Clinical trial NCT04329949
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Cancer mPDAC Metastatic Pancreatic Ductal Adenocarcinoma Glucocorticoid Receptor Nab-paclitaxel GR Antagonist Relacorilant Abraxane
Sponsor: Corcept Therapeutics
Start date: 2020-06-30; Completion date: 2022-03-25
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.

Detailed description:
Relacorilant is a small-molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of metastatic pancreatic ductal adenocarcinoma.

Eligible patients are those with mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.

Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment.

Arms: arm 1: Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
Interventions: intervention 1: Relacorilant, 100 mg and 25 mg intervention 2: Nab-paclitaxel
Intervention descriptions: intervention 1: Relacorilant is supplied as capsules for oral dosing. intervention 2: Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Protocol documents:
Prot_000.pdf: 
Title: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with 
Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT) 
 
NCT Number: NCT04329949 
 
Date: 20 January 2020 






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PROTOCOL SYNOPSIS 
Name of Sponsor 
Corcept Therapeutics  
Name of Active Ingredient 
Relacorilant (CORT125134) 
Study Number 
CORT125134-553 
Title of Study  
A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel in Patients with Metastatic 
Pancreatic Ductal Adenocarcinoma (RELIANT) 
Study Centers  
Approximately 30 centers in the United States. 
Phase of Development 
Phase 3 
Study Objectives 
All study objectives apply to patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) 
treated with relacorilant in combination with nab-paclitaxel.  
Primary 
• To evaluate the objective response rate (ORR), defined as the percentage of patients with 
measurable disease at baseline who achieve confirmed complete response (CR) or partial 
response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, according to 
blinded independent central review (BICR)  
Secondary 
Efficacy 
• To evaluate the ORR per RECIST v1.1, as assessed by the Investigator 
• To evaluate best overall response per RECIST v1.1 
• To evaluate the duration of response (DOR), as assessed by the Investigator and BICR 
• To evaluate disease control rate (DCR) (CR, PR, or stable disease) at 18 weeks, as assessed by 
the Investigator 
• To evaluate progression-free survival (PFS), as assessed by the Investigator 
• To evaluate overall survival (OS) 
• To evaluate PFS rate at 3, 6, and 12 months 
• To evaluate OS rate at 3, 6, and 12 months 
• To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks, in patients who have 
elevated CA19-9 at baseline 
• To assess tumor response based on changes in fluorodeoxyglucose-positron emission 
tomography (FDG-PET) scan from baseline (screening) to 6 weeks per European Organization 
for Research and Treatment of Cancer (EORTC) criteria, according to BICR 
• To evaluate the time to progression (TTP). The duration of disease control on prior 
nab-paclitaxel therapy (if applicable) and on the most recent therapy will also be described. 
Safety 
• To characterize the exposure-toxicity of relacorilant in combination with nab-paclitaxel 
• To assess the safety and tolerability of relacorilant in combination with nab-paclitaxel 
Pharmacokinetics 
• To assess the pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel 


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Population 
Eligible patients are those with metastatic pancreatic adenocarcinoma (mPDAC) who have received at 
least 2 prior lines of therapy for pancreatic ductal adenocarcinoma (PDAC) in any setting, including at 
least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy. 
Number of Patients Planned 
Approximately 80 patients will be enrolled in the study. 
Methodology 
This is a Phase 3, single-arm, open-label, multicenter study to assess the safety and effectiveness of 
relacorilant in combination with nab-paclitaxel in patients with mPDAC.  
The study consists of the following study periods: 
• Screening Period: Within 21 days prior to the first dose of relacorilant. 
• Treatment Period: Both relacorilant and nab-paclitaxel will be administered during the 
Treatment Period, starting on Cycle 1 Day 1 and continuing until disease progression, 
unacceptable toxicity, or other treatment discontinuation criteria are met. Relacorilant (starting 
dose, 100 mg) will be taken once daily and nab-paclitaxel 80 mg/m2 will be administered on 
Days 1, 8, and 15 of each 28-day cycle. All patients, with exception of patients with absolute 
neutrophil count >10,000/mm3, will receive prophylactic G-CSF to reduce the risk of 
neutropenia starting 1 day after each nab-paclitaxel infusion. A minimum of 2 doses of G-CSF 
(filgrastim [5 µg/kg/day]) is recommended.  
• Safety Follow-Up Period: Patients will return for a Post-Treatment Follow-Up Visit 
approximately 30 days after the patient’s final dose of study treatment. Patients who discontinue 
treatment prior to disease progression will continue radiographic tumor assessments per the 
Schedule of Assessments (every 6 to 8 weeks) until unequivocal disease progression. 
• Long-Term Survival Follow-Up Period: All patients will be followed every 3 months after the 
end of treatment, to document dates of and response to subsequent treatments, and for survival.  
Radiographic tumor assessments will be conducted using computed tomography (CT) with contrast of 
the chest, abdomen, and pelvis using standard multiphasic (pancreas) CT imaging protocol guidelines. 
Magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis is acceptable, with Medical 
Monitor approval, if CT with contrast cannot be done. The same method should be used for each 
assessment for a particular patient. Prior to initiating therapy, a baseline tumor scan is required within 
21 days prior to the first dose of relacorilant. Subsequent CT/MRI scans will be obtained every 6 weeks 
(±7 days) from Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent CT/MRI scans will then be 
obtained every 8 weeks (±7 days). CT/MRI scans will continue per this schedule until unequivocal 
disease progression is documented, including in patients who prematurely discontinue therapy. Tumor 
response will be assessed by BICR, and by the Investigator, using RECIST v1.1. CR and PR will be 
confirmed with a subsequent scan at least 4 weeks from the first response.  
The same images (CT or MRI) acquired for radiographic tumor assessments will undergo additional 
imaging assessments for changes in skeletal muscle mass to determine the presence of sarcopenia.  
A baseline FDG-PET scan will be obtained prior to initiating therapy and a post-baseline FDG-PET 
scan will be obtained 6 weeks (±7 days) from Cycle 1 Day 1. 
Pharmacodynamics/Biomarkers 
Patients will be requested to provide an archival or recent tumor biopsy, if available, for exploratory 
markers relevant to pancreatic cancer or the mechanism of action. Patients will also have the option to 
consent to provide an additional on-study biopsy obtained during a procedure conducted as part of their 
standard of care. Pharmacodynamic markers will include mRNA gene panel (blood and tumor 
expression profiles), cytokines, and other exploratory biomarkers. 


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Pharmacokinetics 
PK will be characterized after dosing with the combination of nab-paclitaxel and relacorilant, on 
Cycle 1 Days 1, 2, and 15. Blood samples will be collected for determination of plasma PK parameters 
of relacorilant and/or its metabolites (CORT125336; CORT125337; CORT125295). Blood samples 
will be also be collected for determination of plasma PK parameters of nab-paclitaxel. 
Patient-Reported Outcomes and Quality of Life 
Baseline patient-reported outcomes (PRO) and quality-of-life (QoL) assessments must be collected 
prior to the first dose of relacorilant. Post-baseline assessments will be collected at the beginning of 
every cycle starting at Cycle 2 Day 1, at the End-of-Treatment Visit, and at the 30-day Post-Treatment 
Follow-Up Visit. 
Duration of Treatment and Duration of Study  
Patients will receive treatment until reaching unequivocal progressive disease (PD) (per RECIST v1.1) 
as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment 
discontinuation criteria are met. All patients will be followed for documentation of disease progression 
and survival information (i.e., date and cause of death) and subsequent treatment information 
(i.e., date/duration of treatment, response, and subsequent PD). Survival follow-up will continue every 
3 months until the endpoint of death, the patient is lost to follow-up, or until 2 years following the final 
dose of study treatment in the final patient enrolled. 
Independent Data Monitoring Committee 
An Independent Data Monitoring Committee (IDMC) will be established to conduct periodic and 
ad hoc medical and/or statistical reviews of available safety data to protect the safety and ethical 
interest of patients and protect the scientific validity of the study. The IDMC will also perform an 
interim assessment of efficacy data after 40 patients have enrolled and completed at least 12 weeks of 
treatment, including the second radiographic tumor assessment, and have at least 1 post-baseline tumor 
assessment with a result other than nonevaluable, or discontinued the study due to disease progression 
or toxicity. Enrollment will be paused such that the interim efficacy assessment can be conducted by 
the IDMC before additional patients are enrolled. 
Key Criteria for Inclusion 
Key Inclusion Criteria 
Each patient must meet the following criteria to be eligible for enrollment into this study: 
1. Have histologically confirmed PDAC with metastatic disease. 
2. Have received at least 2 prior lines of therapy for PDAC in any setting, including at least 
1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.  
3. Have received no more than 4 prior lines of cytotoxic or myelosuppressive therapy for PDAC. 
4. Have a measurable lesion at baseline (within 21 days prior to the first dose of relacorilant) per 
RECIST v1.1, as assessed by the Investigator.  
Note: Standard multiphasic (pancreas) protocols should be used for all radiographic tumor 
assessments. The exact same image acquisition and processing parameters should be used 
throughout the study. 
5. Willingness to provide blood samples and tumor tissue (primary or metastatic) for research 
purposes. 
6. Available assessments of CA19-9 (or carcinoembryonic antigen [CEA] and cancer antigen 125 
[CA-125] in non-CA19-9 elevated tumors) within 14 days prior to first dose of relacorilant. 
7. Karnofsky performance status (KPS) score of ≥70. Two observers are required to assess KPS. 
If discrepant, the one with the lowest assessment will be considered true. 
8. Any significant or symptomatic amounts of ascites have been drained prior to enrollment.  


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9. Have adequate gastrointestinal absorption. If the patient has undergone gastric bypass surgery 
and/or surgery of gastrointestinal or hepatobiliary tract, the patient must demonstrate adequate 
absorption as evidenced by albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if present), 
and lack of evidence of malabsorption.  
10. Have adequate organ and marrow function meeting the following criteria: 
a. Absolute neutrophil count ≥1,500 cells/mm3 
b. Platelet count ≥100,000/mm3 
c. Hemoglobin ≥9 g/dL 
d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper 
limit of normal (ULN) (or ≤4 × ULN in patients with liver metastases) 
e. Total bilirubin ≤1.5 × ULN 
f. Creatinine clearance (measured or estimated) >45 mL/min/1.73m2  
g. Albumin ≥3 g/dL (≥30 g/L) 
Key Exclusion Criteria 
Patients who meet any of the following criteria will not be eligible to participate in the study: 
1. Have pancreatic neuroendocrine tumors, lymphoma of the pancreas, acinar pancreatic cancer, 
or ampullary cancer.  
2. Have known untreated parenchymal brain metastasis or have uncontrolled central nervous 
system metastases. Patients with treated and controlled brain metastases must not require 
steroids and must be neurologically stable without corticosteroids for a minimum of 3 weeks 
prior to Cycle 1 Day 1 to be eligible.  
3. Have a 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 enrollment, 
including peripheral neuropathy that is ongoing and greater than Grade 1 in severity, according 
to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
v5.0.  
4. Have taken the following medications prior to enrollment: 
a. An investigational product, cytotoxic chemotherapy or targeted agent within 14 days. 
b. Radiotherapy within 21 days. 
c. Palliative radiotherapy within 1 week of Cycle 1 Day 1, or if toxicities from 
radiotherapy are Grade 2 or higher in severity or have not returned to baseline. If 
palliative radiation therapy included the pelvis, a minimum of 3 weeks is required 
between palliative radiotherapy and the first dose of study treatment. 
d. Systemic or prescription strength topical corticosteroids for the purposes of treating a 
chronic nononcologic indication within 21 days.  
5. Have a requirement for treatment with chronic or frequently used oral or inhaled 
corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, asthma, or 
immunosuppression after organ transplantation). 
6. Have had any major surgery within 21 days prior to enrollment. 
7. Have had endoscopic retrograde cholangiopancreatography with persistence of any of the 
following: 
a. Bilirubin ≥1.5 × ULN 
b. Amylase >2 × ULN and abdominal pain or amylase >3 × ULN (with or without 
symptoms) 
c. Fever or signs of infection 
d. Decreasing hemoglobin or signs of blood loss 
8. Have a rapid decline in KPS or serum albumin (≥20%), or have progressive pain symptoms 
indicative of rapid clinical deterioration in the opinion of the Investigator, prior to enrollment. 
These patients will become ineligible if rapid decline is observed during the Screening Period. 


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Study Treatment, Dose, and Mode of Administration 
Study treatment consists of the investigational product, relacorilant, in combination with nab-paclitaxel. 
Investigational product (Relacorilant): 100-mg or 25-mg softgel capsules.  
Relacorilant 100 mg is to be administered orally once daily in the morning, each day. After the first 
cycle, patients who tolerate their current dose of relacorilant will have their relacorilant dose increased 
in 25-mg increments to a maximum dose of 150 mg once daily. 
Patients should be encouraged to take relacorilant with food and room temperature water.  
Nab-paclitaxel (Abraxane®): Nab-paclitaxel 80 mg/m2 is to be administered via intravenous infusion 
over 30 minutes (±5 minutes) on Days 1, 8, and 15 of each 28-day cycle. 
Reference Product, Dose, and Mode of Administration 
Not applicable. 
Key Criteria for Evaluation 
Primary Endpoint 
Efficacy 
• ORR, defined as the percentage of patients with measurable disease at baseline who achieve 
confirmed CR or PR per RECIST v1.1, according to BICR  
Secondary Endpoints 
Efficacy 
• ORR per RECIST v1.1, according to Investigator assessment 
• Best overall response, defined as the best response recorded from the date of enrollment across 
all time points during study observation period, per RECIST v1.1 according to BICR 
• Best overall response per RECIST v1.1 according to Investigator assessment 
• DOR as measured from the date that the criteria are met for CR or PR until the first date that PD 
is objectively documented and determined by the Investigator  
• DOR as measured from the date that the criteria are met for CR and PR until the first date that 
PD is objectively documented and determined by BICR 
• DCR, defined as the percentage of patients who have achieved CR, PR, or stable disease for 
≥18 weeks, as determined by the Investigator 
• PFS, defined as the time from the date of enrollment to the date the patient experiences 
unequivocal disease progression per RECIST v1.1, as determined by the Investigator, or death 
(all causes of mortality) 
• OS, defined as the time from enrollment until the date of death from any cause 
• PFS rate (proportion of patients who have not progressed) at 3, 6, and 12 months 
• OS rate (proportion of patients surviving) at 3, 6, and 12 months 
• Change in CA19-9 from baseline at 8 weeks and 16 weeks in patients who have elevated 
CA19-9 (CA19-9 >ULN) at baseline 
• CA19-9 response, at 8 weeks and 16 weeks, defined as the percentage of patients with elevated 
CA19-9 at baseline who have ≥50% reduction in CA19-9 
• Tumor response assessed by FDG-PET at 6 weeks per EORTC criteria, according to BICR 
• TTP on study treatment, as determined by the Investigator 
Safety 
• Study drug exposure 
• Exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel 


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• Adverse events (AEs) (including frequency, severity, and relationship to study treatment) and 
deaths 
• Change from baseline in clinical laboratory tests 
• Change from baseline in vital signs (including blood pressure, heart rate) 
• Interpretation of electrocardiogram assessments (normal, abnormal clinically insignificant, or 
abnormal clinically significant) 
• Physical examination findings 
Pharmacokinetics 
• Primary PK parameters of relacorilant and nab-paclitaxel estimated from PK sampling on 
Cycle 1 Days 1, 2, and 15 
Statistical Methods 
Analysis Populations 
• Intent-to-Treat (ITT) Population/Safety Analysis Population: All patients enrolled and treated 
with at least 1 dose of study treatment 
• Evaluable Population: All patients in the ITT Population who have at least one post-baseline 
radiographic tumor assessment available (with results other than nonevaluable) 
• PK Population: All enrolled patients who have PK data collected and available for analysis 
Statistical Analyses 
Analyses of safety and efficacy will focus on estimation of treatment effects via descriptive statistics 
and confidence intervals (CIs). Baseline will be defined as the most recent value prior to the first dose 
of relacorilant. 
Efficacy Analyses 
Response rate endpoints will be summarized by providing the point and interval estimates. Time-to-
event variables will be summarized using Kaplan-Meier estimates and plots. Event probabilities at 
4-, 6-, and 12-month time points and the median time-to-event (if estimable) will be presented.  
The primary analysis of ORR according to BICR will be performed in the ITT Population. ORR will 
also be analyzed in the Evaluable Population. The point estimate and 95% CI will be provided using 
the Clopper-Pearson method. Patients in the ITT Population with no valid post-baseline radiographic 
tumor assessments will be considered nonresponders. 
Secondary endpoints will also be analyzed in the ITT and Evaluable Populations. 
Safety Analyses 
The incidence of treatment-emergent adverse events (TEAEs), defined as AEs occurring after the first 
dose of study treatment through 30 days after the final dose of study treatment, will be summarized 
using Medical Dictionary for Regulatory Activities (MedDRA) by system organ class and preferred 
term. TEAEs will be further summarized by severity and relationship to study treatment.  
Tabular summaries will be created for TEAEs, TEAEs leading to discontinuation of study treatment 
(i.e., relacorilant or nab-paclitaxel), TEAEs leading to dose reduction or interruption, Grade ≥3 TEAEs, 
and serious AEs. A by-patient listing of AEs will also be created. 
All deaths and causes of deaths will be summarized and listed.  
Pharmacokinetic Analyses 
PK parameters of nab-paclitaxel and relacorilant and its metabolites will be calculated, and analyte 
concentration versus time plots will be provided. PK analyses will be performed on the PK Population. 


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Pharmacodynamic Analyses 
Pharmacodynamic parameters and biomarker results will be listed and summarized using descriptive 
statistics, as appropriate. 
Patient-Reported Outcomes and Quality of Life 
Data collected using the PRO instruments and QoL assessments will be listed and summarized using 
descriptive statistics. 
Sample Size 
In this single-arm, estimation study, the efficacy analysis will include the calculation of a 95% CI 
around the ORR point estimate in the ITT Population. The lower bound of the 95% CI for ORR will be 
evaluated to exclude <5%. In addition to evaluating the point and interval estimate around the ORR, the 
efficacy in this study will be evaluated by examining the DOR, as well the DCR, of at least 18 weeks. 
A total of 80 patients in the ITT Population are expected in this study to provide sufficient precision for 
the interval estimates for the ORR.  


