 for details) 
– Serum or urine pregnancy test for female patients of childbearing potential 
(optionally, can be performed at site or serum test can be performed by central 
laboratory) 
– Hematology 
– Chemistry 
– Urinalysis 
– Coagulation (INR) for patients taking warfarin) 
• Central laboratory tests  
– PD/biomarker tests: ACTH, fasting morning cortisol, and FKBP5 
• Tumor assessments if ≥4 weeks have elapsed since the prior tumor assessment and 
progressive disease have not been documented: 
– CAP CT scan with contrast. Tumor assessments will be documented per 
RECIST v1.1 
– For patients with ovarian, fallopian tube, or primary peritoneal cancer: serum CA-125 
• Optional tumor biopsy for patients with disease progression. 
 
6.5 
Telephone Follow-up for Survival  
Patients will be followed for progression and survival via telephone on a quarterly basis for 
1 year after the last dose of study drug (CORT125134 or nab-paclitaxel, whichever is latest) in 
the last patient on treatment.  
6.6 
Unscheduled Visits 
As appropriate, assessments deemed clinically necessary by the Investigator may be done at 
unscheduled visits. 
6.7 
Study Drug Compliance Procedures 
Patients will be instructed to return all used and unused CORT125134 study drug containers at 
each study visit. Patient compliance with the dosing regimen will be assessed by reconciliation 
of the used and unused study drug. The quantity dispensed, returned, used, or lost must be 
recorded. Procedures for return and disposition of study drug by the clinical site are provided in 
Section 10.5.2. 
6.8 
Patient Discontinuation and Withdrawal  
In this study, “study treatment” refers to study drug (CORT125134) in combination with 
nab-paclitaxel, “patient discontinuation” refers to discontinuation of study treatment with the 
possibility of continued assessments, and “patient withdrawal” refers to withdrawal of consent 
and cessation of assessments.  


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6.8.1 Discontinuation of Study Treatment 
Study treatment will be discontinued in the event of any of the following occurrences:  
• Progressive disease. If the patient is experiencing overall clinical benefit, the Investigator 
should discuss the situation with the Medical Monitor, and the patient may be allowed to 
remain on the study, if both the Medical Monitor and the Investigator agree that this is 
appropriate for the patient. 
• Unacceptable toxicity. 
• Withdrawal of consent for treatment by patient. 
• The Investigator decides it is in the patient’s best interest to discontinue treatment and/or 
participation in the study. Reasons may include the following: 
– The patient requires prohibited medications. 
– The patient is not adherent to the protocol. 
• The Sponsor terminates the study. 
• Patient is pregnant. 
 
Patients who discontinue study treatment for reasons other than withdrawal of consent (eg, 
adverse event, Investigator decision) will undergo a Posttreatment/Early Termination Visit and 
will be followed for progression and survival. 
The Investigator should notify the Sponsor within 48 hours if a patient discontinues study 
treatment.  
6.8.2 Withdrawal from Study 
Withdrawal from the study (including all follow up assessments) will occur under the following 
circumstances: 
• Withdrawal of consent for follow-up observation by the patient. 
• Patient is lost to follow-up.  
• Termination by Sponsor 
• Death 
 
Patients may withdraw their consent to participate in the study at any time for any reason without 
prejudice. If a patient withdraws consent, the Investigator should make a reasonable attempt to 
document the specific reason why consent is withdrawn and it should be documented in the 
medical record. A patient can discontinue from treatment but still participate in the 
Posttreatment/End of Treatment Visit and/or Long-term Follow-up (see Section 6.8.1). If a 
patient withdraws from study, no additional Follow-up will be conducted.  
If possible, before the patient withdraws consent or the patient is withdrawn by the Investigator, 
every effort should be made to complete and report the follow-up assessments listed for the 
Posttreatment Visit/Early Termination Visit, as thoroughly as possible. The Investigator should 
notify the Sponsor of the patient’s withdrawal within 48 hours.  


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If a patient is lost to follow-up and cannot be reached by telephone, a certified letter should be 
sent to the patient (or the patient’s legally authorized representative, if appropriate) requesting 
contact with the Investigator. 
6.9 
Early Termination of the Study 
Corcept reserves the right to terminate the study at any time with appropriate notification. 
Reasons for terminating the study may include but are not limited to the following: 
• Potential health hazard to patients, as indicated by the incidence or severity of AEs in this 
or other studies. 
• Unsatisfactory patient enrollment.  
• Inaccurate or incomplete data recording. 
• Stopping rules and criteria specific to this protocol. 
• Administrative reasons. 
 
In addition, the regulatory agency or the site’s IRB has the authority to stop the study. 
6.10 
Replacement of Patients 
Patients withdrawn from Part 1 of Segment I or Segment II for any reasons other than toxicity 
may be replaced to ensure that a sufficient number of DLT-evaluable patients are enrolled to 
identify the MTD and development regimen. 
6.11 
Dose Diary 
A dosing diary will be provided and patients will be instructed to return all unused CORT125134 
and the dose diary during the patient visits. Patients should complete and entry in the diary for 
each self-administered dose of CORT125134. Entries will include the number of capsules as well 
as the date and time of CORT125134 administration. On visit days, CORT125134 should be 
taken in the clinical during the visit and after initial blood draws. Time and dose administered 
should be documented in the clinic charts.  


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7 
RESPONSE MEASURES AND SUMMARY OF DATA COLLECTION 
METHODS 
7.1 
Safety Measures 
Safety will be determined from evaluation of AEs including DLTs, clinical laboratory tests, vital 
signs, ECOG performance status, physical examinations, and ECGs.  
7.1.1 Adverse Events 
All AEs will be recorded from the time of signing of the ICF until 28 days after the last dose of 
study drug. Dose-limiting toxicities as defined in Section 3.3.3 will be assessed throughout the 
study. Patients should be monitored for AEs consistent with the current IB for CORT125134 and 
the Prescribing Information for nab-paclitaxel. To help characterize any possible relationships 
between drug exposure and the clinical event, when an SAE or DLT occurs, ACTH and cortisol 
should be assessed as close to the time of the event as possible and a PK sample may be drawn at 
the discretion of the Investigator 
Details on definitions and reporting of AEs are provided in Section 9. 
7.1.2 Clinical Laboratory Assessments 
Clinical laboratory tests for safety and PD are listed in Table 5 and will be performed at the time 
points shown in Table 9 for Segment I and Table 11 for Segment II. Laboratory draws for PK are 
described in Section 7.3. 
Samples will be processed at local and central laboratories as follows: 
• Local laboratory: hematology, chemistry, insulin, coagulation (INR) for patients taking 
warfarin, urinalysis, and serum or urine pregnancy test (optionally, serum pregnancy can 
be performed by central laboratory at Screening, Baseline, and Posttreatment/Early 
Termination Visits) and tumor markers (eg, CA-125 for patients with ovarian, fallopian 
tube, or primary peritoneal cancer). 
Note: hematology, serum chemistry, and coagulation (INR) assessments may be 
performed at a local laboratory outside of the investigative site laboratory as long as 
laboratory reports are provided to the Investigator within 48 hours of sample draw. 
• Central laboratory: hormone levels (estradiol, testosterone, FSH, LH and DHEA-S), 
thyroid function tests (TSH with reflex total T3 and free T4 if abnormal TSH values are 
observed), C-peptide, morning cortisol, ACTH, and tumor characterization and mRNA 
expression tests, including FKBP5 and glucocorticoid-induced genes or biomarkers of 
GR activity, PG, and PK (PK details in Section 7.3). 
 


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Table 5 
Clinical Laboratory Tests 
Hematology 
Serum Chemistry 
Urinalysis (dipstick) 
Red blood cell (RBC) count  
Sodium  
Bacteria 
Hemoglobin  
Potassium  
Blood 
Hematocrit  
Calcium  
Urobilinogen 
Mean corpuscular volume (MCV) 
Chloride  
Nitrites 
Platelet count 
Phosphorus  
Color 
White blood cell (WBC) count  
Magnesium  
Clarity 
WBC with 5-part differential: 
Serum Creatinine 
pH 
Neutrophils 
Total bilirubin  
Specific gravity 
Lymphocytes 
Albumin  
Ketones 
Monocytes 
Alkaline phosphatase (ALP) 
Protein  
Eosinophils 
Lactate dehydrogenase (LDH) 
Glucose  
Basophils 
Aspartate aminotransferase (AST) 
Bilirubin 
Coagulation 
Alanine aminotransferase (ALT)  
Leukocyte esterase 
International normalized ratio (INR)  
(only for patients taking warfarin) 
Glucose, fasting  
Other a 
Blood urea nitrogen (BUN) 
Serum or urine pregnancy test, if applicable 
Pharmacodynamic a 
Uric acid  
Thyroid-stimulating hormone (TSH) 
C-peptide 
Bicarbonate  
Total T3 b 
ACTH 
Total protein  
Free T4 b 
Fasting morning cortisol c 
 
Estradiol 
FKBP5 c 
 
Testosterone, total, free, and percent free 
Insulin, fasting  
 
Follicle-stimulating hormone (FSH) 
Cytokine and T cell profiles 
 
Luteinizing hormone (LH) 
 
 
Dehydroepiandrosterone-sulfate (DHEA-S) 
 
 
Optional pharmacogenomic sample 
Note: Laboratory draws for PK are described in Section 7.3. 
a  Pharmacodynamic and other laboratory test samples are to be drawn predose.  
b Reflex testing only with abnormal TSH values. 
c May represent a panel of mRNA expression/glucocorticoid-modulated pathways. 
 
Pregnancy tests will be done only for female patients of childbearing potential. A female is 
considered to be of childbearing potential unless she is postmenopausal and without menses for 
12 months or without a uterus and/or both ovaries. If treatment with CORT125134 is stopped for 
7 days or more, a patient should have a negative pregnancy test before restarting drug.  
Any abnormal test results determined to be clinically significant by the Investigator should be 
repeated (at the Investigator’s discretion) until the cause of the abnormality is determined, the 
value returns to baseline or to within normal limits, or the Investigator determines that the 
abnormal value is no longer clinically significant. All abnormal clinical laboratory result pages 
should be initialed and dated by an Investigator, along with a comment regarding whether or not 
the result is clinically significant. Guidance on recording abnormal laboratory findings as AEs is 
provided in Section 9.5. 


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7.1.3 Vital Signs 
Vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) 
will be assessed at the time points shown in Table 9 and Table 11. On days of nab-paclitaxel IV 
administration, vital signs should be collected predose and within 5 minutes after stopping the 
nab-paclitaxel infusion.  
Systolic and diastolic blood pressure will be measured after patients have been at rest (seated) for 
at least 3 minutes. Blood pressure will be recorded in mmHg. Heart rate will be measured in 
beats per minutes after the patient has been in a resting state (seated) for at least 3 minutes.  
7.1.4 ECOG Performance Status 
The ECOG scales and criteria (Table 6) are used by doctors and researchers to assess how a 
patient’s disease is progressing, assess how the disease affects the daily living abilities of the 
patient, and determine appropriate treatment and prognosis (Oken et al. 1982). ECOG 
performance status will be assessed at the time points shown in Table 9 and Table 11. 
If a patient’s ECOG performance status declines to ≥2 between Screening/Baseline and Day 1, 
the patient will no longer be eligible and will be withdrawn from the study. 
Table 6 
ECOG Performance Status 
0 
Fully active, able to carry on all pre-disease activities without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary 
nature, eg, light housework or office work 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more 
than 50% of waking hours 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 
5 
Dead 
Abbreviation: ECOG, Eastern Cooperative Oncology Group 
7.1.5 Physical Examinations 
Complete physical examinations are to be performed at Screening/Baseline; at Day 1 of each 
cycle (except in Segment II, Cycle 1 Day 1 when it is performed on Day −1); and at the 
Posttreatment/Early Termination Visit. Other scheduled physical examinations shown in Table 9 
and Table 11 may be focused, to identify changes from baseline or evaluate changes based on the 
patient’s clinical symptoms.  
Weight will be reported at each visit and height will be recorded at Screening only. Height 
(without shoes) will be measured in centimeters (cm) using an appropriate measuring device. 
Weight (without shoes) will be measured in kilograms (kg) using a scale. Historical patient 
information and/or patient reports should not be used for either measurement. 


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7.1.6 Electrocardiogram 
An ECG will be obtained at the time points shown in Table 9 and Table 11. ECGs will be 
performed and read per ECG vendor specifications. The Investigator may do additional ECG 
measurements on a "for cause" basis as determined by clinical judgment. The Investigator or 
Subinvestigator (physician) will be responsible for review and interpretation of the safety ECG 
results on site and determining whether the ECG is normal, abnormal clinically insignificant, or 
abnormal clinically significant. The ECG report result should be initialed and dated. 
7.2 
Measures of Anticancer Activity 
While this study does not have a formal primary efficacy objective, secondary objectives of this 
study are to make a preliminary assessment of the anticancer activity of the combination of 
CORT125134 and nab-paclitaxel in patients with solid tumors in the dose-finding phase, and in 
patients in the dose-expansion phase. Tumors will be assessed radiologically and response to 
treatment will be determined by using RECIST (v1.1) (Eisenhauer et al. 2009; 
http://www.eortc.be/recist/). Documented tumor measurements are required using computed 
tomography (CT) scans, or magnetic resonance imaging (MRI), as appropriate. In patients with 
ovarian, fallopian tube, or primary peritoneal cancer, CA-125 will be assessed at the time of 
radiologic tumor assessments (baseline and every 6–8 weeks) and response reported per GCIG 
criteria (Rustin et al. 2011) in addition to RECIST v1.1. Other tumor markers collected as 
standard practice (such as cancer antigens 15-3 and 19-9 [CA15-3 and CA19-9], prostate-
specific antigen [PSA], and carcinoembryonic antigen [CEA]) will be documented in the case 
report form. 
At Screening, CAP CT scans that were done with contrast as standard of care within ≤30 days of 
Screening may be used if they meet study quality criteria. If CAP CT scans with contrast were 
done ≤28 days before the first dose of study drug, they do not need to be repeated for the 
baseline measurement.  
Subsequent tumor assessments will be performed at Cycle 3 Day 1 (±7 days) and thereafter 
every 6–8 weeks (no more than 8 weeks between scans) and at time of clinical suspicion of 
disease progression. To ensure comparability, the baseline radiographs/scan, and subsequent 
radiographs/scans to assess response, should be performed using consistent methods and 
identical techniques. The same method (radiological or physical) should be employed and 
assessed by the same individual on each occasion, if possible. RECIST v1.1 will be used to 
determine response (Eisenhauer et al. 2009).  
Confirmation of objective responses is defined as responses that persist on repeat imaging for 
two assessments with a time period of at least 4 weeks between two assessments (4- to 6-week 
window). In the event of a confirmed response, the timing of subsequent tumor assessment will 
be reset at the 6–8 week interval from confirmatory scan. At the Posttreatment/Early Termination 
Visit, tumor assessment will be done if ≥4 weeks have elapsed since the last tumor assessment, 
unless there is documented progressive disease. If progressive disease is documented, an 
additional tumor assessment is not required as part of the final visit. 
Patients will be followed (contacted by telephone) to monitor for survival quarterly for 1 year 
following the last dose of study drug (CORT125134 or nab-paclitaxel, whichever is latest) in the 
last patient on treatment. 


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7.3 
Pharmacokinetic Measures 
Segment I—Blood samples (2-mL sample for analysis of single analyte or 3-mL sample for 
analysis of both analytes) will be collected for determination of the plasma concentrations of 
CORT125134 and its metabolites and nab-paclitaxel at the time points shown in Table 10. In the 
event of an SAE or DLT, a PK sample may be drawn at the discretion of the investigator. 
Serial PK data (approximately 29 samples during the study) will be obtained from all patients in 
Part 1 and approximately 11 samples will be obtained from all patients in Part 2 as shown in 
Figure 4 and Table 10. 
Segment II—Serial PK data (approximately14 samples) will be obtained from all patients in 
Part 1 and Part 2 as shown in Figure 5 and Table 13. 
Should a patient require a dose reduction on study, a PK profile at the new dose level may be 
obtained with patient consent. 
PK Analyses (Both Segments)—Plasma samples will be assayed for CORT125134 and its 
metabolites using liquid chromatography-tandem mass spectrometry method (LC/MS/MS). 
Instructions for collection, sample handling, and shipment are provided in the laboratory manual. 
Instructions for the collection, sample handling, and shipment of plasma samples for analysis of 
nab-paclitaxel levels are provided in the laboratory manual. 
Standard PK parameters will be included in the PK characterization and evaluation of the dose-
exposure relationship and related analyses. An assessment of the correlation between AEs and 
anticancer activity parameters with plasma concentrations will be undertaken. 
An optional PG sample will be collected to assess genetic factors affecting drug metabolism, 
transporters and other PK parameters. 
7.4 
Pharmacodynamic and Biomarker Measures  
Collection of blood samples for determination of PD biomarkers is described in Section 7.1.2. 
The development and improvement of cancer therapies increasingly depends on insights 
gained from analysis of biomolecules. During this study and with the consent of patients (see 
Section 10.1.1), biological samples (eg, blood, plasma, serum, or tumor tissue) will be obtained, 
some for analysis during the study and others for future analysis. These samples will be used to 
develop a better understanding of the mechanisms of both treatment response (predictive 
biomarkers) and disease processes (prognostic biomarkers) and ultimately to identify which 
patients have a high probability to benefit from treatment with CORT125134 and which do not. 
Candidate biomarkers that will be investigated during the study include the PD biomarkers noted 
in Section 7.1.2 (insulin, C-peptide, ACTH, morning cortisol, and FKBP5). An optional baseline 
sample will be obtained for pharmacogenomic assessments that will enhance our understanding 
of drug metabolism. Glucocorticoids have immunosuppressive properties, and many of these are 
effects known to enable cancer cells to evade immune detection and promote tumorigenesis 
(Olnes et al. 2016, Xing et al. 2015). The immunological profile (cytokines and T cell profiling) 
will be assessed to determine the impact of GR antagonism as relevant to enhancing antitumor 
immunity with potential consideration for future combinations with immunotherapies. The T-cell 
profiles may include interferon-gamma; prostaglandin E2; tumor necrosis factor-alpha; 


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transforming growth factor-beta; interleukins (IL-) 2, 4, 10, 12, and 13; T-cell profiling by flow 
cytometry of type 1, 2, and 17 T helper cells (Th1, Th2, Th17 cells), and regulatory T cells (Treg 
cells). Other explorations may include, but are not limited to, potential biomarkers related to the 
following: 
• Disease response 
• GR activation/inhibition  
• GR expression 
• mRNA molecular profiling and assessment of glucocorticoid-regulated pathway and 
panel of GR housekeeping genes 
• Tumor characteristics 
• Cell-free DNA 
• Mechanisms of treatment resistance 
 
The tests will be conducted a central laboratory using a variety of techniques (eg, IHC, 
DNA/RNA analysis). Pharmacodynamic assays may be performed to correlate results of 
biomarker assessments to the physiological effects of CORT125134. Refer to the schedules of 
assessments in Section 12.1 for Segment I and Section 12.2 for Segment II for the timing and 
frequency of all sample collections. Instructions for the collection, handling, and shipment of 
samples are found in the laboratory manual provided for sample collection and handling (see 
Section 10.7). 
7.5 
Pharmacogenomic Testing  
An optional blood sample will be collected at baseline from patients who consent to collection 
for PG analysis to assess genetic factors affecting drug metabolism, transporters and other PK 
parameters. 
7.6 
Tumor Tissue Collection 
For patients enrolling in the study, consent and availability to archived tissue biopsy are required 
for eligibility. If archived tissue is not available, a fresh tumor biopsy can be obtained. 
Specimens obtained closest to the time of study enrollment are preferred, but not required. In 
addition, optional biopsies may be obtained if collected during standard-of-care procedures 
during the study or at the time of disease progression and with consent of the patient. 
Approximately 15 FFPE slides, slices, or curls will be required for each tumor tissue collection 
(tissue block preferred). Refer to the study laboratory manual for complete instructions. 
7.7 
Summary of Methods of Data Collection 
Sponsor personnel or designees will visit the study site before initiation of the study to review 
with the site personnel information about the study drugs, protocol and other regulatory 
document requirements, source document requirements, electronic case report forms (eCRFs), 
monitoring requirements, and procedures for reporting AEs, including SAEs.  
At visits during and after the study, a clinical research associate (CRA) will monitor the site for 
compliance with regulatory documentation, with a focus on accurate and complete recording of 


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data on eCRFs from source documents, adherence to protocol, SAE reporting, and drug 
accountability records.  
Data quality control and analysis will be performed by the Sponsor or a designee, based on a 
predefined analysis  


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8 
STATISTICAL PROCEDURES 
Detailed procedures for statistical analyses to be performed for this study will be provided in a 
separate Statistical Analysis Plan that will be finalized before database lock. 
8.1 
Analysis Populations 
The following populations will be defined for this study: 
• The Safety population will include all patients who received at least one dose of study 
drug.  
• Modified Intent-to-Treat (mITT) population will include all patients who received at least 
one dose of CORT125134. 
• The DLT-evaluable population will include all patients in Part 1 (dose-finding phase) 
who complete 1 cycle of treatment and assessment or who receive at least one dose of 
CORT125134 and discontinue before completing the first cycle because of toxicity.  
• The Response-evaluable population will be the subset of the Safety population with at 
least one post-baseline tumor assessment.  
• The PK-evaluable population will be the subset of the Safety population with adequate 
PK data. 
8.2 
General Statistical Considerations 
All analyses of safety and anticancer activity for this open-label Phase 1/2 study will be 
descriptive in nature and presented by dose group, tumor type, GR status, and overall, as 
appropriate. Descriptive statistics (eg, number of observations, means, standard deviations, 
medians, maximum and minimum values) will be used to summarize continuous variables. 
Frequencies and proportions will be used to summarize categorical variables. Patient listings will 
be provided as appropriate. 
8.2.1 Summary of Demographics and Study Conduct 
Demographic variables such as age, sex, race/ethnicity, and baseline characteristics will be 
summarized for all patient populations.  
Enrollment, major protocol violations and discontinuations from the study will be summarized. 
The reasons for discontinuation will be tabulated. 
8.2.2 Safety Analyses 
Safety Analyses will be conducted on all patients in the Safety population.  
The study primary objective of determining MTD/development regiment will be achieved 
through evaluation of  the incidence, nature, duration, and severity  of toxicities according to the 
NCI-CTCAE, version 4.03. 
Safety will be assessed based on the evaluation of TEAEs including DLTs, clinical laboratory 
tests, vital signs, ECOG performance status, physical examinations, and ECGs.  
All DLTs, and their severity according to the NCI-CTCAE, version 4.03 will be listed by study 
drug dosing regimen. Study drug exposure to both CORT125134 or nab-paclitaxel for each of 


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the DLTs will be listed. Relevant laboratory values will be summarized where appropriate to aid 
in the determination of the MTD. Changes in NCI CTCAE grade will be tabulated. 
The incidence and duration of TEAEs, defined as AEs occurring after the first dose of study drug 
through 28 days after the last dose of either study drug, will be tabulated by Medical Dictionary 
for Regulatory Activities (MedDRA) preferred term and system organ class, and by severity and 
relationship to study drug. All laboratory results and vital sign measurements will be summarized 
using appropriate descriptive statistics.  
The following adverse events will be summarized separately: adverse events leading to 
withdrawal of study drug, adverse events leading to dose reduction or interruption, Grade >=3 
adverse events, Grade 5 adverse events, serious adverse events, and adverse events of special 
interest. 
All TEAEs will be listed.  
All AEs recorded from the time of signing of the ICF until the first dose of study drug will be 
listed separately. 
All deaths and causes of deaths will be summarized and listed. 
8.2.3 Analyses of Anticancer Activity 
A secondary objective of this study is to make a preliminary assessment of the anticancer activity 
as assessed by the investigator of CORT125134 in combination with nab-paclitaxel in patients 
with the selected tumor types.  
All efficacy analyses will be performed on the mITT population (primary analysis population), 
unless otherwise specified. Selected analyses will be performed on the Response-Evaluable 
Population subset. Further details will be specified in the Statistical Analysis Plan (SAP). 
Secondary analyses will characterize anticancer activity for the following endpoints: 
• ORR consisting of the percent of patients with an objective tumor response:  measurable 
disease with partial response (PR) or complete response (CR) as defined by RECIST v1.1 
and confirmed on a second, consecutive scan obtained no less than 4 weeks after the 
criteria for response are first met in cohorts of patients treated with the development 
regimen.  
• Best response defined as the best response recorded from the date of the first dose of 
CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
• Clinical benefit rate (CBR) defined as the percentage of patients who have achieved CR 
or PR, or SD for 6 months or greater.  
• Progression-free survival will be defined as the time from the date the patient receives the 
first dose of CORT125134 or nab-paclitaxel, whichever is earliest, to the date the patient 
experiences unequivocal disease progression per RECIST v1.1 or death (all causes of 
mortality). 
• Duration of response as measured from the date that the criteria are met for complete 
response (CR) or partial response (PR) until the first date that progressive disease is 
objectively documented. 


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• Overall survival defined as the time from date of the first dose of CORT125134 or 
nab-paclitaxel, whichever is earliest, until the date of death from any cause. 
Number and percent of patients achieving each category of response as defined by RECIST 
1.1 will be summarized. Visual displays that incorporate timing and magnitude of response 
(eg, swimmer plots, waterfall plots) will be created. 
PFS and OS will be analyzed using the Kaplan-Meyer method. The Brookmeyer-Crowley 
method will be used to construct 95% percent confidence interval for the median PFS and 
OS. For PFS, patients without a data of disease progression will be analyzed as censored 
observations on the date of last tumor measurement. For OS, patients who are not reported as 
having died will be analyzed as censored observations on the date they were last known to be 
alive.  
Duration of response, best response and ORR will be assessed only in patients with at least 
one measurable lesion at baseline. Best response with percentage change from baseline will 
be shown in a waterfall plot. An estimate of ORR and 95% confidence interval will be 
calculated using Clopper-Pearson method. Analysis of ORR may include patients who were 
treated with the development regimen in Part 1 and have the tumor type selected for 
evaluation in the dose-expansion phase (Part 2). For patients with ovarian, fallopian tube, or 
primary peritoneal cancer, CA-125 response per (GCIG) criteria (Rustin et al. 2011) will also 
be recorded. Summaries of efficacy outcomes by GR status  will include patients with 
evaluable tissue enrolled in any part of the study.  
Duration of Response (DOR): Data for patients who have not experienced disease 
progression or death will be censored at the last tumor assessment date. Kaplan-Meier 
methodology will be used to estimate median DOR. 
Further details of analyses, including analyses of Clinical Benefit Rate, Best Response Rate 
and details of censoring will be specified in the Statistical Analysis Plan. 
8.2.4 Pharmacokinetic Analyses 
Blood samples for serial PK analyses will be collected from all patients in Part 1 (see 
Section 7.3). For patients undergoing serial PK sampling, PK parameters of nab-paclitaxel and 
CORT125134 (and any relevant metabolites) will be calculated and the analyte concentration 
versus time plots will be provided. The following parameters will be included in the PK 
characterization and evaluation of the dose-exposure relationship and related analyses: 
• Cmax, the maximum plasma concentration 
• AUClast, the area under the plasma concentration-time curve from time 0 to time of last 
quantifiable concentration  
• AUCinf, area under the plasma concentration-time curve from time 0 to infinity, 
calculated as AUClast + Clast/λz 
• CL, the systemic plasma clearance 
• Vss, volume of distribution at steady state  
• T1/2, the terminal elimination half-life 
• Tmax, time at which the observed maximum is seen 
• Cmin, predose plasma concentration  


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• Partial AUCs 
8.2.5 Pharmacodynamic Analyses 
Pharmacodynamics will be assessed by measuring blood levels of insulin, C-peptide, 
adrenocorticotropic hormone (ACTH), morning cortisol, tumor characterization, and mRNA 
expression tests, including FKBP5 and glucocorticoid-induced genes or biomarkers of GR 
activity. Cytokines and T-cell profiles will be assessed to explore the effect of CORT125134 
when given alone and in combination with nab-paclitaxel.  
8.3 
Sample Size Calculation 
An adequate number of DLT-evaluable patients will be enrolled to determine the MTD and 
development regimen in Segment I, Part 1 (approximately 62 patients) and Segment II, Part 1 
(approximately 24 patients). Approximately 20 patients will be enrolled in each expansion cohort 
in Part 2 of the study. 


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9 
SAFETY EVENT DOCUMENTATION AND REPORTING 
9.1 
Investigator’s Responsibilities 
Investigators are responsible for monitoring the safety of patients who have entered this study 
and for providing appropriate medical care. Investigators are required to report promptly to 
Corcept or its designee any AE that may reasonably be regarded as caused by, or probably 
caused by, the study drug. If the adverse effect is alarming, the Investigator should report the 
adverse effect immediately. In addition, the Investigators are responsible for alerting Corcept or 
its designee to any event that seems unusual, even if the event may be considered an 
unanticipated benefit to the patient, and for reporting the event on the appropriate eCRF or safety 
report form. 
By exercising appropriate health-care options, the Investigator remains responsible for 
managing AEs that are serious or that cause a patient to withdraw before completing the study. 
Frequency of follow-up of any particular AE is left to the discretion of the Investigator. Duration 
of follow-up and requirements for immediate SAE reporting (within 24 hours of the event) are 
described below. 
9.2 
Monitoring Safety Data during Study 
Safety results collected during the study (eg, AEs, laboratory test results, physical findings) will 
be monitored on an ongoing basis by the Medical Monitor and Investigator. 
9.3 
Definition of an Adverse Event 
An AE is any untoward medical occurrence in a study patient administered a pharmaceutical 
product, which does not necessarily have to have a causal relationship with this treatment. An 
AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product that emerges or 
worsens relative to the patient’s pretreatment baseline.  
Illnesses present before the patient signs the ICF are considered pre-existing conditions and are 
documented on the medical history eCRF. Pre-existing conditions that worsen during the study 
are entered on the AE eCRF.  
9.4 
Definition of a Serious Adverse Event 
An SAE is any AE that meets any of the following criteria: 
• Results in death (ie, the AE caused or led to the fatality) 
• Is life-threatening (ie, the AE refers to an event in which the patient was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might have 
caused death if it were more severe) 
• Requires hospitalization or prolongation of existing hospitalization (ie, hospitalizations 
for scheduled treatments and elective medical/surgical procedures are not SAEs by this 
criterion) 
• Results in persistent or significant disability/incapacity (ie, the AE results in substantial 
reduction of the patient’s ability to perform activities of daily living) 


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• Results in a congenital anomaly or birth defect (ie, an adverse finding in a child or fetus 
of a patient exposed to the study medication before conception or during pregnancy)  
• Involves other medically important conditions (ie, the AE does not meet any of the above 
serious criteria but based on appropriate medical judgment, may jeopardize the patient or 
require medical or surgical intervention to prevent one of the serious outcomes listed in 
these criteria) 
9.5 
Clinical Laboratory Adverse Events 
All out-of-range laboratory values will be determined to be clinically significant or not clinically 
significant by the Investigator. An abnormal laboratory value that leads to a dose modification or 
patient withdrawal from the study will be recorded as an AE on the eCRF. Other clinically 
significant laboratory values may be reported as AEs at the discretion of the Investigator. 
9.6 
Documentation of Adverse Events 
Patients will be evaluated and questioned to identify AEs during the study.  
Collection of AEs will start immediately following signing of the ICF and will continue until 
28 days after the last dose of CORT125134 or nab-paclitaxel. Illnesses present before the patient 
signs the ICF are considered pre-existing conditions and are documented on the medical history 
eCRF. Pre-existing conditions that worsen during the study are entered on the AE eCRF. 
Adverse events that occur from the first dose of CORT125134 through 28 days after 
administration of the last dose of study drug will be considered treatment-emergent AEs and will 
be recorded on the AE eCRF. Any AEs reported more than 28 days after the last dose of study 
drug will be considered posttreatment AEs. 
All AEs will be documented on the AE pages of the eCRF and in the patient’s medical record. 
The following attributes must be assigned:  (1) description, (2) dates of onset and resolution, 
(3) intensity (see Section 9.7.1), (4) relationship to the study drug (see Section 9.7.2), (5) 
“serious” criteria if applicable (see Section 9.4), and (6) action taken. The Investigator will 
actively solicit this information and assess the AEs from the patient in terms of severity and 
relationship to study drug. The Investigator will treat the patient as medically required until the 
AE either resolves or becomes medically stable. This treatment may extend beyond the duration 
of the study. The Investigator will record treatment and medications required for treatment on the 
appropriate eCRF(s). 
In the event that a patient is withdrawn from the study because of an AE, the event must be 
recorded on the Termination eCRF as the reason for discontinuation. 
All AEs considered to be related (see Section 9.7.2) to study drug and all SAEs will be followed 
until resolved or until a stable status has been achieved. 
9.7 
Adverse Event Classification 
9.7.1 Severity (Intensity) Grades of Adverse Events 
The seriousness of an AE should not be confused with its intensity. To describe the maximum 
intensity of the AE on the AE eCRF, the Investigator will use the NCI-CTCAE, version 4.03 
(CTCAE 2010). The NCI-CTCAE version 4.03 is the common standard of AE grading within 


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oncology centers. For events not listed in the CTCAE, the definitions from the CTCAE provided 
in Table 7 should be used to evaluate the grade of severity for the AE. 
Table 7 
Adverse Event Grades Based on the Common Terminology Criteria for 
Adverse Events 
Grade 
Description 
1 
Mild:  asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated 
2 
Moderate:  minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living (eg, preparing meals, shopping for groceries or clothes, using 
the telephone, and managing money) 
3 
Severe:  severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living 
(eg, bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not bedridden) 
4 
Life threatening:  life-threatening consequences; urgent intervention indicated 
5 
Death:  death related to adverse event 
Source:  National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 
(CTCAE 2010). 
 