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CONTENTS 
CLINICAL STUDY PROTOCOL CORT125134-553 .................................................................. 1 
SPONSOR SIGNATURE PAGE ................................................................................................... 2 
PROTOCOL SYNOPSIS................................................................................................................ 3 
CONTENTS .................................................................................................................................. 10 
List of Tables ................................................................................................................................ 16 
List of Figures ............................................................................................................................... 17 
LIST OF ABBREVIATIONS AND DEFINITIONS ................................................................... 18 
1 
INTRODUCTION: BACKGROUND INFORMATION AND 
SCIENTIFIC RATIONALE ............................................................................................. 21 
1.1 
Pancreatic Cancer .............................................................................................................. 21 
1.1.1 Therapeutic Hypothesis ........................................................................................ 22 
1.2 
Relacorilant ....................................................................................................................... 22 
1.2.1 Nonclinical Summary ........................................................................................... 22 
1.2.1.1 In Vitro Pharmacology ........................................................................... 23 
1.2.1.2 In Vivo Studies ...................................................................................... 23 
1.2.2 Clinical Summary ................................................................................................. 24 
1.2.2.1 Efficacy .................................................................................................. 25 
1.2.2.2 Safety ..................................................................................................... 25 
1.3 
Nab-Paclitaxel ................................................................................................................... 26 
1.4 
Rationale for Study Design and Dose Regimen ............................................................... 27 
1.4.1 Differences Statement ........................................................................................... 27 
1.4.2 Rationale for Study Design ................................................................................... 27 
1.4.3 Rationale for Dose Selection ................................................................................ 28 
1.4.4 Rationale for Dose Regimen ................................................................................. 28 
1.5 
Benefits and Risks............................................................................................................. 30 
2 
STUDY OBJECTIVES ..................................................................................................... 31 
2.1 
Primary Objective ............................................................................................................. 31 
2.2 
Secondary Objectives ........................................................................................................ 31 
2.2.1 Efficacy Objectives ............................................................................................... 31 
2.2.2 Safety Objectives .................................................................................................. 31 


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2.2.3 Pharmacokinetic Objectives .................................................................................. 31 
2.3 
Exploratory Objectives ..................................................................................................... 31 
2.3.1 Pharmacodynamics/Biomarkers Objective ........................................................... 32 
2.3.2 Patient-Reported Outcomes/Quality-of-Life Objective ........................................ 32 
3 
STUDY DESIGN.............................................................................................................. 33 
3.1 
Overall Design .................................................................................................................. 33 
3.2 
Study Endpoints ................................................................................................................ 35 
3.2.1 Primary Efficacy Endpoint ................................................................................... 35 
3.2.2 Secondary Endpoints ............................................................................................ 35 
3.2.2.1 Secondary Efficacy Endpoints ............................................................... 35 
3.2.2.2 Safety Endpoints .................................................................................... 36 
3.2.2.3 Pharmacokinetic Endpoints ................................................................... 36 
3.2.3 Exploratory Endpoints .......................................................................................... 36 
3.2.3.1 Exploratory Efficacy Endpoints ............................................................. 36 
3.2.3.2 Pharmacodynamic Endpoints................................................................. 36 
3.2.3.3 Patient-Reported Outcomes and Quality-of-Life Endpoints .................. 37 
3.3 
Number of Patients and Study Participation ..................................................................... 37 
3.3.1 Number of Patients ............................................................................................... 37 
3.3.2 Patient Study Completion ..................................................................................... 37 
3.4 
Definitions: Enrollment, End of Treatment, End of Study, and Study Duration .............. 37 
3.4.1 Enrollment............................................................................................................. 37 
3.4.2 End of Treatment .................................................................................................. 37 
3.4.3 End of Study ......................................................................................................... 38 
3.4.4 Study Duration ...................................................................................................... 38 
3.5 
Study Termination by Sponsor ......................................................................................... 38 
3.6 
Independent Data Monitoring Committee ........................................................................ 38 
3.7 
Imaging Assessments by Blinded Independent Central Review ...................................... 39 
4 
STUDY POPULATION ................................................................................................... 40 
4.1 
Inclusion Criteria .............................................................................................................. 40 
4.2 
Exclusion Criteria ............................................................................................................. 41 
4.3 
Screen Failures .................................................................................................................. 42 


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4.4 
Patient Discontinuation of Treatment or Study Completion/Withdrawal ......................... 43 
4.4.1 Discontinuation of Study Treatment ..................................................................... 43 
4.4.2 Patient Withdrawal from Study/Study Completion .............................................. 44 
4.5 
Replacement of Patients .................................................................................................... 44 
4.6 
Restrictions During Study ................................................................................................. 44 
5 
STUDY TREATMENTS AND MANAGEMENT .......................................................... 45 
5.1 
Relacorilant ....................................................................................................................... 45 
5.1.1 Relacorilant Dose Titration ................................................................................... 46 
5.2 
Nab-Paclitaxel ................................................................................................................... 46 
5.3 
Additional Treatments ...................................................................................................... 47 
5.4 
Dose-Adjustment Criteria ................................................................................................. 47 
5.4.1 Dose Reductions or Delays for Relacorilant ......................................................... 49 
5.4.2 Management of Signs of Excessive Glucocorticoid Receptor Antagonism ......... 50 
5.4.3 Dose Reductions or Delays for Nab-Paclitaxel .................................................... 50 
5.5 
Concomitant Medications and Procedures ........................................................................ 50 
5.5.1 Permitted Concomitant Medications..................................................................... 50 
5.5.2 Permitted Concomitant Therapy Requiring Caution ............................................ 51 
5.5.3 Prohibited Medications ......................................................................................... 52 
5.5.4 Procedures ............................................................................................................. 52 
5.6 
Method of Treatment Assignment and Randomization .................................................... 52 
5.7 
Blinding............................................................................................................................. 52 
5.8 
Dose Diary ........................................................................................................................ 52 
5.9 
Product Accountability and Treatment Compliance ......................................................... 53 
6 
DESCRIPTION OF STUDY ASSESSMENTS AND PROCEDURES AND 
APPROPRIATENESS OF MEASUREMENTS .............................................................. 54 
6.1 
Informed Consent and Screening ...................................................................................... 54 
6.2 
Demographics and Baseline Disease Characteristics ....................................................... 54 
6.3 
Medical and Medication History ...................................................................................... 54 
6.4 
Safety Measures ................................................................................................................ 55 
6.4.1 Physical Examinations .......................................................................................... 55 
6.4.2 Vital Signs ............................................................................................................. 56 


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6.4.3 Height and Weight ................................................................................................ 56 
6.4.4 Pregnancy Test (for Women of Childbearing Potential) ...................................... 56 
6.4.5 Triplicate 12-Lead Electrocardiogram .................................................................. 56 
6.4.6 Adverse Events ..................................................................................................... 56 
6.4.7 Subsequent Anticancer Therapy Status and Survival Follow-Up ......................... 57 
6.4.8 Clinical Laboratory Assessments .......................................................................... 57 
6.4.8.1 Laboratory Parameters ........................................................................... 57 
6.4.8.2 Sample Collection, Preparation, and Shipping ...................................... 59 
6.4.8.3 Blood Volume Summary ....................................................................... 59 
6.5 
Measures of Anticancer Activity ...................................................................................... 59 
6.6 
Exploratory Efficacy Measures ......................................................................................... 60 
6.6.1 Evaluation of Sarcopenia ...................................................................................... 60 
6.6.2 Circulating Tumor Markers .................................................................................. 60 
6.6.3 Karnofsky Performance Status Score ................................................................... 60 
6.7 
Pharmacokinetic Assessments .......................................................................................... 61 
6.8 
Pharmacodynamic/Biomarker Assessments ..................................................................... 61 
6.8.1 Blood Collection for Glucocorticoid-Related Pathways and Exploratory 
Biomarkers ............................................................................................................ 62 
6.8.2 Tumor Biopsy Tissue Collection .......................................................................... 62 
6.9 
Patient-Reported Outcomes and Quality of Life .............................................................. 62 
6.10 
Appropriateness of the Measures ...................................................................................... 62 
7 
STUDY ASSESSMENTS AND PROCEDURES BY STUDY VISIT ............................ 63 
7.1 
Screening (Within 21 days Before the First Dose of Relacorilant) .................................. 63 
7.2 
Cycle 1 Day 1.................................................................................................................... 64 
7.3 
Treatment Period ............................................................................................................... 64 
7.4 
End-of-Treatment Visit ..................................................................................................... 65 
7.5 
30-day Post-Treatment Follow-Up Visit .......................................................................... 65 
7.6 
Long-Term Follow-Up Assessment of Survival ............................................................... 66 
7.7 
Unscheduled Visits ........................................................................................................... 66 
8 
SAFETY EVENT DOCUMENTATION AND REPORTING ........................................ 67 
8.1 
Adverse Event ................................................................................................................... 67 


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8.1.1 Definition .............................................................................................................. 67 
8.1.2 Performing Adverse Events Assessments ............................................................. 67 
8.1.2.1 Adverse Event Follow-Up and Recording ............................................. 68 
8.1.3 Severity ................................................................................................................. 68 
8.1.4 Relationship to Study Treatment .......................................................................... 69 
8.1.5 Expectedness ......................................................................................................... 69 
8.1.6 Clinical Significance ............................................................................................. 70 
8.1.7 Clinical Laboratory Adverse Events ..................................................................... 70 
8.2 
Serious Adverse Events .................................................................................................... 70 
8.2.1 Definition .............................................................................................................. 70 
8.2.2 Reporting Serious Adverse Events ....................................................................... 70 
8.2.2.1 Safety Reporting Contact ....................................................................... 71 
8.2.2.2 Suspected Unexpected Serious Adverse Reactions ............................... 72 
8.3 
Pregnancy .......................................................................................................................... 72 
8.3.1 Maternal Exposure ................................................................................................ 72 
8.3.2 Paternal Exposure ................................................................................................. 72 
8.4 
Treatment of Overdose ..................................................................................................... 72 
8.5 
Emergency Sponsor Contact ............................................................................................. 72 
9 
STATISTICAL METHODS ............................................................................................. 73 
9.1 
Analysis Populations ......................................................................................................... 73 
9.2 
General Statistical Considerations .................................................................................... 73 
9.3 
Hypothesis Testing............................................................................................................ 73 
9.4 
Sample Size Calculation ................................................................................................... 73 
9.5 
Analysis Plan .................................................................................................................... 74 
9.5.1 Patient Disposition ................................................................................................ 74 
9.5.2 Demographic and Baseline Data ........................................................................... 74 
9.5.3 Prior and Concomitant Medications ..................................................................... 74 
9.5.4 Efficacy Analyses ................................................................................................. 75 
9.5.4.1 Analysis of Primary Efficacy Endpoint ................................................. 75 
9.5.4.2 Analysis of Secondary Efficacy Endpoints ............................................ 75 
9.5.4.3 Analysis of Exploratory Endpoints ........................................................ 76 


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9.5.5 Safety Analyses ..................................................................................................... 77 
9.5.6 Pharmacokinetic Analysis ..................................................................................... 77 
9.5.7 Pharmacodynamic Analysis .................................................................................. 78 
9.5.8 Patient-Reported Outcomes and Quality of Life .................................................. 78 
9.5.9 Interim Analysis .................................................................................................... 78 
10 
ETHICAL AND LEGAL CONSIDERATIONS .............................................................. 80 
10.1 
Compliance with Investigational Review Board Regulations .......................................... 80 
10.2 
Ethical Conduct of the Study ............................................................................................ 80 
10.3 
Protection of Human Patients ........................................................................................... 80 
10.3.1 Compliance with Informed Consent Regulations ................................................. 80 
10.3.2 Patient Confidentiality .......................................................................................... 81 
10.3.3 Patient Privacy ...................................................................................................... 81 
11 
ADMINISTRATIVE CONSIDERATIONS ..................................................................... 82 
11.1 
Study Monitoring .............................................................................................................. 82 
11.2 
Quality Management ......................................................................................................... 82 
11.3 
Documentation .................................................................................................................. 83 
11.3.1 Electronic Case Report Forms and Study Records ............................................... 83 
11.3.2 Access to Source Documentation ......................................................................... 83 
11.3.3 Source Documents ................................................................................................ 83 
11.3.4 Study Files and Retention of Study Records ........................................................ 83 
11.4 
Sample Collection, Preparation, and Shipping ................................................................. 84 
11.5 
Long-Term Retention of Biological Samples ................................................................... 84 
11.6 
Clinical Supplies ............................................................................................................... 84 
11.6.1 Inventory, Reconciliation, Return, and Disposition of Clinical Supplies ............. 84 
11.6.2 Clinical Supply Inventory ..................................................................................... 84 
11.6.3 Return or Disposal of Study Drug and/or Supplies .............................................. 85 
11.7 
Drug Accountability.......................................................................................................... 85 
11.8 
Post-Trial Care .................................................................................................................. 85 
11.9 
Noncompliance with the Protocol ..................................................................................... 85 
11.10 Financial Disclosure .......................................................................................................... 86 


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11.11 Publication and Disclosure Policy .................................................................................... 86 
12 
REFERENCES ................................................................................................................. 87 
APPENDIX A: SCHEDULES OF ASSESSMENTS ................................................................... 90 
APPENDIX B: RESPONSE CRITERIA...................................................................................... 97 
APPENDIX C: GENERAL CHEMOTHERAPY GUIDELINES .............................................. 101 
APPENDIX D: EXAMPLES OF PROHIBITED MEDICATIONS OR MEDICATIONS TO BE 
USED WITH CAUTION ................................................................................................ 102 
APPENDIX E: SUMMARY OF CHANGES............................................................................. 103 
 
List of Tables 
Table 1 
Relacorilant: Formulation, Administration, Packaging, and Storage ....................45 
Table 2 
Nab-Paclitaxel: Formulation, Administration, Packaging, and Storage ................46 
Table 3 
Dose Reductions or Delays Due to Adverse Events ..............................................48 
Table 4 
Relacorilant Dose Level Summary ........................................................................49 
Table 5 
Nab-Paclitaxel Dose Reductions............................................................................50 
Table 6 
Clinical Laboratory Tests .......................................................................................58 
Table 7 
Karnofsky Performance Status Score ....................................................................61 
Table 8 
Adverse Event Grades Based on the National Cancer Institute Common 
Terminology Criteria for Adverse Events ..............................................................69 
Table 9 
Causal Attribution Guidance for Adverse Events ..................................................69 
Table 10 
Definitions of Analysis Populations ......................................................................73 
Table 11 
Two-Sided 95% Confidence Intervals of Objective Response Rates with 
80 Patients in the Intent-to-Treat Population .........................................................74 
Table 12 
Pharmacokinetic Variables for Analysis ................................................................78 
Table 13 
Schedule of Clinical Assessments and Procedures ................................................91 
Table 14 
Pharmacokinetic Schedule of Assessments ...........................................................94 
Table 15 
Pharmacodynamic Schedule of Assessments ........................................................95 
Table 16 
Summary of Changes in Protocol CORT125134-553 Amendment 1 .................104 
 


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List of Figures 
Figure 1 
Effect of Relacorilant in Combination with Paclitaxel in a Pancreatic Cancer 
Xenograft Model (MIAPaCa-2 Model) .................................................................24 
Figure 2 
CORT125134-553 Study Design ...........................................................................34 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
AST 
aspartate aminotransferase 
ATC 
Anatomical-Therapeutic-Chemical 
BICR 
blinded independent central review 
CA-125 
cancer antigen 125 
CA19-9 
cancer antigen 19-9 
CEA 
carcinoembryonic antigen 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cmax 
maximum concentration 
COX2 
cyclooxygenase 2 
CR 
complete response 
CT 
computed tomography 
CYP 
cytochrome P450 
DCR 
disease control rate 
DOR 
duration of response 
DLT 
dose-limiting toxicity 
DUSP1 
dual-specificity phosphatase 1 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EORTC 
European Organization for Research and Treatment of Cancer 
FDG 
fluorodeoxyglucose 
FDG-PET 
fluorodeoxyglucose-positron emission tomography 
FOLFIRINOX 
folinic acid, fluorouracil, irinotecan, and oxaliplatin 
FOLFOX 
folinic acid, fluorouracil, and oxaliplatin 
GC 
glucocorticoid 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony-stimulating factor 
GR 
glucocorticoid receptor 


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Abbreviation 
Definition 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HOMA-IR 
homeostatic model assessment of insulin resistance 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation  
IDMC 
Independent Data Monitoring Committee 
IHC 
immunohistochemistry 
IND 
Investigational New Drug  
INR 
international normalized ratio 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
Ki 
inhibition constant 
KPS 
Karnofsky performance status 
MedDRA 
Medical Dictionary for Regulatory Activities 
mPDAC 
metastatic pancreatic ductal adenocarcinoma 
MRI 
magnetic resonance imaging 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
ORR 
objective response rate 
OS 
overall survival 
PD 
progressive disease 
PDAC 
pancreatic ductal adenocarcinoma 
PD-L1 
programmed death-ligand 1 
PET 
positron emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PR 
partial response 
PRO 
patient-reported outcomes 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
QC 
quality control 
QoL 
quality of life 
RECIST 
Response Evaluation Criteria in Solid Tumors 


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Abbreviation 
Definition 
RSI 
reference safety information 
SAE 
serious AEs 
SAP 
statistical analysis plan 
SD 
standard deviation 
SoA 
Schedule of Assessments 
SOP 
standard operating procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
SUV 
standardized uptake value 
TEAE 
treatment-emergent AEs 
TTP 
time to progression 
ULN 
upper limit of normal 
US 
United States 
WHO 
World Health Organisation 
 


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1 
INTRODUCTION: BACKGROUND INFORMATION AND 
SCIENTIFIC RATIONALE 
Relacorilant (also referred to as CORT125134) is a small molecule competitive antagonist of the 
glucocorticoid receptor (GR) being developed by Corcept Therapeutics (Corcept) for indications 
that may benefit from the modulation and/or antagonism of GR. In preclinical tumor models, GR 
has been demonstrated to be involved in chemotherapy resistance, 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). Thus, as a selective and potent GR antagonist, 
relacorilant 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 Phase 3 study (RELacorilant In Pancreatic Adenocarcinoma with Nab-PacliTaxel 
[RELIANT]) is designed to evaluate the efficacy, safety, pharmacokinetics (PK), and 
pharmacodynamics, of relacorilant in combination with nab-paclitaxel in patients with metastatic 
pancreatic ductal adenocarcinoma (mPDAC). Patients must have histologically confirmed 
pancreatic ductal adenocarcinoma (PDAC) to participate.  
1.1 
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. Approximately 56,770 people are expected to be 
diagnosed with pancreatic cancer in the United States (US) and more than 45,750 are expected to 
die from the disease in 2019 (ACS 2019). Worldwide, pancreatic cancer is the seventh leading 
cause of cancer death in both males and females; there were approximately 459,000 new cases 
of pancreatic cancer in 2018 and approximately 432,000 deaths due to the disease 
(Bray et al. 2018).  
Typically, patients present with a later stage of cancer when a surgical cure is no longer an 
option. The 5-year relative survival rate for patients with pancreatic cancer is 8.5%, and among 
patients with metastatic disease the 5-year survival rate is only 2.7% (ACS 2019). Pancreatic 
cancer is one of the few tumor types for which survival has not improved substantially in more 
than 40 years (ACS 2019), demonstrating a critical unmet medical need in this area. Over the 
past decade, first-line treatment for mPDAC has shifted from gemcitabine monotherapy toward 
combination therapy with folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) 
or gemcitabine combined with nab-paclitaxel. A large proportion of patients (56%) with mPDAC 
proceed to receive second-line chemotherapy with a wider spread of regimens used consisting of 
either FOLFOX (folinic acid, fluorouracil, and oxaliplatin), gemcitabine monotherapy, 
gemcitabine + nab-paclitaxel, FOLFIRINOX, or capecitabine (Abrams et al. 2017). Once first- 
and second-line treatments are exhausted for patients with advanced pancreatic cancer, options 
are limited and patients often move to palliation and pain control. The median overall survival 
(OS) for second-line therapies range from 3.3 to 8.8 months (Portal et al. 2015), with only 
22% of patients with metastatic pancreatic cancer receiving third-line chemotherapy 
(Abrams et al. 2017).  
Study CORT125134-553 is the first study designed to evaluate the efficacy of relacorilant and 
nab-paclitaxel in patients with third-line or greater PDAC with metastatic disease. The primary 


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efficacy endpoint is objective response rate (ORR). Historical data in studies of third-line 
therapies for mPDAC are limited but suggest an ORR approaching 0% (Wang-Gillam et 
al. 2019, Le et al. 2019, Macarulla et al. 2017). Similarly, a retrospective review carried out in 
patients with pancreatic adenocarcinoma who received nab-paclitaxel monotherapy after 
experiencing disease progression on standard treatments yielded an ORR of 0% (0 out of 17 
patients achieved a complete response [CR] or partial response [PR]) (Peddi et al. 2013). 
Another study evaluated nab-paclitaxel in patients who received a gemcitabine-based regimen 
(inclusive of patients on second-line therapy); in this study, an ORR of 5% was observed (1 PR 
was reported out of 19 patients treated) (Hosein et al. 2013). In the current study, based on the 
low historical ORRs observed in patients with mPDAC treated with a third-line therapy, the 
lower bound of the 95% confidence interval (CI) for ORR will be evaluated to exclude 10% 
(Section 9.4). 
1.1.1 Therapeutic Hypothesis 
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 to 280 using a validated immunohistochemistry (IHC) assay for 
GR (Block et al. 2017), demonstrating a significant GR expression in the tumor samples studied. 
High rates of GR expression have been shown in several solid tumor types including pancreatic, 
ovarian, and triple-negative breast cancer (Block et al. 2017) and there is evidence that 
dysregulation of cortisol may have implications for disease progression (Weinrib et al. 2010). 
Excess tumor expression of GR could contribute to chemotherapy resistance. In preclinical 
models, stimulation of GR has been shown to reduce chemotherapy sensitivity and blockade of 
GR has been shown to enhance chemotherapy sensitivity (Skor et al. 2013, Isikbay et al. 2014). 
As a selective and potent GR antagonist, relacorilant has the potential to provide a clinical 
benefit in oncologic indications in combination with appropriate chemotherapeutic agents by 
reversing GR-mediated chemotherapy resistance and potentially restoring tumor sensitivity to the 
chemotherapeutic agent. A Phase 1/2 study evaluating the combination of relacorilant and 
nab-paclitaxel in patients with solid tumors is ongoing (CORT125134-550). This is the first 
study designed to evaluate the efficacy of relacorilant and nab-paclitaxel in patients with 
mPDAC after 2 or more prior lines of therapy. 
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 pancreatic 
cancer. The data therefore support the planned evaluation of the combination of relacorilant and 
nab-paclitaxel in this indication. 
1.2 
Relacorilant 
This section briefly summarizes nonclinical and clinical information on relacorilant. Further 
details are provided in the relacorilant Investigator’s Brochure (IB). 
1.2.1 Nonclinical Summary 
Nonclinical 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 


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chemotherapy that would otherwise induce cell death via apoptosis. This mechanism of 
chemotherapy resistance has been demonstrated with the GR agonist dexamethasone and is 
reproducible across several tumor cell line models (Zhang et al. 2006, Stringer-Reasor et al. 
2015). Furthermore, several in vitro xenograft studies have shown that the addition of 
GR antagonists to a tumor cell line treated with chemotherapeutic agents, including taxanes, 
enhances the effects of chemotherapy.  
1.2.1.1 
In Vitro Pharmacology 
Functional GR antagonism was demonstrated in vitro by the ability of relacorilant to block the 
effects of dexamethasone (a potent GR agonist) on tyrosine aminotransferase activity in human 
liver-carcinoma (HepG2) and rat hepatoma cell lines (inhibition constants [Ki] 7.2 nM and 
1.2 nM, respectively) and in primary hepatocytes from rats, monkeys, mini pigs, and humans. In 
the human HepG2 tyrosine aminotransferase (TAT) assay, the metabolite, CORT125201, has 
similar activity to relacorilant. The metabolite, CORT125295, has some activity. CORT125336 
and CORT125337 (previously referred to as CORT125134-M2 and CORT125134-M4, 
respectively) exhibit modest potency. 
Relacorilant has high selectivity for the GR, but no significant affinity for the estrogen receptor 
or the androgen receptor, showing 100%, −1%, and 6% inhibition, respectively, in radioligand 
binding assays at a 1 μM concentration. In contrast to the GR antagonist mifepristone, 
relacorilant has considerably greater selectivity for GR over the progesterone receptor, producing 
only 7% displacement of labeled promegestone at a concentration of 1 μM (relacorilant 
Ki >10 μM, mifepristone Ki = 1.2 nM) in a progesterone receptor ligand binding assay 
(Cerep Report 100011862). The selectivity of relacorilant for GR compared with the 
mineralocorticoid receptor was determined in protein-protein interaction assays. In the GR assay, 
relacorilant had a Ki of 15 nM, whereas in the analogous mineralocorticoid receptor assay, 
relacorilant showed no activity at a concentration of 10 μM. A metabolite of relacorilant, 
CORT125295, is also a selective GR antagonist with no significant affinity for the progesterone 
or androgen receptor (Cerep Report 100043245).  
In safety pharmacology assessments, no remarkable central nervous or respiratory effects were 
seen in rats or cardiovascular system effects in monkeys at the highest oral dose tested 
(200 mg/kg relacorilant). In radioligand binding assays, a 1 μM concentration of relacorilant did 
not produce significant (<50%) inhibition of radioligand binding at 77 of 78 receptors and 
channels in a panel that included the alpha- and beta-adrenergic, cannabinoid, dopaminergic, 
gamma-aminobutyric acid, histamine, endothelin, melatonin, leukotriene, cholinergic, opioid, 
and serotonergic receptors, as well as the transporters for norepinephrine, dopamine, and 
serotonin. A 1 μM concentration of relacorilant produced 58% inhibition at the 
cholecystokinin 1 receptor (Cerep Report 100011862). The metabolite CORT125295 has also 
been tested against a diverse panel of receptors, enzymes and channels and no issues were noted 
(Cerep Report 100032245). 
1.2.1.2 
In Vivo Studies 
In a rat model of cortisone-induced insulin resistance, relacorilant reduced glucose and insulin 
levels when administered orally at doses of 30 mg/kg and 7.5 mg/kg twice daily. Relacorilant in 




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Available efficacy and safety data from Study CORT125134-550 are briefly summarized below. 
While preliminary safety data from Study CORT125134-552 are provided, to date, no efficacy 
analyses have been performed for Study CORT125134-552. 
1.2.2.1 
Efficacy 
Patients in Study CORT125134-550 have been treated with relacorilant doses of 100 mg to 
150 mg with a continuous regimen and 150 mg to 200 mg with an intermittent regimen. All 
treatment regimens included relacorilant in combination with nab-paclitaxel (60 mg/m2 to 
100 mg/m2). 
Preliminary efficacy results were reported in Munster et al. 2019. Data summarized in this 
section are reflective of the efficacy data from this ongoing study as of the data cutoff 
(01 June 2019) date. Final efficacy analyses will be performed when the study is complete.  
Of the 25 patients with PDAC who were evaluable for response, 3 patients had a PR 
(2 confirmed, 1 unconfirmed) and 10 patients had stable disease. Disease control (stable disease 
or better) of 16 weeks or more was observed in 7 patients (28% disease control rate [DCR]). Of 
the 13 patients with ovarian, primary peritoneal, or fallopian tube cancer who were evaluable for 
response, 1 patient had confirmed CR, 2 patients had a PR (1 confirmed, 1 unconfirmed), and 6 
patients had stable disease. Disease control of 16 weeks or more was observed in 5 patients (38% 
disease control rate). In addition, confirmed responses were observed in the following tumor 
types: human papillomavirus-positive vulvar squamous cell cancer (n=1); cholangiocarcinoma, 
(n=1); and acinar pancreatic cancer (n=1). 
In both populations (PDAC and ovarian, primary peritoneal, or fallopian tube cancer), time to 
progression (TTP) was often several-fold longer than previously achieved on taxane therapy and 
GR-specific pharmacodynamic responses were observed, underscoring the contribution of 
relacorilant to disease control. This data is promising and supports further exploration of this 
regimen in patients with PDAC with metastatic disease.  
Study CORT125134-552 is ongoing and no efficacy results are currently available.  
1.2.2.2 
Safety 
Details of all completed and ongoing clinical studies are provided in the IB.  
As of the data cutoff date (01 June 2019), 69 patients with late-stage cancer have received at 
least 1 dose of relacorilant in Study CORT125134-550. Overall, across all dosing regimens 
studied (Section 1.2.2.1), the most common treatment-emergent adverse events (TEAEs) were 
fatigue (52.2%), nausea (46.4%), vomiting (44.9%), and diarrhea (42.0%), and the most frequent 
TEAEs leading to drug interruption were neutropenia (14.5%), vomiting and fatigue (10.1% 
each). The most common TEAEs considered related to relacorilant occurring in 10% or more of 
the patients were nausea (26.1%), rash and vomiting (24.6% each), fatigue (23.2%) diarrhea 
(21.7%), skin hyperpigmentation (18.8%), neutropenia (14.5%), neuropathy peripheral (14.5%), 
nail disorder (13%), and decreased appetite (11.6%). The most common AE of Grade 3 or higher 
considered related to relacorilant occurring in 10% or more of patients in any treatment group 
was neutropenia (11.6%). In the current study, the risk of neutropenia will be managed with 


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mandatory prophylactic growth factors, monitoring, and nab-paclitaxel dose reduction. Patients 
will receive G-CSF starting 1 day after each nab-paclitaxel infusion (Section 5.3).  
Thirteen patients experienced 1 or more adverse events (AEs) that led to discontinuation of study 
treatment. Fatigue and thrombocytopenia were the most common AEs (reported in 2 patients 
each) that led to discontinuation from study treatment. Thirty-three patients who have received at 
least 1 dose of relacorilant have experienced serious AEs (SAEs). The most common SAEs 
(occurring in 2% or more of patients) included vomiting (5.8%), atrial fibrillation, abdominal 
pain, pulmonary embolism, and disease progression (4.3% each), pleural effusion, respiratory 
failure, febrile neutropenia, neutropenia, pyrexia, colitis, pneumonia, and malignant pleural 
effusion (2.9% each). Overall, 6 of the 69 patients had TEAEs that led to death. Five of the 6 
patients who died succumbed to their underlying cancer as a result of disease progression, 
intestinal blockage, or respiratory failure, and the Investigator considered the deaths to be 
unrelated to the study treatment regimen. One patient, who experienced an SAE of Grade 4 
neutropenia, developed urosepsis and died; in this case, the Investigator assessed the urosepsis as 
the cause of death and both events as possibly related to the combination of relacorilant and nab-
paclitaxel. 
As of 28 August 2019, a total of 6 patients have received study treatment (4 patients with 
relacorilant in combination with nab-paclitaxel; 2 patients with nab-paclitaxel alone) in the 
ongoing Study CORT125134-552 in patients with platinum-resistant or platinum-refractory 
ovarian, primary peritoneal, or fallopian tube cancer. One patient receiving the intermittent 
relacorilant regimen Grade 3 SAEs (acute kidney injury, anemia and abdominal pain) that 
resulted in dose interruption; the outcome of all events was considered recovered/resolved. The 
patient subsequently reported a Grade 3 SAE of wound infection that resulted in discontinuation 
of study treatment. The patient was enrolled in hospice with subsequent death due to PD; the 
events were considered unrelated to relacorilant or nab-paclitaxel by the Investigator and 
Sponsor. Refer to the current version of the relacorilant IB for the safety data for this ongoing 
study. 
1.3 
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 (Horwitz 1994). 
Nab-paclitaxel is indicated for the treatment of metastatic adenocarcinoma of the pancreas as 
first-line treatment in combination with gemcitabine, and is also indicated for metastatic breast 
cancer and non-small cell lung cancer (Abraxane USPI 2018; Abraxane SPC 2019). 
The most common adverse reactions (in at least 20% of patients) associated with nab-paclitaxel 
in pancreatic adenocarcinoma are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, 
peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. 
Warnings and precautions include bone marrow suppression (primarily neutropenia), sensory 
neuropathy, sepsis, pneumonitis, hypersensitivity, use in patients with hepatic impairment, and 


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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 cytochrome P450 (CYP)2C8 and 
CYP3A4. Caution should be exercised when administering nab-paclitaxel concomitantly with 
medicines known to inhibit or induce either CYP2C8 or CYP3A4 (Abraxane USPI 2018). 
1.4 
Rationale for Study Design and Dose Regimen  
This is a Phase 3 open-label single-arm study to evaluate the efficacy, safety, PK, 
pharmacodynamics, and patient-reported outcomes (PRO) and quality of life (QoL) of 
relacorilant in combination with nab-paclitaxel in patients with mPDAC. Patients who have 
received at least 2 prior lines of therapy for PDAC in any setting, including at least 1 prior 
gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy, and have 
metastatic disease are eligible for the study. 
1.4.1 Differences Statement 
This is the first study designed to evaluate the efficacy of relacorilant in combination with nab-
paclitaxel in patients with mPDAC after 2 or more prior lines of therapy. 
1.4.2 Rationale for Study Design 
Some solid tumors develop chemotherapy resistance in part via stimulation or upregulation of 
the GR with subsequent expression of cell survival gene products. Nonclinical and clinical data 
obtained to date (Section 1.2) support the investigation of relacorilant, a selective and potent GR 
antagonist, with nab-paclitaxel in patients with mPDAC.  
The current standard of care for patients with pancreatic cancer for patients with good 
performance status includes 2 lines of treatment, with recommended options including a 
gemcitabine-based regimen (monotherapy or gemcitabine combined with nab-paclitaxel) and a 
fluoropyrimidine-based regimen. Once first- and second-line treatments are exhausted for 
patients with advanced pancreatic cancer, treatment options in the third-line setting are limited 
and patients often move to palliation and pain control. Thus for patients with third-line or greater 
mPDAC, current guidelines recommend best supportive care or referral to a clinical trial 
(Tempero et al. 2017), such as this study.  
Given the lack of therapeutic options in this refractory patient population, the single-arm 
open-label design of this study is considered appropriate.  
To reduce bias, all radiological images will be centrally reviewed by blinded independent central 
review (BICR). The primary efficacy endpoint, ORR, will be based on BICR interpretation of 
the tumor scans per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The ORR 
obtained with relacorilant + nab-paclitaxel will be interpreted within the context of available data 
for historical clinical activity of nab-paclitaxel alone. 
An interim assessment by an Independent Data Monitoring Committee (IDMC) will be 
performed after 40 patients have met the specified outcomes (Section 9.5.9). This interim 
assessment may also inform a protocol amendment to increase the sample size and/or adapt the 


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study design, if needed, based upon the magnitude and duration of treatment effects, to further 
support the development of this treatment combination in patients with mPDAC. 
1.4.3 Rationale for Dose Selection 
The doses of relacorilant 100 mg and nab-paclitaxel 80 mg/m2 have been used in patients with 
pancreatic adenocarcinoma in Study CORT125134-550. Preliminary efficacy data from Study 
CORT125134-550 evaluating nab-paclitaxel in conjunction with relacorilant in patients with 
pancreatic adenocarcinoma support a clinical benefit in this patient population. (Section 1.2.2.1).  
Nab-paclitaxel was selected for combination with relacorilant for the following reasons:  
1. Additional anticancer effect by relacorilant has been reproducibly demonstrated in 
several preclinical models across several tumor cells lines in combination with standard 
chemotherapeutics, including paclitaxel. Tumor response has also been observed in 
patients receiving relacorilant in combination with nab-paclitaxel in the Phase 1 
Study CORT125134-550, including in patients who have previously received taxane 
treatment. This supports the proposed mechanism that GR antagonism will delay or 
reverse chemotherapy resistance.  
2. Taxanes are a widely used and efficacious chemotherapy, with applicability to many 
tumor types.  
3. 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 
resistance.  
1.4.4 Rationale for Dose Regimen 
Relacorilant in combination with nab-paclitaxel has been administered using continuous and 
intermittent dosing regimens to patients with advanced solid tumors in Study CORT125134-550 
and has been well tolerated. In the current study, relacorilant will be administered at 100 mg 
once daily (continuous dosing), with possible increase to a maximum dose of 150 mg once daily 
(Section 5.1.1), based on preliminary efficacy and safety results observed in 
Study CORT125134-550.  
The initial starting dose of nab-paclitaxel in Study CORT125134-550 was 80 mg/m2 when dosed 
with continuous relacorilant (100 mg) to account for the expected CYP3A-mediated drug-drug 
interaction resulting in increased nab-paclitaxel exposure. Overall, the toxicities observed with 
the dosing regimen were largely consistent with those of nab-paclitaxel monotherapy and were 
manageable in a similar fashion to weekly nab-paclitaxel. Across all dose levels and dosing 
regimens, dose-limiting toxicities (DLTs) as defined by Grade 3 or higher toxicities leading to 
greater than 1 week delay of nab-paclitaxel during the first cycle of treatment consisted of 
neutropenia, febrile neutropenia, rash, thrombocytopenia, hand/foot syndrome, peripheral 
neuropathy, colitis, diarrhea, and mucositis, with AEs of neutropenia constituting the majority of 
the DLTs. Due to the DLTs of neutropenia, primary prophylaxis with G-CSF was mandated and 
neutropenia was manageable with this implementation. For the continuous relacorilant schedule, 
the dose regimen selected for further clinical evaluation was relacorilant 100 mg and nab-
paclitaxel 80 mg/m2 (administered on Days 1, 8, and 15 of a 28-day cycle) with G-CSF. Of the 




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1.5 
Benefits and Risks  
Relacorilant is an orally active, high-affinity, potent antagonist of GR with good selectivity for 
GR over other steroid receptors. High rates of GR expression have been shown in several solid 
tumor types including pancreatic adenocarcinoma, and nonclinical and clinical data indicate that 
GR antagonism may play a role in enhancing or restoring chemotherapy sensitivity in the 
treatment of patients with pancreatic adenocarcinoma. Early efficacy signals have been observed 
in the Phase 1/2 study in refractory patients with pancreatic cancer at doses and regimens 
proposed in this study (Munster et al. 2018). 
The current safety profile for the use of relacorilant in combination with nab-paclitaxel is based 
on preliminary data from a Phase 1/2 Study (CORT125134-550) in patients with solid tumors 
(Section 1.2.2.2). For patients receiving combination of relacorilant with nab-paclitaxel, 
neutropenia has been the most common dose-limiting toxicity. The risk of neutropenia will be 
managed in this study with mandatory prophylactic growth factors, monitoring, and dose 
reduction. Mucositis and rash are commonly observed toxicities, and these can be managed with 
topical treatments, including triamcinolone. 
Patients will be closely monitored during the study and standard safety tests will be performed at 
regular intervals. Samples will be collected to determine standard PK parameters for relacorilant 
and/or its metabolites (CORT125336, CORT125337, and CORT125295). Samples will also be 
collected to determine standard PK parameters for nab-paclitaxel. 
Concurrent therapy with strong inhibitors of CYP3A4 or CYP3A5 should be avoided, 
particularly drugs with a narrow therapeutic ratio. Drugs with a narrow therapeutic ratio that are 
highly dependent on CYP3A4 for clearance should be avoided. Caution should be exercised 
when administering nab-paclitaxel concomitantly with medicines known to inhibit or induce 
either CYP2C8 or CYP3A4, consistent with the nab-paclitaxel label. 
See the relacorilant IB for further details on the benefits and risks. 