9.7.2 Relationship of Adverse Event to Study Drug or Study Procedure 
The Investigator responsible for the patient’s care (or qualified designee) will assess causality of 
AEs and SAEs based on the causal attribution guidance in Table 8. The Investigator’s 
assessment of causality must be provided for all AEs (serious and nonserious). For each TEAE, 
causality will be attributed to each study drug (CORT125134 and nab-paclitaxel). Regardless of 
the causality assessment for individual AE/SAE reports, Corcept or its designee will promptly 
evaluate all reported safety information against cumulative product experience to identify and 
expeditiously communicate possible new safety findings to Investigators and applicable 
regulatory authorities. 
Table 8 
Causal Attribution Guidance for Adverse Events 
Not related to study drug 
An AE that is judged to be clearly due only to extraneous causes such as 
diseases, environment, and the like. The cause must be noted on the AE eCRF 
Possibly related to study drug 
An AE that might be due to the use of the drug. The relationship in time is 
reasonable; therefore, a causal relationship cannot be excluded. An alternative 
explanation is inconclusive, eg, concomitant drug (s), concurrent disease (s). 
Probably related to study drug  
An AE that might be due to the use of the drug. The relationship in time is 
suggestive. An alternative explanation is less likely, eg, concomitant drug(s) or 
concurrent disease(s). 
Abbreviations: AE, adverse event; eCRF, electronic case report form 


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9.8 
Procedures for Reporting Adverse Events 
Patients will be evaluated and questioned generally to identify AEs during the study. Please refer 
to Section 9.6 for documentation detail. 
All AEs that are drug-related and unexpected (not listed as treatment-related in the current IB or 
approved Prescribing Information) must be reported to the governing IRB) as required by the 
IRB, local regulations, and the governing health authorities. Any AE that is marked “ongoing” at 
the exit visit must be followed-up until resolved or stable. 
9.9 
Procedures for Reporting a Serious Adverse Event 
Any SAE occurring during the study period (beginning with informed consent) and for at least 
28 days after the last dose of study drug must be immediately reported to the designated safety 
contact and recorded on the SAE Form. All patients with an SAE must be followed and the 
outcomes reported. The Investigator must supply the Sponsor and the IRB with any additional 
requested information (eg, autopsy reports and terminal medical reports). 
In the event of an SAE, the Investigator must: 
1. Notify the Sponsor or designee by telephone and in writing within 24 hours of discovery 
as described in the study manual. The Investigator must complete, sign, and date the SAE 
pages, verify the accuracy of the information recorded on the SAE pages with the 
corresponding source documents, and send a copy by fax or email to the Sponsor. 
2. Obtain and maintain in his/her files all pertinent medical records, information, and 
medical judgments from colleagues who assisted in the treatment and follow-up of the 
patient. 
3. Provide the Sponsor or designee complete documentation regarding the event, including a 
statement as to whether the event was or was not related to the use of the investigational 
drug. 
4. Promptly inform the governing IRB of all serious, unexpected, drug-related events that 
occur at his or her site. It is the responsibility of each site to submit Investigational New 
Drug Application Safety Reports provided to them by the Sponsor to their IRB as 
required by the IRB, local regulations, and the governing health authorities. 
5. Email/fax additional follow-up information, if required or available, to the Sponsor or 
designee within 24 hours of receipt and include the information on a follow-up SAE form 
and place with the original SAE information and keep with the appropriate section of the 
eCRF and/or study file 
An AE, regardless of seriousness, is considered unexpected if not reported in the IB or if the 
event is of greater specificity or severity than that described in the IB. 
9.10 
Adverse Event Follow-up 
All AEs will be followed until resolution, until deemed stable by the Principal Investigator, or 
until the patient is deemed by the Principal Investigator to be lost to follow-up. 




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10 
ADMINISTRATIVE ITEMS 
10.1 
Protection of Human Patients 
10.1.1 Compliance with Informed Consent Regulations (21 CFR Part 50) and Relevant 
Country Regulations 
Written informed consent is to be obtained from each patient before enrollment into the study, 
and/or from the patient’s legally authorized representative. The signed ICF(s) will be retained 
with the study center’s records. Each patient will also be given a copy of his or her signed 
ICF(s). 
The ICF must include information about the possible retention of biological samples at the 
conclusion of this study; with the patient’s permission, blood, plasma, serum and tumor tissue 
samples may be obtained for future analysis to help identify biomarkers of disease or 
CORT125134 treatment. In addition, samples may be retained for future determination of drug 
metabolism and pharmacogenomic characteristics that may impact course of disease and/or drug 
response. The purpose of assessing possible biomarkers in this study is to understand their 
potential role in the pathogenesis of cancer and in clinical outcomes. It is understood that some 
countries, municipalities, institutions, or local IRBs do not allow the study of genetic 
polymorphisms. Therefore, the biomarker assessments will only be conducted only at institutions 
in which such research is in accordance with country and local law and institutional regulations. 
Patient participation for such assessments is voluntary and declining participation will in no way 
influence eligibility for this study. Patients agreeing to participate will sign a separate informed 
consent form. 
10.1.2 Compliance with IRB Regulations 
This study is to be conducted in accordance with IRB regulations (US 21 CFR Part 56.103) or 
applicable local regulations. The Investigator must obtain approval from a properly constituted 
IRB before initiating the study and re-approval or review at least annually. Corcept is to be 
notified immediately if the responsible IRB has been disqualified or if proceedings leading to 
disqualification have begun. Copies of all IRB correspondence with the Investigator should be 
provided to Corcept. 
10.2 
Patient Confidentiality 
Patient medical information obtained by this study is confidential, and disclosure to third parties 
other than those noted below is prohibited. The Investigator must ensure that any subject data or 
records that are transmitted are de-identified. Patients should be identified only by their initials 
and/or patient ID number on the eCRFs or other transmitted study related documents.  
Upon the patient’s permission, medical information may be given to his or her personal 
physician or other appropriate medical personnel responsible for his or her welfare.  
Data generated by this study must be available for inspection upon request by representatives of 
the regulatory authority, national and local health authorities, Corcept or its designee, and the 
investigative site’s IRB.  


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A report of the results of this study may be published or sent to the appropriate health authorities 
in any country in which the study drug may ultimately be marketed, but patient identifying 
information will not be disclosed in these documents. 
10.2.1 Patient Privacy 
The Investigator or designee must explain to each patient, before enrollment into the study, that 
for evaluation of study results, the patient’s protected health information obtained during the 
study may be shared with the Sponsor, regulatory agencies, and IRB/Research Ethics Board 
(REB). It is the Investigator’s (or designee’s) responsibility to obtain written permission to use 
protected health information per country-specific regulations, such as the Health Insurance 
Portability and Accountability Act (HIPAA) in the US, from each patient, or if appropriate, the 
patient’s legally authorized representative. If permission to use protected health information is 
withdrawn, it is the Investigator’s responsibility to obtain a written request, to ensure that no 
further data will be collected from the patient, and the patient will be removed from the study. 
Written authorization is to be obtained from each patient before enrollment into the study, and/or 
from the patient’s legally authorized representative in accordance with the applicable privacy 
requirements (ie, the HIPAA Standards for Privacy of Individually Identifiable Health 
Information). 
In accordance with HIPAA requirements, additional purposes of this study include the following: 
• To publish anonymous patient data from the study; and  
• To create and maintain a data repository. 
10.3 
Changes to the Protocol 
The Investigator must not implement any deviation from or changes to the protocol without 
approval by Corcept and prior review and documented approval/favorable opinion from the 
IRB of a protocol amendment, except where necessary to eliminate immediate hazards to study 
patients, or when the changes involve only logistical or administrative aspects of the study 
(eg, change in monitors, change of telephone numbers). 
10.4 
Documentation 
10.4.1 Source Documents 
Source documents may include a patient’s medical records, hospital charts, clinic charts, the 
Investigator’s patient study files, as well as the results of diagnostic tests such as x-rays, 
laboratory tests, and ECGs. All data entered into the eCRF must be substantiated by a source 
document. 
10.4.2 Case Report Form Completion 
The Investigator is responsible for ensuring that data are properly recorded on each patient’s 
eCRFs and related documents in a timely manner.  
Corcept or designee will review all completed eCRFs for completeness.  


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10.4.3 Retention of Documentation 
All study-related correspondence, patient records, consent forms, patient privacy documentation, 
records of the distribution and use of all investigational products, and eCRF data should be 
maintained on file. 
For countries (including the United States) falling within the scope of the International 
Conference on Harmonisation (ICH) guidelines, the Sponsor-specific essential documents should 
be retained until at least 2 years after the last approval of a marketing application in an ICH 
region and until there are no pending or contemplated marketing applications in an ICH region or 
at least 2 years have elapsed since the formal discontinuation of clinical development of the 
investigational product. These documents should be retained for a longer period, however, if 
required by the applicable regulatory requirement(s) or if needed by the Sponsor. 
Corcept requires that it be notified in writing if the Investigator wishes to relinquish ownership 
of the data so that mutually agreed-upon arrangements can be made for transfer of ownership to a 
suitably qualified, responsible person. 
10.5 
Inventory, Reconciliation, Return, and Disposition of Clinical Supplies 
All study drug and related materials should be stored, inventoried, reconciled, and destroyed or 
returned according to applicable state and federal regulations and study procedures. Storage of 
study drug is described in Section 5.6. 
10.5.1 Clinical Supply Inventory 
A detailed inventory must be completed for all study drug. The study drug is to be used in 
accordance with the protocol by patients who are under the direct supervision of an Investigator. 
The study drug must be dispensed only by an appropriately qualified person to patients in the 
study.  
Unused study drug must be kept in a secure location for accountability and reconciliation by the 
study monitor. The Investigator or designee must provide an explanation for any destroyed or 
missing study drug or study materials. 
The Investigator or designee is responsible for maintaining accurate records (including dates and 
quantities) of study drug(s) received, patients to whom study drug is dispensed (patient-by-
patient dose specific accounting), and study drug lost or accidentally or deliberately destroyed. 
The Investigator or designee must retain all unused or expired study supplies until the study 
monitor (on-site CRA) has confirmed the accountability data and Sponsor has approved return or 
destruction. 
10.5.2 Return or Disposal of Study Drug and/or Supplies 
All clinical study drug and/or supplies will either be destroyed by the site per institutional policy, 
or be returned to Corcept or Corcept designee for destruction. 
Unused study drug may be destroyed on site, per the site’s standard operating procedures, but 
only after Sponsor has granted approval for drug destruction. The monitor must account for all 
study drug in a formal reconciliation process, before study drug destruction. All study drug 
destroyed on site must be documented.  


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Documentation must be provided to Sponsor and retained in the Investigator study files. If a site 
is unable to destroy study drug appropriately, the site can return unused study drug to Sponsor 
upon request. The return of study drug or study drug materials must be accounted for on a Study 
Drug Return Form provided by Sponsor. 
10.6 
Monitoring, Audit, and Inspection 
A representative of the Sponsor will monitor the study on a periodic basis. The determination of 
the extent and nature of monitoring will be based on considerations such as the objective, 
purpose, design, complexity, blinding, size, and endpoints of the study. 
Monitoring will be conducted according to Good Clinical Practice (GCP) and standard operating 
procedures for compliance with applicable government regulations. The Investigators must agree 
to allow the monitor access to the clinical supplies, dispensing, and storage areas and to the 
clinical files of the study patients, and, if requested, agrees to assist the monitors.  
The investigators/institutions will permit study-related monitoring, audits, IRB review, and 
regulatory inspection(s) by providing direct access to source data/documents. 
Representatives of FDA or other regulatory and health authorities may also conduct an 
inspection of the study. If informed of such an inspection, the Investigator should notify the 
Sponsor immediately. 
10.7 
Handling of Biological Specimens 
Samples of blood and urine for evaluation of hematology, chemistry, and urinalysis will be 
analyzed locally at Clinical Laboratory Improvement Amendments (CLIA) certified local 
laboratories. 
Blood samples for determination of the plasma concentrations of CORT125134 and its 
metabolites and nab-paclitaxel will be analyzed at central laboratories designated by Corcept. 
Blood samples to evaluate the PD of CORT125134 will be analyzed at central laboratories 
designated by Corcept. 
Tumor tissue samples will be analyzed for GR expression at a laboratory designated by Corcept. 
10.8 
Publications 
Corcept as the Sponsor, has a proprietary interest in this study. Authorship and manuscript 
composition will reflect joint cooperation between multiple Investigators and sites and Corcept 
personnel. Authorship will be established before the writing of the manuscript. As this study 
involves multiple centers, no individual publications will be allowed before completion of the 
final report of the multicenter study except as agreed with Corcept. 


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11 
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Melhem A, Yamada SD, Fleming GF, et al. Administration of glucocorticoids to ovarian cancer 
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mediated protection from apoptosis is associated with induction of the serine/threonine 
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Pang D, Kocherginsky M, Krausz T, Kim SY, Conzen SD. Dexamethasone decreases xenograft 
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Rustin GJ, Vergote I, Eisenhauer E, Pujade-Lauraine E, Quinn M, Thigpen T, et al. 2011. 
Definitions for response and progression in ovarian cancer clinical trials incorporating 
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Gynecol Cancer. 21(2):419–423. doi: 10.1097/IGC.0b013e3182070f17. 
Shah SP, Roth A, Goya R, et al. The clonal and mutational evolution spectrum of primary triple-
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Skor MN, Wonder E, Kocherginsky M, et al. Glucocorticoid receptor antagonism as a novel 
therapy for triple negative breast cancer. Clinical Cancer Res. 2013;19(22):6163-6172. 
Stringer EM, Skor MN, Fleming GF, Conzen SD. The role of the glucocorticoid receptor (GR) in 
inhibiting chemotherapy-induced apoptosis in high-grade serous ovarian carcinoma 
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Stringer-Reasor EM, Baker GM, Skor MN, et al. Glucocorticoid receptor activation inhibits 
chemotherapy-induced cell death in high-grade serous ovarian carcinoma. Gynecologic 
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Szmulewitz RZ, Chung E, Al-Ahmadie H. Serum/glucocorticoid-regulated kinase1 expression in 
primary human prostate cancers. The Prostate. 2012;72:157-164. 
Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, et al. 2013. 
Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: 
American Society of Clinical Oncology/College of American Pathologists clinical 
practice guideline update. J Clin Oncol. 31(31):3997–4013. 
Wu W, Chaudhuri S, Brickley DR, Pang D, Karrison T, Conzen SD. Microarray analysis reveals 
glucocorticoid-regulated survival genes that are associated with inhibition of apoptosis in 
breast epithelial cells. Cancer Res. 2004;64:1757-1764. 
Wu W, Pew T, Zou M, Pang D, Conzen SD. Glucocorticoid receptor-induced MAPK 
phosphatase-1 (MPK-1) expression inhibits paclitaxel-associated MAPK activation and 
contributes to breast cancer cell survival. J Biol Chem. 2005;280:4117-4124. 
Xing K, Gu B, Zhang P, Wu X. Dexamethasone enhances programmed cell death 1 (PD-1) 
expression during T cell activation: an insight into the optimum application of 
glucocorticoids in anti-cancer therapy. BMC Immunology 2015; 16:39. Available at 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480888/pdf 
/12865_2015_Article_103.pdf. Accessed January 2017. 
Zhang C, Beckermann B, Kallifatiditis G, et al. Corticosteroids induce chemotherapy resistance 
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neuroblastoma. Int J Oncol. 2006;29:1295-1301. 
 


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ATTACHMENTS 
 
 




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Note: The acceptable visit window is ± 3 days for Day 1 of each Cycle after Cycle 1. Nab-paclitaxel infusions must be no less than 7 days apart, and the 
recommended window for Day 8 and 15 is no more than +24 hours. No visit window is allowed for Nab-paclitaxel Lead-in Day 2, Cycle 1 Day 1, and Cycle 
1 Day 9 due to the planned collection of the 24-hour PK samples. Posttreatment/Early Termination Visit to occur 28 (±7) days after the last dose of study 
drug. 
a. 
All procedures and examinations should be performed before the administration of study treatment(s), unless specifically stated otherwise. 
b. Inclusion/exclusion criteria and selected safety assessments (vital signs, ECOG, PE, and laboratory tests) are required to be repeated only for patients for 
whom screening assessments were performed >7 days before Day 1 of the 1-week lead-in (first dose of study treatment). 
c. 
Patients in Part 1 will have a 1-week Nab-paclitaxel Lead-in before the 1-week CORT125134 Lead-in. After a minimum of two dose levels are observed, the 
nab-paclitaxel lead-in may be discontinued per the DRC recommendation. 
d. The IRB-approved ICF must be signed before any study-specific procedures or examinations are performed. 
e. 
Including prior cancer treatments. Any new or clinically significant changes in the patient’s medical or oncologic history between signing of the 
IRB-approved ICF and the first dose of study treatment will be recorded on the AE CRF page. 
f. 
Physical examinations at Screening/Baseline, at Day 1 of each cycle, and at the Posttreatment/Early Termination Visit should be complete assessments. 
Other weekly examinations may be focused, to identify changes from Screening/Baseline or evaluate changes based on the patient’s clinical symptoms. 
Weight to be reported at each visit, height at Screening/Baseline Visit only. 
g. On days of nab-paclitaxel IV administration, vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) should be 
collected pre-infusion and within 5 minutes after stopping the nab-paclitaxel infusion.  
h. ECGs to be done at Screening (in triplicate) and at CORT125134 Lead-in Day 7 predose and 2.5 hours ±30 minutes postdose (in duplicate). 
i. 
For women of childbearing potential, serum or urine pregnancy test is required at Screening/Baseline and at Posttreatment/Early Termination Visits. Serum 
or urine pregnancy test to be performed every 3 cycles (approximately every 12 weeks ±1 week). If treatment with CORT125134 is stopped for ≥7 days, 
patient should have a negative pregnancy test before restarting drug. 
j. 
Hematology: see list in Table 5. Nab-paclitaxel Lead-in Day 1 hematology to be obtained if previous hematology done >7 days prior. If weekly hematology 
tests demonstrate CTCAE Grade 3/4 cytopenias, increase frequency as clinically appropriate. Hematology assessments scheduled for the day of study drug 
dosing must be available and assessed for toxicity before dosing. The sampling for hematology assessment may be drawn within 48 hours before dosing.  
k. Chemistry: see list in Table 5. Baseline (Nab-paclitaxel Lead-in Day 1) and Cycle 1 Day 15 laboratory samples should be obtained in a fasting state to 
collect the fasting glucose and fasting insulin samples. Coagulation (INR) performed weekly for patients on warfarin. Samples for these assessments can be 
drawn within 48 hours before dosing.  
l. 
TSH is to be measured at Baseline (Nab-paclitaxel Lead-in Day 1 [predose]) and every 12 weeks (±14 days) for the first year and then every 6 months 
thereafter. Post-Screening, testing can be on the same schedule as pregnancy testing. Free T4 and total T3 will be measured if TSH values are abnormal. 
m. Estradiol, testosterone, FSH, LH, and DHEA-S. Draw predose at Baseline (Nab-paclitaxel Lead-in Day 1) and Cycle 1 Day 15. A fasting, early morning 
specimen (7–9 AM) is preferred. 
n. Urinalysis at Screening, Baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, then every 12 weeks (±14 days) thereafter and at the Posttreatment Visit. 
Microscopy is required only to follow-up clinically significant urine dipstick findings (see list in Table 5). 
o. Tumor assessments (TAs): Screening—CAP CT scans done with contrast as standard of care ≤30 days of Screening may be used if they meet study quality 
criteria. Baseline—CAP CT scans with contrast done ≤28 days before the first dose of study drug will not need to be repeated for this time point. Subsequent 
TAs occur at Cycle 3 Day 1 (±7 days) and thereafter every 6–8 weeks (no more than 8 weeks between scans) and at time of clinical suspicion of disease 
progression. In patients with ovarian, fallopian tube, or primary peritoneal cancer, CA-125 levels will be assessed at the time of radiologic tumor 
assessments; levels of other biomarker collected as standard practice (such as CA15-3 and CA19-9, PSA, and CEA) will be documented in the case report 


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form. At the Posttreatment/Early Termination Visit, TA will be done if ≥4 weeks have elapsed since the prior TA and progressive disease as not been 
documented.  
p. Draw fasting, morning (7–9 AM) C-peptide, ACTH, morning cortisol, and FKBP5 at Baseline (Day 1 of Nab-paclitaxel Lead-in) and at Cycle 1 Day 15 
before administration of any study treatment. FKBP5, morning cortisol, and ACTH will be repeated every 12 weeks (±14 days) for the first year and then 
approximately every 6 months thereafter and at the Posttreatment/End of Treatment Visit. 
q. Cytokines and T cell samples for patients in Part 1 are drawn predose and at 4 hours (±30 minutes) postdose to coincide with the PK time points in Table 10 
on Nab-paclitaxel Lead-in Day 1, on CORT125134 Lead-in Day 7, and Cycle 1 Day 8. For patients in Part 2, samples are drawn at Cycle 1 Day 8 before and 
at 4 hours (±30 minutes) after nab-paclitaxel infusion. Samples at all time points can be drawn with PK sample collections. 
r. 
Tumor tissue for GR IHC (archival or biopsy) is mandatory for patients in the study. Optional tumor tissue biopsy at the time of disease progression. 
s. 
Archival tumor tissue may consist of tumor block or 15 unstained formalin-fixed, paraffin-embedded slides (tissue block preferred). Tumor biopsy for 
screening GR IHC analysis is to be performed if archival tumor tissue is not available.  
t. 
Patients will be followed for progression and survival via telephone on a quarterly basis for 1 year after the last dose of study drug in the last patient on 
treatment. 
u. All AEs, including SAEs, will be recorded from the time of signing of the IRB-approved ICF until 28 days after the last dose of study treatment. An SAE 
related to study procedures or study conduct must be reported to the Sponsor if it occurs before first dose of study drugs. SAEs must be reported as described 
in Section 9.9 of the protocol. Treatment-related AEs ongoing at the Posttreatment Visit should be followed to resolution or until the Investigator considers 
them “chronic” or “stable”. At the occurrence of a SAE or DLT, an additional ACTH, and cortisol blood sample and a PK sample will be drawn at the 
discretion of the Investigator, as close to the event as possible to help characterize any possible relationships between drug exposure and the clinical event. 
v. All concomitant medications (including over-the-counter and herbal treatments) should be recorded from 28 days before the first dose until 28 (±7 days) 
after the last dose of study drug. 
w. See Table 10 for PK sampling times.  
x. CORT25134 will be dispensed to patients as blister packs of capsules to be self-administered orally once daily in the morning, starting with 
CORT125134-550 Lead-In Day 1. Patients should return all unused CORT125134 capsules and the dose diary during the patient visits, and patient 
adherence to treatment should be assessed. On visit days, CORT125134 should be taken in the clinical during the visit and after initial blood draws with 
time and dose administration documented in the clinic charts. On days when CORT125134 and nab-paclitaxel are administered in combination, 
CORT125134 is to be administered within 15 minutes before the start of nab-paclitaxel infusion. 
y. All clinical laboratory results must be available and reviewed by the Investigator or Subinvestigator before each IV infusion of nab-paclitaxel and start of 
subsequent treatment cycles of CORT125134/nab-paclitaxel.  
 
 


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Table 10 
Segment I:  Study Pharmacokinetic Sampling Times 
Cycle 
Day (Scheduled dosing) 
Sample 
Planned 
Time 
Nab-paclitaxel 
Sample 
CORT125134 
Sample 
Note 
Serial PK Sampling Schedule – All Patients in Part 1 
Nab-paclitaxel 
Lead-in  
 
(beforeCORT12513
4 Lead-in) 
Day 1 (nab-paclitaxel infusion) 
1 
Predose 
X 
 
<1 h before start of nab-paclitaxel infusion 
2 
0.5 h 
X 
 
From start of nab-paclitaxel infusion ±10 min 
3 
0.75 
X 
 
From start of nab-paclitaxel infusion ±10 min 
4 
1 h 
X 
 
From start of nab-paclitaxel infusion ±10 min 
5 
2 h 
X 
 
From start of nab-paclitaxel infusion ±10 min 
6 
4 h 
X 
 
From start of nab-paclitaxel infusion ±30 min 
7 
6 h 
X 
 
From start of nab-paclitaxel infusion ±30 min 
Day 2 (no study drug) 
8 
24 h 
X 
 
From start of nab-paclitaxel infusion ±30 min  
CORT12534 
Lead-in 
 
(before Cycle 1) 
Day 1 (CORT125134 oral dose) 
9 
Predose 
 
X 
<1 h before CORT125134  
Day 7 (CORT125134 oral dose) 
10 
Predose 
 
X 
<1 h before CORT125134  
11 
0.5 h 
 
X 
±10 min 
12 
0.75 
 
X 
±10 min 
13 
1 h 
 
X 
±10 min 
14 
2 h 
 
X 
±10 min 
15 
4 h 
 
X 
±30 min 
16 
6 h 
 
X 
±30 min 
Cycle 1 
Day 1 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
17 
Predose 
X 
Xa 
<1 h before CORT125134b  
18 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
Day 8 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
19 
Predose 
X 
Xa 
<1 h before CORT125134 
20 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
21 
0.75 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
22 
1 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
23 
2 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
24 
4 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
 
 
25 
6 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
 
Day 9 (CORT125134 oral dose) 
26 
24 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
and <1 h before CORT125134 
Cycle 1  
Day 15 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
27 
Predose 
X 
Xa 
<1 h before CORT125134 
28 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min  
29 
0.75 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
Continued on next page 
 
 
 
 
 


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Cycle 
Day (Scheduled dosing) 
Sample 
Planned 
Time 
Nab-paclitaxel 
Sample 
CORT125134 
Sample 
Note 
Sampling Schedule – All Patients in Part 2  
Cycle 1 
Day 1 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
1 
Predose 
X 
Xa 
<1 h before CORT125134 
2 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min  
Day 8 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
3 
Predose 
X 
Xa 
<1 h before CORT125134 
 
4 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
5 
0.75 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
6 
1 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
7 
2 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
8 
4 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
 
9 
6 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
Day 15 (CORT125134 oral dose + 
nab-paclitaxel infusion) 
10 
Predose 
X 
Xa 
<1 h before CORT125134 
11 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min  
Abbreviation: PK = pharmacokinetic 
Notes: Samples for PK analysis should be drawn on a line separate from that used for nab-paclitaxel infusion. At time points when samples for analysis of a 
single analyte (either nab-paclitaxel or CORT125134) are drawn, the sample volume will be 2 mL.  
After a minimum of two dose levels in Part 1 are observed, the nab-paclitaxel lead-in may be discontinued per the DRC recommendation. 
a A 3-mL sample for analysis of both CORT125134 and nab-paclitaxel sample will be collected. 
 




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Note:  The acceptable visit window is ±3 days for Day 1 of each Cycle after Cycle 1. Nab-paclitaxel infusions must be no less than 7 days apart, and the 
recommended visit window for Day 8 and Day 15 is no more than +24 hours. On Cycle 1 Day 2 no visit window is allowed due to the planned collection of 
the 24-hour PK samples. Posttreatment/Early Termination Visit to occur 28 (±7) days after the last dose of study drug. 
 
a. 
All procedures and examinations should be performed before the administration of study treatment(s), unless specifically stated otherwise. 
b. Inclusion/exclusion criteria and selected safety assessments (vital signs, ECOG, PE, and laboratory tests) are required to be repeated only for patients for 
whom screening assessments were performed >7 days before Day −1 (first dose of CORT125134). 
c. 
The IRB-approved ICF must be signed before any study-specific procedures or examinations are performed. 
d. Including prior cancer treatments. Any new or clinically significant changes in the patient’s medical or oncologic history between signing of the 
IRB-approved informed consent form and the first dose of study treatments will be recorded on the AE CRF page. 
e. 
Physical examinations at Screening, at Day 1 of each cycle except Cycle 1 Day 1 when it is performed on Baseline/Day −1, and at the Posttreatment/Early 
Termination Visit should be complete assessments. Other weekly examinations may be focused, to identify changes from Screening/baseline or evaluate 
changes based on the patient’s clinical symptoms. Weight to be reported at each visit, height at Screening/Baseline visit only. 
f. 
On days of nab-paclitaxel IV administration, vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) should be 
collected pre-infusion and within 5 minutes after stopping the nab-paclitaxel infusion.  
g. ECGs to be done at Screening (in triplicate) and at Cycle 1 Day 1 pre-CORT125134 dose and 2.5 hours ±30 minutes after start of nab-paclitaxel infusion (in 
duplicate). 
h. For women of childbearing potential, serum or urine pregnancy test is required at Screening/Baseline and at Posttreatment/Early Termination Visits. Serum 
or urine pregnancy test to be performed every 3 cycles (approximately every 12 weeks ±1 week). If treatment with CORT125134 is stopped for ≥7 days, 
patient should have a negative pregnancy test prior to restarting drug. 
i. 
Hematology: see list in Table 5. If weekly hematology tests demonstrate CTCAE Grade 3/4 cytopenias, increase frequency as clinically appropriate. 
Hematology assessments scheduled for the day of study drug dosing must be available and assessed for toxicity before dosing. The sampling for hematology 
assessment may be drawn within 48 hours prior to dosing.  
j. 
Chemistry: see list in Table 5. Baseline/Day –1 and Cycle 1 Day 15 laboratory samples should be obtained in a fasting state to collect the fasting glucose and 
fasting insulin samples. Coagulation (INR) performed weekly for patients on warfarin. Samples for these assessments can be drawn within 48 hours before 
dosing.  
k. TSH is to be measured at Baseline/Day–1 and every 12 weeks (±14 days) for the first year and then every 6 months thereafter. After Screening, testing can 
be on the same schedule as pregnancy testing. Free T4 and total T3 will be measured if TSH values are abnormal. 
l. 
Estradiol, testosterone, FSH, LH, and DHEA-S. Draw predose at Baseline/Day −1 and Cycle 1 Day 15. A fasting, early morning specimen (7–9 AM) is 
preferred. 
m. Urinalysis at Screening, Baseline/Day–1, Cycle 2 Day 1, Cycle 3 Day 1, then every 12 weeks (±14 days) thereafter and at the Posttreatment Visit. 
Microscopy is required only to follow-up clinically significant urine dipstick findings (see list in Table 5). 
n. Cytokine and T cell samples are drawn at Baseline/Day -1 predose, and Cycle 1 Day 1 predose and at 4 hours (±30 minutes) after nab-paclitaxel infusion. 
All samples can be drawn with PK sample collections. 
o. Tumor assessments (TAs): Screening—CAP CT scans done with contrast as standard of care ≤30 days of Screening may be used if they meet study quality 
criteria. Baseline—CAP CT scans with contrast done ≤28 days before the first dose of study drug will not need to be repeated for this time point. Subsequent 
TAs occur at Cycle 3 Day 1 (±7 days) and thereafter every 6–8 weeks (no more than 8 weeks between scans) and at time of clinical suspicion of disease 
progression. In patients with ovarian, fallopian tube, or primary peritoneal cancer, CA-125 levels will be assessed at the time of radiologic tumor 
assessments; levels of other biomarker collected as standard practice (such as CA15-3 and CA19-9, PSA, and CEA) will be documented in the case report 


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form. At the Posttreatment/Early Termination Visit, TA will be done if ≥4 weeks have elapsed since the prior TA and progressive disease as not been 
documented.  
p. Draw fasting, morning (7–9 AM) C-peptide, ACTH, cortisol, and FKBP5 at Baseline/Day −1 before administration of any study treatment and at Cycle 1 
Day 15. FKBP5, morning cortisol, and ACTH will be repeated every 12 weeks (±14 days) for the first year and then approximately every 6 months 
thereafter and at the Posttreatment/End of Treatment assessment 
q. Tumor tissue for GR IHC (archival or biopsy) is mandatory for patients in the study. Optional tumor tissue biopsy at the time of disease progression.  
r. 
Archival tumor tissue may consist of tumor block or 15 unstained, formalin-fixed, paraffin-embedded slides(tissue block preferred). For patients enrolled in 
the study, tumor biopsy for screening GR IHC analysis is to be performed if archival tumor tissue is not available.  
s. 
Patients will be followed for survival via telephone on a quarterly basis for 1 year after the last dose of study drug in the last patient on treatment. 
t. 
All AEs, including SAEs, will be recorded from the time of signing of the IRB-approved ICF until 28 days after the last dose of study drug. An SAE related 
to study procedures or study conduct must be reported to Sponsor if it occurs prior to first dose of study drugs. SAEs must be reported as described in 
Section 9.9 of the protocol. Treatment-related AEs ongoing at the Posttreatment Visit should be followed to resolution or until the Investigator considers 
them “chronic” or “stable”. At the occurrence of a SAE or DLT, an additional cortisol and ACTH sample and a PK sample will be drawn, at the discretion of 
the Investigator, as close to the event as possible to help characterize any possible relationships between drug exposure and the clinical event. 
u. All concomitant medications (including over-the-counter and herbal treatments) should be recorded from 28 days before the first dose until 28 (±7 days) 
after the last dose of study drug. 
v. See Table 13 for PK sampling times.  
w. CORT25134 will be dispensed to patients as blister packs of capsules to be self-administered orally once daily in the morning, starting with 
CORT125134-550 Lead-In Day 1. Patients should return all unused CORT125134 capsules and the dose diary during the patient visits, and patient 
adherence to treatment should be assessed. On visit days, CORT125134 should be taken in the clinical during the visit and after initial blood draws with time 
and dose administration documented in the clinic charts. On days when CORT125134 and nab-paclitaxel are administered in combination, CORT125134 is 
to be administered within 15 minutes before the start of nab-paclitaxel infusion. 
x. All clinical laboratory results must be available and reviewed by the Investigator or Subinvestigator before each IV infusion of nab-paclitaxel and start of 
subsequent treatment cycles of CORT125134/nab-paclitaxel.  
 
 




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Table 13 
Segment II:  Study Pharmacokinetic Sampling Times 
Cycle 
Day (Scheduled Dosing) 
Sample 
Planned 
Time 
Nab-paclitaxel 
Sample 
CORT125134 
Sample 
Note 
Serial PK Sampling Schedule – All patients in Parts 1 and 2, Cycle 1 
Day −1:  Patient self-administers morning CORT125134 doses 
 
 
 
Cycle 1 
Day 1 (CORT125134 morning 
oral dose + nab-paclitaxel 
infusion) 
1 
Predose 
X 
Xa 
<1 h before CORT125134 
 
 
2 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
3 
0.75 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
4 
1 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
5 
2 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
6 
4 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
 
 
7 
6 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
 
Day 2 (CORT125134 morning 
oral dose) 
8 
24 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
and <1 h before CORT125134b 
 
Day 15 (CORT125134 morning 
oral dose + nab-paclitaxel 
infusion) 
9 
Predose 
X 
Xa 
<1 h before CORT125134 
 
 
10 
0.5 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
11 
0.75 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
12 
1 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
13 
2 h 
X 
Xa 
From start of nab-paclitaxel infusion ±10 min 
 
 
14 
4 h 
X 
Xa 
From start of nab-paclitaxel infusion ±30 min 
Abbreviation: PK = pharmacokinetic 
Note: Only patients in Cycle 1 will have serial PK sampling on Day 1 (1 h predose to 6 h postdose) and Day 2 predose and on Day 15 (1 h predose to 4 h postdose).  
Samples for PK analysis should be drawn on a line separate from that used for nab-paclitaxel infusion.  
a A 3-mL sample for analysis of both CORT125134 and nab-paclitaxel sample will be collected. 
b Note: this is the 24-h time point for the Day 1 serial PK.  
 


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12.3 
Investigator’s Brochure and Package Insert 
The current IB for CORT125134 and package insert for nab-paclitaxel will be supplied to 
Investigators in the study materials. 



SAP_001.pdf: 
 
Title: Phase 1/2 Study of CORT125134 in Combination with Nab-
paclitaxel in Patients with Solid Tumors 
 
 
NCT Number: NCT02762981 
 
 
Date: 14 October 2019 


Corcept Therapeutics  
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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STATISTICAL ANALYSIS PLAN 
Corcept Therapeutics  
CORT125134-550 
 
 
 
 
Protocol Title: 
Phase 1/2 Study of CORT125134 in Combination with Nab-
paclitaxel in Patients with Solid Tumors 
Protocol Version 
and Date: 
Amendment 5; 29 May 2018 
Sponsor: 
Corcept Therapeutics Incorporated 
149 Commonwealth Drive 
Menlo Park, CA 94025 
Prepared By: 
 
 
 
Precision for Medicine, Oncology and Rare Disease 
6005 Hidden Valley Road, Suite 170 
Carlsbad, CA 92011 
Document Version 
and Date: 
Version 1.0; 14 October 2019 
 


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Statistical Analysis Plan
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Version 1.0; 14 October 2019
 
 
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1 STATISTICAL ANALYSIS PLAN APPROVAL 
Sponsor: 
Corcept Therapeutics  
Clinical Protocol Number: CORT125134-550 
Protocol Title: 
Phase 1/2 Study of CORT125134 in Combination with 
Nab-paclitaxel in Patients with Solid Tumors 
Document File Name: 
Corcept_CORT-550_SAP_v1.0_14OCT2019 
Document Version and 
Effective Date: 
Version 1.0; 14 October 2019 
Approved By: 
 
 
 
 
Date 
 
 
 
 
 
Date 
 
 
 
 
 
Date 
10/14/2019
10/15/2019
10/14/2019


Corcept Therapeutics  
Statistical Analysis Plan
CORT125134-550 
 
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2 TABLE OF CONTENTS 
 
1 
Statistical Analysis Plan Approval ............................................................................2 
2 
Table of Contents ........................................................................................................3 
3 
List of Abbreviations ..................................................................................................6 
4 
Introduction.................................................................................................................8 
5 
Study Objectives .........................................................................................................8 
5.1 
Primary Study Objective .......................................................................................8 
5.2 
Secondary Study Objectives..................................................................................8 
5.3 
Exploratory Study Objectives ...............................................................................9 
6 
Investigational Plan ....................................................................................................9 
6.1 
Overall Study Design .............................................................................................9 
6.1.1 
Segment I Continuous-Dosing Regimen ........................................................9 
6.1.2 
Segment II Intermittent-Dosing Regimen ...................................................12 
6.2 
Schedule of Assessments ......................................................................................14 
6.3 
Treatments ............................................................................................................20 
6.3.1 
Treatments Administered .............................................................................20 
6.3.2 
Method of Assigning Patients to Treatment Groups ..................................24 
6.4 
Efficacy and Safety Variables .............................................................................25 
6.4.1 
Efficacy Variables ..........................................................................................25 
6.4.2 
Description of Safety Variables ....................................................................29 
6.5 
Data Quality Assurance .......................................................................................31 
7 
Statistical Methods ....................................................................................................32 
7.1 
General Methodology ..........................................................................................32 
7.1.1 
Reporting Conventions ..................................................................................32 
7.1.2 
Summarization by Visit .................................................................................33 
7.1.3 
Standard Calculations ...................................................................................33 
7.2 
Analysis Populations ............................................................................................34 
7.3 
Study Patients .......................................................................................................34 
7.3.1 
Disposition of Patients ...................................................................................34 
7.3.2 
Protocol Deviations ........................................................................................34 
7.3.3 
Demographic and Other Baseline Characteristics ......................................34 
7.4 
Efficacy..................................................................................................................35 
7.4.1 
Datasets Analyzed ..........................................................................................35 
7.4.2 
Measurements of Treatment Compliance ...................................................35 
7.4.3 
Efficacy Endpoint Analysis Methods ...........................................................35 
7.4.4 
Statistical/Analytical Issues ...........................................................................36 
7.4.5 
Pharmacokinetic Analysis .............................................................................37 
7.4.6 
Pharmacodynamic Analysis ..........................................................................38 
7.5 
Safety Analysis .....................................................................................................38 
7.5.1 
Extent of Exposure .........................................................................................38 
7.5.2 
Adverse Events ...............................................................................................39 
7.5.3 
Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events ...............................................................................................41 
7.5.4 
Dose-Limiting Toxicity (DLTs) .....................................................................41 


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7.5.5 
Clinical Laboratory Evaluation ....................................................................41 
7.5.6 
Vital Signs, Physical Findings, and Other Observations Related to 
Safety ...............................................................................................................42 
7.6 
Determination of Sample Size .............................................................................43 
7.7 
Changes in the Conduct of the Study or Planned Analyses .............................43 
8 
References ..................................................................................................................44 
Appendix A: Imputation of Missing/Partially Missing Dates ......................................45 
Appendix B: List of Tables, Figures and Data Listings ...............................................47 
Appendix C: Table Layouts ............................................................................................55 
Appendix D: Figure Layouts.........................................................................................136 
Appendix E: Listing Layouts ........................................................................................144 
 
 
 


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TABLE OF TABLES 
Table 1 
List of Abbreviations .................................................................................6 
Table 2 
Segment I: Study Visits and Procedures ................................................14 
Table 3 
Segment II: Study Visits and Procedures ..............................................17 
Table 4 
Segment I Continous Dosing: Example Dose-Finding Table of 
CORT125134 / Nab-paclitaxel Dose Levels for Part 1 .........................21 
Table 5 
Segment II Intermittent-Dosing Regimen: Example Dose-Finding 
Table of CORT125134 / Nab-paclitaxel Dose Levels for Part 1 ..........21 
Table 6 
Rules for Dose-Finding to Define Maximum Tolerated Dose in Part 1 
of Segment I and II ..................................................................................23 
Table 7 
RECIST v1.1 Response Criteria .............................................................26 
Table 8 
Evaluation of Best Overall Response in Patients Without Initial 
Measurable Disease and Who are Evaluable by CA-125 (GCIG) .......28 
Table 9 
Best Overall Response in Patients with Measurable Disease and Who 
are also Evaluable by CA-125 (GCIG)...................................................29 
Table 10 
Clinical Laboratory Tests........................................................................30 
Table 11 
Censoring Rules for the Analysis of PFS ...............................................36 
 
TABLE OF FIGURES 
Figure 1 
Segment I Continuous-Dosing Regimen: Schematic of Study Drug 
Dosing and Pharmacokintic Sampling Schedule ..................................11 
Figure 2 
Segment II Intermittent-Dosing Regimen: Schematic of Study Drug 
Dosing and Pharmacokinetic Sampling Schedule .................................13 
 
 
 


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3 LIST OF ABBREVIATIONS  
Table 1 
List of Abbreviations  
Abbreviation 
Definition  
ACTH 
adrenocorticotropic hormone 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate transaminase 
ATC 
Anatomical Therapeutic Chemical 
BMI 
body mass index 
BUN 
blood urea nitrogen 
CAP 
chest, abdomen & pelvis 
CBR 
clinical benefit rate 
CR 
complete response 
CRF 
case report form 
CSR 
clinical study report 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DHEA 
dehydroepiandrosterone 
DLT 
dose-limiting toxicity 
DOR 
duration of response 
DRC 
Data Review Committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
ET 
Early Termination 
FSH 
follicle-stimulating hormone 
G-CSF 
granulocyte colony-stimulating factor 
GR 
glucocorticoid receptor 
ICH 
International Conference on Harmonization 
INR 
internalized normalized ratio 
LDH 
lactate dehydrogenase 
LH 
luteinizing hormone 
MCV 
mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
MTD 
maximum tolerated dose 
ORR 
objective response rate 
OS 
overall survival 


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Abbreviation 
Definition  
PD 
pharmacodynamic(s) 
PE 
physical examination 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PR 
partial response 
RBC 
red blood cell 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
TA 
tumor assessment 
TEAE 
treatment-emergent adverse event 
TSH 
thyroid stimulating hormone 
WBC 
white blood cell 
WHO 
World Health Organization 
 


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4 INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to provide comprehensive and 
detailed descriptions of the methods and presentation of data analyses proposed for 
Corcept Therapeutics Protocol CORT125134-550 (Phase 1/2 Study of CORT125134 in 
Combination with Nab-paclitaxel in Patients with Solid Tumors). Descriptions of planned 
analyses are provided in order to avoid post hoc decisions that may affect the 
interpretation of the statistical analysis. The statistical principles applied in the design and 
planned analyses of this study are consistent with the International Conference on 
Harmonisation (ICH) guideline E9 (Statistical Principles for Clinical Trials) (1).  
This SAP will be finalized prior to data analysis and before database lock to provide full 
details, including templates for tables, listings, and figures, to be presented in the clinical 
study report (CSR). Any changes between the statistical methods provided in the clinical 
study protocol and this SAP will be explained herein; any changes or deviations from this 
SAP relative to the final analysis will be fully documented in the CSR. Minor changes or 
deviations from the templates for tables, figures, and listings need not be documented in 
the CSR. 
5 STUDY OBJECTIVES 
5.1 
Primary Study Objective 
The primary objective of this study is to determine the maximum tolerated dose (MTD) 
and the development regimen of the combination of CORT125134 and nab-paclitaxel in 
patients with solid tumors. 
5.2 
Secondary Study Objectives 
The secondary objectives of this study are: 
 To characterize the safety profile of the combination of CORT125134 and nab-
paclitaxel; 
 To characterize the preliminary anticancer activity (objective response rate 
[ORR], progression-free survival [PFS], and overall survival [OS]) of the 
combination of CORT125134 and nab-paclitaxel in patients with solid tumors  in 
a dose-finding phase and in patients with specific tumor types; 
 To characterize the preliminary anticancer activity (ORR, PFS, and OS) of the 
combination of CORT125134 and nab-paclitaxel in patients with glucocorticoid 
receptor (GR)-positive or GR-negative solid tumors enrolled in any part of the 
study;  
 To characterize the pharmacokinetic (PK) and exposure-response of the 
combination of CORT125134 and nab-paclitaxel in patients with solid tumors in a 
dose-finding phase and in patients with specific tumor types; and 


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 To characterize the pharmacodynamic (PD) of the combination of CORT125134 
and nab-paclitaxel indicative of modulation of GR function, including hormornal 
changes and FKBP5.  
5.3 
Exploratory Study Objectives 
The exploratory objectives of this study are: 
 To evaluate molecular, cellular, and soluable markers in peripheral blood and/or 
tumor tissue that may be relevant to the mechanism of action of or 
response/resistance to CORT125134 and 
 To evaluate pharmacogenomic (PG) markers to assess genetic factors affecting 
drug metabolism and transporters. 
6 INVESTIGATIONAL PLAN 
6.1 
Overall Study Design 
This is a Phase 1/2 single-arm, open-label, multi-center study to determine the MTD and 
to assess safety, PK, PD, and preliminary anticancer activity of the combination of 
CORT125134 and nab-paclitaxel in patients with solid tumors. 
The study will consist of two segments to evaluate alternative dosing schedules of 
CORT125134: Segment I will evaluate a continuous-dosing regimen and Segment II will 
evaluate a intermittent-dosing regimen. In Segment I, dose-escalation cohorts will be 
enrolled to determine the MTD and the development regimen for the continuous-dosing 
regimen; thereafter, dose-expansion cohorts will be enrolled and treated with the 
continuous-dosing development regimen to better characterize the antitumor activity in 
patients with specific tumor types and to better define the safety profile. In Segment II, 
dose-escalation cohorts will be enrolled to determine the MTD and the development 
regimen for the intermittent-dosing regimen; thereafter, dose-expansion cohorts will be 
enrolled and treated with the intermittent-dosing development regimen to better 
characterize the anticancer activity of that regimen in patients with specific tumor types 
and to better define the safety profile for that regimen. Enrollment in Segment I and 
Segment II will be mutually exclusive, and the two segments will enroll patiehnts 
concurrently. 
6.1.1 
Segment I Continuous-Dosing Regimen 
 Part 1, Dose-Finding Phase: 
o Patients with any solid tumors for whom nab-paclitaxel is an appropriate 
therapy, in the opinion of the Investigator, will be enrolled according to a 
standard 3+3 cohort design.  


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o The starting dose level will be 100 mg CORT125134, administered once 
daily (QD), in combination with 80 mg/m2 nab-paclitaxel administered on 
Days 1, 8, and 15 of a 28-day cycle. 
o In Part I there will be a 1-week nab-paclitaxel lead-in (1 dose of nab-
paclitaxel on Day 1) and a 1-week CORT125134 lead-in (CORT125134 
daily for 7 days) before the start of Cycle 1, and then 28-day cycles 
consisting of CORT125134 daily for 28 days plus nab-paclitaxel weekly 
for 3 weeks. 
o PK will be characterized after dosing with nab-paclitaxel alone, after 7 
days of dosing with CORT125134 alone, and after dosing with the 
combination of nab-paclitaxel and CORT125134, in Cycle 1 only. 
o After a minimum of two dose levels are observed in Part 1, the nab-
paclitaxel lead-in may be discontinued per Data Review Committee 
(DRC) recommendataion if no meaningful drug-drug interactions are 
observed. If the nab-paclitaxel lead-in is discontinued, the first dose of 
study drug will be the CORT125134 dose on Day 1 of the CORT125134 
lead-in. 
o The DRC will review safety, laboratory, and any available PK data from 
each cohort prior to selecting the dose for the next cohort. Dosing will 
follow the dose-finding table (Table 3Error! Reference source not 
found.). Dose-limiting toxicities (DLTs) will be identified at each dose 
level. The MTD and development regimen to be used in Part 2 will be 
determined. 
o A given dose level may be expanded to further evaluate safety, 
tolerability, PK, or preliminary efficacy at that dose level or in a more 
restricted patient population (ie see pancreatic cancer specific corhort). 
 The Sponsor decided to end study enrollment after completion of Part 1, and plan 
for Part 2 portion of the study was not carried out. 
During Segment 1, patients will have the following in-clinic visits: Screening; Baseline 
(if needed); Days 1 and 2 of a 1-week nab-paclitaxel lead-in and Days 1 and 7 of a 1-
week CORT125134 lead-in before Cycle 1 (patients in Part 1); Cycle 1 Days 1, 8, and 15 
(all patients) and Day 9 (patients in Part 1); Cycle ≥ 2 Days 1, 8, and 15; and a 
Posttreatment or Early Termination (ET) Visit. The Schedule of Visits and Procedures is 
provided in Section 6.2 (Table 2).  
Patients will have safety assessments performed at all scheduled in-clinic visit, PK 
assessments during the 1-week lead-ins for patients in Part 1 only and during Cycle 1 for 
all patients, and PD assessments during Cycle 1. Serial PK sampling will be performed 
for patients.  


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Tumor assessments will occur at Screening (and Baseline if >28 days elapse between 
Screening and Cycle 1 Day 1), at the end of Cycle 2, and thereafter every 6–8 weeks and 
at time of suspicion of disease progression. Confirmation of response will be done as 
needed as per the Response Evaluation Criteria in Solid Tumors (RECIST). In patients 
with ovarian, fallopian tube, or primary peritoneal cancer, CA-125 will be assessed at the 
time of radiologic tumor assessments (baseline and every 6–8 weeks) and response 
reported per Gynecological Cancer Intergroup (GCIG) criteria in addition to RECIST 
v1.1.   
Patients will continue treatment in 28-day cycles until unacceptable toxicity, disease 
progression, or another withdrawal criterion is met. For patients with ovarian, fallopian 
tube, or primary peritoneal cancer, PFS will be based on RECIST 1.1 and progression 
should not be determined early based on increased CA-125 alone. 
A Posttreatment Visit for safety will be scheduled within 28 ±7 days after the last dose of 
study drug. Tumor assessment will be done at this visit if ≥4 weeks have elapsed since 
the prior tumor assessment and progressive disease has not been documented.  
Patients will be contacted by telephone to monitor for survival on a quarterly basis for 1 
year after the last dose of study drug (CORT125134 or nab-paclitaxel, whichever is 
latest) in the last patient on treatment.  
The study design scheme showing the dose schedule and planned PK sampling for 
patients in both parts of Segment I is shown in Figure 1. 
Figure 1 
Segment I Continuous-Dosing Regimen: Schematic of Study Drug 
Dosing and Pharmacokintic Sampling Schedule 
Abbreviations: Nab-Pac, nab-paclitaxel; PK, pharmacokinetic 


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6.1.2 
Segment II Intermittent-Dosing Regimen 
 Part 1, Dose-Finding Phase: 
o Patients with any solid tumor, for whom nab-paclitaxel is an appropriate 
therapy in the opinion of the Investigator, will be enrolled according to a 
standard 3+3 cohort design. 
o The starting dose level will be 200 mg CORT125134 in combination with 
100 mg/m2 nab-paclitaxel. CORT125134 will be administered once daily 
on the day before, the day of, and the day after the nab-paclitaxel infusions 
that will be administered on Days 1, 8, and 15 of the 28-day cycle. 
o PK will be characterized in Cycle 1 only, during treatment with 
combination nab-paclitasel and CORT125134. 
o The DRC will review safety, laboratory, and any available PK data from 
each cohort before selecting the dose for the next cohort. Dosing will 
follow the dose-finding table (Table 4Error! Reference source not 
found.). DLTs will be identified at each dose level. The MTD and 
development regimen to be used in further investigation will be 
determined. 
 The Sponsor decided to end study enrollment after completion of Part 1, and plan 
for Part 2 portion of the study was not carried out. 
 
During Segment II, patients will have the following in-clinic visits: Screening; Baseline/ 
CORT125134 Lead-in (Day −1); Cycle 1 Days 1, 2, 8, and 15 (all patients); Cycle ≥2 
Days 1, 8, and 15; and a Posttreatment or Early Termination Visit. The Schedule of Visits 
and Procedures is provided in Section 6.2 (Table 3).  
Patients in Segment II will follow the same schedule. After completing Screening 
assessments, patients will visit the clinic on Day −1 to complete their Baseline 
assessments then take their first dose of CORT125134. They will return to the clinic on 
Day 1 of Cycle 1 to receive their first infusion of nab-paclitaxel in combination with 
CORT125134, which is the start of the 28-day regimen of CORT125134 and nab-
paclitaxel. 
Patients will have safety assessments performed at all scheduled in-clinic visits, and 
serial PK assessments during the first 24 hours (ie, Day 1 predose through predose on 
Day 2) and on Day 15 of Cycle 1 only.  
Tumor assessments will occur at Screening (and Baseline if >28 days elapse between 
Screening and Cycle 1 Day 1), at the end of Cycle 2, and thereafter every 6–8 weeks and 
at time of suspicion of disease progression. Confirmation of response will be done as 
needed as per RECIST. In patients with ovarian, fallopian tube, or primary peritoneal 
cancer, CA-125 will be assessed at the time of radiologic tumor assessments (baseline 


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and every 6–8 weeks) and response reported per GCIG criteria in addition to RECIST 
v1.1.   
Patients will continue treatment in 28-day cycles until unacceptable toxicity, disease 
progression, or another withdrawal criterion is met. For patients with ovarian, fallopian 
tube, or primary peritoneal cancer, PFS will be based on RECIST 1.1 and progression 
should not be determined early based on increased CA-125 alone. 
A Posttreatment Visit for safety will be scheduled within 28 ±7 days after the last dose of 
study drug. Tumor assessment will be done at this visit if ≥4 weeks have elapsed since 
the prior tumor assessment and progressive disease has not been documented.  
Patients will be contacted by telephone to monitor for survival on a quarterly basis for 1 year 
after the last dose of study drug (CORT125134 or nab-paclitaxel, whichever is latest) in the 
last patient on treatment.  
The study design scheme showing the dose schedule and planned PK sampling for 
patients in both parts of the Segment II is presented in Figure 2Error! Reference source 
not found.. 
Figure 2 
Segment II Intermittent-Dosing Regimen: Schematic of Study Drug 
Dosing and Pharmacokinetic Sampling Schedule 
 
Abbreviation: NPK, pharmacokinetic  
 
 


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6.2 
Schedule of Assessments 
Table 2 
Segment I: Study Visits and Procedures 
Procedures/ 
Examinations a 
Screen-
ing 
Base-
lineb 
1-wk Nab-
paclitaxel Lead-inc 
1-wk CORT125134 
Lead-in 
Cycle 1 
(28-day cycle) 
Cycle 2+ 
(28-day cycles) 
Post
-Tx 
/ ET 
Day  
-28 to -1 
Day -7 
to -1 
Day  
1 
Day  
2 
Day  
1 
Day  
7 
Day 
1 
Day  
8 
Day 
9 
Day  
15 
Day  
1 
Day 
 8 
Day  
15 
Informed consent d  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria b 
X 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
Medical/oncologic history e 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination (PE) b,f 
X 
X 
 
 
 
 
X 
X 
 
X 
X 
X 
X 
X 
Vital signs b,g 
X 
X 
X 
 
 
 
X 
X 
 
X 
X 
X 
X 
X 
ECOG performance status b 
X 
X 
 
 
 
 
X 
X 
 
X 
X 
X 
X 
X 
ECG 
X 
 
 
 
 
Xh 
 
 
 
 
If clinically indicated 
Pregnancy test i 
X 
X 
 
 
 
 
Every 12 wk (±7 d) 
X 
Hematology b,j 
X 
X 
X 
 
X 
 
X 
X 
 
X 
X 
X 
X 
X 
Chemistry and INR b,k 
X 
X 
 
 
 
 
X 
X 
 
X 
X 
X 
X 
X 
Fasting insulin 
 
X 
 
 
 
 
 
 
 
X k 
 
 
 
 
Thyroid function test l 
 
Xl 
 
 
 
 
Every 12 weeks (±14 d) 
 
Hormone levels m 
 
Xm 
 
 
 
 
 
 
 
X 
 
 
 
 
Urinalysis (dipstick) b,n 
X 
X 
 
 
 
 
X 
 
 
 
X n 
 
 
X 
Tumor assessment (RECIST v1.1) o 
X 
X 
 
 
 
 
 
 
 
 
C3 D1 (±7 d) then every 6–8 wk 
Xo 
PD/biomarker blood sample p 
 
Xp 
 
 
 
 
 
 
 
X 
 Every 12 wk (±14 d) 
X 
Cytokine and T cell sample q  
 
 
X 
 
 
X 
 
X 
 
 
 
 
 
 
Optional PG sample 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor tissue for GR IHC: r archival 
or biopsy s 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up for survival t 
 
 
 
 
 
 
 
 
 
 
 
 
 
Xt 
Adverse events u 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Concomitant medications v 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
PK/metabolites sample collection w 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Study treatment administration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 – oral x,y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Nab-paclitaxel – IV x,y 
 
 
X 
 
 
 
X 
X 
 
X 
X 
X 
X 
 
 
Note: The acceptable visit window is ± 3 days for Day 1 of each Cycle after Cycle 1. Nab-paclitaxel infusions must be no less than 7 days apart, and the recommended window for 
Day 8 and 15 is no more than +24 hours. No visit window is allowed for Nab-paclitaxel Lead-in Day 2, Cycle 1 Day 1, and Cycle 1 Day 9 due to the planned collection of the 
24-hour PK samples. Posttreatment/Early Termination Visit to occur 28 (±7) days after the last dose of study drug. 
a. 
All procedures and examinations should be performed before the administration of study treatment(s), unless specifically stated otherwise. 
b. 
Inclusion/exclusion criteria and selected safety assessments (vital signs, ECOG, PE, and laboratory tests) are required to be repeated only for patients for whom screening 
assessments were performed >7 days before Day 1 of the 1-week lead-in (first dose of study treatment). 
c. 
Patients in Part 1 will have a 1-week Nab-paclitaxel Lead-in before the 1-week CORT125134 Lead-in. After a minimum of two dose levels are observed, the nab-paclitaxel 
lead-in may be discontinued per the DRC recommendation. 
d. 
The IRB-approved ICF must be signed before any study-specific procedures or examinations are performed. 
e. 
Including prior cancer treatments. Any new or clinically significant changes in the patient’s medical or oncologic history between signing of the IRB-approved ICF and the 
first dose of study treatment will be recorded on the AE CRF page. 
f. 
Physical examinations at Screening/Baseline, at Day 1 of each cycle, and at the Posttreatment/Early Termination Visit should be complete assessments. Other weekly 
examinations may be focused, to identify changes from Screening/Baseline or evaluate changes based on the patient’s clinical symptoms. Weight to be reported at each visit, 
height at Screening/Baseline Visit only. 
g. 
On days of nab-paclitaxel IV administration, vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) should be collected pre-infusion 
and within 5 minutes after stopping the nab-paclitaxel infusion.  
h. 
ECGs to be done at Screening (in triplicate) and at CORT125134 Lead-in Day 7 predose and 2.5 hours ±30 minutes postdose (in duplicate). 
i. 
For women of childbearing potential, serum or urine pregnancy test is required at Screening/Baseline and at Posttreatment/Early Termination Visits. Serum or urine 
pregnancy test to be performed every 3 cycles (approximately every 12 weeks ±1 week). If treatment with CORT125134 is stopped for ≥7 days, patient should have a 
negative pregnancy test before restarting drug. 
j. 
Hematology: Nab-paclitaxel Lead-in Day 1 hematology to be obtained if previous hematology done >7 days prior. If weekly hematology tests demonstrate CTCAE Grade 3/4 
cytopenias, increase frequency as clinically appropriate. Hematology assessments scheduled for the day of study drug dosing must be available and assessed for toxicity 
before dosing. The sampling for hematology assessment may be drawn within 48 hours before dosing.  
k. 
Chemistry: Baseline (Nab-paclitaxel Lead-in Day 1) and Cycle 1 Day 15 laboratory samples should be obtained in a fasting state to collect the fasting glucose and fasting 
insulin samples. Coagulation (INR) performed weekly for patients on warfarin. Samples for these assessments can be drawn within 48 hours before dosing.  
l. 
TSH is to be measured at Baseline (Nab-paclitaxel Lead-in Day 1 [predose]) and every 12 weeks (±14 days) for the first year and then every 6 months thereafter. Post-
Screening, testing can be on the same schedule as pregnancy testing. Free T4 and total T3 will be measured if TSH values are abnormal. 
m. Estradiol, testosterone, FSH, LH, and DHEA-S. Draw predose at Baseline (Nab-paclitaxel Lead-in Day 1) and Cycle 1 Day 15. A fasting, early morning specimen (7–9 AM) 
is preferred. 
n. 
Urinalysis at Screening, Baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, then every 12 weeks (±14 days) thereafter and at the Posttreatment Visit. Microscopy is 
required only to follow-up clinically significant urine dipstick findings. 
o. 
Tumor assessments (TAs): Screening—CAP CT scans done with contrast as standard of care ≤30 days of Screening may be used if they meet study quality criteria. 
Baseline—CAP CT scans with contrast done ≤28 days before the first dose of study drug will not need to be repeated for this time point. Subsequent TAs occur at Cycle 3 
Day 1 (±7 days) and thereafter every 6–8 weeks (no more than 8 weeks between scans) and at time of clinical suspicion of disease progression. In patients with ovarian, 
fallopian tube, or primary peritoneal cancer, CA-125 levels will be assessed at the time of radiologic tumor assessments; levels of other biomarker collected as standard 
practice (such as CA15-3 and CA19-9, PSA, and CEA) will be documented in the case report form. At the Posttreatment/Early Termination Visit, TA will be done if ≥4 
weeks have elapsed since the prior TA and progressive disease as not been documented.  


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p. 
Draw fasting, morning (7–9 AM) C-peptide, ACTH, morning cortisol, and FKBP5 at Baseline (Day 1 of Nab-paclitaxel Lead-in) and at Cycle 1 Day 15 before administration 
of any study treatment. FKBP5, morning cortisol, and ACTH will be repeated every 12 weeks (±14 days) for the first year and then approximately every 6 months thereafter 
and at the Posttreatment/End of Treatment Visit. 
q. 
Cytokines and T cell samples for patients in Part 1 are drawn predose and at 4 hours (±30 minutes) postdose to coincide with the PK time points on Nab-paclitaxel Lead-in 
Day 1, on CORT125134 Lead-in Day 7, and Cycle 1 Day 8. For patients in Part 2, samples are drawn at Cycle 1 Day 8 before and at 4 hours (±30 minutes) after nab-
paclitaxel infusion. Samples at all time points can be drawn with PK sample collections. 
r. 
Tumor tissue for GR IHC (archival or biopsy) is mandatory for patients in the study. Optional tumor tissue biopsy at the time of disease progression. 
s. 
Archival tumor tissue may consist of tumor block or 15 unstained formalin-fixed, paraffin-embedded slides (tissue block preferred). Tumor biopsy for screening GR IHC 
analysis is to be performed if archival tumor tissue is not available.  
t. 
Patients will be followed for progression and survival via telephone on a quarterly basis for 1 year after the last dose of study drug in the last patient on treatment. 
u. 
All AEs, including SAEs, will be recorded from the time of signing of the IRB-approved ICF until 28 days after the last dose of study treatment. An SAE related to study 
procedures or study conduct must be reported to the Sponsor if it occurs before first dose of study drugs. SAEs must be reported. Treatment-related AEs ongoing at the 
Posttreatment Visit should be followed to resolution or until the Investigator considers them “chronic” or “stable”. At the occurrence of a SAE or DLT, an additional ACTH, 
and cortisol blood sample and a PK sample will be drawn at the discretion of the Investigator, as close to the event as possible to help characterize any possible relationships 
between drug exposure and the clinical event. 
v. 
All concomitant medications (including over-the-counter and herbal treatments) should be recorded from 28 days before the first dose until 28 (±7 days) after the last dose of 
study drug. 
w. See PK sampling times.  
x. 
CORT25134 will be dispensed to patients as blister packs of capsules to be self-administered orally once daily in the morning, starting with CORT125134-550 Lead-In Day 1. 
Patients should return all unused CORT125134 capsules and the dose diary during the patient visits, and patient adherence to treatment should be assessed. On visit days, 
CORT125134 should be taken in the clinical during the visit and after initial blood draws with time and dose administration documented in the clinic charts. On days when 
CORT125134 and nab-paclitaxel are administered in combination, CORT125134 is to be administered within 15 minutes before the start of nab-paclitaxel infusion. 
y. 
All clinical laboratory results must be available and reviewed by the Investigator or Subinvestigator before each IV infusion of nab-paclitaxel and start of subsequent 
treatment cycles of CORT125134/nab-paclitaxel.  
 