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2 
STUDY OBJECTIVES 
All study objectives apply to patients with mPDAC treated with relacorilant in combination with 
nab-paclitaxel. 
2.1 
Primary Objective 
• To evaluate the ORR, defined as the percentage of patients with measurable disease at 
baseline who achieve confirmed CR or PR per RECIST v1.1, according to BICR 
2.2 
Secondary Objectives 
2.2.1 Efficacy Objectives 
• To evaluate the ORR per RECIST v1.1, as assessed by the Investigator 
• To evaluate best overall response per RECIST v1.1  
• To evaluate the duration of response (DOR) according to the Investigator and BICR 
• To evaluate DCR (CR, PR, or stable disease) at 18 weeks, as assessed by the Investigator 
• To evaluate progression-free survival (PFS), as assessed by the Investigator 
• To evaluate overall survival (OS) 
• To evaluate PFS rate at 3, 6, and 12 months 
• To evaluate OS rate at 3, 6, and 12 months 
• To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks, in patients who have 
elevated CA19-9 at baseline 
• To assess tumor response based on changes in fluorodeoxyglucose-positron emission 
tomography (FDG-PET) scan at 6 weeks per European Organization for Research and 
Treatment of Cancer (EORTC) criteria, according to BICR 
• To evaluate the time to progression (TTP) on study treatment (relacorilant + 
nab-paclitaxel). The duration of disease control on prior nab-paclitaxel therapy (if 
applicable), and on the most recent therapy will also be described.  
2.2.2 Safety Objectives 
• To characterize the exposure-toxicity of relacorilant in combination with nab-paclitaxel 
• To assess the safety and tolerability of relacorilant in combination with nab-paclitaxel 
2.2.3 Pharmacokinetic Objectives 
• To assess the PK of relacorilant in combination with nab-paclitaxel 
2.3 
Exploratory Objectives 
• To assess the impact of relacorilant in combination with nab-paclitaxel on body 
composition, via computed tomography (CT)/magnetic resonance imaging (MRI) scans 
for sarcopenia  
• To integrate changes in CA19-9 with tumor response rates by FDG-PET scan, in patients 
who have elevated CA19-9 at baseline 
• To assess the changes in carcinoembryonic antigen (CEA) and cancer antigen 125 
(CA-125) at 8 and 16 weeks in patients who do not have elevated CA19-9 at baseline 


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• To assess changes in Karnofsky performance status (KPS) score 
2.3.1 Pharmacodynamics/Biomarkers Objective 
• To explore molecular, cellular, and soluble markers in peripheral blood and/or tumor 
tissue that have possible relevance to the mechanism of action of, or response/resistance 
to, relacorilant in combination with nab-paclitaxel 
2.3.2 Patient-Reported Outcomes/Quality-of-Life Objective 
• To assess PRO and QoL in terms of physical function, symptoms, and utilization of 
health care resources 


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3 
STUDY DESIGN 
3.1 
Overall Design 
This is a Phase 3, single-arm, open-label, multicenter study to assess the safety and effectiveness 
of relacorilant in combination with nab-paclitaxel in patients with mPDAC. Patients will enroll at 
approximately 30 centers in the US. 
A detailed description of study visits and procedures is provided in Table 13.  
The study consists of a single phase with the following study periods: 
• Screening Period: Within 21 days prior to the first dose of relacorilant. 
• Treatment Period: Both relacorilant and nab-paclitaxel will be administered during the 
Treatment Period, starting on Cycle 1 Day 1 and continuing until disease progression, 
unacceptable toxicity, or other treatment discontinuation criteria are met. Relacorilant 
(starting dose 100 mg) will be taken once daily and nab-paclitaxel 80 mg/m2 will be 
administered on Days 1, 8, and 15 of each 28-day cycle. All patients, with exception of 
patients with absolute neutrophil count (ANC) >10,000/mm3, will receive prophylactic 
G-CSF to reduce the risk of neutropenia starting 1 day after each nab-paclitaxel infusion. 
A minimum of 2 doses of G-CSF (filgrastim [5 µg/kg/day]) is recommended. 
• Safety Follow-Up Period: Patients will return for a Post-Treatment Follow-Up Visit 
approximately 30 days after the patient’s final dose of study treatment. Patients who 
discontinue treatment prior to disease progression will continue radiographic tumor 
assessments per the Schedule of Assessments (SoA) (every 6 to 8 weeks) until 
unequivocal disease progression. 
• Long-Term Survival Follow-Up Period: All patients will be followed every 3 months 
after the end of treatment, to document dates and response to subsequent treatment, and 
for survival.  
Patients with mPDAC who have received at least 2 prior lines of therapy for PDAC in any 
setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior 
fluoropyrimidine-based therapy will be eligible to enroll in the study.  
Radiographic tumor assessments will be conducted using CT with contrast of the chest, 
abdomen, and pelvis using standard multiphasic (pancreas) CT imaging protocol guidelines. 
MRI of the chest, abdomen, and pelvis is acceptable, with Medical Monitor approval, if CT with 
contrast cannot be done. The same method should be used for each assessment for a particular 
patient. Prior to initiating therapy, a baseline tumor scan is required within 21 days prior to the 
first dose of relacorilant. Subsequent CT/MRI scans will be obtained every 6 weeks (±7 days) 
from Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent CT/MRI scans will then be 
obtained every 8 weeks (±7 days). CT/MRI scans will continue per this schedule until 
unequivocal disease progression is documented, including in patients who prematurely 
discontinue therapy. Tumor response will be assessed by BICR, and by the Investigator, using 
RECIST v1.1. CR and PR will be confirmed with a subsequent scan at least 4 weeks from the 
first response.  


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The same images (CT or MRI) acquired for radiographic tumor assessments will undergo 
additional imaging assessments for changes in skeletal muscle mass to determine the presence of 
sarcopenia.  
A baseline FDG-PET scan will be obtained prior to initiating therapy and a post-baseline 
FDG-PET scan will be obtained 6 weeks (±7 days) from Cycle 1 Day 1.  
Radiographic scans will be quality checked, anonymized and stored centrally.  
Patients will remain on treatment until unequivocal progressive disease (PD) per RECIST v1.1, 
as determined by the Investigator, or until meeting other criteria for discontinuation of the study 
regimen (Section 4.4.1). Patients will return for a Post-Treatment Follow-Up Visit approximately 
30 days after the patient’s final dose of relacorilant or nab-paclitaxel, whichever is latest, for a 
final visit (Section 7.5).  
Patients will be followed for survival information (i.e., date and cause of death) and information 
on subsequent treatments (i.e., date/duration of treatment, response, and subsequent PD). 
Survival follow-up will continue every 3 months until the endpoint of death, the patient is lost to 
follow-up, or until 2 years following the final dose of study treatment in the final patient enrolled 
(Section 7.6).  
See Figure 2 for an illustration of the study design. 
Figure 2 
CORT125134-553 Study Design 
 
CT, computed tomography; FDG-PET, fluorodeoxyglucose-positron emission tomography; MRI, magnetic 
resonance imaging; PK, pharmacokinetic. 
a Patients will return for a Post-Treatment Follow-Up Visit approximately 30 days after the patient’s final dose of 
study treatment. Patients who discontinue treatment prior to disease progression will continue radiographic tumor 
assessments (CT/MRI) every 6 to 8 weeks until unequivocal disease progression. Patients will continue to be 
followed for survival information every 3 months. 
b Patients will have CT/MRI scans every 6 weeks (±7 days) from Cycle 1 Day 1 for 24 weeks. After Week 24, 
subsequent CT/MRI scans will then be obtained every 8 weeks (±7 days). 


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Pharmacodynamics/Biomarkers 
Patients will be requested to provide an archival or recent tumor biopsy, if available, for other 
exploratory markers relevant to pancreatic cancer or the mechanism of action. Patients will have 
the option to consent to provide an additional on-study biopsy obtained during a procedure 
conducted as part of their standard of care. Pharmacodynamic markers will include mRNA gene 
panel (blood and tumor expression profiles), cytokines, and other exploratory biomarkers.  
Pharmacokinetics 
PK will be characterized after dosing with the combination of nab-paclitaxel and relacorilant, on 
Cycle 1 Days 1, 2, and 15. Blood samples will be collected for determination of plasma PK 
parameters of relacorilant and/or its metabolites (CORT125336; CORT125337; CORT125295). 
Blood samples will be also be collected for determination of plasma PK parameters of nab-
paclitaxel. 
Patient-Reported Outcomes and Quality of Life 
Baseline PRO and QoL assessments must be collected prior to the first dose of relacorilant. Post-
baseline assessments will be collected at the beginning of every cycle starting with Cycle 2 Day 
1, at the End-of-Treatment Visit, and at the 30-day Post-Treatment Follow-Up Visit. 
A detailed description of the study visits and procedures are provided in the SoA (Table 13), PK 
schedule (Table 14), and pharmacodynamic schedule (Table 15). 
All data will be recorded in an electronic case report form (eCRF). 
3.2 
Study Endpoints 
3.2.1 Primary Efficacy Endpoint  
The primary efficacy endpoint is ORR, defined as the percentage of patients with measurable 
disease at baseline who achieve confirmed CR or PR per RECIST v1.1, according to BICR. 
3.2.2 Secondary Endpoints 
3.2.2.1 
Secondary Efficacy Endpoints 
Efficacy will be assessed by evaluating the following endpoints: 
• ORR per RECIST v1.1, according to Investigator assessment 
• Best overall response, defined as the best response recorded from the date of enrollment 
across all time points during study observation period, per RECIST v1.1 according to 
BICR 
• Best overall response per RECIST v1.1 according to Investigator assessment 
• DOR as measured from the date that the criteria are met for CR or PR until the first date 
that PD is objectively documented and determined by the Investigator 
• DOR as measured from the date that the criteria are met for CR and PR until the first date 
that PD is objectively documented and determined by BICR 
• DCR, defined as the percentage of patients who have achieved CR, PR, or stable disease 
for ≥18 weeks, as determined by the Investigator 


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• PFS, defined as the time from the date of enrollment to the date the patient experiences 
unequivocal disease progression per RECIST v1.1, as determined by the Investigator, or 
death (all causes of mortality)  
• OS, defined as the time from date of enrollment until the date of death from any cause 
• PFS rate (proportion of patients who have not progressed) at 3, 6, and 12 months 
• OS rate (proportion of patients surviving) at 3, 6, and 12 months 
• Change in CA19-9 from baseline at 8 weeks and 16 weeks in patients who have elevated 
CA19-9 (CA19-9 > upper limit of normal [ULN]) at baseline 
• CA19-9 response, at 8 weeks and 16 weeks, defined as the percentage of patients with 
elevated CA19-9 at baseline who have ≥50% reduction in CA19-9 
• Tumor response assessed by FDG-PET at 6 weeks per EORTC criteria, according to 
BICR  
• TTP on study treatment, as determined by the Investigator 
3.2.2.2 
Safety Endpoints 
Safety will be assessed by evaluating the following endpoints:  
• Study drug exposure 
• Exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel 
• AEs (including frequency, severity, and relationship to study treatment) and deaths 
• Change from baseline in clinical laboratory tests 
• Change from baseline in vital signs (including blood pressure, heart rate) 
• Interpretation of electrocardiogram (ECG) assessments (normal, abnormal clinically 
insignificant, or abnormal clinically significant) 
• Physical examination findings 
3.2.2.3 
Pharmacokinetic Endpoints 
PK will be assessed by evaluating the following: 
• Primary PK parameters of relacorilant and nab-paclitaxel estimated from PK sampling on 
Cycle 1 Days 1, 2, and 15 
3.2.3 Exploratory Endpoints 
3.2.3.1 
Exploratory Efficacy Endpoints 
• Presence of sarcopenia by CT/MRI scans of body composition (i.e., skeletal muscle 
mass) 
• Change in CEA and CA-125 from baseline in patients who do not have elevated CA19-9 
at baseline 
• Change from baseline in KPS score 
3.2.3.2 
Pharmacodynamic Endpoints 
Baseline assessment of:  
• Homeostatic model assessment of insulin resistance (HOMA-IR) 


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• Immune and GC function-related cytokines 
• Markers of sarcopenia or cachexia 
• Hematology parameters, such as differential complete blood count 
• RNA analyses from circulating cells and tumor tissue of immune, tumor, and GC-related 
genes such as cyclooxygenase 2 (COX2) and dual-specificity phosphatase 1 (DUSP1) 
• Tumor somatic DNA mutation panel  
• Tumor IHC: immune infiltrate, programmed death-ligand 1 (PD-L1), and other 
exploratory markers 
Change from baseline of:  
• HOMA-IR 
• Immune and GC function-related cytokines 
• Markers of sarcopenia or cachexia 
• Hematology parameters, such as differential complete blood count 
• RNA analyses from circulating cells of immune, tumor, and GC-related genes such as 
COX2 and DUSP1 
3.2.3.3 
Patient-Reported Outcomes and Quality-of-Life Endpoints  
Changes from baseline of PRO and QoL scores according to the following instruments:  
• National Comprehensive Cancer Network/FACT-hepatobiliary-pancreatic symptom 
index (NFHSI-18) (Butt et al. 2012)  
• Patient-Reported Outcomes Measurement Information System (PROMIS) (Cella et al. 
2007) short form  
• EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L/VASc) 
• A questionnaire for healthcare service utilization 
3.3 
Number of Patients and Study Participation 
3.3.1 Number of Patients 
Approximately 80 patients will be enrolled in the study. 
3.3.2 Patient Study Completion 
Patients are considered to have completed the study if they have completed all phases of the 
study including the Long-Term Follow-Up Assessments (Section 7.6). 
3.4 
Definitions: Enrollment, End of Treatment, End of Study, and Study Duration 
3.4.1 Enrollment 
Eligible patients will be considered enrolled once they have received the first dose of relacorilant 
on Cycle 1 Day 1. 
3.4.2 End of Treatment 
Refer to Section 4.4.1 for patients who discontinue treatment. 


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The end of treatment is defined as the date on which the patient received his or her last treatment, 
relacorilant or nab-paclitaxel, whichever is latest. 
3.4.3 End of Study 
Refer to Section 4.4.2 for patient withdrawal from the study.  
The end of study is defined as the date of last contact (visit, telephone, email) with the last study 
patient. The Sponsor (Corcept) will ensure that the Institutional Review Board (IRB) and the 
regulatory authority are notified that the study has finished according to the Sponsor’s standard 
operating procedures and/or local or national regulations. 
3.4.4 Study Duration 
The total patient accrual duration is expected to be 24 months, with an overall expected study 
duration of 42 months. 
3.5 
Study Termination by Sponsor 
If the Sponsor, Investigator, Study Monitor, or regulatory officials discover conditions arising 
during the study that indicate that the study should be halted or that the study site’s participation 
should be terminated, this action may be taken after appropriate consultation between the 
Sponsor and Investigator. Conditions that may warrant termination of the study include, but are 
not limited to, the following: 
• Discovery of an unexpected, serious, or unacceptable risk to the patients enrolled in the 
study 
• Decision on the part of the Sponsor to suspend or discontinue testing, evaluation, or 
development of the product. 
Study termination and follow-up will be performed in compliance with applicable regulations. 
3.6 
Independent Data Monitoring Committee  
An IDMC will be established to conduct periodic and ad hoc medical and/or statistical reviews 
of available data to protect the safety and ethical interest of patients and protect the scientific 
validity of the study. The IDMC will comprise independent consultants (medical and statistical) 
with relevant expertise, who will meet on a regular basis, and as needed for more urgent issues.  
The IDMC will be provided with data from this study, including safety and efficacy variables, 
for periodic review. The first meeting of the IDMC will occur after 40 patients have enrolled and 
met the criteria for the interim assessment (Section 9.5.9), and will include review of efficacy 
and safety data. Enrollment will be paused such that the interim assessment can be conducted by 
the IDMC before additional patients are enrolled. Subsequent reviews of safety will occur as 
specified by the IDMC, with a minimum frequency of approximately 12 months. The IDMC may 
recommend changes in the protocol based on futility, toxicity, or compelling evidence of 
efficacy. Further details describing the IDMC composition, responsibilities, decision rules, and 
contents of data reports will be described in the IDMC Charter. 


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3.7 
Imaging Assessments by Blinded Independent Central Review 
BICR will be used to minimize bias in interpretation of the radiological findings and provide 
independent adjudication of assessments. Radiological findings will be reviewed by at least 
2 central independent readers who are blinded to Investigator assessments and clinical data. In 
the event that there is a discordance between the 2 reviewers, a third radiologist will adjudicate 
the assessments of the first 2 radiologists and determine which of the 2 is the most accurate. 
Radiographic scans will be quality checked, anonymized and stored centrally. Further details will 
be provided in the imaging charter. 


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4 
STUDY POPULATION 
4.1 
Inclusion Criteria 
Each patient must meet all of the following criteria to be enrolled in the study: 
1. Have 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 21-day Screening Period. 
2. Are male or female patients ≥18 years old. 
3. Have histologically confirmed PDAC with metastatic disease. 
4. Have received at least 2 prior lines of therapy for PDAC in any setting, including at least 
1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.  
5. Have received no more than 4 prior lines of cytotoxic or myelosuppressive therapy for 
PDAC.  
6. Have a measurable lesion at baseline (within 21 days prior to the first dose of 
relacorilant) per RECIST v1.1, as assessed by the Investigator. 
Note: Standard multiphasic (pancreas) protocols should be used for all radiographic 
tumor assessments. The exact same image acquisition and processing parameters 
should be used throughout the study. 
7. Willingness to provide blood samples and tumor tissue (primary or metastatic) for 
research purposes. 
8. Available assessments of CA19-9 (or CEA and CA-125 in non-CA19-9 elevated tumors) 
within 14 days prior to first dose of relacorilant. 
9. KPS score of ≥70. Two observers are required to assess KPS. If discrepant, the one with 
the lowest assessment will be considered true. 
10. Any significant or symptomatic amounts of ascites have been drained prior to enrollment.  
11. Are able to take oral medications. 
12. Have adequate gastrointestinal absorption. If the patient has undergone gastric bypass 
surgery and/or surgery of gastrointestinal or hepatobiliary tract, the patient must 
demonstrate adequate absorption as evidenced by albumin ≥3.0 g/dL, controlled 
pancreatic insufficiency (if present), and lack of evidence of malabsorption.  
13. Have adequate organ and marrow function meeting the following criteria: 
a. ANC ≥1,500 cells/mm3 
b. Platelet count ≥100,000/mm3 
c. Hemoglobin ≥9 g/dL 
d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN (or 
≤4 × ULN in patients with liver metastases) 
e. Total bilirubin ≤1.5 × ULN 
f. Creatinine clearance (measured or estimated) >45 mL/min/1.73m2  
g. Albumin ≥3g/dL (≥30 g/L) 
14. Are not pregnant or lactating.  
15. Patients of childbearing potential must use appropriate precautions to avoid pregnancy:  
a. Women who are postmenopausal or permanently sterilized are considered of 
nonchildbearing potential. A woman is postmenopausal if it has been ≥12 months 
since her last menstruation, without an alternative medical cause. Accepted methods 


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of permanent sterilization methods are hysterectomy, bilateral salpingectomy and/or 
bilateral oophorectomy.  
b. Women of childbearing potential must use a highly effective contraception with low 
user-dependency throughout the study and then for at least 6 months after the final 
dose of relacorilant or nab-paclitaxel, whichever is latest. Accepted methods of highly 
effective contraception with low user-dependency are: 
i. 
An intrauterine device (hormonal or nonhormonal), provided that the patient 
has tolerated its use for at least 3 months before enrollment and undertakes not 
to have it removed for 1 month after the final dose of study treatment. 
ii. 
Abstinence from heterosexual intercourse, when it is in line with the patient’s 
preferred and usual lifestyle. Periodic abstinence and withdrawal are NOT 
acceptable. 
iii. 
Vasectomized partner provided that the partner is the sole sexual partner of the 
trial participant and that the vasectomized partner has received medical 
assessment of the surgical success. 
c. Oral hormonal contraceptives are NOT permitted. 
d. Male patients should agree to use an adequate method of contraception starting with 
the first dose of study treatment through 3 months after the final dose of study 
treatment (relacorilant or nab-paclitaxel, whichever is latest). Male patients should 
not father a child while receiving study treatment (including refraining from sperm 
donation).  
4.2 
Exclusion Criteria 
Patients who meet any of the following criteria will not be eligible to participate in the study: 
1. Have pancreatic neuroendocrine tumors, lymphoma of the pancreas, acinar pancreatic 
cancer, or ampullary cancer.  
2. Have known untreated parenchymal brain metastasis or have uncontrolled central 
nervous system metastases. Patients must not require steroids and must be neurologically 
stable without corticosteroids for a minimum of 3 weeks prior to Cycle 1 Day 1.  
3. Have a 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 
enrollment, including peripheral neuropathy that is ongoing and greater than Grade 1 in 
severity, according to National Cancer Institute Common Terminology Criteria for 
Adverse Events (NCI-CTCAE) v5.0. 
4. Have a history of hypersensitivity or severe reaction to either relacorilant or 
nab-paclitaxel, or to similar classes of either drug.  
5. Have taken the following medications prior to enrollment: 
a. An investigational product, cytotoxic chemotherapy or targeted agent within 14 days. 
b. Radiotherapy within 21 days. 
c. Palliative radiotherapy within 1 week of Cycle 1 Day 1, or if toxicities from 
radiotherapy are Grade 2 severity or higher or have not recovered to baseline. 
d. Systemic or prescription strength topical corticosteroids for the purposes of treating a 
chronic nononcologic indication within 21 days.  