 


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Table 3 
Segment II: Study Visits and Procedures 
Procedures/ 
Examinationsa 
Screening 
Baseline/CORT125134 
Lead-in b 
Cycle 1 
(28-day cycle) 
Cycle 2+ 
(28-day cycles) 
Post-Tx / 
ET 
Day −28 to −2  
Day −1 
Day 1 
Day 2 
Day 8, 15 
Day 1 
Day 8, 15 
Informed consent c  
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria b 
X 
X 
 
 
 
 
 
 
Medical/oncologic history d 
X 
 
 
 
 
 
 
 
Physical examination (PE) b,e 
X 
X 
 
 
X 
X 
X 
X 
Vital signs b,f 
X 
X 
X 
 
X 
X 
X 
X 
ECOG performance status b 
X 
X 
 
 
X 
X 
X 
X 
ECG g 
X 
 
Xg 
 
 
If clinically indicated 
Pregnancy test h 
X 
X 
Every 12 weeks (±7 days) 
X 
Hematology b,i 
X 
X 
X 
 
X 
X 
X 
X 
Chemistry and INR b,j 
X 
X 
 
 
X 
X 
X 
X 
Fasting insulin  
 
X 
 
 
X i 
 
 
 
Thyroid function test k 
 
X 
Every 12 wk (±14 days) 
 
Hormone levels l 
 
X 
 
 
X l 
 
 
 
Urinalysis (dipstick) b,m 
X 
X 
 
 
 
X 
 
X 
Cytokine and T cell sample n 
 
X 
X 
 
 
 
 
 
Optional PG sample  
 
X 
 
 
 
 
 
Tumor assessment (RECIST v1.1) o 
X 
X 
 
 
 
Cycle 3 Day 1 (±7 days) 
then every 6–8 wk 
Xo 
PD/biomarker blood sample collection p 
 
Xp 
 
 
X 
Every 12 wk (±14 d) 
X 
Tumor tissue for GR IHC:q archival or biopsy r 
X 
 
 
 
 
 
 
 
Follow-up for survival s 
 
 
 
 
 
 
 
Xs 
Adverse events t 
X 
 
 
 
 
 
 
X 
Concomitant medications u 
X 
 
 
 
 
 
 
X 
PK/metabolites sample collection v 
 
 
Xv 
Xv 
Xv 
 
 
 
Study treatment administrationw,x 
 
 
 
 
 
 
 
 


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Note:  The acceptable visit window is ±3 days for Day 1 of each Cycle after Cycle 1. Nab-paclitaxel infusions must be no less than 7 days apart, and the recommended visit 
window for Day 8 and Day 15 is no more than +24 hours. On Cycle 1 Day 2 no visit window is allowed due to the planned collection of the 24-hour PK samples. 
Posttreatment/Early Termination Visit to occur 28 (±7) days after the last dose of study drug. 
 
a. 
All procedures and examinations should be performed before the administration of study treatment(s), unless specifically stated otherwise. 
b. 
Inclusion/exclusion criteria and selected safety assessments (vital signs, ECOG, PE, and laboratory tests) are required to be repeated only for patients for whom screening 
assessments were performed >7 days before Day −1 (first dose of CORT125134). 
c. 
The IRB-approved ICF must be signed before any study-specific procedures or examinations are performed. 
d. 
Including prior cancer treatments. Any new or clinically significant changes in the patient’s medical or oncologic history between signing of the IRB-approved informed 
consent form and the first dose of study treatments will be recorded on the AE CRF page. 
e. 
Physical examinations at Screening, at Day 1 of each cycle except Cycle 1 Day 1 when it is performed on Baseline/Day −1, and at the Posttreatment/Early Termination Visit 
should be complete assessments. Other weekly examinations may be focused, to identify changes from Screening/baseline or evaluate changes based on the patient’s clinical 
symptoms. Weight to be reported at each visit, height at Screening/Baseline visit only. 
f. 
On days of nab-paclitaxel IV administration, vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) should be collected pre-infusion 
and within 5 minutes after stopping the nab-paclitaxel infusion.  
g. 
ECGs to be done at Screening (in triplicate) and at Cycle 1 Day 1 pre-CORT125134 dose and 2.5 hours ±30 minutes after start of nab-paclitaxel infusion (in duplicate). 
h. 
For women of childbearing potential, serum or urine pregnancy test is required at Screening/Baseline and at Posttreatment/Early Termination Visits. Serum or urine 
pregnancy test to be performed every 3 cycles (approximately every 12 weeks ±1 week). If treatment with CORT125134 is stopped for ≥7 days, patient should have a 
negative pregnancy test prior to restarting drug. 
i. 
Hematology: If weekly hematology tests demonstrate CTCAE Grade 3/4 cytopenias, increase frequency as clinically appropriate. Hematology assessments scheduled for the 
day of study drug dosing must be available and assessed for toxicity before dosing. The sampling for hematology assessment may be drawn within 48 hours prior to dosing.  
j. 
Chemistry: Baseline/Day –1 and Cycle 1 Day 15 laboratory samples should be obtained in a fasting state to collect the fasting glucose and fasting insulin samples. 
Coagulation (INR) performed weekly for patients on warfarin. Samples for these assessments can be drawn within 48 hours before dosing.  
k. 
TSH is to be measured at Baseline/Day–1 and every 12 weeks (±14 days) for the first year and then every 6 months thereafter. After Screening, testing can be on the same 
schedule as pregnancy testing. Free T4 and total T3 will be measured if TSH values are abnormal. 
l. 
Estradiol, testosterone, FSH, LH, and DHEA-S. Draw predose at Baseline/Day −1 and Cycle 1 Day 15. A fasting, early morning specimen (7–9 AM) is preferred. 
m. Urinalysis at Screening, Baseline/Day–1, Cycle 2 Day 1, Cycle 3 Day 1, then every 12 weeks (±14 days) thereafter and at the Posttreatment Visit. Microscopy is required only 
to follow-up clinically significant urine dipstick findings. 
n. 
Cytokine and T cell samples are drawn at Baseline/Day -1 predose, and Cycle 1 Day 1 predose and at 4 hours (±30 minutes) after nab-paclitaxel infusion. All samples can be 
drawn with PK sample collections. 
o. 
Tumor assessments (TAs): Screening—CAP CT scans done with contrast as standard of care ≤30 days of Screening may be used if they meet study quality criteria. 
Baseline—CAP CT scans with contrast done ≤28 days before the first dose of study drug will not need to be repeated for this time point. Subsequent TAs occur at Cycle 3 
Day 1 (±7 days) and thereafter every 6–8 weeks (no more than 8 weeks between scans) and at time of clinical suspicion of disease progression. In patients with ovarian, 
fallopian tube, or primary peritoneal cancer, CA-125 levels will be assessed at the time of radiologic tumor assessments; levels of other biomarker collected as standard 
practice (such as CA15-3 and CA19-9, PSA, and CEA) will be documented in the case report form. At the Posttreatment/Early Termination Visit, TA will be done if ≥4 
weeks have elapsed since the prior TA and progressive disease as not been documented.  
p. 
Draw fasting, morning (7–9 AM) C-peptide, ACTH, cortisol, and FKBP5 at Baseline/Day −1 before administration of any study treatment and at Cycle 1 Day 15. FKBP5, 
morning cortisol, and ACTH will be repeated every 12 weeks (±14 days) for the first year and then approximately every 6 months thereafter and at the Posttreatment/End of 
Treatment assessment 
q. 
Tumor tissue for GR IHC (archival or biopsy) is mandatory for patients in the study. Optional tumor tissue biopsy at the time of disease progression.  


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r. 
Archival tumor tissue may consist of tumor block or 15 unstained, formalin-fixed, paraffin-embedded slides(tissue block preferred). For patients enrolled in the study, tumor 
biopsy for screening GR IHC analysis is to be performed if archival tumor tissue is not available.  
s. 
Patients will be followed for survival via telephone on a quarterly basis for 1 year after the last dose of study drug in the last patient on treatment. 
t. 
All AEs, including SAEs, will be recorded from the time of signing of the IRB-approved ICF until 28 days after the last dose of study drug. An SAE related to study 
procedures or study conduct must be reported to Sponsor if it occurs prior to first dose of study drugs. SAEs must be reported as described in the protocol. Treatment-related 
AEs ongoing at the Posttreatment Visit should be followed to resolution or until the Investigator considers them “chronic” or “stable”. At the occurrence of a SAE or DLT, an 
additional cortisol and ACTH sample and a PK sample will be drawn, at the discretion of the Investigator, as close to the event as possible to help characterize any possible 
relationships between drug exposure and the clinical event. 
u. 
All concomitant medications (including over-the-counter and herbal treatments) should be recorded from 28 days before the first dose until 28 (±7 days) after the last dose of 
study drug. 
v. 
See PK sampling times.  
w. CORT25134 will be dispensed to patients as blister packs of capsules to be self-administered orally once daily in the morning, starting with CORT125134-550 Lead-In Day 
1. Patients should return all unused CORT125134 capsules and the dose diary during the patient visits, and patient adherence to treatment should be assessed. On visit days, 
CORT125134 should be taken in the clinical during the visit and after initial blood draws with time and dose administration documented in the clinic charts. On days when 
CORT125134 and nab-paclitaxel are administered in combination, CORT125134 is to be administered within 15 minutes before the start of nab-paclitaxel infusion. 
x. 
All clinical laboratory results must be available and reviewed by the Investigator or Subinvestigator before each IV infusion of nab-paclitaxel and start of subsequent 
treatment cycles of CORT125134/nab-paclitaxel.  
 
 


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6.3 
Treatments 
6.3.1 
Treatments Administered 
Study treatments for Segment I, Continous-Dosing Regimen: 
 CORT125134 is administered orally once daily in the morning for 7 days in a 1-
week lead-in prior to Cycle 1 and once daily in the morning for 28 days during 
each 28-day cycle, preferably at the same time each day.  
o On the days nab-paclitaxel is administered, CORT125134 should be taken 
within 15 minutes before the start of nab-paclitaxel infusion.  
o On in-clinic visit days, CORT125134 should not be taken at home but 
brought to the clinic and taken after any scheduled predose PK samples 
are drawn. 
 Nab-paclitaxel is administered by IV infusion over 30 minutes on Day 1 of a 1-
week nab-paclitaxel lead-in for patients in Part 1 and on Days 1, 8, and 15 of each 
28-day cycle for all patients. Nab-paclitaxel infusions must be no less than 7 days 
apart. After a minimum of two dose levels are observed, the nab-paclitaxel lead-in 
may be discontinued per the DRC recommendation. 
Study treatments for Segment II, Intermittent-Dosing Regimen: 
 CORT125134 is administered orally once daily in the morning the day before, the 
day of, and the day after nab-paclitaxel infusion.  
o On the days nab-paclitaxel is administered, CORT125134 should be taken 
within 15 minutes before the start of nab-paclitaxel infusion.  
o On in-clinic visit days, CORT125134 should not be taken at home but 
brought to the clinic and taken after any scheduled predose PK samples 
are drawn. 
 Nab-paclitaxel is administered by IV infusion over 30 minutes on Days 1, 8, and 
15 of each 28-day cycle for all patients. Nab-paclitaxel infusions must be no less 
than 7 days apart.  
6.3.1.1 
Dose Levels in Segment I 
In Segment I, the starting dose in Part 1 is 100 mg CORT125134 in combination with 
80 mg/m2 nab-paclitaxel. CORT125134 dose escalation will proceed by a maximum of 
50 mg per dose level. Example target dose levels for evaluation in Segment I, Part 1 are 
shown in Table 4Error! Reference source not found.. The starting dose of 100 mg C
ORT125134 is at the low end of the anticipated range of doses, yet retains the potential 
for PD effect. The starting dose of 80 mg/m2 nab-paclitaxel is at the lower end of the 


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range for a standard dose of nab-paclitaxel. With the starting dose level set in a 
conservative manner, the plan is to escalate the investigational product, CORT125134, 
sequentially in 50 mg increments through the dose-finding phase of the study. 
Table 4 
Segment I Continous Dosing: Example Dose-Finding Table of 
CORT125134 / Nab-paclitaxel Dose Levels for Part 1 
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose a 
(mg/m2) 
−1  
50 
80 
1 Starting dose 
100 
80 
2 
150 
80 
3 
200 
80 
4 
250 b 
80 
a 
Taking the nab-paclitaxel exposure and safety data into account, the nab-paclitaxel dose may be increased to 100 
mg/m2 or decreased to 60 mg/m2. Nab-paclitaxel and CORT125134 will not be escalated simultaneously; therefore, 
a change in dose for nab-paclitaxel would constitute a separate dose level. 
b    Doses may exceed 250 mg CORT125134 based on safety and PK data and DRC recommendation. 
6.3.1.2 
Dose Levels in Segment II 
In Segment II, the starting dose level in Part 1 is 200 mg CORT125134 in combination 
with 100 mg/m2 nab-paclitaxel. CORT125134 dose escalation is expected to proceed by 
100 mg per dose level (Table 5). However, CORT125134 doses may be escalated in 
50 mg increments if recommended by DRC. In Segment II, the DRC may recommend 
modifying  the nab-paclitaxel dose to 80 mg/m2 based on the nab-paclitaxel exposure and 
safety data. As noted above, enrollment in Segment I and Segment II will be mutually 
exclusive, and the two segments will enroll patients concurrently. 
Table 5 
Segment II Intermittent-Dosing Regimen: Example Dose-Finding 
Table of CORT125134 / Nab-paclitaxel Dose Levels for Part 1 
Dose Level 
CORT125134 Dose  
(mg) 
Nab-paclitaxel Dose  
(mg/m2) 
−1 
150 
100 
1 – Starting dose 
200 
100 
2 
300 
100 
3 
400 a 
100 
a 
Doses may exceed 400 mg CORT125134 based on DRC recommendation. 
Nab-paclitaxel may be dose reduced or dosed increased based on PK and DDI findings.  
CORT125134 doses may change in 50, or 100 mg increments based on DRC recommendations. 
6.3.1.3 
Dose Finding-Process 
Dose-finding decisions including selection of dose levels for cohorts, determination of 
the MTD and development regimen, and stopping enrollment, as applicable, will be 
performed by a DRC. The key principles guiding DRC recommendations for dose levels 
in dose-finding are to ensure that patients receive nab-paclitaxel at therapeutic exposures 
and to sequentially increase the dose of CORT125134 as tolerated.  


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Dose escalation or de-escalation will occur only after review of data from the first cohort 
by the DRC. If a lower dose level is explored and is well tolerated, the DRC may 
recommend re-escalating either CORT125134 or nab-paclitaxel. 
During the Part 1 Dose-Escalation Phase, on review of safety, laboratory, and available 
PK data from each cohort, the DRC may recommend proceeding to the next dose level 
per Table 4 for Segment I and per Table 5 for Segment II. Alternatively, taking PK and 
safety data into account, the DRC could recommend modifying the nab-paclitaxel dose 
(eg, with an increase to 100 mg/m2 or a decrease to 60 mg/m2 in Segment I) for reasons 
including: 
 Dose finding requires greater resolution to the titration of nab-paclitaxel exposure 
than may be induced by changes in dose of CORT125134 due to significant 
metabolic interaction (eg, increasing nab-paclitaxel dose by one step would 
increase nab-paclitaxel exposure to a lesser degree than increasing CORT125134 
dose by one step). 
 There is no significant metabolic interaction between CORT125134 and 
nab-paclitaxel. 
 An AE profile is encountered that is not suggestive of a nab-paclitaxel effect and 
hence may be attributed to CORT125134. 
For dose escalation, either CORT125134 or nab-paclitaxel, but not both, will be changed 
in the next dose level, based on recommendations by the DRC. If a lower dose level is 
explored and is well tolerated, the DRC may recommend re-escalating either 
CORT125134 or nab-paclitaxel. 
All patients in the Part 1 Dose-Escalation cohorts in Segment I and Segment II will be 
treated with CORT125134 plus nab-paclitaxel and assessed for 1 cycle. Approximately 
5 patients may be initially enrolled in a cohort, and non-DLT evaluable patients may be 
replaced to allow for a minimum of 3 evaluable patients for each cohort. Depending on 
the number of patients with DLTs, additional patients will be enrolled in the same cohort 
or additional cohorts will be enrolled following the criteria described in Table 6.  


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Table 6 
Rules for Dose-Finding to Define Maximum Tolerated Dose in Part 1 
of Segment I and II 
No. of Evaluable Patients 
with DLT at a Dose Level 
(cohort of <6 evaluable 
patients) 
 
 
Dose-Escalation Decision Rule in Cycle 1 
0  
 
Enroll cohort at next higher dose level.  
1  
 
Expand current dose level to 6 patientsa 
 
If 1 of 6 patients (<33%) experiences DLT, enroll cohort at 
next higher dose level.  
 
If ≥2 of 6 patients (≥ 33%) experience DLT: 
– 
Enroll cohort at next lower dose level, if available.  
OR 
– 
Declare next lower dose level as the MTD. 
≥2  
 
If ≥2 patients experience DLT: 
– 
Enroll cohort at next lower dose level, if available.  
OR 
– 
Declare next lower dose level as the MTD. 
Abbreviations: DLT, dose-limiting toxicity; MTD, maximum tolerated dose 
a 
The DRC may make the recommendation to adjust the size of a cohort to more than 6 patients to further the 
evaluation of a given dose level, such as further evaluation of PK data or tolerability. If cohorts are >6 patients, the 
decision rule will be based on the percentage of patients experiencing DLT within that cohort. 
The MTD is defined as the highest dose at which <33% (eg, 0 of 3 or 1 of 6 patients, with 
a minimum of 6 patients if 1 DLT is observed) experiences a DLT during Cycle 1. 
Alternatively, a different (lower) dose level may be declared the MTD depending on the 
nature, severity, and frequency of toxicities to date. Safety data that become available for 
patients remaining on-study after Cycle 1 will be taken into consideration when making 
decisions about dose escalation.  
The dose level selected for the development regimen may be equal to or lower than the 
MTD and its selection will take into account other issues such as safety data occurring 
after the first cycle.  
A sufficient number of patients will be enrolled in each cohort to ensure that there are 
DLT-evaluable patients available for determination of the MTD and identification of the 
development regimen. The number of DLT-evaluable patients may be inclusive of all 
cohorts at that dose level and schedule (such as advanced solid tumor and pancreatic 
cancer cohorts in Segment I) for determination of the MTD or dose-finding decisions, per 
DRC recommendation. If two distinct DLTs, such as events occurring in different 
MedDRA system organ classes, are observed within a dose level, the DRC may 
recommend expanding the cohort to >6 patients to further evaluate the tolerability of that 
dose level. DLT-evaluable patients will include those who complete one cycle of 
treatment or those who withdraw from the study due to toxicity during Cycle 1.  
 DLT-evaluable patients will include those who complete one cycle of treatment or 
those who withdraw from the study due to toxicity during Cycle 1.  
 


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 Non-evaluable patients will include patients who withdraw from the study prior to 
completion of Cycle 1 for reasons other than toxicity (eg, lost to follow-up, 
withdrawal of consent, disease progression, or receipt of ≤80% of CORT125134 
dosing due to reasons other than toxicity); these patients may be replaced.  
 
 PK for patients with a history of GI resection or gastric bypass surgery will be 
considered separately from the remainder of the cohort. The safety data for these 
patients will be taken into consideration in the assessment of the overall 
tolerability of a given cohort. A minimum number of patients evaluable for DLT 
will be enrolled to a cohort to consider the tolerability at this dose level who don’t 
have a history of GI resection/gastric bypass surgery.  
 
Based on safety data from the initial dose-finding cohorts, the DRC may recommend 
following an alternative dose-finding strategy that evaluates any of the dose levels in the 
planned Part 1 phases with inclusion of granulocyte colony-stimulating factor (G-CSF).  
 
 A given dose level may be expanded to further evaluate safety, tolerability, PK, or 
preliminary efficacy at that dose level or in a more restricted patient population.  
 
 A dose of CORT125134 100 mg continuous dosing and nab-paclitaxel 60 mg/m2 
with prophylactic G-CSF support will be explored in patients with pancreatic 
cancer. Initially, approximately 6–8 patients will be enrolled in this cohort. The 
DRC will review the safety and tolerability after 6 DLT-evaluable patients 
complete 1 cycle of therapy. If the dose-limiting toxicity (DLT) rate exceeds 33%, 
the dose will be declared non-tolerable for this population (tumor type and similar 
line of therapy) and no additional patients will be enrolled to that cohort. 
Alternatively, a higher or lower dose level may be evaluated, per the 
recommendation of the DRC based on safety and PK data. Once the dose level is 
declared tolerable, the cohort will be expanded to include approximately 12–15 
additional patients to further assess the safety and efficacy of this dose level. 
Safety and efficacy data from all pancreatic cancer patients receiving this dose 
level will be summarized. The DRC will take into consideration the overall 
tolerability and toxicities observed in this cohort(s) to inform dose escalation 
decisions and the recommended Phase 2 dose.  
6.3.2 
Method of Assigning Patients to Treatment Groups 
This is an open-label study with approximately 146 patients planned; estimates are as 
follows: 
 Segment I Continuous-Dosing Regimen—Part 1, approximately 62 patients;  
In addition to the standard dose finding process, approximately 6–8 patients with 
pancreatic cancer will be enrolled in Part 1 at a dose level of CORT125134 100 
mg continuous dosing and nab-paclitaxel 60 mg/m2 with prophylactic G-CSF. 
The DRC will review the safety and tolerability after 6 DLT-evaluable patients 
complete 1 cycle of therapy. If the dose-limiting toxicity (DLT) rate exceeds 33%, 
the dose will be declared non-tolerable for this population (tumor type and similar 


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line of therapy) and no additional patients will be enrolled to that cohort. 
Alternatively, a higher or lower dose level may be evaluated, per the 
recommendation of the DRC based on safety and PK data. Once the dose level is 
declared tolerable, the cohort will be expanded to include approximately 12–15 
additional patients to further assess the safety and efficacy of this dose level. 
Segment II Intermittent-Dosing Regimen—Part 1, approximately 24 patients.  
6.4 
Efficacy and Safety Variables 
6.4.1 
Efficacy Variables 
6.4.1.1 
Analysis of Anticancer Activity 
The efficacy objective of this study is to make a preliminary assessment of the anticancer 
activity of CORT125134 in combination with nab-paclitaxel in patients with the selected 
tumor types. The efficacy analyses will characterize anticancer activity for the following 
endpoints: 
 
 ORR consisting of the percent of patients with an objective tumor response: 
measurable disease with partial response (PR) or complete response (CR) as 
defined by RECIST v1.1 and confirmed on a second, consecutive scan obtained 
no less than 4 weeks after the criteria for response are first met in cohorts of 
patients treated with the development regimen.  
 
 Best response defined as the best response recorded from the date of the first dose 
of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points 
during study observation period (including both confirmed and unconfirmed 
responses).  
 
 Clinical benefit rate (CBR) defined as the percentage of patients who have 
achieved CR or PR, or SD for 16 weeks or greater.  
 
 Progression-free survival will be defined as the time from the date the patient 
receives the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, to 
the date the patient experiences unequivocal disease progression per RECIST v1.1 
or death (all causes of mortality).  
 
 Duration of response (DOR) as measured from the date that the criteria are met 
for complete response (CR) or partial response (PR) until the first date that 
progressive disease is objectively documented. 
 
 Overall survival defined as the time from date of the first dose of CORT125134 or 
nab-paclitaxel, whichever is earliest, until the date of death from any cause. 
 
Table 7 defines the RECIST v1.1 Response Criteria. 


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Table 7 
RECIST v1.1 Response Criteria 
Response 
Criteria 
Complete Response (CR) Disappearance of all target lesions.  Any pathological 
lymph nodes (whether target or non-target) must have 
reduction in short axis to < 10 mm. 
Partial Response (PR) 
At least a 30% decrease in the sum of diameters of target 
lesions, taking as reference the baseline sum diameters. 
Progressive Disease (PD) At least a 20% increase in the sum of diameters of target 
lesions, taking as reference the smallest sum on study (this 
includes the baseline sum if that is the smallest on study).  
In addition to the relative increase of 20%, the sum must 
also demonstrate an absolute increase of at least 5 mm.  
(Note:  the appearance of one or more new lesions is also 
considered progression). 
Stable Disease (SD) 
Neither sufficient shrinkage to qualify for PR nor sufficient 
increase to qualify for PD, taking as reference the smallest 
sum diameters while on study. 
 
Tumor tissue will be collected for GR IHC analysis throughout the study and summarized 
as part of the clinical study report; however, summarization of GR expression is outside 
the scope of this SAP. 
6.4.1.2 
Gynecological Cancer Intergroup Definitions for Response and 
Progression in Ovarian Cancer 
Tumor response and assessment according to GCIG is described below. This description 
is not exhaustive and the source (5) should be referred to for further detail. 
6.4.1.2.1 
Definition of Response 
A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a 
pretreatment sample. The response must be confirmed and maintained for at least 28 
days. Patients can be evaluated according to CA-125 only if they have a pretreatment 
sample that is at least twice the upper limit of the reference range and within 2 weeks 
before starting the treatment. 
To calculate CA-125 responses accurately, the following rules apply: 
 Intervening samples and the 28-day confirmatory sample must be less than or 
equal to (within an assay variability of 10%) the previous sample. 
 Variations within the reference range of CA-125 levels will not interfere with the 
response definition. 
 For each patient, the same assay method must be used, and the assay must be 
tested in a quality control scheme. 


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 Patients are not evaluable by CA-125 if they have received mouse antibodies 
(unless the assay used has been shown not to be influenced by human antimouse 
antibody) or if there has been medical and/or surgical interference with their 
peritoneum or pleura during the previous 28 days (e.g., paracentesis). If assessing 
therapy that includes 2 treatment modalities for relapse (e.g., surgery and 
chemotherapy), any CA-125 response results from both treatment modalities. CA-
125 cannot distinguish between the effects of the 2 treatments. 
The date when the CA-125 level is first reduced by 50% is the date of the CA-125 
response. To calculate response per GCIG criteria, an intent-to-treat analysis will be used 
that includes all patients with an initial CA-125 level of at least twice the upper limit of 
the reference range as eligible and evaluable. In addition, as a separate analysis, those 
patients who have a CA-125 response and whose CA-125 level falls to within the 
reference range can be classified as CA-125 complete responders. In Table 8 and Table 9 
where CA-125 is stated as normalized or normal, means within the reference range. The 
reference range for CA-125 is 0 units/mL to 35 units/mL 
6.4.1.2.2 
Evaluation of Best Overall Response in Patients without Initial 
Measurable Disease and Evaluable by CA-125 (GCIG) 
CA-125 may be used to evaluate response in patients without initial measurable disease 
either because no measurable disease is evident on radiological imaging or because 
appropriate imaging has not been performed as demonstrated in Table 8. 


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Table 8 
Evaluation of Best Overall Response in Patients Without Initial 
Measurable Disease and Who are Evaluable by CA-125 (GCIG) 
CA-125 
Nontarget  
Lesions a  
New Lesions  
Overall 
Response 
Best Response for 
This Category Also 
Requires 
Response and Normalized 
CR 
No 
CR 
Confirmed and 
maintained for at 
least 28 days 
Response 
Non-PD 
No 
PR 
Normalized but no response  
Non-CR/Non-PD 
No 
SD 
Non-PR/non-PD 
Non-PD 
No 
SD 
 
PD 
Any 
Yes or No 
PD 
 
Any 
PD b 
Yes or No 
PD 
 
Any 
Any 
Yes 
PD 
 
Abbreviations: CR, Complete response; PD, progressive disease; PR, partial response; SD, stable disease. 
a Nontarget lesions include ascites and peritoneal thickening, which are not measurable according to 
RECIST. 
b Unequivocal progression in nontarget lesions may be accepted as disease progression.  
6.4.1.2.3 
Evaluation of Best Overall Response in Patients with Initial 
Measurable Disease and Who are Also Evaluable by CA-125 
(GCIG) 
A report that combines both CA-125 and RECIST v1.1 criteria is likely to include 
patients who are measurable by one or both of the criteria and who may have events at 
different time points. It should be determined according to Table 9. In patients who have 
measurable disease by both criteria, the date of response will be the date of the earlier of 
the two events if this approach to combined response reporting is to be used. In the 
combined assessment of CA-125 and RECIST v1.1 response, the following algorithm 
applies when determining the best overall response. If patients have progressive disease 
(PD) according to RECIST v1.1 within 28 days of CA-125 response, they are classified 
as having PD. If the PD according to RECIST v1.1 is longer than 28 days before or after 
the CA-125 response, they are classified as having partial response. Patients whose best 
response according to RECIST v1.1 is stable disease but who have a CA-125 response 
are classified as CA-125 responders. 


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Table 9 
Best Overall Response in Patients with Measurable Disease and Who 
are also Evaluable by CA-125 (GCIG) 
Target Legion a 
Nontarget b 
New Lesion 
CA-125 
Best Overall 
Response 
CR 
CR 
No 
Normal  
CR 
CR 
Non-CR Non-PD 
No 
Not PD 
PR 
CR 
CR 
No 
PR but not normal 
PR 
CR 
NE 
No 
PR 
PR 
PR 
Non-PD or NAE 
No 
Not PD 
PR 
NAE 
Non-PD 
No 
PR 
PR 
PD or New >28 days from CA-125 PR c 
PR 
PR 
SD 
Non-PD 
No 
PR 
PR 
SD 
Non-PD or NAE 
No 
Not PR and not PD 
SD 
PD or New ≤28 days From CA-125 PR c 
PR 
PD 
PD 
Any 
Yes or No 
Any 
PD 
Any 
PD 
Yes or No 
Any 
PD 
Any 
Any 
Yes 
Any 
PD 
Any 
Any 
Yes or No 
PD 
PD 
Abbreviations: CA-125, cell surface antigen 125; CR, Complete response; NE, Not evaluated; NAE, not all 
evaluated; PD, progressive disease; PR, partial response; SD, stable disease. 
a Target lesions include up to 5 measurable lesions (2 per organ) as deﬁned by RECIST v1.1.  
b Nontarget lesions include ascites and peritoneal thickening which are not measurable according to 
RECIST v1.1. 
c Patients who have a CA-125 response that occurs more than 28 days from PD according to RECIST v1.1 
are considered a PR, according to best response, but PD if the RECIST v1.1 PD is within 28 days of 
CA-125 response. 
 
6.4.1.2.4 
Reporting of Response According to both RECIST v1.1 and CA-
125 (GCIG) Criteria 
In this study, responses will be reported separately for both tumor response per 
RECIST v1.1 and CA-125 response per GCIG. A combined response endpoint based on 
both RECIST v1.1 and GCIG will also be reported. Tumor response will be assessed by 
the Investigator or local radiologist using RECIST v1.1. CA-125 response and the 
combined response will be derived based upon local CA-125 results. 
6.4.2 
Description of Safety Variables 
6.4.2.1 
Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a study patient 
administered a pharmaceutical product, which does not necessarily have to have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended 


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sign (including an abnormal laboratory finding), symptom, or disease temporarily 
associated with the use of a medicinal (investigational) product, whether or not related to 
the medicinal (investigational) product that emerges or worsens relative to the patient’s 
pretreatment baseline.  
Illnesses present before the patient signs the ICF are considered pre-existing conditions 
and are documented on the medical history electronic case report form (eCRF). Pre-
existing conditions that worsen during the study are entered on the AE eCRF. 
6.4.2.2 
Laboratory Parameters 
Table 10 displays the Laboratory Parameters collected: 
Table 10 
Clinical Laboratory Tests 
Hematology 
Serum Chemistry 
Urinalysis (dipstick) 
Red blood cell (RBC) count  
Sodium  
Bacteria 
Hemoglobin  
Potassium  
Blood 
Hematocrit  
Calcium  
Urobilinogen 
Mean corpuscular volume (MCV) Chloride  
Nitrites 
Platelet count 
Phosphorus  
Color 
White blood cell (WBC) count  
Magnesium  
Clarity 
WBC with 5-part differential: 
Serum Creatinine 
pH 
Neutrophils 
Total bilirubin  
Specific gravity 
Lymphocytes 
Albumin  
Ketones 
Monocytes 
Alkaline phosphatase (ALP) 
Protein  
Eosinophils 
Lactate dehydrogenase (LDH) 
Glucose  
Basophils 
Aspartate aminotransferase (AST) Bilirubin 
Coagulation 
Alanine aminotransferase (ALT)  Leukocyte esterase 
International normalized ratio 
(INR)  
(only for patients taking warfarin) 
Glucose, fasting 
Other a 
Blood urea nitrogen (BUN) 
Serum or urine pregnancy test, if applicable 
Pharmacodynamic a 
Uric acid  
Thyroid stimulating hormone (TSH) 
C-peptide 
Bicarbonate  
Total T3 b 
ACTH 
Total protein  
Free T4 b 
Fasting morning cortisol c 
 
Estradiol 
FKBP5 c 
 
Testosterone, total, free, and percent free 
Insulin, fasting  
 
Follicle-stimulating hormone (FSH) 
Cytokine and T cell profiles 
 
Luteinizing hormone (LH) 
 
 
Dehydroepiandrosterone-sulfate (DHEA-S) 
 
 
Optional pharmacogenomic sample 
a  
Pharmacodynamic and other laboratory test samples are to be drawn predose.  
b 
Reflex testing only with abnormal TSH values. 
c 
May represent a panel of mRNA expression/glucocorticoid-modulated pathways. 


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6.4.2.3 
Vital Signs 
Vital signs (heart rate, systolic and diastolic blood pressure, temperature, and respiration rate) 
will be assessed. On days of nab-paclitaxel IV administration, vital signs should be collected 
predose and within 5 minutes after stopping the nab-paclitaxel infusion.  
Systolic and diastolic blood pressure will be measured after patients have been at rest (seated) 
for at least 3 minutes. Blood pressure will be recorded in mmHg. Heart rate will be measured 
in beats per minutes after the patient has been in a resting state (seated) for at least 3 minutes. 
6.4.2.4 
ECOG Performance Status 
The ECOG scales and criteria are used by doctors and researchers to assess how a 
patient’s disease is progressing, assess how the disease affects the daily living abilities of 
the patient, and determine appropriate treatment and prognosis. 
If a patient’s ECOG performance status declines to ≥2 between Screening/Baseline and 
Day 1, the patient will no longer be eligible and will be withdrawn from the study. 
6.4.2.5 
Physical Examinations 
Weight will be reported at each visit and height will be recorded at screening only. 
Height (without shoes) will be measured in centimeters (cm) using an appropriate 
measuring device. Weight (without shoes) will be measured in kilograms (kg) using a 
scale. Historical patient information and/or patient reports should not be used for either 
measurement. 
6.4.2.6 
ECG 
Electrocardiograms (ECGs) will be performed and read per ECG vendor specifications. 
The Investigator may do additional ECG measurements on a "for cause" basis as 
determined by clinical judgment. The Investigator or Subinvestigator (physician) will be 
responsible for review and interpretation of the safety ECG results on site and 
determining whether the ECG is normal, abnormal clinically insignificant, or abnormal 
clinically significant. The ECG report result should be initialed and dated. 
6.5 
Data Quality Assurance 
Report summaries will be generated using validated Base SAS software, version 9.4 or 
higher, on a PC or server-based platform. Additional validated software may be used to 
generate analyses, as needed.  
All SAS programs that create outputs or supporting analysis datasets will be validated by 
a second statistical programmer or biostatistician. At a minimum, validation of programs 
will consist of a review of the program log, review of output or dataset format and 
structure, and independent confirmatory programming to verify output results or dataset 
content. Additionally, all outputs will undergo a review by a senior level team member 
before finalization. 


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The content of the source data will be reviewed on an ongoing basis by project statistical 
programmers and statisticians. Data will be checked for missing values, invalid records, 
and extreme outliers through defensive programming applications, analysis-based edit 
checks, and other programmatic testing procedures. All findings will be forwarded to the 
project data manager for appropriate action and resolution.  
7 STATISTICAL METHODS 
7.1 
General Methodology 
Data will be analyzed by Precision for Medicine, Oncology and Rare Disease 
(“Precision”) personnel. Statistical analyses will be reported with tables, figures and 
patient data listings, presented in rich text format, and using recommended ICH 
numbering. Output specifications for all tables, listings and figures will be in 
conformance with guidelines specified by the ICH (2).  
7.1.1 
Reporting Conventions 
Efficacy tables and figures will be summarized by segment, tumor type, and for all 
patients combined. Safety tables and figures will be summarized by segment, dose level, 
and for all patients combined. Tables summarizing demographics and other baseline 
characteristics will include columns for segment, tumor type, and for all patients 
combined. In general, all data collected will be presented in patient data listings, for all 
enrolled patients. Listings will be ordered by segment, part, cohort, site, patient number, 
and assessment or event date.  
In general, continuous variables will be summarized to indicate the population sample 
size (N), number of patients with available data (n), mean, SD, median, minimum, and 
maximum values. Categorical variables will be summarized by the population size (N), 
number of patients with available data (n), number of patients in each category, and the 
percentage of patients in each category. Unless otherwise noted, the denominator to 
determine the percentage of patients in each category will be based on the number of 
patients with available data. Select ordinal data may be summarized using both 
descriptive statistics and counts and percentages of patients in each category, as 
appropriate. 
Non-zero percentages will be rounded to one decimal place. Rounding conventions for 
presentation of summary statistics will be based on the precision of the variable of 
summarization, as it is collected in its rawest form (ie, on the case report form [CRF] or 
as provided within an external file) and are outlined as follows: 
 The mean and median will be rounded to one more decimal place than the 
precision of the variable of summarization; 
 Measures of variability (eg, SD, SE) will be rounded to two more decimal places 
than the precision of the variable of summarization; and 


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 Minimum and maximum values will be presented using the same precision as the 
variable of summarization. 
Other statistics (eg, CIs) will be presented using the same general rules outlined above, or 
assessed for the most appropriate presentation based on the underlying data. 
7.1.2 
Summarization by Visit 
Data summarized by study visit will be based on the nominal, scheduled visit as reported 
on the CRF. Data collected at unscheduled and early termination visits will not be 
included in tabular summaries by visit but will be presented in patient data listings. 
7.1.3 
Standard Calculations 
Where appropriate, the calculated study day of each assessment or event will be 
presented with the assessment or event date on patient data listings, where study day will 
be determined as: 
 The assessment/event date minus the date of first dose, if the assessment/event 
date is prior to the date of first dose (resulting in a negative study day); and 
 The assessment/event date minus the date of first dose, plus one, if the 
assessment/event date is on or after the date of first dose; 
where first dose is defined as the date the study treatment CORT125134 is first 
received.  
Other variables requiring calculations will be derived using the following formulas: 
 Days: A duration between two dates expressed in days will be calculated using 
the following conventions: 
o Later date – (earlier date + 1), if the earlier date is on or after the date of 
first dose of study treatment; or 
o Later date – earlier date, if the earlier date is prior to the date of first dose 
of study treatment. 
 Months: A duration expressed in months will be calculated by dividing the 
duration in days by (365.25 / 12); 
 Years: A duration expressed in years will be calculated by dividing the duration 
in days by 365.25. 


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7.2 
Analysis Populations 
The following populations will be defined for this study: 
 The Safety population will include all patients who received at least one dose of 
CORT125134.  Patients who received only nab-paclitaxel and never received 
CORT125134 will be separately described. 
 Modified Intent-to-Treat (mITT) population will include all patients who received 
at least one dose of CORT125134. The mITT population concides with the Safety 
population. 
 The DLT-evaluable population will include all patients in Part 1 (dose-finding 
phase) who complete 1 cycle of treatment and assessment or who receive at least 
one dose of CORT125134 and discontinue before completing the first cycle 
because of toxicity.  
 The Response-evaluable population will be the subset of the Safety population 
with at least one post-baseline tumor assessment.  
 The PK-evaluable population will be the subset of the Safety population with 
adequate PK data. 
7.3 
Study Patients 
7.3.1 
Disposition of Patients 
Patient disposition will be summarized for all enrolled patients by segment, tumor type, 
and dose level. Summaries will include the number and percentage of patients in each 
analysis population, primary reason for ending treatment, if the patient agreed to survival 
status monitoring, if the patient completed the survival follow-up period, and reason for 
study discontinuation. Patient disposition will also be summarized separately for each 
study center. 
7.3.2 
Protocol Deviations 
Deviations from the protocol and relevant details will be tracked throughout the study 
and summarized as part of the clinical study report; however, summarization is outside 
the scope of this SAP.  
7.3.3 
Demographic and Other Baseline Characteristics 
Demographic variables including age, sex, ethnicity and race, will be summarized by 
segment and tumor type for the safety, DLT-evaluable, and response-evaluable 
populations.  


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Age as reported on the CRF will be summarized using descriptive statistics. Sex, 
ethnicity, and race will be summarized with the number and percentage of patients in 
each parameter category. 
Baseline characteristics include medical history, height, weight, and body mass index 
(BMI). BMI will be calculated as: weight (kg) / [height (cm) / 100]2.  Baseline 
characteristics will be summarized for the mITT Population by segment, tumor type, and 
for all patients combined. Height, weight, and BMI at baseline will be summarized using 
descriptive statistics.  
Cancer type will be summarized by segment, tumor type, and for all patients combined 
for each analysis population. Summaries will include frequency counts and percentages 
or descriptive statistics for cancer type, prior lines of cancer therapy, and prior taxane. 
Frequency counts and percentages summarize patients reporting abnormal medical 
history by system organ class for the safety population will be presented coded using the 
Medical Dictionary for Regulatory Activities (MedDRA), Version 19.0. 
7.4 
Efficacy 
7.4.1 
Datasets Analyzed 
All efficacy summaries will be based on the mITT population. A subset of the efficacy 
analyses will be performed on the Response-evaluable population as well. The mITT 
population concides with the Safety population. 
7.4.2 
Measurements of Treatment Compliance 
Compliance to the study treatment regimen will be determined separately for 
CORT125134 and nab-paclitaxel as the total dose received divided by the expected dose 
received, multiplied by 100. Dosing compliance will be summarized using descriptive 
statistics, by segment, tumor type, and for all patients combined based on the Safety 
Population. The number and percentages of patients who are < 80% compliant and 
≥ 80% compliant within each group will be summarized. 
7.4.3 
Efficacy Endpoint Analysis Methods 
The analysis population is the mITT population. Analyses for ORR, BOR, and CBR will 
also be performed using the Response-Evaluable Population. The efficacy endpoints 
include best response, CBR, OS, PFS, DOR, ORR as defined by RECIST v1.1, and CA-
125 response per GCIG criteria (patients with ovarian, fallopian tube, or primary 
peritoneal cancer only). 
For OS, PFS, and DOR will be analized in the mITT population only using the Kaplan-
Meier method to estimate the survival functions, using time to event and a censoring 
variable. The Kaplan-Meier curves will be plotted. Results will be presented by segment, 
tumor type, and for all patients combined. Counts and percentages for number of patients 


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who experienced the event of interest and those who are censored are presented along 
with minimum and maximum survival months. The median, 25th and 75th percentiles will 
be estimated and their corresponding Brookmeyer-Crowley 95% CIs using the Kaplan-
Meier estimates. The survival estimates will be provided for 6 months, 12 months and 24 
months survival time with their corresponding 95% CIs.  
PFS is defined as time from date of first dose of CORT125134 or nab-paclitaxel, 
whichever is earlier, to the date of unequivocal disease progression per RECIST v1.1 or 
death from any cause, whichever occurs first. The censoring rules are described in Table 
11. 
Table 11 
Censoring Rules for the Analysis of PFS 
Censoring Categories 
Date of Censoring 
Patients who did not have baseline or postbaseline 
tumor assessments and did not die on or before the 
data cutoff date  
Date of first dose of CORT125134 or nab-
paclitaxel, whichever is earliest +1 
Patients who did not have disease progression and did 
not die on or before the data cutoff date 
Date of the last adequate tumor assessment on 
or before the data cutoff date 
Patients who had 2 or more consecutive missed 
scheduled tumor assessments immediately prior to 
disease progression 
Date of the last adequate tumor assessment 
without evidence of disease progression 
before the 2 missed tumor assessments and on 
or before the data cutoff date 
PFS, progression-free surivival. 
Overall survival defined as the time from date of the first dose of CORT125134 or 
nab-paclitaxel, whichever is earliest, until the date of death from any cause. Patients who 
are not reported as having died before the data cutoff date will be analyzed as censored 
observations on the date they were last known to be alive.  
Duration of response is measured from the date that the criteria are met for complete 
response (CR) or partial response (PR) until the first date that progressive disease is 
objectively documented. Patients who have not experienced disease progression or death 
before the data cutoff date will be censored at the last tumor assessment date. 
Best response, CBR, and ORR will be summarized in the mITT and Response-evaluable 
populations, by segment, tumor type, and for all patients combined. Counts and 
percentages will be summarized according to the specified criteria with exact 95% 
bionomial CIs (Clopper-Pearson). The overall response rate (CR or PR) and the CBR 
(CR or PR or SD) will be presented for the RECIST criteria. Best response with 
percentage change from baseline will be displayed in a waterfall plot. 
7.4.4 
Statistical/Analytical Issues 
7.4.4.1 
Adjustments for Covariates 
There are no planned applications of covariate adjustments; all statistical results are 
descriptive in nature. 


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7.4.4.2 
Handling of Dropouts or Missing Data 
Detailed rules for imputation of missing/partially missing dates for adverse events and 
prior/concomitant medications/procedures are provided in Appendix A: Imputation of 
Missing/Partially Missing Dates. All other analyses will be based on observed data only.  
7.4.4.3 
Interim Analyses and Data Monitoring 
A DRC will perform the safety monitoring of the study drug in accordance with 
procedures detailed in a DRC Charter. The DRC will monitor data throughout the course 
of dose-finding (Part 1), and make recommendations regarding dose escalation for each 
cohort. 
No interim analyses are planned for the purposes of early stopping of the study or 
modifying the study design. However, data may be reviewed periodically by the Sponsor, 
as needed. 
7.4.4.4 
Multicenter Studies 
This is a multicenter study, with approximately 8 sites expected to participate. Efficacy 
data collected from all study centers will be pooled for data analysis. The effect of study 
center on the efficacy analysis results may be explored post-hoc, as needed. 
7.4.4.5 
Multiple Comparisons/Multiplicity 
There will be no adjustments for multiple comparisons in the efficacy analysis for this 
study. Results are descriptive in nature and there will be no formal comparisons made 
among treatment groups. 
7.4.4.6 
Use of an “Efficacy Subset” of Patients 
All efficacy analysis will be performed on the mITT population. A subset of efficacy 
analyses will also be perfomerf on the Response-evaluable population since this 
population is the subset of the Safety population with at least one post-baseline tumor 
assessment. 
7.4.4.7 
Active-Control Studies Intended to Show Equivalence 
This study does not include an active-control product and is not intended to demonstrate 
equivalence between any two drug products. 
7.4.4.8 
Examination of Subgroups 
There are no planned analyses to assess efficacy results by subgroups. 
7.4.5 
Pharmacokinetic Analysis 
Pharmacokinetic analysis will be summarized in a separate report and is outside the scope 
of this SAP. 


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7.4.6 
Pharmacodynamic Analysis 
Pharmacodynamic analysis will be summarized in a separate report and is outside the 
scope of this SAP. 
7.5 
Safety Analysis 
Safety analysis will be carried out for the Safety Population, to include all patients who 
receive at least one dose of nab-paclitaxel or CORT125134. Patients who do not 
complete the study, for whatever reason, will have all available data up until the time of 
termination included in the analysis.  
7.5.1 
Extent of Exposure 
Extent of exposure to nab-paclitaxel and CORT125134 will be summarized for the Safety 
Population by segment, dose level, and for all patients combined separately for each 
study drug.  
 Number of Cycles of Treatment: The number of cycles for each study drug will be 
presented based on the last visit when the patient received treatment. 
 Duration of Exposure: The duration of exposure for each study drug will be 
presented in days and calculated as the last dose of study drug minus the date of 
the first dose of study drug, plus one. 
 Total Dose Received: The total dose received for each study drug will be the sum 
of the actual dose administered for the duration of exposure. 
For subjects where their dose received is either zero or missing, a received dose of 
zero is included in the total dose received derivation. 
 Total Dose Expected: The total dose expected is calculated for each study drug. 
The expected study drug dosing schedule is as follows: 
o For Segment I patients CORT125134 is expected to be taken daily starting 
at the CORT125134 lead-in. Nab-paclitaxel is expected to be taken on 
nab-paclitaxel lead-in Day 1, and Day 1, 8, and 15 of each cycle. 
o For Segment II patients CORT125134 is expected to be taken on Day 1, 2, 
7, 8, 9, 14, 15, 16, and 28 of each cycle. Nab-paclitaxel is expected to be 
taken on Day 1, 8, and 15 of each cycle.  
The expected drug dosing schedule is used in combination with the actual date 
and dose of study drug administration to calculate the total dose expected. A 
subject will have expected dose calculations based on all days within a cycle as 
determined by the earliest start date and the latest end date within a given cycle. 
For subjects where their dose received is either zero or missing, an associated 
expected dose is included in the toal dose expected derivation.  


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 Relative Dose Intensity: Relative dose intensity is calculated for each study drug 
as the total dose received divided by the total dose expected, multiplied by 100. 
Number of cyles, duration of exposure, total dose received, total dose expected and 
relative dose intensity will be summarized using descriptive statistics for each study drug 
separately.  
7.5.2 
Adverse Events 
Treatment-emergent adverse events (TEAEs) are defined as those adverse events (AEs) 
with onset after the first dose of CORT125134 or existing events that worsened after the 
first dose during the study through 28 days after the last dose of either study drug. TEAEs 
will be summarized by segment, dose level, and for all patients combined. Events 
reported with a partial onset date (eg, month and year are reported but the day is missing) 
will be considered to be treatment-emergent if it cannot be confirmed that the event onset 
was prior to the first dose of study drug based on the available date entries. 
Verbatim terms on case report forms will be mapped to preferred terms and system organ 
classes using the Medical Dictionary for Regulatory Activities (MedDRA, version 19.0).   
Summaries that are displayed by system organ class and preferred terms will be ordered 
by descending incidence of system organ class and preferred term within each system 
organ class. Summaries displayed by preferred term only will be ordered by descending 
incidence of preferred term. Summaries of the following types will be presented: 
 Overall summary of number of unique TEAEs and treatment-emergent serious 
adverse events (SAEs) and patient incidence of TEAEs meeting various criteria 
will be presented for the Safety population. 
 Patient incidence of TEAEs by MedDRA system organ class and preferred term; 
 Patient incidence of TEAEs by MedDRA preferred term; 
 Patient incidence of the most frequently-occurring TEAEs (ie, TEAEs occurring 
in ≥ 10% of the Safety population) by MedDRA preferred term; 
 Patient incidence of the most frequently-occurring TEAEs (ie, TEAEs occurring 
in ≥ 10% of the Safety population) by CTCAE grade and MedDRA system organ 
class and preferred term; 
 Patient incidence of the most frequently-occurring TEAEs (ie, TEAEs occurring 
in ≥ 10% of the Safety population) by CTCAE ≥ Grade 3 and MedDRA preferred 
term; 
 Patient incidence of TEAEs by CTCAE grade and MedDRA system organ class 
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 Patient incidence of TEAEs related to CORT125134 by MedDRA system organ 
class and preferred term; 
 Patient incidence of TEAEs related to CORT125134 by MedDRA preferred term;  
 Patient incidence of the most frequently-occurring TEAEs related to 
CORT125134 (ie, related TEAEs occurring in ≥ 10% of the Safety population) by 
MedDRA preferred term; 
 Patient incidence of TEAEs by CTCAE ≥ Grade 3 by MedDRA system organ 
class and preferred term; 
 Patient incidence of TEAEs by CTCAE ≥ Grade 3 by MedDRA preferred term; 
 Patient incidence of TEAE by CTCAE ≥ Grade 3 TEAEs related to study drugs 
(CORT125134 and nab-paclitaxel) by MedDRA system organ class and preferred 
term; 
 Patient incidence of TEAEs leading to withdrawal of study drugs (any study drug, 
CORT125134, and nab-paclitaxel) by MedDRA system organ class and preferred 
term; 
 Patient incidence of TEAEs leading to study drug interruption (any study drug, 
CORT125134, and nab-paclitaxel) by MedDRA system organ class and preferred 
term; 
 Patient incidence of TEAEs leading to study drug reduction (any study drug, 
CORT125134, and nab-paclitaxel) by MedDRA system organ class and preferred 
term; 
 Patient incidence of TEAEs leading to death by MedDRA system organ class and 
preferred term; 
 Patient incidence of SAEs by MedDRA system organ class and preferred term; 
 Patient incidence of Non-Hematolgical AEs 
At each level of summarization (eg, any adverse event, system organ class, and preferred 
term), patients experiencing more than one TEAE will be counted only once. In the 
summary of TEAEs with TEAE ≥ Grade 3, patients will be counted once at the highest 
grade reported at each level of summarization; in the summary of TEAEs by relationship, 
patients will be counted once at the closest relationship to study drugs. 
An overall summary of number of unique neutropenia TEAEs and treatment-emergent 
serious adverse events (SAEs) and patient incidence of TEAEs meeting various criteria 
will be presented for the Safety population. Neutropenia adverse events are those 
reporting a preferred term of “neutropenia,” “febrile neutropenia,” or “neutrophil count 


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decreased” using the Medical Dictionary for Regulatory Activities (MedDRA), version 
19.0. The time to onset of first neutropenia TEAE and first neutropenia TEAE with 
CTCAE ≥ Grade 3 will be summarized for the Safety population. 
Adverse event data will be presented in data listings by patient, segment, tumor type, 
dose level, and event. SAEs and adverse events leading to discontinuation of the study 
drugs will be presented in separate data listings. 
7.5.3 
Deaths, Other Serious Adverse Events, and Other Significant Adverse 
Events 
All deaths during the study, including the post treatment follow-up period, will be listed 
by patient, to include the primary cause of death and summarized in a table. Serious 
adverse events and other significant adverse events, including those that led to 
withdrawal, interruption, or dose reduction of the study drug, will be provided in separate 
patient data listings. 
Primary cause of death as reported on the end of study case report form will be 
summarized by segment, dose level, and for all patients combined for the Safety 
population. The number of patients where death occurred within 28 days of last study 
drug dose and the number of patients where death did not occur within 28 days of last 
study drug dose will be presented. Primary cause of death will be summarized with the 
number and percentage of patients in each category.  
7.5.4 
Dose-Limiting Toxicity (DLTs) 
DLTs that occur during Cycle 1 of treatment will be presented in a data listing by 
segment and dose level for the DLT-evaluable population. 
7.5.5 
Clinical Laboratory Evaluation 
All descriptive summaries of laboratory results will be based on data analyzed by the 
central laboratory and presented in Système International units as suggested by the Center 
for Biologics Evaluation and Research and the Center for Drug Evaluation and Research 
(3). All data will be included in by-patient data listings. Laboratory measurements 
identified as abnormal (i.e., outside the normal range) will be listed separately by patient, 
laboratory test and unit. 
Clinical laboratory measurements, including serum chemistry and hematology, will be 
summarized by segment, dose level, and for all patients combined. Descriptive statistics 
will be presented for observed values and changes from baseline at each visit where 
parameters were scheduled to be collected per the clinical study protocol.  
Where applicable, laboratory results classified as “clinically significant” will be 
presented. Summary results will include the count and percentage of patients for each 
laboratory parameter within each part and group. 


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Where applicable, hematology and chemistry results for select parameters will be 
assigned a toxicity grade based on the National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI CTCAE), version 4.03 (4). Five-by-five contingency 
tables will be presented for lab tests where toxicity grading can be applied to summarize 
the shift from the baseline grade to the worst post-baseline grade. Grades will be 
presented as none (Grade 0), mild (Grade 1), moderate (Grade 2), severe (Grade 3), or 
life-threatening (Grade 4). Death related to adverse event (ie, Grade 5) cannot be 
determined with available laboratory-based data collection and, thus, will not be 
summarized as a category. Summary results will include the count and percentage of 
patients within each shift category.  
7.5.6 
Vital Signs, Physical Findings, and Other Observations Related to Safety 
7.5.6.1 
Vital Signs 
Vital sign parameter measurements will be summarized by segment, dose level, and for 
all patients combined. Descriptive statistics will be presented for results and change from 
baseline at each visit where parameters were scheduled to be collected.  
7.5.6.2 
12-Lead Electrocardiogram 
Twelve-Lead ECG interval parameters of QTc intervals calculated using Bazett’s 
correction and Fridericia’s correction, QTcB and QTcF, will be summarized by segment, 
dose level, and for all patients combined. Descriptive statistics will be presented for 
observed values and changes from baseline at each visit where parameters were 
scheduled to be collected. 
Twelve-lead ECG will be classified by the investigator as normal or abnormal and will be 
presented to summarize the shift from the baseline to the worst post-baseline value. 
Summary results will include the number and percentage of patients within each shift 
category. 
Prolonged QTc intervals will be summarized as QTcB and QTcF measurements (msec) 
categorized as >450, >470 and >500 at each visit. Change from baseline will also be 
summarized with a change of >30 or >60 from baseline value.  
7.5.6.3 
ECOG Performance Status 
ECOG exams are to be performed at Screening/Baseline, at Day 1, 8, and 15 of each 
cycle, and at the Posttreatment/Early Termination Visit. ECOG performance status will 
be presented in patient data listings by patient and date. 
7.5.6.4 
Physical Examination 
Complete physical examinations are to be performed at Screening/Baseline, at Day 1 of 
each cycle, and at the Posttreatment/Early Termination Visit. Results of the physical 
examination will be presented in patient data listings by patient, study visit, and body 
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7.5.6.5 
Prior and Concomitant Medications 
Medications will be coded using the World Health Organization (WHO Drug March 1, 
2014 version, enhanced) dictionary. Medications entered on the case reports formats will 
be mapped to Anatomic Therapeutic Chemical (ATC) drug class (level 4) and drug name.  
Prior and concomitant medications will be summarized separately by part and overall by 
segment and dose level. A prior medication is defined as any medication administered 
prior to the date of the first dose of study drug. A concomitant medication is defined as 
any medication administered on or after the date of first dose of study drug. A medication 
may be defined as both prior and concomitant. If it cannot be determined whether a 
medication was received prior to the start of study drug dosing due to partial or missing 
medication start and end dates, it will be considered a prior medication. Likewise, if it 
cannot be determined whether a medication was received after the start of study drug 
dosing, it will be considered concomitant. Detailed rules for imputation of 
missing/partially missing dates for adverse events and prior/concomitant 
medications/procedures are provided in Appendix A: Imputation of Missing/Partially 
Missing Dates.   
For the summary of both prior medications and concomitant medications, the number and 
percentage of patients receiving any medication will be summarized, as will the number 
and percentage receiving any medication by ATC drug class and generic drug name. 
Patients reporting use of more than one medication at each level of summarization (any 
medication received, ATC class, and generic drug name) will be counted only once. ATC 
class terms will be displayed by descending order of incidence, as will generic drug 
names within each ATC class. The study phase during which each medication was 
received (eg, prior, concomitant, or both) will be presented on the listing of prior and 
concomitant medications. 
7.6 
Determination of Sample Size 
There is no formal sample size calculation or hypothesis testing in this study. An 
adequate number of DLT-evaluable patients will be enrolled to determine the MTD and 
development regimen in Segment I, Part 1 (approximately 42 patients) and Segment II, 
Part 1 (approximately 24 patients).  
7.7 
Changes in the Conduct of the Study or Planned Analyses 
The Sponsor decided to end study enrollment after completion of Part 1, and plan for Part 
2 portion of the study was not carried out. 
There were no changes to the study conduct or planned analyses identified within the 
development of this SAP, relative to the descriptions provided within the clinical study 
protocol. 
 
 


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8 REFERENCES 
1. International Conference on Harmonization of Technical Requirements for 
Registration of Pharmaceuticals for Human Use. Statistical principles for clinical 
trials (E9). International Conference on Harmonization; 1998. 
2. M2 eCTD: Electronic Common Technical Document Specification Appendix 7, 
provided by the International Conference on Harmonization. Available from: 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformatio
n/Guidances/ucm073240.pdf 
3. Data Standards: Position on Use of SI Units for Lab Tests. U.S Food and Drug 
Administration; 25 October 2013. Available from: 
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm372553.
htm  
4. U.S. Department of Health and Human Services. Common Terminology Criteria 
for Adverse Events (CTCAE), Version 4.03. 14 June 2010. Available from: 
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-
14_QuickReference_8.5x11.pdf.   
5. Rustin, G. (2011). Definitions for Response and Progression in Ovarian Cancer 
Clinical Trials Incorporating RECIST 1.1 and CA 125 Agreed by the 
Gynecological Cancer Intergroup (GCIG). International Journal Of Gynecologic 
Cancer, 21(2), 419-423. 
 
 


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APPENDIX A: IMPUTATION OF MISSING/PARTIALLY MISSING 
DATES 
Missing data will not be imputed unless otherwise specified.   
For safety analyses, incomplete date of last dose of study drug that is missing the day of 
the month, the 15th of the month will be used to impute the missing data.  When 
imputing partial last dose dates, the last assessment date and death date will be taken into 
consideration.  This imputation rule will be used to determine the treatment-emergent 
period.   
Adverse Events and Concomitant Medications  
The imputation rule for the safety analyses will be used to address the issues with partial 
dates.  The imputed dates will be used to determine the treatment-emergent period.  For 
adverse events with a partial date, available date parts (year, month, and day) of the 
partial date will be compared with the corresponding date components of the start date 
and end date of the treatment-emergent period to determine if the event is treatment 
emergent.  When in doubt, the adverse event will be considered treatment emergent by 
default.  The following rules will be applied to impute partial dates for adverse events:  
If start date of an adverse event is partially missing, impute as follows:  
 If both month and day are missing and year = year of treatment start date, then set 
to treatment start date  
 If both month and day are missing and year ≠ year of treatment start date, then set 
to January 01  
 If day is missing and month and year = month and year of treatment start date, 
then set to treatment start date  
 If day is missing and month and year ≠ month and year of treatment start date, 
then set to first of the month  
 If start date is completely missing, set to treatment start date as long as adverse 
event end date is not before treatment start date  
If end date of an adverse event is partially missing, impute as follows:  
 If both month and day are missing, then set to December 31  
 If only day is missing, then set to last day of the month  
 If end date is completely missing, do not impute  
When the start date or end date of a medication is partially missing, the date will be 
imputed to determine whether the medication is prior or concomitant (or both).  The 
following rules will be applied to impute partial dates for medications:  
If start date of a medication is partially missing, impute as follows:  
 If both month and day are missing, then set to January 01  
 If only day is missing, then set to the first of the month  


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If end date of a medication is partially missing, impute as follows:  
 If both month and day are missing, then set to December 31  
 If only day is missing, then set to last day of the month  
If start date or end date of a medication is completely missing, do not impute. 
 