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6. Have a requirement for treatment with chronic or frequently used oral or inhaled 
corticosteroids for medical conditions or illnesses (e.g., rheumatoid arthritis, asthma, or 
immunosuppression after organ transplantation). 
7. Are taking a concomitant medication that is a strong CYP3A or CYP2C8 inhibitor or 
inducer, or a substrate of CYP3A or CYP2C8 and has a narrow therapeutic window (See 
Appendix D).  
8. Concurrent treatment with mifepristone or other GR antagonists. 
9. Have any clinically significant uncontrolled condition(s) or any medical condition which 
in the opinion of the Investigator places the patient at an unacceptably high risk for 
toxicities or impair study participation or cooperation. 
a. History of significant cardiac disease defined as New York Heart Association class III 
or IV, myocardial infarction within 6 months of enrollment, or unstable angina within 
6 months of enrollment. 
b. Active infection that requires parenteral antibiotics within 14 days. 
c. Bowel obstruction or gastric outlet obstruction within 14 days. 
d. Has known psychiatric or substance abuse disorders that would interfere with 
cooperation with the requirements of the trial. 
e. Advanced chronic obstructive pulmonary disease or hepatic cirrhosis. 
10. Have had any major surgery within 21 days prior to enrollment. 
11. Have had endoscopic retrograde cholangiopancreatography with persistence of any of the 
following: 
a. Bilirubin ≥1.5 × ULN 
b. Amylase >2 × ULN and abdominal pain or amylase >3 × ULN (with or without 
symptoms) 
c. Fever or signs of infection 
d. Decreasing hemoglobin or signs of blood loss 
12. Have a history of human immunodeficiency virus (HIV) or current chronic/active 
infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). 
a. Patients with chronic or active hepatitis B as diagnosed by serologic tests are 
excluded from the study. In equivocal cases, hepatitis B or C polymerase chain 
reaction results may be performed and must be negative for enrollment. 
13. Have a rapid decline in KPS score or serum albumin (≥20%), or have progressive pain 
symptoms indicative of rapid clinical deterioration, in the opinion of the Investigator, 
prior to enrollment. These patients will become ineligible if rapid decline is observed 
during the Screening Period. 
4.3 
Screen Failures 
Screen failures are defined as patients who consent to participate in the clinical study but are not 
entered in the study. The reason for screen failure should be recorded. 
A patient who has failed screening due to a reason that is temporary and expected to resolve 
(e.g., mild intercurrent infection) may be rescreened. 


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4.4 
Patient Discontinuation of Treatment or Study Completion/Withdrawal  
In this study, patient “discontinuation” refers to discontinuation of study treatment. Patients who 
discontinue study treatment will continue to be followed for the study endpoints. This may 
include patients who have discontinued treatment due to disease progression, toxicity, 
Investigator decision, or personal decision. These patients will continue with the End-of-
Treatment and 30-Day Follow-up Visits, radiographic tumor assessments (if disease progression 
has not occurred), and survival assessments. If a patient wishes to discontinue treatment and 
refuses further study procedures, the patient should be asked if he/she is willing to continue with 
the survival assessments (which can be conducted over the telephone) (Section 7.6).  
Patient study completion refers to completion of all study procedures and Long-Term Follow-Up 
Assessments (Section 3.3.2). Patient “withdrawal” refers permanent withdrawal and cessation of 
all study treatments, procedures, and assessments without further follow-up (withdrawal of 
consent). If a patient wishes to withdraw consent to further participation in the study entirely, 
including Long-Term Survival Follow-Up, this should be clearly documented (1) in the patient’s 
medical record and signed by the Investigator and (2) in the clinical study database (i.e., eCRF).  
4.4.1 Discontinuation of Study Treatment  
Patients may discontinue treatment at any time at their own request, or they may have study 
treatment discontinued, at any time, at the discretion of the Investigator or Sponsor for safety or 
the inability of the patient to comply with the protocol-required SoA. 
Reasons for study treatment discontinuation may include any of the following:  
• Patient has PD per RECIST v1.1, as determined by the Investigator. 
• Patient has unacceptable toxicity. 
• Patient experiences an AE. 
• Patient refuses further study treatment (follow-up permitted by the 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. 
– Clinically significant deterioration of the patient's medical status, as determined by 
the Investigator. 
– The patient requires alternative anticancer agents or radiation therapy. 
– The patient is not compliant with protocol requirements. 
• Patient is pregnant. 
• Any of the criteria listing in Section 4.4.2, as patients who withdraw/complete the study 
will also discontinue treatment. 
Disease progression based on FDG-PET alone should not be used to make decisions regarding 
tumor response, patient management, or to discontinue treatment. A transient metabolic flare 
associated with changes in uptake and metabolism of [18F]-fluorodeoxyglucose (FDG) may 
occur early in treatment and should not be considered evidence of disease progression. Clinical 
deterioration or changes on FDG-PET that may be indicative of disease progression, including 
new “hot spots” suggestive of new lesions, should be confirmed by biopsy or CT/MRI scan per 
RECIST v1.1. 


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Patients will return for a Post-Treatment Follow-Up Visit approximately 30 days after the 
patient’s final dose of study treatment, and should report any AEs, including SAEs, for 30 days 
after the last administration of study drug (see Section 8.1.2). Patients who discontinue study 
treatment prior to PD will continue radiographic tumor assessments per the SoA (every 
6 to 8 weeks) until unequivocal disease progression. After patients experience PD, they will enter 
the Long-Term Survival Follow-Up Period, during which they will continue to be followed for 
survival information (see Section 7.6). 
The date when the patient discontinues treatment and the reason for discontinuation must be 
recorded on the eCRF.  
For guidelines about temporary interruption of treatment or treatment modifications, see 
Section 5.4. 
4.4.2 Patient Withdrawal from Study/Study Completion 
Patients may voluntarily withdraw from the study at any time. 
Reasons for study exit may include the following medical or administrative reasons: 
• Withdrawal of consent for further follow-up by the patient or legal representative 
•  Completed the study (Section 3.3.2) 
• Death 
• Termination of the study by the Sponsor 
• Lost to follow-up 
4.5 
Replacement of Patients 
Patients who withdraw from study early may be replaced, at the discretion of the Sponsor and the 
Investigator, to ensure that sufficient patients complete the study to achieve the objectives.  
4.6 
Restrictions During Study 
The following restrictions apply to patients in this study (prohibited or limited-use medications 
are described in Section 5.5):  
Dietary Restrictions—Foods such as grapefruit and Seville orange, including marmalade and 
juices made from these fruits will be prohibited from 14 days prior to the first dose of study 
treatment and until the last treatment cycle is completed. 
Contraception—Women of childbearing potential and men who participate in this study must 
agree to use effective contraception as outlined in Section 4.1. 


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5 
STUDY TREATMENTS AND MANAGEMENT 
Study drug is defined as the investigational product, relacorilant. The co-administered drug in 
this study is nab-paclitaxel. 
Study treatment consists of relacorilant and nab-paclitaxel administered to a study patient 
according to the study protocol. 
5.1 
Relacorilant 
Relacorilant description, packaging, and store are described in Table 1. For further information, 
see the relacorilant IB. 
Table 1 
Relacorilant: Formulation, Administration, Packaging, and Storage 
Specifications 
Relacorilant 
Description 
For each capsule, relacorilant (CORT125134) is prepared
 
 
Supplied 
Study drug is supplied as softgel capsules, containing 100 mg (yellow capsule) or 
25 mg (brown capsule) of relacorilant. 
Unit dose strength(s)  
100 mg, 25 mg 
Dose level(s) 
100 mg once daily, with titration up to 150 mg once daily, as tolerated 
(Section 5.1.1) 
Administration  
Orally, with 8 oz of room temperature water. 
Capsules are to be swallowed whole and should not be chewed, dissolved, or 
opened prior to swallowing. 
Regimen 
Administer relacorilant once daily in the morning, each day.  
Patients should be encouraged to take relacorilant with food except on days when 
protocol-specified assessments require fasting or if the patient is not able to tolerate 
food intake with the medication. 
Restrictions 
Medicines/foods known to strongly inhibit CYP3Aor CYP2C8, and substrates of 
CYP3A with a narrow therapeutic window should be avoided. See Section 5.5. 
Missed doses 
If noticed >6 hours after scheduled dose, skip dose and take next scheduled dose. 
Dispensing study drug 
Dispense to patients according to their visit schedule. 
Packaging and labeling 
Relacorilant softgel capsules, 25 mg or 100 mg, will be provided in bottles 
containing 30 capsules each. 
Each bottle will be labeled as required per country-specific requirements. 
Storage 
Store as follows:  
• In a secure location 
• At 20–25 °C (68–77 °F)  
• Excursions permitted 15–30 °C (59–86 °F) 
• Out of reach and sight of children 
Note: Procedures for inventory, reconciliation, and destruction or return of study drug are provided in Section 11.6. 


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5.1.1 Relacorilant Dose Titration 
Relacorilant dose will be increased in patients who tolerated the 100 mg once daily dose after the 
first cycle. 
Cycle 2 Day 1 
If during the first cycle of treatment, the patient did not experience any intolerable Grade 2 
toxicities or Grade 3 or 4 toxicities attributed to study treatment, then the relacorilant dose will 
be escalated to 125 mg once daily, beginning on Cycle 2 Day 1.  
Cycle 3 Day 1 
For patients whose relacorilant dose has been escalated to 125 mg, if no intolerable Grade 2 nor 
any Grade 3 or 4 toxicities require dose reduction or omission of either relacorilant or nab-
paclitaxel in Cycle 2, then the relacorilant dose can be escalated to 150 mg once daily, beginning 
on Cycle 3 Day 1.  
If the dose was not escalated during Cycle 1 or 2, then the dose should not be escalated in future 
cycles. For all cycles, dose delays and reductions will be managed according to Section 5.4.1. 
5.2 
Nab-Paclitaxel 
Details of the co-administered drug, nab-paclitaxel, are provided in Table 2.  
Table 2 
Nab-Paclitaxel: Formulation, Administration, Packaging, and Storage 
Specifications 
Nab-Paclitaxel (Abraxane) 
Dosage formulation 
The chemical name for paclitaxel is 5β,20-epoxy-1,2α,4,7β,10β,13α-
hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-
benzoyl-3-phenylisoserine. The empirical formula is C47H51NO14. 
Supplied 
Single-use 50-mL vial 
Unit dose strength(s) 
Each 50-mL vial contains 100 mg paclitaxel and approximately 900 mg of 
human albumin as a stabilizer.  
Administration  
Administer reconstituted formulation as an intravenous infusion over 30 minutes 
(±5 minutes). 
Dose level(s) 
80 mg/m2 
Regimen 
Administer on Days 1, 8, and 15 of each 28-day cycle. 
Nab-paclitaxel infusions must be no less than 7 days apart. 
Restrictions 
On Cycle 1 Day 1 and Cycle 1 Day 15, the start of nab-paclitaxel infusion must 
be within 15 minutes after relacorilant dose. 
Missed doses 
Refer to Section 5.4.3 and Appendix C. 
Dispensing study treatment 
Nab-paclitaxel will be administered in the clinic. 
Packaging and labeling 
Refer to current prescribing information or Summary of Product Characteristics. 


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Specifications 
Nab-Paclitaxel (Abraxane) 
Storage 
• Store un-reconstituted nab-paclitaxel should be stored at 20–25°C (68–77°F) in 
its carton.  
• Store vials should be stored in their original cartons. Use reconstituted 
paclitaxel immediately. If not used immediately, place the vial in its carton and 
store at 2–8°C (36–46°F) for a maximum of 8 hours.  
• Store both forms in an area free of environmental extremes and accessible only 
to study personnel.  
• Discard partially and completely used vials according to the site’s guidelines 
Record disposition on the Study Drug Accountability Record Form.  
Manufacturer 
Commercially available (Abraxis Biosciences, LLC, a wholly owned subsidiary 
of Celgene Corporation) 
5.3 
Additional Treatments 
All patients, with exception of patients with ANC >10,000/mm3, will receive prophylactic 
G-CSF to reduce the risk of neutropenia starting 1 day after each nab-paclitaxel infusion. A 
minimum of 2 doses of G-CSF (filgrastim [5 µg/kg/day]) is recommended.  
G-CSF should not be administered if ANC exceeds 10,000/mm3. Pegfilgrastim may be used for 
patients with a chemotherapy-free window of 2 weeks.  
Prophylactic treatment with G-CSF will be per protocol, as stated above. In addition, G-CSF 
treatment may be used to provide support for a patient with clinically meaningful neutropenia or 
to maintain dose intensity as consistent with the institutional guidelines and standard practice.  
5.4 
Dose-Adjustment Criteria 
Every effort should be made to administer study treatment on the planned dose and schedule. 
In the event of toxicity, dosing may be delayed, modified, temporarily interrupted, or 
permanently discontinued as described below. In the event of multiple toxicities, dose 
modification should be based on the worst toxicity observed.  
If study treatment is interrupted for >28 days with the approval of the Medical Monitor, clinical 
laboratory assessments may also be interrupted, if clinically significant laboratory abnormalities 
have resolved to Grade 1 or baseline. Tumor assessments (CT/MRI and CA-125) and PRO/QoL 
assessments should continue per the SoA. 
General chemotherapy dosing guidelines are provided in Appendix C. 
 


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Table 3 
Dose Reductions or Delays Due to Adverse Events 
Adverse Event 
Nab-Paclitaxel Dose Modification 
Relacorilant Dose Modification 
Neutropenia:  
(ANC 1,000-1,499) 
Day 1 of any cycle:  
• Delay Day 1 dose until ANC is 1,500 or 
higher 
Day 8 or 15 of any cycle: 
• No change 
• Withhold dose until ANC is 
1,500 or higher 
• Reinitiate at same dose level 
Neutropenia:  
(ANC <1,000) 
Day 1 of any cycle:  
• Delay Day 1 dose until ANC is 1,500 or 
higher.  
• Reduce 1 dose level 
Day 8 or 15 of any cycle: 
• Omit dose 
• Reduce 1 dose level 
• Withhold dose until ANC is 
1,500 or higher 
• Reinitiate at same dose level 
Febrile neutropenia: 
Grade 3 or 4 
• Withhold dose until fever resolves and 
ANC is 1,500 or higher.  
• Reduce 1 dose level 
• Withhold dose until fever 
resolves and ANC is 1,500 or 
higher 
• Reinitiate at same dose level 
Thrombocytopenia: 
(Platelets 50,000-99,999) 
Day 1 of any cycle:  
• Delay Day 1 dose until platelet is 100,000 
or higher 
Day 8 or 15 of any cycle: 
• No change  
• No change 
Thrombocytopenia: 
(Platelets <50,000) 
Day 1 of any cycle:  
• Delay Day 1 dose until platelet is 100,000 
or higher 
Day 8 or 15 of any cycle: 
• Omit dose and then reduce nab-paclitaxel 
by 1 dose level 
• No change 
Peripheral neuropathy: 
Grade 3 or 4 
• Delay dose until symptoms improve to 
Grade 1 or better 
• Reduce 1 dose level 
• No change 
Cystoid macular edema 
• Discontinue nab-paclitaxel 
• Discontinue relacorilant 
Cutaneous toxicity: Grade 3 
• Withhold dose until improvement to 
Grade 1 or lower, or to baseline if Grade 2 
toxicity was present at study entry  
• Reduce 1 dose level  
• Withhold dose until 
improvement to Grade 1 or 
lower, or to baseline if Grade 2 
toxicity was present at study 
entry  
• Reinitiate at same dose level 
Cutaneous toxicity: Grade 4 
• Discontinue nab-paclitaxel 
• Discontinue relacorilant 


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Adverse Event 
Nab-Paclitaxel Dose Modification 
Relacorilant Dose Modification 
Mucositis:  
Grade 3 or 4 
• Withhold dose until improvement to 
Grade 1 or lower, or to baseline if Grade 2 
toxicity was present at study entry  
• Reduce 1 dose level 
• Withhold dose until 
improvement to Grade 1 or 
lower, or to baseline if Grade 2 
toxicity was present at study 
entry  
• Reinitiate at same dose level 
Diarrhea:  
Grade 3 or 4 
• Withhold dose until improvement to 
Grade 1 or lower, or to baseline if Grade 2 
toxicity was present at study entry  
• Reduce 1 dose level 
• Withhold dose until 
improvement to Grade 1 or 
lower, or to baseline if Grade 2 
toxicity was present at study 
entry  
• Reinitiate at same dose level 
Other hematologic or non-
hematologic AE:  
Grade 3 or 4 
• Withhold dose until severity of AE 
improves to Grade 1 or lower, or to 
baseline if Grade 2 toxicity was present at 
study entry 
• Reduce 1 dose level 
• For AEs attributable only to 
nab-paclitaxel, continue 
relacorilant unchanged. 
• For AEs attributable to 
relacorilant, withhold dose until 
severity of AE improves to 
Grade 1 or lower (or to baseline 
if Grade 2 toxicity was present 
at study entry) and reinitiate at 
the same or reduced dose level 
(see Section 5.4.1 for more 
details) 
AE, adverse event; ANC, absolute neutrophil count.  
5.4.1 Dose Reductions or Delays for Relacorilant 
For any patient who experiences Grade 3 or 4 toxicity that is attributable to relacorilant but not 
nab-paclitaxel or the underlying disease, relacorilant 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, relacorilant will be resumed. If the patient is taking relacorilant 125 mg or 
150 mg daily, then resume relacorilant at a lower dose (relacorilant dose reductions to occur in 
25-mg increments) (Table 4). Daily relacorilant dose should not be lower than 100 mg. If dose 
reduction is required when the patient is taking relacorilant 100 mg daily, relacorilant will be 
discontinued and the patient will continue on nab-paclitaxel alone. 
Table 4 
Relacorilant Dose Level Summary 
Relacorilant Dose Level 
Daily Dose 
Dose Level +2 (eligible patients to escalate on Cycle 3 Day 1) a 
150 mg 
Dose Level +1 (eligible patients to escalate on Cycle 2 Day 1) a 
125 mg 
Starting Dose Level 
100 mg 
Dose Level -1 
Discontinue Relacorilant 
a See Section 5.1.1 for details. 


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5.4.2 Management of Signs of Excessive Glucocorticoid Receptor Antagonism 
For patients treated with relacorilant, signs or symptoms related to excessive GR antagonism 
may develop. If signs and/or symptoms of excessive GR antagonism such as malaise, fatigue, 
lethargy, weakness, anorexia, nausea, vomiting, abdominal pain, or altered mental status are 
present, particularly if coexistent, treatment with relacorilant 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 (e.g., dexamethasone 4 mg daily for 3 days and then 
tapered by 1 mg per day, or as indicated based on clinical response). 
 
 In the event of significant trauma or surgery 
through 28 days after the final dose of relacorilant, supplemental glucocorticoids (GCs) and 
appropriate medical care may be needed to prevent excessive GR antagonism that may arise due 
to increased cortisol requirements in the perioperative period. 
5.4.3 Dose Reductions or Delays for Nab-Paclitaxel 
After Cycle 1 Day 1, if there is a delay in nab-paclitaxel administration for any reason, the 
following applies: 
• If an infusion is delayed by >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 
Investigator.  
• If treatment with nab-paclitaxel is delayed for >4 weeks (omission of nab-paclitaxel for 
>28 days), the Medical Monitor should be notified. 
Nab-paclitaxel dose reductions should be made based on observed toxicities secondary to 
treatment (Table 3). Sequential dose reductions (Table 5) may be made at the discretion of the 
Investigator. A maximum of 2 dose reductions are allowed.  
Table 5 
Nab-Paclitaxel Dose Reductions 
Nab-paclitaxel Dose Level 
Weekly Dose 
Starting Dose Level 
80 mg/m2 
Dose Level -1 
60 mg/m2 
Dose Level -2 
60 mg/m2 biweekly  
(on Days 1 and 15 of each cycle) 
Note: Nab-paclitaxel administered on Days 1, 8, and 15 of each 28-day cycle unless otherwise noted. 
5.5 
 Concomitant Medications and Procedures 
5.5.1 Permitted Concomitant Medications 
Best supportive care and treatment should be prescribed as appropriate to each patient to manage 
disease-related symptoms (e.g., anti-emetics, antibiotics, transfusions, nutritional support, and 
pain control) according to institutional guidelines or ASCO guidelines.  
Permitted treatments also include standard therapies for concurrent medical conditions.  


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Patients must be instructed to notify the investigational site about any new medications they take 
after the start of study treatment. All medications (other than study treatments) administered 
within 30 days of study entry and during the study must be listed on the concomitant medications 
eCRF. 
Concurrent anticancer therapy with agents other than relacorilant and nab-paclitaxel is not 
allowed. See Section 5.5.3 for other prohibited concomitant medications. 
5.5.2 Permitted Concomitant Therapy Requiring Caution 
Permitted medications to be used with caution from 1 week before first relacorilant dose through 
the 30-day Post-Treatment Follow-Up Visit are as follows: 
• Warfarin: If used, conduct additional international normalized ratio (INR) monitoring. 
• Sulfonylureas: If used, conduct close glucose monitoring to assess for diabetic control. 
• Corticosteroids: 
– Systemic corticosteroids. Short courses of prednisone for non–cancer-related reasons 
are permitted if clinically required (e.g., as premedication for imaging contrast 
administration). Relacorilant treatment should be withheld during corticosteroid 
administration, and the Medical Monitor should be notified. 
• Potent (Group 3) topical corticosteroids for treatment of oral mucositis is allowed. Use 
for other indications should be done with caution due to the potential for systemic 
absorption, and the Medical Monitor should be contacted to discuss the treatment 
approach.  
• Marijuana is metabolized by the liver and interacts with CYPs, so should be used with 
caution with relacorilant. 
Relacorilant is a strong inhibitor of CYP3A in vivo. In healthy subjects, the exposure area under 
the curve of midazolam was increased ~9-fold upon co-administration with relacorilant, relative 
to midazolam alone; therefore, due to the potential for drug-drug interactions, drugs with a 
narrow therapeutic ratio that are highly dependent on CYP3A for clearance should be avoided.  
The metabolism of nab-paclitaxel is catalyzed, in part, by CYP2C8. Caution should be exercised 
when administering nab-paclitaxel concomitantly with medicines known to inhibit CYP2C8 
(Abraxane USPI 2018; Abraxane SPC 2019).  
Due to potential drug-drug interactions, the following medications are permitted but must be 
used with caution or avoided, if possible, from 1 week before first relacorilant dose through the 
30-day Post-Treatment Follow-Up Visit: 
• Inhibitors of CYP2C8 
• Sensitive substrates of CYP3A that do not have a narrow therapeutic index 
• Moderate inhibitors of CYP3A 
• Moderate inducers of CYP3A and CYP2C8 
For examples of medications to be used with caution, see Appendix D. 


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5.5.3 Prohibited Medications 
As the metabolism of both nab-paclitaxel and relacorilant are mediated in part by CYP3A, there 
is potential for CYP3A inhibitors to increase nab-paclitaxel and relacorilant exposure.  
Medicines/food known to strongly inhibit CYP3A are prohibited (see Section 4.6 for dietary 
restrictions). 
The following medications are prohibited during treatment with relacorilant in this study: 
• St. John’s wort 
• Strong inhibitors or inducers of CYP3A 
• Substrates of CYP3A with narrow therapeutic windows 
• Other investigational and antineoplastic therapies 
• Other GR antagonists (e.g., mifepristone) 
Patients should be counseled to avoid consumption of grapefruit and Seville oranges (including 
marmalade and juices made from these fruits) from 14 days prior to the first dose of study 
treatment and until the last treatment cycle is completed. 
Examples of medications that are prohibited or are to be used with caution are listed in 
Appendix D. It is not possible to produce an exhaustive list of medications that fall into the 
categories, so if in question, please refer to the appropriate product label. If the Investigator 
determines that such a medication is medically necessary, the Investigator will notify the 
Medical Monitor and discuss the Investigator's use of these medications and the Investigator's 
plans to medically monitor the patient. 
5.5.4 Procedures 
If a patient requires surgery during the study, then this needs to be discussed with the Medical 
Monitor. If surgery affects a target lesion, that patient will be considered nonevaluable for 
response from that point forward and will continue to be followed for disease progression. 
Radiation therapy is not allowed during the study. 
5.6 
Method of Treatment Assignment and Randomization 
This is a nonrandomized study (i.e., no randomization or allocation methods will be used in 
this study). 
5.7 
Blinding 
This is an open-label study. No blinded study treatments will be used in this study. To 
reduce bias, the primary endpoint, ORR per RECIST v1.1, will be assessed based on BICR. 
5.8 
Dose Diary 
Dose diary cards will be provided to patients, and patients will be instructed to return all unused 
relacorilant and the dose diary card at the study visits as indicated in the SoA (Table 13). 
Patients should complete an entry in the dose diary card for each self-administered dose of 
relacorilant and note doses of any concomitant medications taken. Entries will include the 


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number of capsules as well as the date and time of relacorilant administration. On visit days, 
relacorilant should be taken in the clinic during the visit and after initial blood draws. Time and 
dose administered should be documented in the clinic charts.  
5.9 
Product Accountability and Treatment Compliance  
Patients will be instructed to return all used and unused 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 11.6. 


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6 
DESCRIPTION OF STUDY ASSESSMENTS AND PROCEDURES AND 
APPROPRIATENESS OF MEASUREMENTS 
Study procedures and their timing are summarized in the SoA (Table 13).  
Additional evaluations/testing may be performed at unscheduled time points, if deemed clinically 
indicated or necessary by the Investigator and/or the Sponsor, for reasons related to patient 
safety. In some cases, such evaluation/testing may be potentially sensitive in nature (e.g., HIV, 
Hepatitis C, etc.), and thus local regulations may require that additional informed consent be 
obtained from the patient. In these cases, such evaluations/testing will be performed in 
accordance with those regulations. 
The Investigator and Sponsor will conduct the study in accordance with International Council for 
Harmonisation (ICH) Good Clinical Practice (GCP) and local regulations. Adherence to the 
study design requirements, including those specified in the study schedule, is essential and 
required for study conduct, and the Investigator must ensure that trial procedures are performed 
as described in the protocol. During the study, procedures and observations will be monitored to 
confirm that study requirements are being followed as outlined in the study schedule. 
6.1 
Informed Consent and Screening 
Written informed consent must be obtained in order for a patient to participate in this study. The 
ICF, which has been approved by the appropriate IRB, must be signed by the patient before any 
study-mandated procedures are performed. Study patients must be notified of any changes that 
might affect their willingness to continue in the study in an update to the ICF and be given the 
opportunity to ask questions and/or withdraw consent. The patient’s agreement must be 
documented in writing. 
All screening evaluations must be completed and reviewed to confirm that potential patients 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
patients screened and to confirm eligibility or record reasons for screening failure (see 
Section 4.3), as applicable.  
Procedures conducted as part of the patient’s routine clinical management (e.g., blood count) and 
obtained before signing of the ICF may be used for screening purposes provided the procedures 
meet the protocol-specified criteria and are performed within the time frame defined in Table 13. 
6.2 
Demographics and Baseline Disease Characteristics 
Patient demographic data, including age, sex, and race will be documented at Screening.  
6.3 
Medical and Medication History 
Medical history, including details regarding illnesses and allergies, date(s) of onset, and whether 
conditions are currently ongoing, and medication history will be collected on all patients during 
Screening. Any new or clinically significant changes in the patient’s medical or oncologic 
history between providing informed consent and the first dose of study treatment will be 
recorded on the AE eCRF page.  


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The following information will be collected:  
• Complete medical history, including documentation of any clinically significant medical 
condition.  
– Please note that if the patient has lost ≥15 lb (6.8 kg) over the 3 months prior to 
screening, “weight loss” should be entered as an active condition on the Medical 
History. 
• History of tobacco and alcohol use.  
• Presence and severity of any symptoms/conditions associated with pancreatic cancer 
including malabsorption or malnutrition. 
• Detailed oncologic history, including but not limited to:  
– Date of primary cancer diagnosis  
– Anatomic site of primary tumor 
– Stage of primary tumor 
– Pathology (histology or cytology) of primary tumor  
– Surgical history, including previous Whipple procedure and residual disease at the 
completion of neoadjuvant treatment: complete resection (R0), residual tumor cells 
on resection margins (R1), or macroscopic residual tumor cells (R2) 
– Presence of biliary stent at screening 
– Anticancer and radiation treatments administered (including initiation and completion 
dates, type of modality, response, and reason for discontinuation)  
– Metastasis information (including the current sites of metastases, presence of liver or 
pulmonary metastases, presence of peritoneal carcinomatosis and histological 
markers)  
– Prior molecular testing/tumor profiling (including repeat biopsy from primary 
pathology, blood-based assays for molecular markers, and determinants of prognosis 
or drug sensitivity). The data collected will be the results of tumor molecular profiling 
or genetic testing relevant to the cancer. Where possible, a comprehensive report 
would be preferred to a summary or notes on the results.  
6.4 
Safety Measures 
Safety will be determined from evaluation of AEs, physical examinations, clinical laboratory 
tests, vital signs, and ECGs at the times indicated in Table 13.  
6.4.1 Physical Examinations 
Physical examinations will be performed according to the SoA (Table 13).  
A comprehensive physical examination will be performed at Screening, Cycle 1 (Days 1 and 15) 
and Day 1 of each subsequent cycle, at the End-of-Treatment Visit, and at the 30-day 
Post-Treatment Follow-Up Visit. A targeted physical examination will be performed at Days 8 
and 15 of each cycle. Physical examination findings will be recorded in the appropriate eCRF by 
the Investigator or qualified designee.  


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6.4.2 Vital Signs 
Vital signs will be measured at the visits indicated in Table 13 and will include resting heart rate, 
blood pressure, respiratory rate, and body temperature. Heart rate (beats per minute), 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 mm Hg. The heart rate should be recorded over 
30 seconds or longer. 
6.4.3 Height and Weight 
Height and weight will be measured and body mass index calculated during Screening, and 
weight will be measured at each visit where a physical examination is performed (Table 13). 
Weight will be measured without overcoat and shoes, and with only light clothing.  
6.4.4 Pregnancy Test (for Women of Childbearing Potential) 
For female patients of childbearing potential, a quantitative serum or urine pregnancy test will be 
performed to confirm that the patient meets eligibility requirements. A serum or urine pregnancy 
test will be obtained within 48 hours prior to the first dose of relacorilant and reviewed prior to 
enrollment. Pregnancy tests will be repeated every 12 weeks (±7 days), or more frequently if 
required according to local requirements. Patients considered not of childbearing potential must 
be documented as being surgically sterile or postmenopausal (amenorrheic for ≥12 months).  
If treatment with relacorilant is stopped for ≥7 days, a female patient of childbearing potential 
should have a negative pregnancy test before restarting study drug. If pregnancy test results are 
equivocal in patients with evidence to support lack of pregnancy, the results should be discussed 
with the Medical Monitor and the Investigator’s interpretation with supporting information 
documented in the source documents. 
6.4.5 Triplicate 12-Lead Electrocardiogram 
Twelve-lead ECG tracings, in triplicate, will be obtained from all patients at the times indicated 
in Table 13. Patients should be lying down for at least 10 minutes before each ECG evaluation.  
The Investigator or qualified designee will indicate on the site’s copy whether the ECG was 
normal, abnormal but not clinically significant, or abnormal and clinically significant and 
document this on the ECG eCRF. Any new or worsened abnormality noted as clinically 
significant will be reported as an AE. The original ECG tracing or copy with the physician’s 
assessment will be retained in the patient’s records at the study site.  
6.4.6 Adverse Events 
Details on definitions and reporting of AEs are provided in Section 8. 
All AEs will be recorded from the time of signing the ICF until 30 days after the final dose of 
study treatment. Patients should be monitored for AEs consistent with the current IB for 
relacorilant and the labeling for nab-paclitaxel.  


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6.4.7 Subsequent Anticancer Therapy Status and Survival Follow-Up 
The Investigator or qualified designee will review and document all new anticancer therapy 
initiated after the final dose of study treatment. If a patient initiates a new anticancer therapy 
within 30 days after the final dose of study treatment, the Post-Treatment Follow-Up Visit must 
occur before the first dose of the new therapy.  
Once new anticancer therapy has been initiated, the patient will move into the Long-Term 
Survival Follow-Up Period (Section 7.6). 
6.4.8 Clinical Laboratory Assessments 
6.4.8.1 
Laboratory Parameters 
Clinical laboratory tests to be performed are listed in Table 6 and should be performed according 
to the SoA provided in Table 13. Laboratory assessments for PK are described in Section 6.7. 
Samples for HOMA-IR assessment (insulin and glucose) are to be collected under fasting 
conditions at the time points specified in the pharmacodynamic schedule (Table 15) and the 
HOMA-IR calculated (Matthews et al. 1985).  
Fasting status at the time of laboratory tests will be documented in the eCRF. 
Samples will be processed at local and central laboratories as follows: 
• Local laboratory: hematology, chemistry, glucose, insulin, coagulation (activated partial 
thromboplastin time [aPTT] and INR), urinalysis, and serum or urine pregnancy test, and 
tumor markers (CA19-9, CEA, and CA-125) 
• Central laboratory: tumor characterization and mRNA expression tests (including COX2 
and DUSP1 and GC-induced genes or biomarkers of GR activity), and PK assessments 
(see Section 6.7) 
Local laboratory data will be used for immediate treatment decisions and for safety assessment. 
If laboratory tests for screening are performed greater than 2 days prior to the first dose of 
relacorilant, hematology and chemistry should be repeated with 48 hours of Cycle 1 Day 1 and 
reviewed prior to enrollment to confirm eligibility. After Cycle 1 Day 1, pre-dose laboratory 
procedures can be conducted up to 72 hours prior to the study visit/nab-paclitaxel infusion.  
The Investigator will review all local laboratory reports, evaluate the results, and sign/date the 
report. Laboratory values for an analyte that are outside of the normal range for that analyte per 
the applicable reference range will be identified and can be repeated at the Investigator’s 
discretion.  


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Table 6 
Clinical Laboratory Tests 
Hematology 
Serum Chemistry 
Urinalysis (Dipstick) 
Red blood cell count  
Hemoglobin  
Hematocrit  
Platelet count 
White blood cell (WBC) count  
WBC with 5-part differential: 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Sodium  
Potassium  
Calcium  
Chloride  
Phosphorus a 
Magnesium a 
Serum Creatinine 
Total bilirubin 
Albumin  
Alkaline phosphatase  
Lactate dehydrogenase (at Screening only) 
Aspartate aminotransferase  
Alanine aminotransferase  
Glucose, document whether fasting or nonfasting 
Blood urea nitrogen 
Uric acid  
Bicarbonate  
Total protein  
Bacteria 
Blood 
Urobilinogen 
Nitrites 
Color 
Clarity 
pH 
Specific gravity 
Ketones 
Protein  
Glucose  
Bilirubin 
Leukocyte esterase 
Coagulation 
Other b 
Pregnancy Test 
International normalized ratio 
Activated partial thromboplastin 
time 
 
HIV immunoassay c 
Hepatitis B/C serology d 
Serum or urine β-HCG, if 
applicable 
Tumor Markers 
Pharmacodynamic 
 
CA19-9 
CA-125 e 
CEA e 
See Table 15 for details 
 
β-HCG, beta human chorionic gonadotropin; CA-125, cancer antigen 125; CA19-9, cancer antigen 19-9; CEA, 
carcinoembryonic antigen; HIV, human immunodeficiency virus; PCR, polymerase chain reaction. 
Note: See Table 13 for the laboratory test schedule. 
a Magnesium and phosphorus at Screening and Day 1 of each cycle only. 
b Must be confirmed as negative prior to enrollment. 
c Fourth generation immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen. 
d Serologic assays for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), 
antibody to hepatitis B surface antigen (anti-HBs), and anti-hepatitis C antibodies. In equivocal cases, PCR assay 
for hepatitis B or C may be performed and must be negative for enrollment. 
e CA-125 and CEA will only be measured in those patients who do not have elevated CA19-9 at Screening.  