 
 


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APPENDIX B: LIST OF TABLES, FIGURES AND DATA LISTINGS 
List of Tables 
Number 
Description 
Analysis Set 
Source 
Listing(s) 
14.1 
Demographic Data Summaries 
 
 
14.1.1.1 
Patient Disposition  
All Enrolled Patients 
16.2.1 
14.1.1.2 
Patient Disposition by Study 
Center  
All Enrolled Patients 
16.2.1 
14.1.2.1 
Demographic and Baseline 
Characteristics  
mITT Population 
16.2.4.1 
14.1.2.2 
Demographic and Baseline 
Characteristics  
DLT-Evaluable 
Population 
16.2.4.1 
14.1.2.3 
Demographic and Baseline 
Characteristics  
Response-Evaluable 
Population 
16.2.4.1 
14.1.4 
Medical History  
Safety Population 
16.2.4.6 
14.1.5 
Prior Medications 
Safety Population 
16.2.9.5 
14.2 
Efficacy Data Summary Tables 
 
 
14.2.1.1 
Efficacy Analysis: Best Response 
Defined by RECIST v1.1 
mITT Population 
16.2.6.2 
14.2.1.2 
Efficacy Analysis: Best Response 
Defined by RECIST v1.1 
Response-Evaluable 
Population 
16.2.6.2 
14.2.3 
Survival Analysis: Overall 
Survival   
mITT Population 
16.2.6.5 
14.2.4 
Survival Analysis: Progression-
Free Survival 
mITT Population 
16.2.6.5 
14.2.5 
Survival Analysis: Duration of 
Response 
mITT Population 
16.2.6.5 
14.2.6.1 
Efficacy Analysis: Best Response 
for CA-125 Defined by GCIG 
Criteria 
mITT Population 
16.2.6.2 
14.2.6.2 
Efficacy Analysis: Best Response 
for CA-125 Defined by GCIG 
Criteria 
Response-Evaluable 
Population 
16.2.6.2 
14.2.7.1 
Efficacy Analysis: Best Response 
for CA-125 Defined by GCIG 
Criteria and RECIST v1.1 
mITT Population 
16.2.6.2 
14.2.7.2 
Efficacy Analysis: Best Response 
for CA-125 Defined by GCIG 
Criteria and RECIST v1.1 
Response-Evaluable 
Population 
16.2.6.2 
14.3 
Safety Data Summaries 
 
 
14.3.1  
Displays of Adverse Events 
 
 
14.3.1.1 
Overall Summary of Treatment-
Emergent Adverse Events  
Safety Population 
16.2.7 


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Number 
Description 
Analysis Set 
Source 
Listing(s) 
14.3.1.2 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term 
Safety Population 
16.2.7 
14.3.1.3 
Most Frequently-Occurring (≥ 
10% Overall) Treatment-
Emergent Adverse Events  
Safety Population 
16.2.7 
14.3.1.4 
Treatment-Emergent Adverse 
Events by System Organ Class, 
Preferred Term, and CTCAE 
Grade 
Safety Population 
16.2.7 
14.3.1.5. 
Treatment-Emergent 
CORT125134 Related Adverse 
Events by System Organ Class 
and Preferred Term 
Safety Population 
16.2.7 
14.3.1.6 
Most Frequently-Occurring (≥ 
10% Overall) Treatment-
Emergent Adverse Events 
Related to CORT125134 
Safety Population 
16.2.7 
14.3.1.7 
Most Frequently-Occurring (≥ 
10% Overall) Treatment-
Emergent Adverse Events by 
System Organ Class and 
Preferred Term and CTCAE 
Grade 
Safety Population 
16.2.7 
14.3.1.8 
Treatment-Emergent Grade ≥ 3 
Adverse Events by System Organ 
Class and Preferred Term 
Safety Population 
16.2.7 
14.3.1.9 
Treatment-Emergent Grade ≥ 3 
Adverse Events Related to 
CORT125134 by System Organ 
Class and Preferred Term 
Safety Population 
16.2.7 
14.3.1.10 
Treatment-Emergent Grade ≥ 3 
Adverse Events Related to Nab-
paclitaxel by System Organ Class 
and Preferred Term 
Safety Population 
16.2.7 
14.3.1.11 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Withdrawal of Any Study Drug 
Safety Population 
16.2.7 
14.3.1.12 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Withdrawal of CORT125134 
Safety Population 
16.2.7 


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Number 
Description 
Analysis Set 
Source 
Listing(s) 
14.3.1.13 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Withdrawal of Nab-paclitaxel 
Safety Population 
16.2.7 
14.3.1.14 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Interruption of Any Study Drug 
Safety Population 
16.2.7 
14.3.1.15 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Interruption of CORT125134 
Safety Population 
16.2.7 
14.3.1.16 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Interruption of Nab-Paclitaxel 
Safety Population 
16.2.7 
14.3.1.17 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Reduction of Any Study Drug 
Safety Population 
16.2.7 
14.3.1.18 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Reduction of CORT125134 
Safety Population 
16.2.7 
14.3.1.19 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Reduction of Nab-paclitaxel 
Safety Population 
16.2.7 
14.3.1.20 
Treatment-Emergent Adverse 
Events by System Organ Class 
and Preferred Term Leading to 
Death 
Safety Population 
16.2.7 
14.3.1.21 
Serious Treatment-Emergent 
Adverse Events by System Organ 
Class and Preferred Term 
Safety Population 
16.2.7 
14.3.1.22 
Summary of Treatment-Emergent 
Neutropenia Adverse Events 
Safety Population 
16.2.7 
14.3.1.23 
Time to Onset of Treatment-
Emergent Neutropenia Adverse 
Events 
Safety Population 
16.2.7 
14.3.1.24 
Treatment-Emergent Adverse 
Events by Preferred Term 
Safety Population 
16.2.7 


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Number 
Description 
Analysis Set 
Source 
Listing(s) 
14.3.1.25 
Treatment-Emergent 
CORT125134 Related Adverse 
Events by Preferred Term 
Safety Population 
16.2.7 
14.3.1.26 
Treatment-Emergent Grade ≥ 3 
Adverse Events by Preferred 
Term 
Safety Population 
16.2.7 
14.3.1.27 
Treatment-Emergent 
CORT125134 Related Grade ≥ 3 
Adverse Events by Preferred 
Term 
Safety Population 
16.2.7 
14.3.1.28 
Non-Hematological Adverse 
Events 
Safety Population 
16.2.7 
14.3.1.29 
Primary Cause of Death 
Safety Population 
14.3.2.1 
14.3.2 
Listing of Deaths, Other 
Serious and Significant Adverse 
Events 
 
 
14.3.2.1 
Listing of Deaths  
All Enrolled Patients 
 
14.3.2.2 
Listing of Serious Adverse Events  Safety Population 
 
14.3.3 
Narratives of Deaths, Other 
Serious Adverse Events, and 
Certain Other Significant 
Adverse Events* 
 
 
14.3.4 
Abnormal Laboratory Values 
Listing 
 
 
14.3.4.1 
Listing of Abnormal Hematology 
Values  
Safety Population 
 
14.3.4.2 
Listing of Abnormal Chemistry 
Values  
Safety Population 
 
14.3.5 
Extent of Exposure 
 
 
14.3.5.1 
Extent of Exposure  
Safety Population 
16.2.5.1; 
16.2.5.2 
14.3.5.2 
Study Drug Compliance  
Safety Population 
16.2.5.1; 
16.2.5.2 
14.3.6 
Laboratory Summaries 
 
 
14.3.6.1 
Hematology – Univariate 
Summary by Parameter and Visit 
Safety Population 
14.3.4.1; 
16.2.8.1 
14.3.6.2 
Hematology – Summary of Post-
Baseline Clinically Significant 
Values 
Safety Population 
14.3.4.1; 
16.2.8.1 
14.3.6.3 
Chemistry – Univariate Summary 
by Parameter and Visit 
Safety Population 
14.3.4.2; 
16.2.8.2 


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Number 
Description 
Analysis Set 
Source 
Listing(s) 
14.3.6.4 
Chemistry – Summary of Post-
Baseline Clinically Signficiant 
Values 
Safety Population 
14.3.4.2; 
16.2.8.2 
14.3.6.5 
Shift from Baseline to Worst 
Post-Baseline NCI CTCAE 
Toxicity Grade by Laboratory 
Parameter 
Safety Population 
14.3.4.1 - 
14.3.4.2; 
16.2.8.1 - 
16.2.8.2 
14.3.7 
Vital Signs, Physical Findings 
and Other Observations 
 
 
14.3.7.1 
Vital Signs – Univariate 
Summary by Parameter and Visit 
Safety Population 
16.2.9.1 
14.3.7.2 
12-Lead Electrocardiogram – 
Univariate Summary by 
Parameter and Visit 
Safety Population 
16.2.9.4 
14.3.7.3 
12-Lead Electrocardiogram 
Overall Interpretation – Shift 
from Baseline to Worst Post-
Baseline Value 
Safety Population 
16.2.9.4 
14.3.7.4 
12-Lead Electrocardiogram – QT 
Interval Categories  
Safety Population 
16.2.9.4 
14.3.7.5 
Concomitant Medications  
Safety Population 
16.2.9.5 
*Narratives of deaths, other serious adverse events, and certain other significant adverse 
events will not be generated by analysis programming and are outside the scope of this 
analysis plan.  
 
 


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List of Figures 
Number 
Description 
Analysis Set 
Source Tables 
and/or Listing(s) 
14.4 
Efficacy Data Figures 
 
 
14.4.1.1 
Kaplan-Meier Plot of Overall 
Survival 
mITT Population 
14.2.3; 16.2.6.2 
14.4.1.2 
Kaplan-Meier Plot of Overall 
Survival by Tumor Type 
mITT Population 
14.2.3; 16.2.6.2 
14.4.2.1 
Kaplan-Meier Plot of 
Progression-Free Survival 
mITT Population 
14.2.4; 16.2.6.2 
14.4.2.2 
Kaplan-Meier Plot of 
Progression-Free Survival by 
Tumor Type 
mITT Population 
14.2.4; 16.2.6.2 
14.4.3.1 
Kaplan-Meier Plot of 
Duration of Response  
mITT Population 
14.2.5; 16.2.6.2 
14.4.3.2 
Kaplan-Meier Plot of 
Duration of Response by 
Tumor Type 
mITT Population 
14.2.5; 16.2.6.2 
14.4.4 
Waterfall Plot of Best 
Response based on RECIST 
v1.1 Criteria 
mITT Population 
14.2.3; 16.2.6.2 
14.4.5 
Swim Plot of RECIST v1.1 
Criteria 
mITT Population 
16.2.1; 16.2.6.3 
14.4.6 
Swim Plot of Toxicity and 
Study Status  
mITT Population 
16.2.1; 16.2.5.2 
 
 


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Patient Data Listings 
Number 
Description 
16.2.1 
Discontinued Patients 
16.2.1 
Patient Disposition 
16.2.2 
Protocol Deviations 
16.2.2 
Informed Consent and Eligibility Criteria 
16.2.3 
Patients Excluded from the Efficacy Analysis 
16.2.3 
Patients Excluded from the Efficacy Analysis 
16.2.4 
Demographic Data 
16.2.4.1 
Demographics 
16.2.4.2 
Cancer History 
16.2.4.3 
Prior Cancer Related Surgery 
16.2.4.4 
Prior Radiotherapy 
16.2.4.5 
Prior Systemic Therapy 
16.2.4.6 
Medical History 
16.2.5 
Compliance and/or Drug Concentration Data 
16.2.5.1 
Study Drug Administration: CORT125134 
16.2.5.2 
Study Drug Administration: Nab-paclitaxel 
16.2.5.3 
Concentration Data: CORT125134 
16.2.6 
Individual Efficacy Response Data 
16.2.6.1 
RECIST Non-Target Lesions 
16.2.6.2 
RECIST Target Lesions 
16.2.6.3 
Percentage Change of Target Lesions from Baseline 
16.2.6.4 
Survival Status 
16.2.6.5 
Tumor Tissue Collection 
16.2.6.6 
Tumor Markers 
16.2.6.7 
Study Treatment and Prior Systemic Therapy Duration 
16.2.7 
Adverse Events 
16.2.7.1 
Adverse Events 
16.2.7.2 
Grade ≥ 3 Adverse Events 
16.2.7.3 
Adverse Events Leading to Withdrawal of CORT125134 
16.2.7.4 
Adverse Events Leading to Withdrawal of Nab-paclitaxel 
16.2.7.5 
Adverse Events Leading to CORT125134 Interruption 
 
16.2.7.6 
Adverse Events Leading to Nab-paclitaxel Interruption 
 
16.2.7.7 
Adverse Events Leading to CORT125124 Reduction 
16.2.7.8 
Adverse Events Leading to Nab-paclitaxel Reduction 
16.2.7.9 
Adverse Events Leading to Death 
16.2.7.10 
Dose-Limiting Toxicity 
16.2.8 
Listing of Individual Laboratory Measurements 
16.2.8.1 
Hematology 
16.2.8.2 
Chemistry 
16.2.8.3 
Urinalysis 
16.2.8.4 
Urine/Serum Pregnancy Test 


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Number 
Description 
16.2.9 
Additional Safety Listings 
16.2.9.1 
Vital Signs 
16.2.9.2 
ECOG Performance Status 
16.2.9.3 
Physical Examination 
16.2.9.4 
12-Lead Electrocardiogram 
16.2.9.5 
Prior and Concomitant Medications  
16.2.9.6 
Granulocyte Colony-Simulating Factor 


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APPENDIX C: TABLE LAYOUTS 
 


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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.1.1 
Patient Disposition 
All Enrolled Patients 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Safety Population[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
DLT-Evaluable Population[3] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Response-Evaluable Population[4] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Reason for Ending Treatment 
 
 
 
 
 
 
 
 
 
 
 
Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Lost to Follow-Up 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Physician Decision 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Pregnancy 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Progressive Disease 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Study Terminated by Sponsor 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Withdrawl by Patient 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Agreed to Survival Status Monitoring 
 
 
 
 
 
 
 
 
 
 
 
Yes 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
No 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Completed Survival Follow-Up Period 
 
 
 
 
 
 
 
 
 
 
 
Yes 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
No 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: DLT=dose-limiting toxicity; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Safety Population includes all patients who received at least one dose of study treatment.  
[3] DLT-Evaluable population includes all patients in Part 1 who complete 1 cycle of treatment and assessment or who +inue before completing the first cycle because of toxicity. 
[4] Response-Evaluable population is the subset of the Safety population with at least one post-baseline tumor assessment. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.1.1 
Patient Disposition 
All Enrolled Patients 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Reason for Study Discontinuation  
 
 
 
 
 
 
 
 
 
 
 
   Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Lost to Follow-Up 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Study Terminated by Sponsor 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Withdrawl by Patient 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: DLT=dose-limiting toxicity; PDAC=pancreatic ductal adenocarcinoma  
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Safety Population includes all patients who received at least one dose of study treatment.  
[3] DLT-Evaluable population includes all patients in Part 1 who complete 1 cycle of treatment and assessment or who discontinue before completing the first cycle because of toxicity. 
[4] Response-Evaluable population is the subset of the Safety population with at least one post-baseline tumor assessment. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 


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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.1.2 
Patient Disposition by Study Center 
All Enrolled Patients 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
Study Center 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site 1 
Safety Population[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
DLT-Evaluable Population[3] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Response-Evaluable Population[4] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Reason for Ending Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Lost to Follow-Up 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Physician Decision 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Pregnancy 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Progressive Disease 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Study Terminated by Sponsor 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Withdrawl by Patient 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Agreed to Survival Status Monitoring 
 
 
 
 
 
 
 
 
 
 
 
 
Yes 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
No 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Completed Survival Follow-Up Period 
 
 
 
 
 
 
 
 
 
 
 
 
Yes 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
No 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site 2 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: DLT=dose-limiting toxicity; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
 [2] Safety Population includes all patients who received at least one dose of study treatment.  
[3] DLT-Evaluable population includes all patients in Part 1 who complete 1 cycle of treatment and assessment or who +inue before completing the first cycle because of toxicity. 
[4] Response-Evaluable population is the subset of the Safety population with at least one post-baseline tumor assessment. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 59 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.1.2 
Patient Disposition by Study Center 
All Enrolled Patients 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
Study Center 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site 1 
Reason for Study Discontinuation  
 
 
 
 
 
 
 
 
 
 
 
   Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Lost to Follow-Up 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Study Terminated by Sponsor 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Withdrawl by Patient 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
Site 2 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: DLT=dose-limiting toxicity; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Safety Population includes all patients who received at least one dose of study treatment.  
[3] DLT-Evaluable population includes all patients in Part 1 who complete 1 cycle of treatment and assessment or who discontinue before completing the first cycle because of toxicity. 
[4] Response-Evaluable population is the subset of the Safety population with at least one post-baseline tumor assessment. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 60 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.2.1 
Demographic and Baseline Characteristics 
mITT Population 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Age (years)[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
x 
 
x 
   Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Sex 
 
 
 
 
 
 
 
 
 
 
 
   Male 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Female 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Ethnicity 
 
 
 
 
 
 
 
 
 
 
 
Hispanic or Latino 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Not Hispanic or Latino 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Race 
 
 
 
 
 
 
 
 
 
 
 
American Indian or Alaska Native 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Asian 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Black or African American 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Native Hawaiian or Other Pacific Islander 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
White 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: BMI=body mass index; PDAC=pancreatic ductal adenocarcinoma; TNBC=triple-negative breast cancer 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Age as collected on the case report form. 
[3] Cancer type as collected on the cancer history case report form. Patients may be included in more than one category. 
[4] Number of distinct cancer therapy regimens. 
[5] Number of patients with prior lines of cancer therapy that contain the text "taxo," "taxel," or "xane." 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 61 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.1.2.1 
Demographic and Baseline Characteristics 
mITT Population 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Height (cm) 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  
x.x (x.xx) 
Median 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
   Min, Max 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
 
 
 
 
 
 
 
 
 
 
 
 
Weight (kg) 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  
x.x (x.xx) 
Median 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
   Min, Max 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
 
 
 
 
 
 
 
 
 
 
 
 
BMI (kg/m2) 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  
x.x (x.xx) 
Median 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
Min, Max 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: BMI=body mass index; PDAC=pancreatic ductal adenocarcinoma; TNBC=triple-negative breast cancer 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Age as collected on the case report form. 
[3] Cancer type as collected on the cancer history case report form. Patients may be included in more than one category. 
[4] Number of distinct cancer therapy regimens. 
[5] Number of patients with prior lines of cancer therapy that contain the text "taxo," "taxel," or "xane." 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 62 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.1.2.1 
Demographic and Baseline Characteristics 
mITT Population 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Cancer Type[3] 
 
 
 
 
 
 
 
 
 
 
 
   Pancreatic Ductal Adenocarcinoma 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Ovarian / Primary Peritoneal 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Sarcoma / Chondrosarcoma 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Head and Neck 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Melanoma / Uveal Melanoma 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Triple-negative Breast Cancer (TNBC) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Breast (Hormone Receptor Positive) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Cervical / Vulvar 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Rectal 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Other 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Prior lines of cancer therapy[4] 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  
x.x (x.xx) 
Median 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
Min, Max 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x 
 
x.x, x.x 
x.x, x.x 
x.x, x.x 
x.x, x.x  
x.x, x.x 
 
 
 
 
 
 
 
 
 
 
 
 
Prior taxane[5] 
 
 
 
 
 
 
 
 
 
 
 
Yes 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   No 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
Abbreviations: BMI=body mass index; PDAC=pancreatic ductal adenocarcinoma; TNBC=triple-negative breast cancer 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Age as collected on the case report form. 
[3] Cancer type as collected on the cancer history case report form. Patients may be included in more than one category. 
[4] Number of distinct cancer therapy regimens. 
[5] Number of patients with prior lines of cancer therapy that contain the text "taxo," "taxel," or "xane." 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm  
 
 
 
 
 
 
 
 
 
See Programming Notes on next page 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 63 of 188
 
Repeat for the following: 
 
Table 14.1.2.2 
Demographic and Baseline Characteristics (DLT-Evaluable Population) 
Table 14.1.2.3 
Demographic and Baseline Characteristics (Response-Evaluable Population) 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 64 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.4 
Medical History 
Safety Population 
 
Body System / 
   Preferred Term[2] 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Body System #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   … 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body System #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: PDAC=pancreatic ductal adenocarcinoma 
 
Note: At each level of summarization (any body system and preferred term), patients reporting more than one medical history event are counted only once. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
 [2] Medical history terms are coded to body system and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), Version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 65 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.1.5 
Prior Medications 
Safety Population 
 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Patients Receiving any Prior Medications 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
ATC Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Generic Drug Name #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Generic Drug Name #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   … 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ATC Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Generic Drug Name #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Generic Drug Name #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   … 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ATC=anatomic therapeutic chemical; PDAC=pancreatic ductal adenocarcinoma; WHO=World Health Organization 
 
Notes: 
 
Prior medications are those medications received prior to the first dose of study treatment. 
 
Medications are coded to ATC drug class (level 4) and generic drug names using the WHO Drug dictionary, March 1, 2014 Version. 
 
At each level of summarization (any medication, ATC class, generic drug name), patients reporting use of more than one medication are counted only once. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort medications by descending order of ATC class incidence and by descending order of drug name incidence within ATC class, based on the overall incidence (ie, sum over all treatment 
groups). 
 
When creating ATC level 4 drug class, utilize level 3 term if level 4 is missing in dataset and level 2 if both level 3 and level 4 are missing in the dataset 
 
 


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Statistical Analysis Plan
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Corcept Therapeutics  
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Page x of y
Table 14.2.1.1 
Efficacy Analysis: Best Response Defined by RECIST v1.1 
mITT Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
  Unconfirmed (CR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
  Confirmed (CR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Partial Response (PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
  Unconfirmed (PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
  Confirmed (PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Stable Disease (SD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Progressive Disease (PD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Missing or Not Evaluable (NE) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
Objective Response Rate (CR or PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Unconfirmed (CR or PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
Confirmed (CR or PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: mITT=modified intent-to-treat; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Objective response rate is defined by RECIST v1.1 as best response of CR or PR from the start of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Clinical benefit rate is defined as the patients who have achieved CR or PR, or SD for 16 weeks or greater. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.2.1.1 
Efficacy Analysis: Best Response Defined by RECIST v1.1 
mITT Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
Clinical Benefit Rate (CBR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Unconfirmed CBR 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
Confirmed CBR 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
Abbreviations: mITT=modified intent-to-treat; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Objective response rate is defined by RECIST v1.1 as best response of CR or PR from the start of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Clinical benefit rate is defined as the patients who have achieved CR or PR, or SD for 16 weeks or greater. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.2.1.1 
Efficacy Analysis: Best Response Defined by RECIST v1.1 
mITT Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen 
 
 
 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
  Unconfirmed (CR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
  Confirmed (CR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Partial Response (PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
  Unconfirmed (PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
  Confirmed (PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stable Disease (SD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Progressive Disease (PD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Missing or Not Evaluable (NE) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Objective Response Rate (CR or PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Unconfirmed (CR or PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
Confirmed (CR or PR) 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: mITT=modified intent-to-treat; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Objective response rate is defined by RECIST v1.1 as best response of CR or PR from the start of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses). 
 
Clinical benefit rate is defined as the patients who have achieved CR or PR, or SD for 16 weeks or greater. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 69 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.2.1.1 
Efficacy Analysis: Best Response Defined by RECIST v1.1 
mITT Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen 
 
 
 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Benefit Rate (CBR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   Unconfirmed CBR 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
   Confirmed CBR 
n (x.x%) 
 
 n (x.x%) 
 
 n (x.x%) 
 
 
n (x.x%) 
 
 n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: mITT=modified intent-to-treat; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
Objective response rate is defined by RECIST v1.1 as best response of CR or PR from the start of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses). 
 
Clinical benefit rate is defined as the patients who have achieved CR or PR, or SD for 16 weeks or greater. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
Programming Note: 
 
Repeat for the following: 
 
Table 14.2.1.2 
Efficacy Analysis: Best Response Defined by RECIST v1.1 (Response-Evaluable Population) 
 
 
 


Corcept Therapeutics 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
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Table 14.2.3 
Survival Analysis: Overall Survival 
mITT Population 
 
Survival Estimates (Months) 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Number (%) of Patients Who Died 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Number (%) of Patients Censored 
 
 
 
 
 
 
 
 
 
 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Quartiles (95% CI)[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   25th Percentile 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Median[3] 
 
 
 
 
 
 
 
 
 
 
 
   75th Percentile 
 
 
 
 
 
 
 
 
 
 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Range (Patients Who Died) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Range (All Patients) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: mITT=modified intent-to-treat 
 
Note: Overall survival is defined as the time from date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, to the date of death for any cause. Patients with no documentation of death 
on-study are censored at the date at which they are last known to be alive. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
 [2] Kaplan-Meier product-limit estimates. 
[3] Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.2.4 
Survival Analysis: Progression-Free Survival 
mITT Population 
 
Survival Estimates (Months) 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Number (%) of  Patients with Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Number (%) of Patients Censored 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
Quartiles (95% CI)[3] 
 
 
 
 
 
 
 
 
 
 
 
   25th Percentile 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
   Median[4] 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
   75th Percentile 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
x (x, x) 
x (x, x) 
x (x, x) 
 
x (x, x) 
 
 
 
 
 
 
 
 
 
 
 
Range (Patients Who Died) 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
x, x 
 
x, x 
Range (All Patients) 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Estimated Survival Distribution Function 
(# of Patients at Risk)[2] 
 
 
 
 
 
 
 
 
 
 
 
   6 Months 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
 x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n)  
x.xxxx (n) 
   12 Months 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
 x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n)  
x.xxxx (n) 
   24 Months 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
 x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n) 
x.xxxx (n)  
x.xxxx (n) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: mITT=modified intent-to-treat; RECIST=response evaluation criteria in solid tumors v1.1 
 
Note: Progression-free survival is defined as the time from date of first dose of CORT125134 or nab-paclitaxel, whichever is earliest, to the date of documented disease progression per RECIST v1.1 or 
death for any cause, whichever occurs first. Patients with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Kaplan-Meier product-limit estimates using the Brookmeyer-Crowley method. 
[3] Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 72 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.2.5 
Survival Analysis: Duration of Response 
mITT Population 
 
Survival Estimates (Months) 
Segment I: Continuous-Dosing Regimen 
 
Segment II: Intermittent-Dosing Regimen 
 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
PDAC[1] 
(N= ) 
Ovarian 
Cancer[1] 
(N= ) 
Other Solid 
Tumors[1] 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Number of Patients with Response 
n  
n  
n  
n  
 
n  
n  
n  
n  
 
n 
 
 
 
 
 
 
 
 
 
 
 
 
Number (%) of Patients with Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Number (%) of Patients Censored 
 
 
 
 
 
 
 
 
 
 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Quartiles (95% CI)[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   25th Percentile 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
   Median[3] 
 
 
 
 
 
 
 
 
 
 
 
   75th Percentile 
 
 
 
 
 
 
 
 
 
 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Range (Patients with Event) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
Range (All Patients) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CR=complete response; mITT=modified intent-to-treat; PR=partial response 
 
Notes:  
 
Duration of response is defined as the date that criteria are met for CR or PR until the first date that progressive disease or death is objectively documented, whichever occurs first.  
        Patients with no documentation of disease progression or death on-study are censored at the date of last available tumor assessment. 
 
Includes only patients who experience a response on-study.  
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Kaplan-Meier product-limit estimates. 
[3] Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 73 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.2.6.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria 
mITT Population 
Ovarian Cancer Patients 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Partial Response (PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Stable Disease (SD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Progressive Disease (PD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Missing or Not Evaluable (NE) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat 
 
Note: A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as complete 
responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.2.6.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria 
mITT Population 
Ovarian Cancer Patients 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen 
 
 
 
Best Response 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Partial Response (PR) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Stable Disease (SD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Progressive Disease (PD) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
Missing or Not Evaluable (NE) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat 
 
Note: A CA-125 response is defined by GCIG as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as 
complete responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: 
 
Repeat for the following: 
 
Table 14.2.6.2 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria (Response-Evaluable Population) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
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CORT125134-550 
Page x of y
Table 14.2.7.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria and RECIST v1.1 
mITT Population 
Ovarian Cancer Patients 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Best Response by RECIST v1.1 
   Response for CA-125 by GCIG 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
Combined Overall Response Rate 
(RECIST Response or CA-125 Response) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
Partial Response (PR) 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat; NE=not evaluable; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
A CA-125 response is defined by GCIG as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as 
complete responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 76 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.2.7.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria and RECIST v1.1 
mITT Population 
Ovarian Cancer Patients 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Best Response by RECIST v1.1 
   Response for CA-125 by GCIG 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
Stable Disease (SD) 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
Progressive Disease (PD) 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
Missing or Not Evaluable (NE) 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   Yes 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat; NE=not evaluable; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
A CA-125 response is defined by GCIG as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as 
complete responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 77 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
 
Table 14.2.7.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria and RECIST v1.1 
mITT Population 
Ovarian Cancer Patients 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen 
 
 
 
Best Response by RECIST v1.1 
   Response for CA-125 by GCIG 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Combined Overall Response Rate 
(RECIST Response or CA-125 Response) 
n (x.x%) xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete Response (CR) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Partial Response (PR) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat; NE=not evaluable; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
A CA-125 response is defined by GCIG as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as 
complete responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 78 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.2.7.1 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria and RECIST v1.1 
mITT Population 
Ovarian Cancer Patients 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen 
 
 
 
Best Response by RECIST v1.1 
   Response for CA-125 by GCIG 
PDAC[1] 
(N= ) 
 
Ovarian Cancer[1] 
(N= ) 
 
Other Solid Tumors[1] 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
n (%) 
95% CI[2] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stable Disease (SD) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Progressive Disease (PD) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Missing or Not Evaluable (NE) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Yes 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   No or PD 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
   NE 
n (x.x%) xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 n (x.x%) 
xx.x%, xx.x% 
 
n (x.x%) 
xx.x%, xx.x%  n (x.x%) 
xx.x%, xx.x% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: GCIG=Gynecological Cancer Intergroup; mITT=modified intent-to-treat; NE=not evaluable; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
A CA-125 response is defined by GCIG as at least a 50% reduction in CA-125 levels from a pretreatment sample. Patients whose CA-125 levels fall within the reference range are classified as 
complete responders. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes all 
patients not included in PDAC and ovarian cancer groups.  
[2] Exact binomial confidence intervals (Clopper-Pearson). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
 
See Programming Notes on next page 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 79 of 188
 
Programming Note: 
 
Repeat for the following: 
 
Table 14.2.7.2 
Efficacy Analysis: Best Response for CA-125 Defined by GCIG Criteria and RECIST v1.1 (Response-Evaluable Population) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 80 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety Population 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
Total Number of TEAEs 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
 
xx 
Total Number of TESAEs 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
 
xx 
 
 
 
 
 
 
 
 
 
 
Number (%) of Patients Reporting at Least One: 
 
 
 
 
 
 
 
 
 
 
 TEAE 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE Related to CORT125134[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE Related to Nab-paclitaxel[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE ≥ Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE ≥ Grade 3 Related to CORT125134[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE ≥ Grade 3 Related to Nab-paclitaxel[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE Leading to Discontinuation of: 
 
 
 
 
 
 
 
 
 
 
   Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   CORT125134 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Nab-paclitaxel 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE Requiring Dose Interruption of: 
 
 
 
 
 
 
 
 
 
 
   Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   CORT125134 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Nab-paclitaxel 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 TEAE Leading to Dose Reduction of: 
 
 
 
 
 
 
 
 
 
 
   Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   CORT125134 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Nab-paclitaxel 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Abbreviations: TEAE=CORT125134 treatment-emergent adverse event; TESAE=CORT125134 treatment-emergent serious adverse event 
 
Note: Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Patients reporting more than one adverse event are counted only once using the closest relationship to study drug. Not related events includes those reported as “Not Related” to study drug; related 
events include those reported as “Possibly Related” or “Probably Related” to study drug. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 81 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.1 
Overall Summary of Treatment-Emergent Adverse Events 
Safety Population 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
TEAE Causing Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
TESAE 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
TESAE Related to CORT125134[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
TESAE Related to Nab-paclitaxel[2] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Abbreviations: TEAE=CORT125134 treatment-emergent adverse event; TESAE=CORT125134 treatment-emergent serious adverse event 
 
Note: Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Patients reporting more than one adverse event are counted only once using the closest relationship to study drug. Not related events includes those reported as “Not Related” to study drug; related 
events include those reported as “Possibly Related” or “Probably Related” to study drug. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 82 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.2 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 83 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.1.3 
 
Most Frequently-Occurring (≥ 10% Overall) Treatment-Emergent Adverse Events 
Safety Population 
 
Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Patients reporting more than one adverse event are counted only once. Summary includes all events reported by ≥ 10% of patients in the Safety Population. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: Sort events by descending order of preferred term incidence, based on the overall incidence (ie, sum over all treatment groups). 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 84 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
14.3.1.4 
Treatment-Emergent Adverse Events by System Organ Class, Preferred Term, and CTCAE Grade 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
 
CTCAE 
Grade 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
Preferred Term #1 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: CTCAE=Common Terminology Criteria for Adverse Events v4.03 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted using the highest CTCAE grade, v4.03. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
See programming notes on the next page. 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 85 of 188
 
Programming Notes:  
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 86 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.5 
Treatment-Emergent CORT125134 Related Adverse Events by System Organ Class and Preferred Term  
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One CORT125134 Related Adverse 
Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. Related adverse events are those 
reported as “Possibly Related” or “Probably Related” to CORT125134. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs related to CORT125134 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 87 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.1.6 
 
Most Frequently-Occurring (≥ 10% Overall) Treatment-Emergent Adverse Events Related to CORT125134 
Safety Population 
 
Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Patients reporting more than one related adverse event are counted only once. Summary includes all related events (ie, “Possibly Related,” “Probably Related,” or “Definitely Related” to 
CORT125134) reported by ≥ 10% of patients in the Safety Population. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: Sort events by descending order of preferred term incidence, based on the overall incidence (ie, sum over all treatment groups). 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 88 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.7 
Most Frequently-Occurring (≥ 10% Overall) Treatment-Emergent Adverse Events by System Organ Class and Preferred Term and CTCAE Grade 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
 
CTCAE  
Grade 
Segment I: Continuous-Dosing Regimen[1] 
 Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Most Frequently-
Occurring (≥ 10% Overall) Adverse Event  
Any Grade 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
Any Grade 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Preferred Term #1 
Any Grade 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 5 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: CTCAE=Common Terminology Criteria for Adverse Events, v4.03 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term) patients reporting more than one adverse event are counted only once using the highest CTCAE grade, v4.03. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2), 
[2] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 89 of 188
 
 
Programming Notes: 
 
Sort events by descending order of of system organ class incidence and by descending order of preferred term incidence, based on the overall incidence (ie, sum over all treatment groups). 
 
AEs with a missing CTCAE Grade are excluded from the table 
 
“Any Grade” Total is used to determine the ≥ 10% for each Segment 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.8 
Treatment-Emergent Grade ≥  3 Adverse Events by System Organ Class and Preferred Term 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Grade ≥ 3 
Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Grade ≥ 3 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 91 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.1.9 
 
Treatment-Emergent Grade ≥ 3 Adverse Events Related to CORT125134 by System Organ Class and Preferred Term 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One CORT125134 
Related Grade ≥ 3 Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. Related adverse events are those 
reported as “Possibly Related” or “Probably Related” to CORT125134. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs related to CORT125134 with grade ≥ 3 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 92 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.1.10 
 
Treatment-Emergent Grade ≥ 3 Adverse Events Related to Nab-paclitaxel by System Organ Class and Preferred Term 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Nab-paclitaxel 
Related Grade ≥ 3 Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one related and severe adverse event are counted only once. Related adverse events 
are those reported as “Possibly Related,” “Probably Related,” or “Definitely Related” to Nab-paclitaxel.  
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 93 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.11 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Withdrawal of Any Study Drug 
Safety Population 
 
 
System Organ Class[2] /  
 
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to Withdrawal of Any Study Drug  
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 or Nab-paclitaxel is “Drug Withdrawn.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Withdrawn’ or Action Taken with Nab-paclitaxel = ‘Drug Withdrawn’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 94 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.12 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Withdrawal of CORT125134 
Safety Population 
 
 
System Organ Class[2] /  
 
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to Withdrawal of CORT125134  
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 is “Drug Withdrawn.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Withdrawn’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 95 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.13 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Withdrawal of Nab-paclitaxel 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to Withdrawal of Nab-paclitaxel 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with Nab-paclitaxel is “Drug Withdrawn.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with Nab-paclitaxel = ‘Drug Withdrawn’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 96 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.14 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Interruption of Any Study Drug 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event Leading to Any 
Study Drug Interruption 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 or Nab-paclitaxel is “Dose Interrupted” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).  
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Interrupted’ or ‘Drug Interrrupted and then Dose Reduced’ or Action Taken with Nab-Paclitaxel = ‘Drug Interrupted’ or ‘Drug 
Interrrupted and then Dose Reduced’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 97 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.15 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Interruption of CORT125134 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to CORT125134 Interruption 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 is “Dose Interrupted” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).  
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Interrupted’ or ‘Drug Interrrupted and then Dose Reduced’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 98 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.16 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Interruption of Nab-paclitaxel 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event Leading to Nab-
paclitaxel Interruption 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with Nab-paclitaxel is “Dose Interrupted” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with Nab-paclitaxel = ‘Drug Interrupted’ or ‘Drug Interrupted and then Dose Reduced’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 99 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.17 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Reduction of Any Study Drug 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event Leading to 
Any Study Drug Reduction 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 or Nab-paclitaxel is “Dose Reduced” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Reduced’ or ‘Drug Interrupted and then Dose Reduced’ or Action Taken with Nab-paclitaxel = ‘Drug Reduced’ or ‘Drug Interrupted 
and then Dose Reduced’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 100 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.18 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Reduction of CORT125134 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse 
Event Leading to CORT125134 Reduction 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with CORT125134 is “Dose Reduced” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with CORT125134 = ‘Drug Reduced’ or ‘Drug Interrupted and then Dose Reduced’  
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 101 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.19 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Reduction of Nab-paclitaxel 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to Nab-paclitaxel Reduction 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
Includes events when action taken with Nab-paclitaxel is “Dose Reduced” or “Drug Interrupted and then Dose Reduced.” 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Action Taken with Nab-paclitaxel = ‘Drug Interrupted’ or ‘Drug Interrupted and then Dose Reduced’ 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 102 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.20 
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Leading to Death 
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Adverse Event 
Leading to Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Outcome = ‘Fatal’ or CTCAE Grade = 5 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 103 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.21 
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term  
Safety Population 
 
System Organ Class[2] /  
  Preferred Term[2] 
Segment I: Continuous-Dosing Regimen[1] 
 Segment II: Intermittent-Dosing Regimen[1]  
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
Patients Reporting at Least One Serious Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
System Organ Class #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event, system organ class, and preferred term), patients reporting more than one serious adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort events by descending order of system organ class incidence and by descending order of preferred term incidence within system organ class, based on the overall incidence (ie, sum over all 
treatment groups). 
 