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6.4.8.2 
Sample Collection, Preparation, and Shipping 
Instructions for collection, preparation, and shipping of all laboratory samples will be provided 
in the study laboratory manual. Long-term retention of biological samples is described in 
Section 11.5. 
6.4.8.3 
Blood Volume Summary 
Blood samples will be used for analysis of safety laboratory, efficacy, PK, pharmacodynamic, 
and biomarker parameters (Table 6). The total volume of blood to be collected from each patient 
will be specified in the ICF. 
6.5 
Measures of Anticancer Activity  
Tumors will be assessed using CT/MRI scans and response to treatment will be determined by 
using RECIST v1.1 (Eisenhauer et al. 2009; Appendix B). In addition, this study includes 
FDG-PET scans of tumors and measurements of circulating tumor markers (CA19-9 in patients 
with elevated CA19-9 at baseline; or CEA and CA-125 in patients without elevated CA19-9). 
A baseline tumor scan with CT/MRI is required within 21 days prior to the first dose of 
relacorilant. CT scans/MRI scans with contrast of the chest, abdomen, and pelvis collected 
≤21 days before the first dose of relacorilant do not have to be repeated for the baseline 
measurement, if they meet study quality criteria and are of the same methods and technique 
anticipated to be used for radiographic tumor assessments throughout the duration of the study. 
Patients must have measurable lesions at baseline per RECIST v1.1, as determined by the 
Investigator, to be eligible for the study. Imaging for other areas of suspected metastatic disease 
(e.g. neck, brain or bones) not covered by the required imaging should also be performed. 
Subsequent post-treatment CT/MRI scans are required every 6 weeks (±7 days) from Cycle 1 
Day 1 for 24 weeks. After Week 24, subsequent CT/MRI scans will then be obtained every 
8 weeks (±7 days). CT/MRI scans will continue per this schedule, irrespective of treatment 
delays, until unequivocal PD is documented, including in patients who discontinue treatment 
prematurely. To ensure comparability, the baseline tumor scans, and subsequent tumor scans to 
assess response should be performed using the same imaging technique, acquisition, and 
processing parameters in a patient throughout the study, unless medically contraindicated.  
The use of CT from positron emission tomography (PET)/CT scans can only be used to assess 
tumor response per RECIST v1.1 if the CT scan is of diagnostic quality (i.e., use of intravenous 
contrast using a pancreas protocol). 
Tumor response will be assessed by BICR, and by the Investigator, using RECIST v1.1. 
Treatment decisions will be based on the Investigator's assessment of disease, and not based on 
the assessment by BICR. 
Confirmation of objective responses is defined as responses that persist on repeat imaging for 
2 assessments with a time period of at least 4 weeks between the 2 assessments. The 
confirmatory scan should be obtained no earlier than 4 weeks from the initial determination of 
response, and within 5 weeks of response when feasible. At the Post-Treatment Visit, a CT/MRI 
scan will be performed if ≥4 weeks have elapsed since the last radiographic tumor assessment, 


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unless there is documented PD. If PD is documented, an additional radiographic tumor 
assessment is not required as part of the final visit. 
A baseline FDG-PET scan will also be obtained prior to initiating therapy (collected ≤21 days 
before the first dose of relacorilant) and a post-baseline FDG-PET scan will be obtained 6 weeks 
(±7 days) from Cycle 1 Day 1. The area of coverage will be from the mid-thigh to the base of the 
skull, including additional areas of known or suspected disease. Accurate FDG injection and 
scan times, as well as weight height, and fasting time, must be recorded. For the FDG-PET 
review component of BICR, a single-reader paradigm will be used to review an individual 
patient’s data sequentially by time point. 
BICR readers will receive all radiographic images performed for tumor assessment from the 
sites. The process for image collection and transmission to the BICR readers are provided in the 
Site Imaging Manual. 
6.6 
Exploratory Efficacy Measures 
6.6.1 Evaluation of Sarcopenia 
The same images (CT or MRI) acquired for tumor assessments will undergo additional 
evaluation by BICR for changes in skeletal muscle mass to determine the presence of sarcopenia. 
The details for exploratory sarcopenia analysis will be documented in the imaging charter.  
6.6.2 Circulating Tumor Markers 
Circulating tumor markers (i.e., CA19-9 in patients with elevated CA19-9 at baseline, or CEA 
and CA-125 in those without elevated CA19-9) will be assessed every 4 weeks from Cycle 1 
Day 1 for the first 12 months of treatment. Baseline and follow-up measurements for any given 
patient should be performed at the same laboratory using the same testing diagnostic method, 
when possible. Treatment decisions should not be made solely on the basis of changes in 
CA19-9. Increasing CA19-9 values potentially indicative of disease progression should be 
confirmed with an additional evaluation of CA19-9 and with radiographic tumor assessments per 
RECIST v1.1 to avoid discontinuing treatment prematurely. 
6.6.3 Karnofsky Performance Status Score 
See Table 7 for KPS score criteria; KPS score will be assessed by the Investigator or a qualified 
designee at the visits indicated in Table 13.  
Patients must have a KPS score of ≥70 at Screening to be eligible for enrollment. Two observers 
are required to assess the KPS score at Screening. If the values obtained by each observer are 
discrepant, the one with the lowest assessment will be considered true. 
For visits during the Treatment Period, KPS score will be assessed prior to the nab-paclitaxel 
infusion.  


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Table 7 
Karnofsky Performance Status Score 
KPS Score 
Description 
100 
Normal, no complaints, no evidence of disease 
90 
Able to carry on normal activity, minor signs or symptoms of disease 
80 
Normal activity with effort, some signs or symptoms of disease 
70 
Cares for self. Unable to carry on normal activity or to do active work 
60 
Requires occasional assistance, but is able to care for most of his needs 
50 
Requires considerable assistance and frequent medical care 
40 
Disabled, requires special care and assistance 
30 
Severely disabled, hospitalization is indicated although death is not imminent 
20 
Hospitalization necessary, very sick, active supportive treatment necessary 
10 
Moribund, fatal processes progressing rapidly 
0 
Dead 
KPS, Karnofsky performance status. 
Source: Yates et al. 1980 
6.7 
Pharmacokinetic Assessments 
Blood samples will be collected for determination of plasma concentrations of relacorilant and/or 
its metabolites (CORT125336, CORT125337, and CORT125295). Blood samples will be also be 
collected for determination of plasma concentrations of nab-paclitaxel (Table 14).  
Standard PK parameters (Table 12) 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 of relacorilant and nab-paclitaxel will also be 
undertaken. 
6.8 
Pharmacodynamic/Biomarker Assessments 
The development and improvement of therapies increasingly depends on insights gained from 
analysis of biomarkers. During this study and with the consent of patients (see Section 10.3.1), 
biological samples (e.g., blood, plasma, and serum) will be obtained, either for analysis during 
the study or 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 relacorilant and those who do not.  
The tests will be conducted using a variety of techniques (e.g., IHC and DNA/RNA analysis). 
Pharmacodynamic assays may be performed to correlate results of biomarker assessments to the 
physiological effects of relacorilant. A schedule of pharmacodynamic assessments, with timing 
and frequency of sample collections is provided in Table 15.  


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6.8.1 Blood Collection for Glucocorticoid-Related Pathways and Exploratory Biomarkers  
Blood will be collected by venipuncture. Samples are to be obtained at the time points indicated 
in Table 15. Pharmacodynamics will be assessed by measuring fasting blood levels of insulin 
and glucose. Immune biomarkers including cytokines and immune cell characteristics will also 
be assessed. Blood samples will also be tested for markers of sarcopenia/cachexia, such as C-
reactive protein and interleukin 6.  
An immune, tumor, and GC-related gene panel (including COX2 and DUSP1) will also be 
performed. In order to permit future bridging studies to other potential GC-related gene panel 
assays, 2 additional tubes of blood must be obtained from all patients to be tested at a future date. 
In the event of DNA/RNA extraction failure, a replacement genetic blood sample may be 
requested from the patient. Signed informed consent will be required to obtain a replacement 
sample unless it was included in the original consent. 
6.8.2 Tumor Biopsy Tissue Collection 
Patients will be requested to provide an archival or recent tumor biopsy, if available. Patients 
will also have the option to consent to provide an additional on-study biopsy obtained during a 
procedure conducted as part of their standard of care. 
Tumor biopsy samples will be evaluated for pharmacodynamic markers as indicated in Table 15. 
6.9 
Patient-Reported Outcomes and Quality of Life 
PRO and QoL will be assessed in this study using the NFHSI-18 questionnaire (Butt et al. 2012), 
PROMIS (Cella et al. 2007) short form, EQ-5D-5L/VASc (Herdman et al. 2011), and a 
questionnaire for healthcare service utilization.  
Baseline PRO and QoL assessments will be collected at Screening prior to the first dose of 
relacorilant. Post-baseline assessments will be collected every cycle starting with Cycle 2 Day 1, 
at the End-of-Treatment Visit, and at the 30-Day Post-Treatment Follow-Up Visit. PRO 
assessments should be completed prior to discussing the results of tumor assessments with the 
patient. 
Patients should be encouraged to respond to all of the questions. While the patient is still at the 
site, the Investigator or designee will need to check the forms for completeness. If a patient is not 
able to complete the forms for any reason, this should be documented in the source. If a patient is 
not able to come to the site, the questionnaire may be sent (e.g., mail, courier, email, 
electronically) with a request to complete the forms and return them to the site as instructed by 
the site staff. 
6.10 
Appropriateness of the Measures 
Standard clinical, PK, statistical, and laboratory procedures will be utilized in this study. The 
efficacy measurements in this study are standard. 


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7 
STUDY ASSESSMENTS AND PROCEDURES BY STUDY VISIT 
The SoA with scheduled visit dates and acceptable visit windows is provided in Table 13. A PK 
schedule is provided in Table 14. A pharmacodynamics schedule is provided in Table 15. 
7.1 
Screening (Within 21 days Before the First Dose of Relacorilant) 
Screening will be within 21 days before the first dose of relacorilant and may take place on more 
than 1 day within the 3-week Screening Period. If a patient was screened more than 21 days 
before the date of their first administration of study drug, that patient must be rescreened. A 
patient who has failed screening due to a reason that is temporary and expected to resolve may 
be rescreened.  
At the start of the Screening Period, 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. After written 
informed consent is obtained, prospective patients will be evaluated for entry into the study 
according to the inclusion and exclusion criteria (Sections 4.1 and 4.2). 
Available measurements of CA19-9 (or CEA and CA-125 in non-CA19-9 elevated tumors) are 
required within 14 days prior to first dose of relacorilant. Patients will be requested to provide an 
archival or recent tumor biopsy, if available, for exploratory markers relevant to pancreatic 
cancer or the mechanism of action.  
A CT/MRI scan and FDG-PET scan of the chest, abdomen, and pelvis will be performed within 
21 days prior to the first dose of relacorilant to evaluate disease status per RECIST v1.1. 
The following Screening procedures will also be performed at the site:  
• Record baseline demographics  
• Record medical/oncologic history  
• Record prior and concomitant medications  
• Perform and review a serum or urine pregnancy test for female patients of childbearing 
potential prior to enrollment (48-hour window prior to the first dose of relacorilant)  
• Assess KPS score 
• Perform comprehensive physical examination  
• Measure height  
• Measure body weight  
• Record vital signs  
• Perform 12-lead ECGs (performed in triplicate)  
• Collect laboratory samples: hematology, coagulation (aPTT and INR), serum chemistry, 
urinalysis, and hepatitis B and C serologies and HIV immunoassay  
• Perform PRO/QoL assessments  
• Record AEs (only if events that occur after the time written informed consent is obtained; 
see Section 8.1) 


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7.2 
Cycle 1 Day 1 
Patients should arrive at the clinic in the fasting state for this visit. 
At the Cycle 1 Day 1 Visit, eligibility criteria will be confirmed to ensure patients continue to 
meet the inclusion and exclusion criteria. Eligible patients will then receive their first dose of 
relacorilant and be enrolled (Section 3.4.1) at this visit. Each patient enrolled will be assigned a 
patient number that will be used on patient documentation throughout the study.  
Patients will undergo the procedures listed below and enter the Treatment Period: 
• Perform and review a serum or urine pregnancy test for female patients of childbearing 
potential prior to the first dose of relacorilant (48-hour window from the first dose), if 
applicable 
• Record concomitant medications 
• Assess KPS score 
• Measure weight 
• Perform physical examination 
• Provide dose diary card to all patients 
• Dispense relacorilant (see Section 5.1) 
• Administer nab-paclitaxel (see Section 5.2) 
• Collect laboratory sample for serum chemistry and hematology 
• Collect samples for measuring circulating tumor markers (CA19-9 in patients with 
elevated CA19-9 at baseline, or CEA and CA-125 in those without elevated CA19-9) 
• Collect PK samples (see Table 14 for details) 
• Collect samples for pharmacodynamic assessments (Table 15 for details) 
• Record AEs (see Section 8.1) 
7.3 
Treatment Period 
Visits will be conducted according to Table 13. The acceptable visit window for scheduling 
conflicts during the Treatment Period is +1 days for all visits, unless the window spans a 
weekend. Visit windows are relative to the most recent infusion of nab-paclitaxel (Appendix C). 
Refer to Section 5.4.3 for nab-paclitaxel infusion delays due to toxicity. 
Study procedures at each visit will be performed according to the SoA (Table 13). Radiographic 
tumor assessments will continue every 6 to 8 weeks (±7 days) until unequivocal PD is 
documented in a patient.  
Patients should come to the clinic in the fasting state for the following visits for 
pharmacodynamic assessments (Table 15): Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 15, 
Cycle 3 Day 1, Day 1 of every 3 cycles from Cycle 3, and at the End-of-Treatment Visit/upon 
disease progression.  
The following procedures will be performed at all study visits during the Treatment Period 
according to Table 13: 
• Record concomitant medications 
• Assess treatment compliance. Patients will be instructed to return all unused study drug 
and their dose diary card at each visit. 


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The following procedures will be performed at all study visits except for Cycle 1 Day 2: 
• Administer nab-paclitaxel according to schedule (see Section 5.2) 
• Measure weight 
• Perform physical examination 
• Record vital signs 
• Collect laboratory samples: hematology and serum chemistry 
The following procedures will be performed on Day 1 of each cycle only, according to Table 13: 
• Assess KPS score 
• Provide new dose diary card to all patients 
• Dispense relacorilant (see Section 5.1) 
• Collect samples for measuring circulating tumor markers (CA19-9 in patients with 
elevated CA19-9 at baseline, or CEA and CA-125 in those without elevated CA19-9) 
• Perform PRO/QoL assessments 
7.4 
End-of-Treatment Visit 
Patients should come to the clinic in the fasting state for this visit for pharmacodynamic 
assessments. 
The following assessments should be performed during the End-of-Treatment Visit according to 
the SoA (Table 13): 
• Tumor assessments (CT/MRI) by RECIST v1.1 
• Assess KPS score 
• Record concomitant medications 
• Perform physical examination 
• Measure weight 
• Record vital signs 
• Perform 12-lead ECGs (performed in triplicate) 
• Collect laboratory samples: hematology, serum chemistry, and urinalysis 
• Collect samples for measuring circulating tumor markers (CA19-9 in patients with 
elevated CA19-9 at baseline, or CEA and CA-125 in those without elevated CA19-9) 
• Assess treatment compliance. Patients will be instructed to return all unused study drug 
and their dose diary card at each visit 
• Perform PRO/QoL assessments 
• Collect samples for pharmacodynamic assessments (see Table 15 for details) 
• Record AEs (see Section 8.1) 
For patients who end study treatment but have not yet experienced PD, the radiographic tumor 
assessments will continue until unequivocal PD is documented. 
7.5 
30-day Post-Treatment Follow-Up Visit 
The following assessments should be performed 30 days after the patient’s final dose of study 
treatment (relacorilant or nab-paclitaxel, whichever is latest) according to the SoA (Table 13): 


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• Assess KPS score 
• Record concomitant medications 
• Perform physical examination 
• Measure weight 
• Record vital signs 
• Collect laboratory samples: hematology, coagulation (aPTT and INR), serum chemistry, 
and urinalysis 
• Assess treatment compliance. Patients will be instructed to return all unused study drug 
and their dose diary card. 
• Perform PRO/QoL assessments 
• Record AEs (see Section 8.1) 
7.6 
Long-Term Follow-Up Assessment of Survival  
Patients who discontinue treatment at any time will continue to be followed for survival 
information (i.e., the date and cause of death, and subsequent treatments including date/duration 
of treatment, response, and PD on subsequent therapy). Survival information and post-therapy 
information will be collected at 3 month intervals (or as requested by the Sponsor to support data 
analysis) beginning on the date of progression and continuing until the endpoint of death, the 
patient is lost to follow-up, or until 2 years following the final dose of study treatment in the final 
patient enrolled. Post-therapy information will include name(s) of post-therapy regimens, post-
therapy dates of initiation and completion, and response to subsequent therapies and reason for 
discontinuation. Study staff will consult public records for survival status if patient withdraws 
consent. 
7.7 
Unscheduled Visits 
As appropriate, assessments deemed clinically necessary by the Investigator may be done at 
unscheduled visits. 


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8 
SAFETY EVENT DOCUMENTATION AND REPORTING 
8.1 
Adverse Event 
8.1.1 Definition 
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 a clinically significant 
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, whether or not it 
is considered to be related to the investigational product.  
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. 
8.1.2 Performing Adverse Events Assessments 
Investigators are responsible for monitoring the safety of patients who have entered this study 
and for providing appropriate medical care. 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.  
Safety results collected during the study (e.g., AEs, laboratory test results and physical findings) 
will be monitored on an ongoing basis by the Medical Monitor and Investigator.  
Collection of AEs will start immediately following signing of the ICF and will continue until 
30 days after the final dose of relacorilant or nab-paclitaxel, whichever is latest. Any worsening 
AEs or any SAEs that occur more than 30 days after the final dose of study treatment, which are 
attributed to study treatment, will also be recorded on the corresponding AE eCRF. Events of 
death that are considered related to study treatment, which occur more than 30 days after the 
final dose of study treatment, should also be recorded on the AE eCRF.  
New signs or symptoms or worsening in severity of a cancer symptom that occur in association 
with PD should be recorded as AEs. AEs that occur after the first dose of study treatment and up 
to and including 30 days after administration of the final dose of study treatment will be 
considered TEAEs. AEs reported more than 30 days after the final dose of study treatment will 
be considered post-treatment AEs.  
All AEs will be documented on the AE eCRF and in the patient’s medical record. The following 
attributes must be assigned:  
1. Description  
2. Dates of onset and resolution  
3. Severity (see Section 8.1.2.1)  
4. Relationship to study treatment (see Section 8.1.4)  


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5. Seriousness criteria if applicable (see Section 8.2.2)  
6. Action taken  
The Investigator will actively solicit this information and assess the AEs in terms of severity and 
relationship to each study drug. AEs (including laboratory abnormalities that constitute AEs) 
should be described using a unifying diagnosis whenever possible, rather than individual 
underlying signs and symptoms. 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 of the AE on the appropriate pages of the eCRF.  
If an AE leads to treatment discontinuation, the corresponding event must be recorded on the 
End-of-Treatment eCRF as the reason for treatment discontinuation. In the event that a patient is 
withdrawn from the study because of an AE, the corresponding event must be recorded on the 
End-of-Study eCRF as the reason for withdrawal.  
All AEs considered to be related (see Section 8.1.4) to study treatment and all SAEs will be 
followed until resolved or until a stable status has been achieved (see Section 8.2 for details on 
SAE reporting).  
All SAEs that are related to study treatment and unexpected (not reported in the reference safety 
information [RSI] in the IB or if the event is of greater severity or frequency than that described 
in the RSI) must be reported to the governing IRB as required by the IRB, local regulations, and 
the governing health authorities (see Section 8.2.2). 
8.1.2.1 
Adverse Event Follow-Up and Recording 
All AEs will be followed until resolution, until deemed stable by the Investigator, or until the 
patient is deemed by the Investigator to be lost to follow-up. 
8.1.3 Severity 
The seriousness of an AE should not be confused with its severity. To describe the maximum 
severity of the AE on the AE eCRF, the Investigator will use the NCI-CTCAE, v5.0 (NCI 2017). 
For events not listed in the NCI-CTCAE, the definitions from the NCI-CTCAE provided in 
Table 8 should be used to evaluate the grade of severity for the AEs. 