Include all AEs with Serious = ‘Yes’  
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 104 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.1.22 
Summary of Treatment-Emergent Neutropenia Adverse Events 
Safety Population 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
100 mg / 80 mg/m2 
150 mg / 
80 mg/m2 
(N= ) 
 
 
150 mg / 80 mg/m2 
200 mg / 
100 mg/m2 
(N= ) 
Total 
(N= ) 
 
 
60 mg/m2 
(N= ) 
- G-CSF[2] 
(N= ) 
+ G-CSF[2] 
(N= ) 
Total 
(N= ) 
 
- G-CSF[2] 
(N= ) 
+ G-CSF[2] 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Total Number of Neutropenia TEAEs 
xx 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
 
xx 
Total Number of Neutropenia TESAEs 
xx 
xx 
xx 
xx 
xx 
 
xx 
xx 
xx 
xx 
 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
Number (%) of Patients Reporting at Least One 
Neutropenia Event: 
 
 
 
 
 
 
 
 
 
 
 
 
 TEAE 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE ≥ Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE Leading to Discontinuation of Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE Requiring Dose Interruption of Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE Leading to Dose Reduction of Any Study Drug 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE Outcome as Recovering or Resolved[3] 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TEAE Causing Death 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 TESAE 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%)  n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: G-CSF=granulocyte colony-stimulating factor; TEAE=CORT125134 treatment-emergent adverse event; TESAE=CORT125134 treatment-emergent serious adverse event 
 
Notes:  
 
Neutropenia adverse events are those reporting a preferred term of “neutropenia,” “febrile neutropenia,” or “neutrophil count decreased” using the Medical Dictionary for Regulatory Activities 
(MedDRA), version 19.0. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Segment I – G-CSF is defined as Cohort 1 and 2 and + G-CSF is defined as Cohort 3, 4, 5 and Pancreatic Cancer Cohort. Segment II – G-CSF is defined as Cohort 1 and 2 and + G-CSF is defined as 
Cohort 3. 
[3] Recovered or Resolved events include those reported as “Recovered/Resolved” or “Recovered/Resolved with Sequelae.” 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 


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Table 14.3.1.23 
Time to Onset of Treatment-Emergent Neutropenia Adverse Events 
Safety Population 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 80 mg/m2 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
150 mg / 80 mg/m2 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
- G-CSF[2] 
(N= ) 
+ G-CSF[2] 
(N= ) 
- G-CSF[2] 
(N= ) 
+ G-CSF[2] 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Time to Onset of First Neutropenia TEAE (days)[3] 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
Median  
x.x 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
Min, Max (Range) 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
 
x, x (x) 
 
 
 
 
 
 
 
 
 
 
 
 
Time to Onset of First Neutropenia TEAE ≥ Grade 3 (days)[3] 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
n 
 
n 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx)  x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
Median  
x.x 
x.x 
x.x 
x.x 
x.x 
 
x.x 
x.x 
x.x 
x.x 
 
x.x 
Min, Max (Range) 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
 
x, x (x) 
x, x (x) 
x, x (x) 
x, x (x) 
 
x, x (x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: G-CSF=granulocyte colony-stimulating factor; TEAE=CORT125134 treatment-emergent adverse event 
 
Notes:  
 
Neutropenia adverse events are those reporting a preferred term of “neutropenia,” “febrile neutropenia,” or “neutrophil count decreased” using the Medical Dictionary for Regulatory Activities 
(MedDRA), version 19.0. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Segment I – G-CSF is defined as Cohort 1 and 2 and + G-CSF is defined as Cohort 3, 4, 5 and Pancreatic Cancer Cohort. Segment II – G-CSF is defined as Cohort 1 and 2 and + G-CSF is defined as 
Cohort 3. 
[3] Time to onset in days is calculated as the first neutropenia adverse event start date – the date of first dose of CORT125134 + 1. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 
 


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Statistical Analysis Plan
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Table 14.3.1.24 
Treatment-Emergent Adverse Events by Preferred Term 
Safety Population 
 
Preferred Term[1] 
Segment I: Continuous-Dosing Regimen 
(N= ) 
Segment II: Intermittent-Dosing Regimen 
(N= ) 
Total 
(N= ) 
 
 
 
Patients Reporting at Least One Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
… 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort events by descending order of preferred term incidence based on the overall incidence (ie, sum over all treatment groups). 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


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Table 14.3.1.25 
Treatment-Emergent CORT125134 Related Adverse Events by Preferred Term 
Safety Population 
 
Preferred Term[1] 
Segment I: Continuous-Dosing Regimen 
(N= ) 
Segment II: Intermittent-Dosing Regimen 
(N= ) 
Total 
(N= ) 
 
 
 
Patients Reporting at Least One CORT125134 Related Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
… 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event and preferred term), patients reporting more than one adverse event are counted only once. Related adverse events are those reported as “Possibly 
Related” or “Probably Related” to CORT125134. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort events by descending order of preferred term incidence based on the overall incidence (ie, sum over all treatment groups). 
 
Include all AEs related to CORT125134 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


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Table 14.3.1.26 
Treatment-Emergent Grade ≥ 3 Adverse Events by Preferred Term 
Safety Population 
 
Preferred Term[1] 
Segment I: Continuous-Dosing Regimen 
(N= ) 
Segment II: Intermittent-Dosing Regimen 
(N= ) 
Total 
(N= ) 
 
 
 
Patients Reporting at Least One Grade ≥ 3 Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
… 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event and preferred term), patients reporting more than one adverse event are counted only once. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort events by descending order of preferred term incidence based on the overall incidence (ie, sum over all treatment groups). 
 
Include all AEs with Grade ≥ 3 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table 14.3.1.27 
Treatment-Emergent CORT125134 Related Grade ≥ 3 Adverse Events by Preferred Term 
Safety Population 
 
Preferred Term[1] 
Segment I: Continuous-Dosing Regimen 
(N= ) 
Segment II: Intermittent-Dosing Regimen 
(N= ) 
Total 
(N= ) 
 
 
 
Patients Reporting at Least One CORT125134 Related Grade ≥ 3 Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
 
 
Preferred Term #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
Preferred Term #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
… 
 
 
 
 
 
 
 
Notes:  
 
At each level of summarization (any event and preferred term), patients reporting more than one adverse event are counted only once. Related adverse events are those reported as “Possibly 
Related” or “Probably Related” to CORT125134. 
 
Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
 
[1] Adverse events are coded to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Sort events by descending order of preferred term incidence based on the overall incidence (ie, sum over all treatment groups). 
 
Include all AEs related to CORT125134 with Grade ≥ 3 
 
Exclude AEs which occur > 28 days after last dose of study drug (any study drug) 
 
 


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Table 14.3.1.28 
Non-Hematological Adverse Events  
Safety Population 
 
Criteria 
Segment I: Continuous-Dosing Regimen[1] 
 Segment II: Intermittent-Dosing Regimen[1]  
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
ALT or AST > 10x ULN 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
ALT or AST > 20x ULN 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
ALT or AST > 3x ULN and Bilirubin > 2x ULN 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal 
 
Note: Percentages are based on the number of patients with at least one non-missing post-screening value. Patients are counted once within each category if they have at least one measurement collected 
post screening. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


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Table 14.3.1.29 
Primary Cause of Death 
Safety Population 
 
Primary Cause of Death 
Segment I: Continuous-Dosing Regimen[1] 
 Segment II: Intermittent-Dosing Regimen[1]  
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
Death Occurred Within 28 days of Last Study Drug Dose 
 
 
 
 
 
 
 
 
 
 
   Progressive Disease 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Cancer 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Other 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Death Did Not Occur Within 28 days of Last Study Drug Dose 
 
 
 
 
 
 
 
 
 
 
   Progressive Disease 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Cancer 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Adverse Event 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Other 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Death occurring within 28 days of last study drug dose as collected on the End of Study Case Report Form. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
 
 


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Table 14.3.2.1 
Listing of Deaths 
All Enrolled Patients 
 
 
Segment Cohort[1] 
 
Patient ID 
Date of Death  
(Study Day[2]) 
Primary Cause of Death 
Did Patient Death Occur Within 28 
Days of Last Study Drug Dose? 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
ddMMMyyyy (xx) 
Adverse event or cause of death from the end of study CRF 
Yes / 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


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Table 14.3.2.2 
Listing of Serious Adverse Events 
Safety Population 
 
 
 
Segment Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
  Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
CTCAE 
Grade 
 
 
Serious Criteria 
Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
  Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Congenital 
Anomaly or Birth 
Defect / 
Significant 
Disability / 
Death / 
Hospitalization / 
Life Threatening / 
Other Medically 
Important Event 
Display all that 
are reported, 
separated by a 
comma 
C: Not Related to 
Study Drug / 
C: Unlikely Related 
to Study Drug/ 
C: Possibly Related  
to Study Drug/ 
C: Related to Study 
Drug 
N: Not Related to 
Study Drug / 
N: Unlikely Related 
to Study Drug/ 
N: Possibly Related  
to Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted 
and then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted 
and then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a 
comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Serious = ‘Yes’  
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.4.1 
Listing of Abnormal Hematology Values 
Safety Population 
 
 
Segment Cohort[1] 
 
Patient ID Visit 
Collection Date and 
Time (Study Day[2]) Test 
 
Unit 
 
Normal Range 
 
Result 
 
Alert 
Clinically 
Significant 
Comment 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
Screening 
ddMMMyyyy  
HH:MM (xx) 
Test #1 
Test #2 
Unit 
xxx – xxx 
xxx 
Low / 
High 
Yes / 
No 
Comments 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2) 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
Repeat for the following: 
 
Table 14.3.4.2 
Listing of Abnormal Chemistry Values (Safety Population) 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
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Table 14.3.5.1 
Extent of Exposure 
Safety Population 
 
Drug Sampling 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 
Number of Cycles of Treatment Total 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
Duration of Exposure (days)[2] 
Total 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Total Dose Received (mg)  
Lead-In 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Duration of exposure is calculated as the date of last dose of drug – the date of first dose of drug + 1. 
[3] Relative dose intensity is calculated as the total dose received / total dose expected * 100. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.5.1 
Extent of Exposure 
Safety Population 
 
Drug Sampling 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1]  
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 Total Dose Expected (mg) 
Lead-In 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
 
Relative Dose Intensity (%)[3] Lead-In 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).    
[2] Duration of exposure is calculated as the date of last dose of drug – the date of first dose of drug + 1. 
[3] Relative dose intensity is calculated as the total dose received / total dose expected * 100. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 117 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
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Table 14.3.5.1 
Extent of Exposure 
Safety Population 
 
Drug Sampling 
 
Segment I: Continuous-Dosing Regimen[1] 
 Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel 
Number of Cycles of Treatment Total 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
Duration of Exposure (days)[2] 
Total 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Total Dose Received (mg/m2)  
Lead-In 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Duration of exposure is calculated as the date of last dose of drug – the date of first dose of drug + 1. 
[3] Relative dose intensity is calculated as the total dose received / total dose expected * 100. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 118 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Table 14.3.5.1 
Extent of Exposure 
Safety Population 
 
Drug Sampling 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Total Dose Expected (mg/m2) Lead-In 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
 
Relative Dose Intensity (%)[3] 
Lead-In 
 
 
 
 
 
 
 
 
 
 
 
 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Duration of exposure is calculated as the date of last dose of drug – the date of first dose of drug + 1. 
[3] Relative dose intensity is calculated as the total dose received / total dose expected * 100. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 119 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.5.2 
Study Drug Compliance 
Safety Population 
 
Study Drug 
Study Drug Compliance (%)[2] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
< 80% Compliant 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
≥ 80% Compliant 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel 
n 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
Median 
x 
x 
x 
x 
 
x 
x 
x 
 
x 
 
Min, Max 
x, x 
x, x 
x, x 
x, x 
 
x, x 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
 
< 80% Compliant 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
≥ 80% Compliant 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Study drug compliance is calculated as the total dose received / the expected dose received x 100. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 120 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.6.1 
Hematology – Univariate Summary by Parameter and Visit 
Safety Population 
Part 1 of 2 
Segment I: Continuous-Dosing Regimen 
Parameter 
Visit 
100 mg / 60 mg/m2 
(N= ) 
 
100 mg / 80 mg/m2 
(N= ) 
 
150 mg / 80 mg/m2 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Hemoglobin (g/L) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Lead In: Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Platelet Count (109/L) 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: WBC=white blood cell 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 121 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.6.1 
Hematology – Univariate Summary by Parameter and Visit 
Safety Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
Parameter 
Visit 
150 mg / 80 mg/m2 
(N= ) 
 
200 mg / 100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Hemoglobin (g/L) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Lead In: Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Platelet Count (109/L) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: WBC=white blood cell 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Continue for remaining regularly-scheduled visits (Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15,(continue on Days 1, 8, 15 for Cycles 2+), Posttreatment) 
 
Continue for regularly-collected hematology parameters (WBC (109/L),  Absolute Neutrophils (109/L)) 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 122 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.6.2 
Hematology – Summary of Post-Baseline Clinically Significant Values 
Safety Population 
 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
Hemoglobin 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Platelet Count 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
WBC 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Absolute Neutrophils 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: WBC=white blood cell 
 
Notes: 
 
This table summarizes laboratory values that are deemed to be clinically significant by the investigator at any point post-baseline. 
 
At each level of summarization (parameter), patients reporting more than one clinically significant value are counted only once. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 123 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.6.3 
Chemistry – Univariate Summary by Parameter and Visit 
Safety Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Parameter 
Visit 
100 mg / 60 mg/m2 
(N= ) 
 
100 mg / 80 mg/m2 
(N= ) 
 
150 mg / 80 mg/m2 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
AST (SGOT) (U/L) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Lead In: Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ALT (SGPT) (U/L) 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ALT (SGPT)=alanine aminotransferase; AST (SGOT)=aspartate aminotransferase 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134.  
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
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Corcept Therapeutics  
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Table 14.3.6.3 
Chemistry – Univariate Summary by Parameter and Visit 
Safety Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
Parameter 
Visit 
150 mg / 80 mg/m2 
(N= ) 
 
200 mg / 100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
AST (SGOT) (U/L) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Lead In: Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ALT (SGPT) (U/L) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ALT (SGPT)=alanine aminotransferase; AST (SGOT)=aspartate aminotransferase 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134.  
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
See Programming Notes on next page 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
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Programming Notes:  
 
Continue for remaining regularly-scheduled visits: (Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15,(continue on Days 1, 8, 15 for Cycles 2+), Posttreatment ) 
 
Continue for regularly-collected chemistry parameters: (Total Bilirubin (µmol/L), Sodium (mmol/L), Potassium (mmol/L)) 
 
 


Corcept Therapeutics 
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Table 14.3.6.4 
Chemistry – Summary of Post-Baseline Clinically Significant Values 
Safety Population 
 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
AST (SGOT) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
ALT (SGPT) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ALT (SGPT)=alanine aminotransferase; AST (SGOT)=aspartate aminotransferase 
 
Notes: 
 
This table summarizes laboratory values that are deemed to be clinically significant by the investigator at any point post-baseline. 
 
At each level of summarization (parameter), patients reporting more than one clinically significant value are counted only once. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Continue for regularly-collected chemistry parameters with incidence: (Total Bilirubin, Direct Bilirubin, Sodium, Potassium)  
 
 


Corcept Therapeutics 
Statistical Analysis Plan
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Version 1.0; 14 October 2019
 
 
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Table 14.3.6.5 
Shift from Baseline to Worst Post-Baseline NCI CTCAE Toxicity Grade by Laboratory Parameter 
Safety Population 
 
Parameter 
   Baseline Assessment[2] 
Worst Post- 
Baseline Grade[3] 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
 
 
Absolute Neutrophils 
Grade 0 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 0 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
   Grade 1 
Grade 0 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
Grade 2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 3 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
Grade 4 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Grade 4 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events v4.03; NCI=National Cancer Institute  
 
Notes: 
 
Laboratory measurements are classified according to CTCAE, v4.03.  
 
Percentages are based on the number of patients with a non-missing baseline value and at least one non-missing post-baseline value. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2).   
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134.  
[3] The worst post-baseline grade is defined as the highest NCI CTCAE grade reported after the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: Continue for regularly-collected hematology and chemistry tests with NCI CTCAE grading assigned: (WBC, Hemoglobin, Platelet Count, AST (SGOT), ALT (SGPT), Total Bilirubin, 
Sodium, Potassium) 
 
 
 


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Table 14.3.7.1 
Vital Signs – Univariate Summary by Parameter and Visit 
Safety Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
Vital Sign 
Visit 
100 mg / 60 mg/m2 
(N= ) 
 
100 mg / 80 mg/m2 
(N= ) 
 
150 mg / 80 mg/m2 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Systolic Blood Pressure (mmHg) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Nab-Paclitaxel Lead 
In Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diastolic Blood Pressure (mmHg) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
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Corcept Therapeutics  
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CORT125134-550 
 
Page x of y
Table 14.3.7.1 
Vital Signs – Univariate Summary by Parameter and Visit 
Safety Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
Parameter 
Visit 
150 mg / 80 mg/m2 
(N= ) 
 
200 mg / 100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Systolic Blood Pressure (mmHg) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 
x.x (x.xx) 
 
 
x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
x 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
Nab-paclitaxel Lead In: Day 1 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
Cycle 1 Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diastolic Blood Pressure (mmHg) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes:  
 
Continue for remaining regularly-scheduled visits (Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, (continue on Days 1, 8, 15 for Cycles 2+), Posttreatment) 
 
Continue for regularly-collected vital signs (Respiratory Rate (breaths/min), Temperature (C), Heart Rate (beats/min)) 
 
 
 


Corcept Therapeutics 
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Confidential 
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Corcept Therapeutics  
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Table 14.3.7.2 
12-Lead Electrocardiogram – Univariate Summary by Parameter and Visit 
Safety Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen 
ECG Parameter 
Visit 
100 mg / 60 mg/m2 
(N= ) 
 
100 mg / 80 mg/m2 
(N= ) 
 
150 mg / 80 mg/m2 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Heart Rate (bpm) Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
 x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In 
Day 7 Pre-Dose 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
 x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In 
Day 7 Post-Dose 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RR Interval (msec) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ECG=electrocardiogram; QTc=Corrected QT interval 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
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CORT125134-550 
 
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Table 14.3.7.2 
12-Lead Electrocardiogram – Univariate Summary by Parameter and Visit 
Safety Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
ECG Parameter 
Visit 
150 mg / 80 mg/m2 
(N= ) 
 
200 mg / 100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Heart Rate (bpm) 
Baseline[2] 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
 
 
n 
 
 
n 
 
 
n 
 
   Mean (SD) 
x.x (x.xx) 
 
 
x.x (x.xx) 
 
 
x.x (x.xx) 
 
 
x.x (x.xx) 
 
   Median 
x 
 
 
x 
 
 
x 
 
 
x 
 
   Min, Max 
x, x 
 
 
x, x 
 
 
x, x 
 
 
x, x 
 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In Day 7 Pre-Dose 
 
 
 
 
 
 
 
 
 
 
 
   n 
n 
n 
 
n 
n 
 
n 
n 
 
n 
n 
   Mean (SD) 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
 
x.x (x.xx) 
x.x (x.xx) 
   Median 
x 
x 
 
x 
x 
 
x 
x 
 
x 
x 
   Min, Max 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
x, x 
x, x 
 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In Day 7 Post-Dose 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RR Interval (msec) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ECG=electrocardiogram; QTc=Corrected QT interval 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Notes:  
 
Continue for regularly-collected ECG parameters (PR Interval (msec), QRS Duration (msec), QT Interval (msec), RR Interval (msec), Heart Rate (beats/min), QTcB (msec), QTcF (msec)) 
 
Continue for regularly collected visits (Cycle 1 Day 8 Pre-Dose, Cycle 1 Day 8 Post-Dose) 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
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Confidential 
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Corcept Therapeutics  
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Table 14.3.7.3 
12-Lead Electrocardiogram Overall Interpretation – Shift from Baseline to Worst Post-Baseline Value 
Safety Population 
Part 1 of 2 
 
Segment I: Continuous-Dosing Regimen[1] 
Overall Interpretation 
100 mg / 60 mg/m2 
(N= ) 
Baseline Assessment[2] 
 
100 mg / 80 mg/m2 
(N= ) 
Baseline Assessment[2] 
 
150 mg / 80 mg/m2 
(N= ) 
Baseline Assessment[2] 
 
Total 
(N= ) 
Baseline Assessment[2] 
Normal 
Abnormal 
 
Normal 
Abnormal 
 
Normal 
Abnormal 
 
Normal 
Abnormal 
 
 
 
 
 
 
 
 
 
 
 
Worst Post-Baseline Assessment 
(n= ) 
 
(n= ) 
 
(n= ) 
 
(n= ) 
   Normal 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
   Abnormal 
n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
 n (x.x%) 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Percentages are based on the number of patients with a non-missing baseline value and at least one non-missing post-baseline value. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 133 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.7.3 
12-Lead Electrocardiogram Overall Interpretation – Shift from Baseline to Worst Post-Baseline Value 
Safety Population 
Part 2 of 2 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
 
Overall Interpretation 
150 mg / 80 mg/m2 
(N= ) 
 
200 mg / 100 mg/m2 
(N= ) 
 
Total 
(N= ) 
 
Total 
(N= ) 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
Observed 
Value 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
Worst Post-Baseline Assessment 
(n= ) 
 
(n= ) 
 
(n= ) 
 
(n= ) 
   Normal 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
   Abnormal 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Percentages are based on the number of patients with a non-missing baseline value and at least one non-missing post-baseline value. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134. 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Table 14.3.7.4 
12-Lead Electrocardiogram – QT Interval Categories 
Safety Population 
 
 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
Visit[2] 
QTc Category 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
Baseline 
Number of Patients 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
 
 
 
 
 
 
 
 
> 450 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
> 470 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
> 500 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In 
Day 7 Pre-Dose 
Number of Patients 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
 
 
 
 
 
 
 
 
> 450 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
> 470 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
> 500 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
Change from Baseline 
 
 
 
 
 
 
 
 
 
 
   > 30 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   > 60 msec 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
CORT125134 Lead In 
Day 7 Post-Dose 
… 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviation: QTc=Corrected QT interval 
 
Note: Denominators for percentages are based on the number of patients within each treatment group with non-missing data at each visit. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Baseline is defined as the last available measurement taken prior to the first dose of CORT125134.  
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note: Continue for regularly collected visits (Cycle 1 Day 8 Pre-Dose, Cycle 1 Day 8 Post-Dose) 
 


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Table 14.3.7.5 
Concomitant Medications 
Safety Population 
 
 
Segment I: Continuous-Dosing Regimen[1] 
 
Segment II: Intermittent-Dosing Regimen[1] 
 
 
ATC Class / 
   Generic Drug Name 
100 mg / 
60 mg/m2 
(N= ) 
100 mg / 
80 mg/m2 
(N= ) 
150 mg / 
80 mg/m2 
(N= ) 
Total 
(N= ) 
 
150 mg / 
80 mg/m2 
(N= ) 
200 mg / 
100 mg/m2 
(N= ) 
Total 
(N= ) 
 
Total 
(N= ) 
 
 
 
 
 
 
 
 
 
 
Patients Receiving any Concomitant Medications 
n 
n 
n 
n 
 
n 
n 
n 
 
n 
 
 
 
 
 
 
 
 
 
 
ATC Class #1 
 
 
 
 
 
 
 
 
 
 
   Generic Drug Name #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Generic Drug Name #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
ATC Class #2 
 
 
 
 
 
 
 
 
 
 
   Generic Drug Name #1 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
   Generic Drug Name #2 
n (x.x%) 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
n (x.x%) 
n (x.x%) 
 
n (x.x%) 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ATC=anatomic therapeutic chemical; WHO=World Health Organization 
 
Notes: 
 
Concomitant medications are those medications received after the first dose of study treatment. 
 
Medications are coded to ATC drug class (level 4) and generic drug names using the WHO Drug dictionary, March 1, 2014 Version. 
 
At each level of summarization (any medication, ATC class, generic drug name), patients reporting use of more than one medication are counted only once. 
 
[1] Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Reference: Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort medications by descending order of ATC class incidence and by descending order of drug name incidence within ATC class, based on the overall incidence (ie, sum over all treatment groups). 
 
When creating ATC level 4 drug class, utilize level 3 term if level 4 is missing in dataset and level 2 if both level 3 and level 4 are missing in the dataset 
 
 
 
 
 
 


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APPENDIX D: FIGURE LAYOUTS 
 
 
 


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Figure 14.4.1.1 
Kaplan-Meier Plot of Overall Survival 
PDAC 
mITT Population 
 
 
 
Abbreviation: PDAC=pancreatic ductal adenocarcinoma; S=segment 
 
Notes:  
 
PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes 
all patients not included in PDAC and ovarian cancer groups. 
 
Number of patients at risk are displayed by month along the x-axis. 
 
Reference: Table/Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


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Programming Note: Continue for cancer types: Ovarian Cancer, Other Solid Tumors 
 
Table 14.4.1.2 
Kaplan-Meier Plot of Overall Survival by Tumor Type* 
Table 14.4.2.1 
Kaplan-Meier Plot of Progression-Free Survival 
Table 14.4.2.2 
Kaplan-Meier Plot of Progression-Free Survival by Tumor Type* 
Table 14.4.3.1 
Kaplan-Meier Plot of Duration of Response  
Table 14.4.3.2 
Kaplan-Meier Plot of Duration of Response by Tumor Type* 
*Use above mock with a separate KM curve for each of the following Tumor Types: PDAC, Ovarian Cancer, Other Solid Tumors. Legend will have 1-3 for each tumor type 


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Figure 14.4.4 
Waterfall Plot of Best Response based on RECIST v1.1 Criteria 
PDAC 
mITT Population 
 
 
 
Abbreviations: CR=complete response; PD=progressive disease; PDAC=pancreatic ductal adenocarcinoma; PR=partial response; RECIST=response evaluation criteria in solid tumors v1.1; SD=stable 
disease 
 
Notes:  
 
PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes 
all patients not included in PDAC and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Best response is defined by RECIST v1.1 as the best response recorded from the date of the first dose of CORT125134 or nab-paclitaxel, whichever is earliest, across all time points during study 
observation period (including both confirmed and unconfirmed responses).  
 
The percentage change from baseline is the maximum percentage decrease (or minimum increase if no decrease) in the sum of the longest diameters of target lesions at a given visit relative to 
baseline. 
Reference: Table/Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
 
 
 
See programming notes on the next page. 
PD
PD
PD
PD
PD
PD
SD
SD
SD
SD
SD
SD
SD
SD
SD
PR
PR
PR
PR
PR
PR
CR
CR
CR
CR
CR
CR
CR
CR
-100
-80
-60
-40
-20
0
20
40
60
80
100
120
% Change from Baseline
Segment II Other Solid Tumors
Segment II Ovarian Cancer
Segment II PDAC
Segment I Other Solid Tumors
Segment I Ovarian Cancer
Segment I PDAC


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Programming Notes:  
 
Continue for cancer types: Ovarian Cancer, Other Solid Tumors  
 
X-axis to include Patient IDs along tick marks 
 
 


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Figure 14.4.5 
Swim Plot of RECIST v1.1 Criteria 
PDAC 
mITT Population 
 
 
Abbreviations: PDAC=pancreatic ductal adenocarcinoma; RECIST=response evaluation criteria in solid tumors v1.1 
 
Notes:  
 
PDAC includes all pancreatic cancer patients excluding acinar subtype. Ovarian Cancer includes all ovarian cancer patients excluding juvenile granulosa subtype. Other Solid Tumors includes 
all patients not included in PDAC and ovarian cancer groups. 
 
Time (weeks) from start of CORT125134 or nab-paclitaxel, whichever is earliest, until last dose of any study drug displayed 
 
Complete response, partial response, stable disease, and progressive disease are defined using RECIST v1.1. 
 
Reference: Table/Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
 
 
 
See Programming Notes on the next page 
 
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
xxx-xxxx
0
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17 18 19 20 21 22 23
Weeks
Patient
Patient ID
Segment II Other Solid Tumors
Segment II Ovarian Cancer
Segment II PDAC
Segment I Other Solid Tumors
Segment I Ovarian Cancer
Segment I PDAC
X
Complete response
Partial response
Stable disease
Progressive disease
Ongoing
Withdrew consent
Dose interruption
Death


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Programming Note: Continue for cancer types: Ovarian Cancer, Other Solid Tumors 
 
 


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Corcept Therapeutics  
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Figure 14.4.6 
Swim Plot of Nab-Paclitaxel Toxicity and Study Status 
mITT Population 
 
Abbreviation: PDAC=pancreatic ductal adenocarcinoma 
 
Reference: Table/Listing #(s) 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
Death
20
80
20
80
100
90
70
60
0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
Weeks
Subject
Discontinuation
Reason for
H-Score
GR Status
Segment II Other Solid Tumors
Segment II Ovarian Cancer
Segment II PDAC
Segment I Other Solid Tumors
Segment I Ovarian Cancer
Segment I PDAC
X
Dose Not Changed
Dose Reduced
Drug Interrupted
Drug Int. and then Dose Reduced
Drug Discontinued
Toxicity [1]
Ongoing
Study Discontinuation


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APPENDIX E: LISTING LAYOUTS 
 
 
 


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Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.1 
Patient Disposition 
 
 
 
 
Segment Cohort[1] 
 
Patient ID 
 
 
Completed Survival 
Follow-Up Period 
Date of Study 
Completion or 
Discontinuation 
(Study Day[2]) 
Reason for Discontinuation 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Yes / 
No 
ddMMMyyyy (xx) 
Death / 
Lost to Follow-Up / 
Study Terminated by Sponsor / 
Withdrawl by Patient: Specify / 
Other: Specify 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


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Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.2 
Informed Consent and Eligibility Criteria 
 
 
 
 
Segment 
 
Cohort[1] 
 
 
 
Patient ID 
 
Patient Sign 
Informed 
Consent? 
 
 
Date Informed 
Consent Signed 
Inclusion/Exclusion Criteria Waivers 
Met All 
Eligability 
Criteria? 
 
Criterion  
Identifier 
Criterion 
 
Inclusion/Exclusion 
Category 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxx 
 
 
 
 
Yes / 
No 
ddMMMyyyy 
Yes /  
No 
Inclusion # / 
Exclusion # 
Criteria 
Inclusion / 
Exclusion 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
  
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


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Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.3 
Patients Excluded from the Efficacy Analysis 
 
Segment Cohort[1] 
Patient ID 
Response-Evaluable Population[2] Reason for Exclusion from the Efficacy Analysis 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxx 
 
 
 
 
Yes / 
No 
Reason (eg, screen failure, patient did not receive study drug, protocol violation, etc.), 
including any relevant specifications / 
Did not have at least one post-baseline tumor response evaluation 
 
 
… 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Response-Evaluable population is the subset of the Safety population with at least one post-baseline tumor assessment. 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


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Listing 16.2.4.1 
Demographics 
 
Segment Cohort[1] 
Patient ID 
Date of Birth Age (years)[2] 
Sex 
Ethnicity 
Race 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy 
xx 
Male / 
Female 
Hispanic or Latino / 
Not Hispanic or Latino 
Black or African American / 
American Indian or Alaska Native / 
Asian / 
Native Hawaiian or Other Pacific Islander / 
White 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CRF=case report form; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Age is listed as reported on the CRF. 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
If multiple races are reported for a given patient, display all that are reported in the “Race” column, separated by a semicolon.  
 
 


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Listing 16.2.4.2 
Cancer History 
 
 
 
 
Segment Cohort[1] 
 
 
 
Patient ID 
 
 
Date of Initial 
Diagnosis 
Cancer Type 
Histology 
 
 
Molecular 
Typing 
 
Stage at 
Initial 
Diagnosis 
 
 
Stage at 
Screening 
Triple Negative Breast Cancer (TNBC) 
ER 
(% cells 
positive) 
PR 
(% cells 
positive) HER2 
FISH 
HER2+ 
≤ 1.8 
 
BRCA 
Result 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
ddMMMyyyy NSCLC / 
Pancreatic / 
Ovarian / 
Sarcoma / 
Head and Neck / 
Melanoma / 
TNBC)/ 
Other: Specify 
Histology 
Typing 
Stage 
Stage 
xx 
xx 
HER2 IHC Score 0 / 
HER IHC Score 1 / 
FISH Ratio of 
HER2/CEN-17 
Yes / 
No 
1 / 
2 / 
1 and 2 / 
Wild 
Type / 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: BRCA=breast caner 1 (gene); ER=estrogen receptor; FISH=fluorescence in situ hybridization; HER2=human epithelial receptor-2; NSCLC=non-small cell lung cancer; OT=other tumor; 
OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; PR=progesterone receptor 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
  
Path\filename.sas ddmmmyyyy hh:mm 
  
Programming Notes: 
 
Sort conditions based on initial diagnosis date. If partial onset dates are reported (eg, month and year only), separate out the portions of the date to sort separately by year, then month, then day.  
 
 


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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.4.3 
Prior Cancer Related Surgery 
 
Segment Cohort[1] 
Patient ID 
Prior Cancer  
Related Surgery? 
Surgery Date 
Surgical Procedure 
Significant Details 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Yes / 
No 
ddMMMyyyy 
Procedure 
Details 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
  
Programming Notes: 
 
Sort conditions based on surgery date. If partial onset dates are reported (eg, month and year only), separate out the portions of the date to sort separately by year, then month, then day.  
 
 


Corcept Therapeutics 
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Listing 16.2.4.4 
Prior Radiotherapy 
 
Segment Cohort[1] 
Patient ID 
Prior Radiation 
Therapy? 
Site 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
Yes / 
No 
Abdomen/Viscera / 
Adrenals / 
Bone / 
Bone Marrow / 
Bladder / 
Chest Wall / 
CNS/Brain 
Kidney / 
Liver / 
Lung / 
Lymph Nodes / 
Pancreas / 
Peritoneum / 
Pleura / 
Prostate Gland / 
Spleen / 
Stomach / 
Whole Body / 
Other: Specify 
 
… 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
  
 
 


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Statistical Analysis Plan
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Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.4.5 
Prior Systemic Therapy 
 
 
 
 
Segment Cohort[1] 
 
 
Patient ID 
Prior Cancer 
Therapy for 
Disease 
Indication? 
 
Date of First 
Dose 
 
Date of Last 
Dose 
Agent Type 
Agent 
Name 
Reason for 
Administration 
 
 
Best 
Response 
Prior Line  
Response Duration 
Reason for 
Discontinuation 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Yes / 
No 
ddMMMyyyy ddMMMyyyy Chemotherapy / 
Hormonal Therapy / 
Immunotherapy / 
Other: Specify 
Name 
Neoadjuvant / 
Adjuvant / 
Radio Sensitizing / 
Locally Advanced / 
Metastatic Disease / 
Other: Specify 
Display all that are 
reported, separated 
by a comma 
CR / 
PR / 
SD / 
PD / 
NE 
Platinum refractory 
(progression during 
treatment) / 
Platinum resistance 
(reoccurance < 6 
months) / 
Platinum sensitive 
(recurrence > 6 
months) / 
Other: Specify 
Relapse/Progressive 
Disease / 
Toxicity: Specify / 
Unknown / 
Other: Specify 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CR=complete response; NE=not evaluable; OT=other tumor; OVCA=ovarian tumor; PD=progressive disease; PDAC=pancreatic ductal adenocarcinoma; PR=partial response; SD=stable 
disease 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
  
Programming Notes: 
 
Sort conditions based on date of first dose. If partial onset dates are reported (eg, month and year only), separate out the portions of the date to sort separately by year, then month, then day.  
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 153 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.4.6 
Medical History 
 
Segment Cohort[1] 
Patient ID 
Body System 
Diagnosis/Condition 
Onset Date 
Resolution Date 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Body System 
Diagnosis /Condition  
ddMMMyyyy 
ddMMMyyyy / 
Ongoing 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
  
Programming Notes: 
 
Sort conditions based on onset date. If partial onset dates are reported (eg, month and year only), separate out the portions of the date to sort separately by year, then month, then day.  
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 154 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.5.1 
Study Drug Administration: CORT125134 
 
 
Segment Cohort[1] 
 
Patient ID Visit 
Dose Date  
and Time 
 
Stop Date 
 
Dose (mg) 
 
Total Dose Expected (mg) 
 
Total Dose Received (mg) 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
CORT125134 Lead-In Day 1 
… 
ddMMMyyyy 
HH:MM 
ddMMMyyyy 
xx 
xx 
xx 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 155 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.5.2 
Study Drug Administration: Nab-paclitaxel 
 
 
 
Segment Cohort[1] 
 
 
Patient ID 
 
 
Date Administered 
Planned 
Dose 
(mg/m2) 
Total 
Prepared 
Dose (mg) 
 
 
Infusion Start 
 
 
Infusion Stop 
 
Total  
Infusion Time Total Dose Administered? 
Total Dose 
Administered 
(mg/m2) 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
ddMMMyyyy 
xx 
xx 
hh:mm 
hh:mm 
hh:mm 
Yes / 
Drug Interupted / 
Drug Withdrawn / 
Dose Reduced: Specify / 
Rate Changed: Specify / 
Drug Delayed: Specify / 
Dose Not Given: Specify / 
Toxicity / 
Infusion Related Reaction / 
Other Adverse Event / 
Venous Access Related / 
Other: Specify 
xx 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 
Path\filename.sas ddmmmyyyy hh:mm 
  
Programming Notes: 
 
Sort based on date administered. If partial onset dates are reported (eg, month and year only), separate out the portions of the date to sort separately by year, then month, then day.  
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 156 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.5.3 
Concentration Data: CORT125134 
 
 
Segment Cohort[1] 
Patient ID 
Visit 
Date Collected 
(Study Day[2]) 
Time Point 
Time Collected 
Actual Time 
Relative to Dose 
Plasma Drug Concentration 
(mg) 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
CORT125134 Lead-In Day 1 ddMMMyyyy (xx) / 
Not Done 
Pre-Dose 
hh:mm 
-hh:mm 
xx 
CORT124134 Lead-In Day 7 ddMMMyyyy (xx) / 
Not Done 
Pre-dose 
hh:mm 
hh:mm 
xx 
0.5 hour 
hh:mm 
hh:mm 
xx 
… 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134  
 
Path\filename.sas ddmmmyyyy hh:mm 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 157 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.1 
RECIST Non-Target Lesions 
 
 
 
 
 
SegmentCohort[1] 
 
 
 
 
Patient ID 
 
 
 
Date of Scan 
(Study Day[2]) Anatomical Site 
 
 
 
Anatomical 
Description Lesion Status 
Method of  
Assessment 
Scan Slice 
Thickness 
Overall 
Evaluation of 
Non Target 
Lesions 
(RECIST 1.1) 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy 
(xx) 
 
Abdomen/Viscera / 
Adrenals / 
Bladder / 
Bone / 
Breast / 
Chest Wall / 
CNS/Brain / 
Kidney / 
Liver / 
Lymph Node / 
Lung / 
Pancreas / 
Peritoneium / 
Pleura / 
Prostate / 
Skin / 
Stomach / 
Spleen / 
Other: Specify 
Description Baseline Assessment / 
Stable Disease (Lesion present) / 
Complete Response (Disapperance of lesion) / 
Progressive Disease (Unequivocal progression 
and/or Clinical progression based on clinical 
signs/symptoms) / 
Unevaluable (Status unknown) / 
Not evaluated 
Conventional CT / 
Spiral CT / 
MRI / 
PET/CT / 
X-ray / 
Other: Specify 
2.5 mm / 
5 mm / 
10 mm / 
Other: Specify 
CR / 
PD / 
Non-CR/Non-
PD / 
NE / 
Unequivocal 
Progression 
 
 
… 
 
 
 
 
Abbreviations: CR=complete response; NE=inevaluable; OT=other tumor; OVCA=ovarian tumor; PD=progressive disease; PDAC=pancreatic ductal adenocarcinoma; RECIST=response evaluation 
criteria in solid tumors 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 158 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.2 
RECIST Target Lesions 
 
 
 
 
Segment Cohort[1] 
 
 
 
Patient ID 
 
 
Date of Scan 
(Study Day[2]) 
Anatomical  
Site 
 
 
Anatomical 
Description Lesion Status 
Method of  
Assessment 
Scan Slice 
Thickness 
 
 
Axis 
(mm) 
 
 
Sum of the 
Diameters 
Overall 
Evaluation of 
Target Lesions 
(RECIST 1.1) 
Overall 
Response 
(RECIST 
1.1) 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy 
(xx) 
 
Abdomen/Viscera / 
Adrenals / 
Bladder / 
Bone / 
Breast / 
Chest Wall / 
CNS/Brain / 
Kidney / 
Liver / 
Lymph Node / 
Lung / 
Pancreas / 
Peritoneium / 
Pleura / 
Prostate / 
Skin / 
Stomach / 
Spleen / 
Other: Specify 
Description Baseline Assessment / 
Stable Disease (does not 
meet PR or PD criteria) / 
Partial Response (>= 30% 
decrease from baseline in 
sum of diameters) / 
Progressive Disease (>= 
20% increase and >= 5 mm 
from nadir) / 
Too Small to Measure 
(default 5 mm per RECIST 
1.1) / 
Complete Response 
(Disapperance of all non-
nodal lesions; Any 
pathological LN must have 
SAD < 10 mm) / 
Not evaluated / 
Lesion Merged or 
Coalesced (LD of coalesced 
lesion is added to the sum) / 
Lesion split or Divided 
(LDs of the fragmented 
portions are added to the 
sum) 
Conventional CT / 
Spiral CT / 
MRI / 
PET/CT / 
X-ray / 
Other: Specify 
2.5 mm / 
5 mm / 
10 mm / 
Other: 
Specify 
xx 
xx 
CR / 
PR / 
PD / 
SD / 
NE 
CR / 
PR / 
PD / 
SD / 
NE 
 
Abbreviations: LD=longest diameter; LN=lymph node; OT=other tumor; OVCA=ovarian tumor; PD=progressive disease; PDAC=pancreatic ductal adenocarcinoma; PR=partial response; 
RECIST=response evaluation criteria in solid tumors; SAD=short axis diameter 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 159 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.6.3 
Percentage Change of Target Lesions from Baseline 
 
 
 
 
Sum of Diameters (mm)[3] 
Overall 
Evaluation of 
Target Lesions 
Overall 
Evaluation of 
Non-Target Lesions 
RECIST v1.1 
Overall Response 
Segment Cohort[1] 
Patient ID 
Cancer Type 
Date of Scan 
(Study Day[2]) 
Result 
% Change 
from 
Baseline 
% Change 
from 
Nadir 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
NSCLC / 
Pancreatic / 
Ovarian / 
Sarcoma / 
Head and Neck / 
Melanoma / 
TNBC / 
Breast / 
Cervical / 
Rectal / 
Other: Specify 
Display all that 
are reported, 
separated by a 
comma 
ddMMMyyyy (xx) 
 
xx 
xx 
xx 
 
 
 
 
 
 
 
CR / 
PR / 
SD / 
PD / 
NE 
CR / 
PR / 
SD / 
PD / 
NE 
CR / 
PR / 
SD / 
PD / 
NE 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CR=complete response; NE=not evaluable; NSCLC=non-small cell lung cancer; OT=other tumor; OVCA=ovarian tumor; PD=progressive disease; PDAC=pancreatic ductal 
adenocarcinoma; PR=partial response; RECIST=response evaluation criteria in solid tumors v1.1; SD=stable disease; TNBC=triple-negative breast cancer 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of study treatment 
[3] Sum of Diameters (mm) percent change from baseline and percent change from nadir are used to assess a response criteria for RECIST v1.1. Percent change from nadir defines nadir as the smallest 
measurement up to and including the visit of interest. 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 160 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.4 
Survival Status 
 
Segment Cohort[1] 
 
Patient ID 
Date of Survival Follow-Up 
(Study Day[2]) 
Method of Contact 
 
Patient Alive 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy (xx) 
Telephone / 
Hospital/Clinic Visit / 
Hospital/Clinic Visit Note / 
Written communication / 
Other: Specify / 
Unable to contact 
N / 
Y / 
U 
 
 
… 
 
Abbreviations: N=No; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; U=Unknown (lost to follow up); Y=Yes 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 161 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.5 
Tumor Tissue Collection 
 
Segment Cohort[1] 
 
 
Patient ID 
Date Biopsy  
Procedure Perfomed 
(Study Day[2]) 
Sample Type 
Biopsy Site 
Sample Submitted 
for GR IHC 
Analysis 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy (xx) 
Achival Tumor Tissue: Specify / 
Fresh Tumor Biopsy 
Abdomen/Viscera / 
Adrenals / 
Bone Marrow / 
Bone / 
Breast / 
Chest Wall / 
CNS/Brain / 
Pancreas / 
Bladder / 
Kidney / 
Liver / 
Lymph Nodes / 
Lung / 
Peritoneum / 
Pleura / 
Stomach / 
Spleen / 
Prostate / 
Other: Specify 
Yes / 
No 
… 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 162 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.6 
Tumor Markers 
 
 
Segment Cohort[1] 
 
Patient ID 
 
Markers 
Date of Collection 
(Study Day[2]) 
 
Result 
 
Units 
% Change from 
Baseline[3] 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
CA125 / 
PSA / 
Other: specify 
ddMMMyyyy (xx) 
xx 
units/mL / 
ng/mL / 
Other: specify 
xx% 
… 
 
Abbreviations: OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
[3] Baseline defined as the last result measured prior to first dose of study treatment 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 163 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.6.7 
Study Treatment and Prior Systemic Therapy Duration 
 
Segment Cohort[1] 
 
 
 
Patient ID 
 
Duration of  
Nab-Paclitaxel 
(months[2]) 
 
Duration of 
CORT125134 
(months[2]) 
On Study 
Progressive 
Disease per 
RECIST 
Agent Name 
Agent Type 
 
Duration of Prior 
Systemic Therapy 
(months[2]) 
Prior Systemic Therapy 
Response Duration 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
xx 
xx 
Yes / 
No 
Agent 
Chemotherapy / 
Hormonal Therapy / 
Immonotherapy / 
Other: specify 
xx 
Progression During Treatment / 
Recurrence <6 Months / 
Recurrence >6 Months / 
> 1 Year / 
< 2 Years / 
> 2 Years / 
< 5 Years / 
> 5 Years / 
Other: specify 
… 
 
 
Abbreviations: CR=complete response; OT=other tumor; OVCA=ovarian tumor; PR=partial response; PD=progressive disease; PDAC=pancreatic ductal adenocarcinoma; NE=not evaluable; SD=stable 
disease 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] (Date of last dose  – Date of first dose+1) / (365.25/12). 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Notes: 
 
Sort Agents based on duration of prior systemic therapy. If partial onset dates are reported (eg, month and year only), use the first of the month to perform the duration calculation. Prior therapies 
with the month and day missing should present a missing duration. 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 164 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.1 
Adverse Events  
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to Study 
Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study 
Drug 
N: Not Related to Study 
Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and 
then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and 
then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a 
comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; DLT=dose-limiting toxicity; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of study treatment 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 
 
 
See Programming Notes on next page 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 165 of 188
 
Programming Note: Generate listing in XLS format as well with the following updates: 1. Population updated to use All Patients; 2. Add column for “Cycle 1 Day 1 Visit Date” prior to Start Date. 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 166 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.2 
Grade ≥ 3 Adverse Events  
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to Study 
Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study Drug 
N: Not Related to Study 
Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted 
and then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted 
and then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a 
comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Grade ≥ 3 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 167 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.3 
Listing of Adverse Events Leading to Withdrawal of CORT125134 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with  
Nab-Paclitaxel 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to Study 
Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study 
Drug 
N: Not Related to Study 
Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
Dose Not Changed / 
Dose Reduced / 
Drug Interrupted / 
Drug Interrupted and 
then Dose  
Reduced / 
Drug Withdrawn / 
Not Applicable / 
Unknown 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with CORT125134 is “Drug Withdrawn.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with CORT125134 = ‘Drug Withdrawn’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 168 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.4 
Listing of Adverse Events Leading to Withdrawal of Nab-paclitaxel 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with  
CORT125134 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to 
Study Drug / 
C: Unlikely Related 
to Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study 
Drug 
N: Not Related to 
Study Drug / 
N: Unlikely Related 
to Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
Dose Not Changed / 
Dose Reduced / 
Drug Interrupted / 
Drug Interrupted and 
then Dose  
Reduced / 
Drug Withdrawn / 
Not Applicable / 
Unknown 
Fatal / 
Not Recovered/Not 
Resolved/ 
Recovered/Resolved/ 
Recovered/Resolved 
with Sequelae / 
Recovering/Resolving
/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with Nab-paclitaxel is “Drug Withdrawn.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with Nab-paclitaxel = ‘Drug Withdrawn’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 169 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.5 
Listing of Adverse Events Leading to CORT125134 Interruption 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to  
Study Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study 
Drug 
N: Not Related to  
Study Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and 
then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and 
then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with CORT125134 is “Dose Interrupted” or “Drug Interrupted and then Dose Reduced.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with CORT125134 = ‘Drug Interrupted’ or ‘Drug Interrupted and then Dose Reduced’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 170 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.6 
Listing of Adverse Events Leading to Nab-paclitaxel Interruption 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to  
Study Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study  
Drug 
N: Not Related to  
Study Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and 
then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and 
then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a 
comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with Nab-paclitaxel is “Dose Interrupted” or “Drug Interrupted and then Dose Reduced.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with Nab-paclitaxel = ‘Drug Interrupted’ or ‘Drug Interruputed and then Dose Reduced’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 171 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.7 
Listing of Adverse Events Leading to CORT125134 Reduction 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to  
Study Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study  
Drug 
N: Not Related to  
Study Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with 
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and 
then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and 
then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with CORT125134 is “Dose Reduced” or “Drug Interrupted and then Dose Reduced.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with CORT125134 = ‘Dose Reduced’ or ‘Drug Interrupted and then Dose Reduced’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 172 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.8 
Listing of Adverse Events Leading to Nab-paclitaxel Reduction 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
Outcome 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 1 / 
Grade 2 / 
Grade 3 / 
Grade 4 / 
Grade 5 
Yes / 
No 
C: Not Related to  
Study Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study  
Drug 
N: Not Related to  
Study Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and 
then Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and 
then Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a comma 
Fatal / 
Not 
Recovered/
Not 
Resolved/ 
Recovered/
Resolved/ 
Recovered/
Resolved 
with 
Sequelae / 
Recovering/
Resolving/ 
Unknown 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: Includes events where action taken with Nab-paclitaxel is “Dose Reduced” or “Drug Interrupted and then Dose Reduced.” 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Note: Include all AEs with Action Taken with Nab-paclitaxel = ‘Dose Reduced’ or ‘Drug Interrupted and then Dose Reduced’ 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 173 of 188
 
Corcept Therapeutics 
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
Page x of y
Listing 16.2.7.9 
Listing of Adverse Events Leading to Death 
Safety Population 
 
 
 
Segment 
 
 
Cohort[1] 
 
Patient 
ID 
System Organ Class[2] / 
Preferred Term[2] / 
Event Name 
 
Treatment-
Emergent[3] 
Start Date  
and Time  
(Study Day[4]) 
End Date  
and Time 
(Study Day[4]) 
 
CTCAE 
Grade 
 
 
Serious Relationship to[5] 
Action Taken with[6] 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
System Organ Class / 
Preferred Term / 
Event Name 
Yes / 
No 
ddMMMyyyy 
HH:MM (xx) 
ddMMMyyyy 
HH:MM (xx) / 
Ongoing 
Grade 5 
Yes / 
No 
C: Not Related to  
Study Drug / 
C: Unlikely Related to 
Study Drug/ 
C: Possibly Related to 
Study Drug/ 
C: Related to Study  
Drug 
N: Not Related to  
Study Drug / 
N: Unlikely Related to 
Study Drug/ 
N: Possibly Related to 
Study Drug/ 
N: Related to Study 
Drug 
Sepearate C and N 
Relationship with a  
comma 
C: Dose Not Changed / 
C: Dose Reduced / 
C: Drug Interrupted / 
C: Drug Interrupted and then 
Dose  
Reduced / 
C: Drug Withdrawn / 
C: Not Applicable / 
C: Unknown 
N: Dose Not Changed / 
N: Dose Reduced / 
N: Drug Interrupted / 
N: Drug Interrupted and then 
Dose  
Reduced / 
N: Drug Withdrawn / 
N: Not Applicable / 
N: Unknown 
Sepearate C and N 
Relationship with a comma 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events, v4.03; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Adverse events are coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 19.0. 
[3] Treatment-emergent adverse events are those events that occur from the first dose of CORT125134 through 28 days after administration of the last dose of study drug. 
[4] Time (days) relative to date of first dose of CORT125134 
[5] C: reports answer to question on case report form regarding relationship to CORT125134; N: reports answer to question on case report form regarding relationship to Nab-paclitaxel 
[6] C: reports answer to question on case report form regarding action taken with CORT125134; N: reports answer to question on case report form regarding action taken with Nab-paclitaxel 
 
Path\filename.sas ddmmmyyyy hh:mm 
Programming Notes: 
 
Include all AEs with Outcome = ‘Fatal’ or CTCAE Grade = 5 


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Statistical Analysis Plan
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Database Date/Analysis: DDMMMYYYY/Draft
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Listing 16.2.7.10 
Dose-Limity Toxicities 
DLT Evaluable Population 
 
Segment Cohort[1] 
Patient ID 
Pancreatic Cohort 
DLT Evaluable 
Experienced DLT 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
 
Yes / 
No 
Yes / 
No 
Yes / 
No 
 
 
 
 
 
 
 
Abbreviations: DLT=dose llimiting toxicity; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 


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Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
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Listing 16.2.8.1 
Hematology 
Part 1 of 2 
 
 
 
Segment Cohort[1] 
 
 
Patient ID 
Visit 
 
Collection Date 
(Study Day[2]) 
 
Collection 
Time 
 
RBC Count 
(1012/L) 
 
Hematocrit 
(L/L) 
 
Hemoglobin 
(g/L) 
 
MCH 
(pg) 
 
MCHC 
(g/L) 
 
MCV 
(fL) 
Platelet 
Count 
(109/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=clinically significant; H=high; L=low; MCH=mean corpuscular hemoglobin; MCHC=mean corpuscular hemoglobin concentration; MCV=mean corpuscular volume; OT=other tumor; 
OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; RBC=red blood cell  
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.1 
Hematology 
Part 2 of 2 
 
 
 
Segment Cohort[1] 
 
 
Patient ID Visit 
 
Collection Date 
(Study Day[2]) 
 
Collection 
Time 
WBC  
Count 
(109/L) 
Absolute 
Neutrophils 
(109/L) 
Absolute 
Lymphocytes 
(109/L) 
Absolute 
Monocytes 
(109/L) 
Absolute 
Eosinophils 
(109/L) 
Absolute 
Basophils  
(109/L) 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
 
 
… 
 
 
 
 
 
 
 
 
Abbreviations: CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; WBC=white blood cell 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 [2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.2 
Chemistry 
Part 1 of 4 
 
 
 
Segment Cohort[1] 
 
Patient 
ID 
Visit 
 
Collection Date 
(Study Day[2]) 
 
Collection 
Time 
AST  
(SGOT) 
(U/L) 
ALT  
(SGPT) 
(U/L) 
Alkaline 
Phosphatase 
(U/L) 
Total 
Bilirubin 
(µmol/L) 
Direct 
Bilirubin 
(µmol/L) 
 
GGT  
(U/L) 
 
Albumin 
(g/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AST (SGOT)=aspartate aminotransferase; ALT (SGPT)=alanine aminotransferase; BUN=blood urea nitrogen; CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian 
tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 [2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 178 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.2 
Chemistry 
Part 2 of 4 
 
 
Segment Cohort[1] 
Patient 
ID 
Visit 
Collection Date 
(Study Day[2]) 
Collection 
Time 
Total Protein  
(g/L) 
BUN  
(mmol/L) 
Creatinine 
(µmol/L) 
Sodium 
(mmol/L) 
Potassium 
(mmol/L) 
Magnesium 
(mmol/L) 
Chloride 
(mmol/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L x.x CS, H/L 
x.x CS, H/L 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CO2=Carbon Dioxide; CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
 [2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 179 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.2 
Chemistry 
Part 3 of 4 
 
 
Segment Cohort[1] 
Patient 
ID 
Visit 
Collection Date 
(Study Day[2]) 
Collection 
Time 
Phosphorus 
(mmol/L) 
Calcium 
(mmol/L) 
CO2 
(mmol/L) 
Glucose 
(mmol/L) 
Cholesterol 
(mmol/L) 
Triglycerides 
(mmol/L) 
HDL Cholesterol 
(mmol/L) 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
x.x CS, H/L x.x CS, H/L x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CO2=Carbon Dioxide; CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 180 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.2 
Chemistry 
Part 4 of 4 
 
 
Segment Cohort[1] 
Patient 
ID 
Visit 
Collection Date 
(Study Day[2]) 
Collection 
Time 
LDL Cholesterol 
(mmol/L) 
Amylase 
(µkat/L) 
Lipase 
(µkat/L) 
Creatinine Kinase 
(U/L) 
LDH  
(µkat/L) 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy (xx) 
HH:MM 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
x.x CS, H/L 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CO2=Carbon Dioxide; CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.3 
Urinalysis 
 
 
Segment Cohort[1] 
Patient 
ID 
Visit 
Collection Date 
(Study Day[2]) 
Collection 
Time 
 
Appearance 
Bilirubin 
(mg/dL) 
 
Color 
Glucose 
(mg/dL) 
 
Ketones 
 
Nitrite 
 
pH 
Occult 
Blood 
Specific 
Gravity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
… 
ddMMMyyyy 
(xx) 
HH:MM 
Result 
Result 
Result 
Result 
Result 
Result 
x.x CS, H/L 
Result 
x.x CS, H/L 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=clinically significant; H=high; L=low; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
Note: H = high; L = low is displayed if result is outside the reference range 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.8.4 
Urine/Serum Pregnancy Test 
 
 
Segment Cohort[1] 
Patient 
ID 
Visit 
Collection Date 
(Study Day[2]) 
Collection 
Time 
 
Result 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
Screening 
… 
ddMMMyyyy (xx) 
HH:MM 
Positive / 
Negative / 
N/A 
 
 
… 
 
 
 
 
Abbreviations: N/A=not applicable; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.1 
Vital Signs 
 
 
 
Segment Cohort[1] 
 
 
Patient ID Visit 
 
Visit Date 
 (Study Day[2]) 
Systolic Blood 
Pressure 
(mmHg) 
Diastolic Blood 
Pressure 
(mmHg) 
Respiratory 
Rate 
(breaths/min) 
 
Temperature 
(°C) 
 
Heart Rate  
(bpm) 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
Screening 
… 
ddMMMyyyy (xx) 
xxx 
xxx  
xxx 
xx.x 
xxx 
 
 
 
 
 
 
 
 
 
Abbreviations: BMI=body mass index; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.2 
ECOG Perfomance Status 
 
 
Segment Cohort[1] 
 
Patient ID 
Date of ECOG 
(Study Day[2]) 
ECOG Performance Status 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
ddMMMyyyy (xx) / 
Not Done 
0 – Fully active, able to carry on all pre-disease activities without restriction / 
1 – Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, 
light housework or office work / 
2 – Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of 
waking hours / 
3 – Capable of only limited self-care, confined to bed or chair more than 50% of waking hours / 
4 – Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair / 
5 - Dead 
 
 
Abbreviations: ECOG=Eastern Cooperative Oncology Group; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.3 
Physical Examination 
 
Segment Cohort[1] 
Patient ID Visit 
Assessment Date 
 (Study Day[2]) 
Body System 
Condition 
Clinically 
Significant 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
 
 
 
 
Screening 
ddMMMyyyy (xx) / 
Not Done 
General Appearance / 
HEENT / 
Hematologic/Lymphatic /  
Respiratory / 
Cardiovascular / 
Gastrointestinal / 
Musculoskeletal/Extremity / 
Psychiatric / 
Neurological / 
Urogenital / 
Dermatological / 
Other: Specify 
Normal / 
Abnormal: Description of abnormalities / 
Not Done: Specify 
Yes / 
No 
… 
 
 
 
Abbreviations: HEENT=head, eyes, ears, nose and throat; N/A=not applicable; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
[3] Only collected during the brief physical examination collected at all visits after screening 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
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Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.4 
12-Lead Electrocardiogram 
 
 
 
Segment Cohort[1] 
 
 
Patient ID Visit 
 
Date of ECG 
(Study Day[2]) 
 
Time of 
ECG 
PR 
Interval 
(msec) 
QRS 
Duration 
(msec) 
QT 
Interval 
(msec) 
RR 
Interval 
(msec) 
Heart 
Rate 
(bpm) 
QTCF 
Interval 
(msec) 
QTCB 
Interval 
(msec) Overall Interpretation 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx Screening 
ddMMMyyyy 
(xx) / 
Not Done 
HH:MM 
xx 
xx 
xx 
xx 
xx 
xx 
xx 
Normal / 
Abnormal, NCS: Specify /  
Abnormal, CS: Specify 
… 
 
 
 
 
 
 
 
 
Abbreviations: CS=clinically significant; ECG=electrocardiogram; NCS=not clinically significant; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; QTc=corrected QT 
interval 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 187 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.5 
Prior and Concomitant Medications 
 
 
 
Segment Cohort[1] 
 
Patient 
ID 
ATC Class[2] / 
 Generic Drug Name[2] / 
   Medication Name 
 
 
Phase[3] 
 
Start Date 
(Study Day[4]) 
 
End Date 
(Study Day[4]) 
Dose 
Unit 
Route 
Frequency Indication 
 
 
 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
ATC Class / 
 Generic Drug Name / 
   Medication Name 
P / 
C / 
P, C 
ddMMMyyyy 
(xx) 
ddMMMyyyy 
(xx) / 
Ongoing 
Dose 
Unit 
Route 
Frequency Medical History: specify / 
Adverse Event: specify /  
Prophylaxis / 
Other: Specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ATC, anatomic therapeutic chemical; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma; WHODDE, World Health Organization Drug Dictionary 
Enhanced 
 
Note: Concomitant medications are those medications received after the first dose of study treatment. 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Medications are coded to ATC class (level 4) and drug names using the WHODDE, March 1, 2014 Version. 
[3] The study phase during which each medication was received. P = prior (ie, received prior to the first dose of study drug); C = concomitant (ie, received on or after the first dose of study drug); P, C = 
both prior and concomitant 
[4] Time (days) relative to date of first dose of CORT125134 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note:  
 
If specifications for indications are reported as an AE or MH #, merge with AE/MH data to present the actual reported event as the specification. 
 
When creating ATC level 4 drug class, utilize level 3 term if level 4 is missing in dataset and level 2 if both level 3 and level 4 are missing in the dataset 
 


Corcept Therapeutics 
Statistical Analysis Plan
CORT125134-550 
 
Version 1.0; 14 October 2019
 
 
Confidential 
Page 188 of 188
 
Corcept Therapeutics  
Database Date/Analysis: DDMMMYYYY/Draft
CORT125134-550 
 
Page x of y
Listing 16.2.9.6 
Granulocyte Colony-Simulating Factor 
 
 
 
Segment Cohort[1] 
 
Patient 
ID 
 
 
Cycle # 
ATC Class[2] / 
 Generic Drug Name[2] / 
   Medication Name 
 
Start Date 
(Study Day[3]) 
 
End Date 
(Study Day[3]) 
Granulocyte  
Colony-Stimulating 
Factor 
Reason for Taking Growth Factor 
 
 
 
 
 
 
 
 
1 
 
 
 
 
 
 
 
 
2 
100/60 PDAC / 
100/80 PDAC / 
150/80 PDAC / 
100/60 OVCA / 
100/80 OVCA / 
150/80 OVCA / 
100/60 OT / 
100/80 OT / 
150/80 OT  
150/80 PDAC / 
200/100 PDAC / 
150/80 OVCA / 
200/100 OVCA / 
150/80 OT / 
200/100 OT 
xxx-xxxx 
x 
ATC Class / 
 Generic Drug Name / 
   Medication Name 
ddMMMyyyy (xx) 
ddMMMyyyy (xx) 
Factor 
Prophylactic (high risk such as 
elderly) / 
Nadir / Low ANC / 
Febrile neutropenia / 
Infection / 
Other: specify 
 
 
 
 
 
 
 
 
Abbreviations: ATC, anatomic therapeutic chemical; OT=other tumor; OVCA=ovarian tumor; PDAC=pancreatic ductal adenocarcinoma 
 
[1] PDAC includes all pancreatic cancer patients excluding acinar subtype. OVCA includes all ovarian cancer patients excluding juvenile granulosa subtype. OT includes all patients not included in PDAC 
and ovarian cancer groups. Dose levels represent: CORT125134 Dose (mg) / Nab-paclitaxel Dose (mg/m2). 
[2] Medications are coded to ATC class (level 4) and drug names using the WHODDE, March 1, 2014 Version. 
[3] Time (days) relative to date of first dose of study treatment 
 
Path\filename.sas ddmmmyyyy hh:mm 
 
Programming Note:  
 
When creating ATC level 4 drug class, utilize level 3 term if level 4 is missing in dataset and level 2 if both level 3 and level 4 are missing in the dataset 
 


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