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Table 8 
Adverse Event Grades Based on the National Cancer Institute 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 (e.g., 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 (e.g., 
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 AE 
Source: National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (NCI 2017)  
AE, adverse event. 
8.1.4 Relationship to Study Treatment 
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 9. The Investigator’s 
assessment of causality must be provided for all AEs (serious and nonserious). Relationship to 
study treatment (relacorilant and/or nab-paclitaxel) will be assessed for all AEs. 
Table 9 
Causal Attribution Guidance for Adverse Events 
Not related  
An AE that is judged to be clearly due only to extraneous causes such as 
diseases, environment, and the like or for which it is temporally 
implausible to be related to use of the drug. The cause must be noted on 
the AE eCRF. 
Possibly related 
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, e.g., concomitant drug(s), 
concurrent disease(s). 
Probably related 
An AE that might be due to the use of the drug. The relationship in time is 
suggestive. An alternative explanation is less likely, e.g., concomitant 
drug(s) or concurrent disease(s). 
AE, adverse event; eCRF, electronic case report form. 
8.1.5 Expectedness 
An AE, regardless of seriousness, is considered unexpected if not reported in the RSI in the IB or 
if the event is of greater severity or frequency than described in the RSI. 


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8.1.6 Clinical Significance 
The Investigator is responsible for determining whether an AE is clinically significant for the 
patient or the study overall. Clinical significance will be documented in the patient’s medical 
records with the AE information. 
8.1.7 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/interruption, treatment discontinuation, 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. 
8.2 
Serious Adverse Events 
8.2.1 Definition 
An SAE is any AE that meets any of the following criteria:  
• Results in death (i.e., the AE caused or led to the fatality).  
• Is life-threatening (i.e., 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 (i.e., hospitalizations 
for scheduled treatments and elective medical/surgical procedures are not SAEs by this 
criterion). 
• Results in persistent or significant disability/incapacity (i.e., the AE results in substantial 
reduction of the patient’s ability to perform activities of daily living).  
• Results in a congenital anomaly or birth defect (i.e., an adverse finding in a child or fetus 
of a patient exposed to study treatment before conception or during pregnancy).  
• Involves other medically important conditions (i.e., 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).  
Important medical events that might not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, they 
may jeopardize the patient and may require medical or surgical intervention to prevent one of the 
outcomes listed above. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasia or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
8.2.2 Reporting Serious Adverse Events 
Any SAE occurring during the study period (beginning with informed consent) and for at least 
30 days after the final dose of relacorilant must be reported within 24 hours to the designated 
safety contact (Section 8.2.2.1) and recorded on the SAE Form. All patients with an SAE must 


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be followed and the outcomes reported. The Investigator must supply the Sponsor and the IRB 
with any additional requested information (e.g., autopsy reports and terminal medical reports).  
If an SAE results in death, the death should be considered an outcome, not an event. The event or 
condition leading to death should be recorded and reported as a single medical concept on the 
AE eCRF. Generally, only one such event should be reported. “Fatal” will be recorded as the 
outcome of this respective event; death will not be recorded as a separate event. The eCRF 
should reflect that the death was due to an AE with the corresponding reason (e.g., sepsis) 
documented. 
If the primary cause of death is PD, the cause of death should be clearly identified on the Death 
eCRF as progression of the cancer under study.  
All SAEs occurring from the time of informed consent until 30 days following the final dose of 
study treatment (relacorilant or nab-paclitaxel, whichever is latest) must be reported to the 
designated safety contact (Section 8.2.2.1) within 24 hours of the knowledge of the occurrence. 
After this period, Investigators should continue to report all deaths and SAEs that are considered 
to be related to prior treatment with study drug. Any death occurring greater than 30 days after 
the final dose of study treatment requires expedited reporting within 24 hours only if it is 
considered possibly or probably related to study treatment.  
The Investigator or designee will complete the SAE reporting form, including whether the event 
was or was not related to the investigational drug and send to the designated safety contact. The 
clinical staff will obtain and maintain all pertinent medical records, information, and medical 
judgments from colleagues who assisted in the treatment and follow-up of the patient within the 
patient files.  
The Investigator or designee will promptly inform the governing IRB of all serious, unexpected, 
drug-related events that occur at his or her site or per the IRB regulations. It is the responsibility 
of each site to submit Investigational New Drug (IND) Safety Reports, as applicable, provided to 
them by the Sponsor to their IRB as required by the IRB, local regulations, and the governing 
health authorities.  
The Investigator or designee will fax or email additional follow-up information, if required and 
available, to the contact provided within 24 hours of receipt. This information should be included 
on a follow-up SAE Form, placed with the original SAE Form, and kept with the appropriate 
section of the eCRF and/or study patient file.  
SAE reporting contact information is provided in Section 8.2.2.1. 
8.2.2.1 
Safety Reporting Contact 
Covance Safety is the SAE reporting contact for this study and can be contacted via the 
following: 
• Email: 
  
• Fax:  
 


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8.2.2.2 
Suspected Unexpected Serious Adverse Reactions 
The Sponsor will ensure that the regulatory authority is informed promptly of any Suspected 
Unexpected Serious Adverse Reaction (SUSAR) for the investigational medicinal product in 
accordance with US Regulations and EU Directive 2001/20/EC. The reference document used 
for SUSAR reporting will be the RSI in the most current version of the IB for relacorilant and the 
current US package insert or Summary of Product Characteristics for nab-paclitaxel. 
8.3 
Pregnancy 
8.3.1 Maternal Exposure 
All pregnancies occurring during the study and within 30 days of the final dose of study 
treatment should be immediately reported to the Sponsor. The outcome of any conception 
occurring from the date of the first dose of study treatment through within 30 days of the final 
dose of study treatment will be followed and documented for up to 2 months after the completion 
of pregnancy. 
8.3.2 Paternal Exposure 
Pregnancy of the patient’s partner is not considered to be an AE. However, the outcome of all 
pregnancies should be followed and documented, if possible. To capture information about a 
pregnancy from the partner of a male patient, the Investigator or designee must first obtain the 
consent of the male patient’s partner; the male patient should not be asked to provide this 
information. A consent form specific to this situation must be used. The outcome of any 
conception occurring from the date of the first dose of study treatment until 30 days after the 
final dose of study treatment should be followed and documented, for up to 2 months after the 
completion of pregnancy. 
8.4 
Treatment of Overdose 
There is currently no experience with overdose of relacorilant. The Sponsor does not recommend 
specific treatment for an overdose; however, the Investigator should:  
• Contact the Medical Monitor immediately.  
• Closely monitor the patient for any AE/SAE and laboratory abnormalities until 
any symptoms resolve.  
• Obtain a plasma sample for PK analysis within 3 days from the date of the last 
dose of study treatment if requested by the Medical Monitor (determined on a 
case-by-case basis).  
• Document the quantity of the excess dose as well as the duration of the overdose 
in the eCRF. 
8.5 
Emergency Sponsor Contact 
In a medical emergency (i.e., an event that requires immediate attention regarding the treatment 
of a patient, operation of the clinical study, and/or the use of the investigational product), study 
site personnel will apply appropriate medical intervention according to current standards of care 
and will contact the Medical Monitor. 


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9 
STATISTICAL METHODS 
9.1 
Analysis Populations 
The analysis populations are defined in Table 10.  
Table 10 
Definitions of Analysis Populations 
Population 
Description 
ITT Population/Safety Analysis 
Population 
All patients enrolled (see Section 3.4.1) and treated with at least 1 dose of 
study treatment 
Evaluable Population 
All patients in the ITT Population who have at least one post-baseline 
radiographic tumor assessment (with a result other than nonevaluable) 
PK Population 
All enrolled patients who have PK data collected and available for analysis 
ITT, Intent-to-Treat; PK, pharmacokinetics. 
9.2 
General Statistical Considerations 
The statistical analysis will be conducted by the Sponsor and/or its designee. Statistical methods 
will be prespecified and documented in detail in a statistical analysis plan (SAP), to be finalized 
before database lock. 
All relevant data collected on the eCRF will be presented in by-patient data listings, to include 
the site identifier, patient number, and starting dose group. Listings presenting study data over 
time will include the dose of study drug the patient received at the time of data collection. 
In general, continuous variables will be summarized by the number of patients with non-missing 
data, mean, standard deviation (SD), median, minimum, and maximum values. Categorical 
variables will be summarized by the number and percentage of patients in each category. 
Time-to-event variables will be summarized using Kaplan-Meier estimates and plots. 
Baseline will be defined as the most recent value prior to the first dose of relacorilant. 
9.3 
Hypothesis Testing 
Analyses of safety and efficacy will focus on estimation of treatment effects via descriptive 
statistics and confidence intervals (CIs). No formal hypotheses testing is planned. 
9.4 
Sample Size Calculation 
In this single-arm, estimation study, the efficacy analysis will include the calculation of a 
95% CI around the ORR point estimate in the Intent-to-Treat (ITT) Population. The lower bound 
of the 95% CI for ORR will be evaluated to exclude 10%. This lower bound for the ORR is 
supported by historical data in studies of third-line therapies in the setting of mPDAC 
(Section 1.1). In addition to evaluating the point and interval estimate around the ORR, the 
efficacy in this study will be evaluated by examining the DOR, as well the DCR, of at least 
18 weeks.  
A total of 80 patients in the ITT Population are expected to provide sufficient precision for the 
interval estimates for ORR. In Table 11, the 95% CI estimates around ORR were obtained using 


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the Clopper-Pearson method (Clopper and Pearson 1934). Patients with no post-baseline 
radiographic tumor assessments available will be considered nonresponders.  
Table 11 
Two-Sided 95% Confidence Intervals of Objective Response Rates with 
80 Patients in the Intent-to-Treat Population 
Number of ORs 
ORR Estimate 
95% CI of ORR 
(%) 
8 
10.0% 
4.4 – 18.8 
10 
12.5% 
6.2 – 21.8 
12 
15.0% 
8.0 – 24.7 
14 
17.5% 
9.9 – 27.6 
16 
20.0% 
11.9 – 30.4 
18 
22.5% 
13.9 – 33.2 
22 
27.5% 
18.1 – 38.6 
CI, confidence interval; OR, objective response; ORR, objective response rate. 
 
With 80 patients planned in the study, and assuming a median survival of 6.5 months, with 
12 months of accrual, 18 months of study duration, and a 10% drop-out rate, approximately 
50 OS events will be observed by the end of the study.  
9.5 
Analysis Plan 
9.5.1 Patient Disposition 
Patient disposition summaries will include the number of enrolled patients, the number of 
enrolled patients in each analysis population, the number of patients completing the study per 
protocol, and the number of patients terminating the study early by the primary reason for 
withdrawal. 
9.5.2 Demographic and Baseline Data 
Demographics baseline data will include frequency and percentages for categorical variables, 
and mean, SD, median, minimum, and maximum for continuous variables. Demographic and 
baseline characteristics will be summarized for all patients.  
9.5.3 Prior and Concomitant Medications 
Verbatim terms on eCRFs will be mapped to Anatomical/Therapeutic Chemical (ATC) class and 
Generic Drug Names using the most current version of the World Health Organization (WHO) 
Drug Dictionary at the time of the analysis. Concomitant medications will be summarized for all 
patients.  
The duration of treatment on the prior nab-paclitaxel regimen (if applicable) and on the most 
recent treatment regimen will be calculated.  


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9.5.4 Efficacy Analyses 
Response rate endpoints will be summarized by providing the point and interval estimates. 
Time-to-event variables will be summarized using Kaplan-Meier estimates and plots. Event 
probabilities at 4-, 6-, and 12-month time points and the median time-to-event (if estimable) will 
be presented.  
9.5.4.1 
Analysis of Primary Efficacy Endpoint 
The primary endpoint is defined in Section 3.2.1. 
The primary analysis of ORR per BICR will be performed in the ITT Population. ORR will also 
be analyzed in the Evaluable Population, as a supportive analysis to the primary endpoint 
analysis. The point estimate and 95% CI will be provided using the Clopper-Pearson method 
(Clopper and Pearson 1934). Patients in the ITT Population with no valid post-baseline 
radiographic tumor assessments will be considered nonresponders.  
9.5.4.2 
Analysis of Secondary Efficacy Endpoints 
The secondary efficacy endpoints are defined in Section 3.2.2. 
Best overall response will be analyzed in the ITT and Evaluable Populations. It will be reported 
as the number and percentages of patients achieving CR, PR, stable disease, PD, and 
nonevaluable as their best response recorded from the date of enrollment across all time points 
during study observation period, according to BICR, and according to Investigator assessment. 
Patients who have a post-baseline scan that cannot be evaluated because of the quality of the 
image or other reasons will have “nonevaluable” recorded as their response at that visit. If all 
post-baseline scans are inevaluable, the patient will have “nonevaluable” recorded as their 
best response. Best overall response will be presented categorically and graphically as a 
waterfall plot.  
DOR will be analyzed in the ITT and Evaluable Populations. DOR is measured from the date 
that the criteria are met for CR or PR until the first date that PD is objectively documented or 
death (all cause) whichever comes first. DOR will be analyzed using Kaplan-Meier methods. 
Censoring rules will be described in the SAP. 
DCR will be analyzed in the ITT and Evaluable Populations. DCR is defined as the percentage 
of patients who have achieved confirmed CR or PR, or stable disease for ≥18 weeks. The point 
estimate and 95% CI will be calculated using the Clopper-Pearson method. Patients in the ITT 
Population with no valid post-baseline radiographic tumor assessment will be considered 
nonresponders.  
PFS will be analyzed in the ITT and Evaluable Populations. PFS is defined as the time from 
enrollment to the date the patient experiences unequivocal disease progression per RECIST v1.1 
or death (all causes of mortality), whichever comes first. PFS will be analyzed using 
Kaplan-Meier methods. Censoring rules will be described in the SAP. 
OS will be analyzed in the ITT and Evaluable Populations. OS is defined as the time from 
enrollment until the date of death from any cause. OS will be analyzed using Kaplan-Meier 
methods. Censoring rules will be described in the SAP.  


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Estimates of PFS rates at 3, 6, and 12 months will be calculated using Kaplan-Meier methods. 
OS rate (proportion of patients surviving) at 3, 6, and 12 months will be calculated using Kaplan-
Meier methods. 
Change in CA19-9 from baseline in patients who have elevated CA19-9 at baseline (baseline 
CA19-9 >ULN) will be reported for the ITT and Evaluable Populations. Summary statistics will 
be provided at each of the time points during the observation period. 
Percentage of patients with elevated CA19-9 at baseline who have ≥50% reduction in CA19-9 at 
8 and 16 weeks will be reported for the ITT and Evaluable Populations. The point estimate and 
the 95% CI (using the Clopper-Pearson method) will be reported. 
FDG-PET tumor response will be summarized at 6 weeks for the ITT and Evaluable Populations. 
FDG-PET response will be reported as the number and percentages of patients achieving 
complete metabolic response, partial metabolic response, stable metabolic disease, and 
progressive metabolic disease according to BICR assessment of changes in standardized uptake 
values (SUVs) from the baseline FDG-PET scan to the post-baseline (6-week) scan using 
EORTC criteria (Young et al. 1999). The SUVs obtained from FDG-PET scans will be 
summarized by visit in a table and presented graphically in waterfall plots. 
TTP on study treatment will be summarized in the ITT and Evaluable Populations. TTP is 
defined as the time from enrollment to disease progression per RECIST v1.1 as determined by 
the Investigator. TTP will be analyzed using Kaplan-Meier methods. Censoring rules will be 
described in the SAP. 
9.5.4.3 
Analysis of Exploratory Endpoints 
The exploratory efficacy endpoints are defined in Section 3.2.3. 
Presence of sarcopenia by CT/MRI scans of body composition (i.e., skeletal muscle mass) will 
be analyzed in the ITT and Evaluable Populations. The percent change in skeletal muscle mass 
from baseline will be summarized. Summary statistics will be provided at each of the post-
baseline time points during the observation period. 
Change in CEA and CA-125 from baseline, in patients who do not have elevated CA19-9 at 
baseline, will be reported for the ITT and Evaluable Populations. Summary statistics will be 
reported for each time point during the observation period. 
The percentage of patients with elevated CEA who have ≥50% reduction in CEA, at 8 weeks and 
16 weeks, will be reported for ITT and Evaluable Populations. Point estimates and 95% CIs 
(using Clopper-Pearson method) will be provided. 
The percentage of patients with elevated CA-125 who have ≥50% reduction in CA-125, at 
8 weeks and 16 weeks, will be reported for the ITT and Evaluable Populations. Point estimates 
and 95% CIs (using the Clopper-Pearson method) will be provided. 
All PRO/QoL endpoints (Section 6.9) will be analyzed in the ITT Population and summarized 
for patients experiencing clinical benefit (response and/or disease control ≥18 weeks). Summary 
statistics will be provided for baseline and observed values at all post-baseline time points during 


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the observation period as well as changes from baseline. Details on analysis methods will be 
provided in the SAP. 
9.5.4.3.1 Subgroup Analyses 
The primary and secondary efficacy endpoints will be analyzed for the following subgroups of 
the ITT and Evaluable Populations: 
• Prior progression on/after nab-paclitaxel-based therapy 
• Prior lines of therapy (2 vs. ≥3) 
• Demographics (age, gender, race) 
• KPS score (≥70 to <90 vs. ≥90 to 100) 
• Site of metastatic disease (lung and lymph nodes only vs. liver vs. other) 
• Time since diagnosis of pancreatic ductal adenocarcinoma to time of informed consent 
• Original tumor location (head vs. body vs. tail of pancreas) 
9.5.5 Safety Analyses 
Safety analyses will be conducted on the Safety Analysis Population as described in Section 9.1.  
The incidence of TEAEs, defined as AEs occurring after the first dose of study treatment through 
30 days after the final dose of study treatment, will be summarized using Medical Dictionary for 
Regulatory Activities (MedDRA) by system organ class and preferred term. TEAEs will be 
further summarized by severity and relationship to study treatment. For each patient, if multiple 
incidences of the same AEs occur, the maximum severity reported will be used in summaries.  
All AEs (whether TEAEs or not) will be listed by individual patient, including information 
regarding onset, duration, severity, and relationship to study drug. SAEs and AEs that lead to 
withdrawal from the study will be listed by individual patient.  
The following AEs will be summarized separately: AEs leading to discontinuation of study drug 
(relacorilant or nab-paclitaxel), dose reduction or interruption, Grade ≥3 AEs and SAEs.  
All deaths and causes of deaths will be summarized and listed.  
Clinical laboratory test results, vital sign measurements, and abnormal ECG values will be 
summarized by parameter, visit, and time point using descriptive statistics, to include the change 
from baseline values. Shift tables will be constructed that describe changes from baseline to the 
end of treatment.  
By-patient safety listings will be provided. 
9.5.6 Pharmacokinetic Analysis 
PK parameters of nab-paclitaxel and relacorilant and its metabolites will be calculated, and 
analyte concentration versus time plots will be provided. Example PK variables for analysis are 
listed in Table 12; details of the PK analyses will be described in the SAP finalized before 
database lock. PK analyses will be performed on the PK Population (Section 9.1).  


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Table 12 
Pharmacokinetic Variables for Analysis 
%AUCex 
Proportion of AUC0-∞ estimated by extrapolation after tz, as a percentage 
λz 
Apparent terminal rate constant  
AUC 
Area under the concentration-time curve 
AUC0–24h 
AUC values from time 0 to 24 hours post-dose 
AUC0-∞ 
AUC values from time 0 extrapolated to infinity 
AUCinf 
AUC values from time 0 extrapolated to infinity 
AUClast 
AUC values from time 0 to time of last measurable concentration 
AUC0-tz 
AUC from time 0 until tz 
AUCtau 
AUC over a dose-interval 
Cmax 
Maximum concentration 
Cmin 
Minimum concentration within a dose interval 
CL/F 
Apparent oral clearance  
t1/2 
Apparent terminal elimination half-life 
tlag 
Latest time after dosing before the first quantifiable concentration 
Tmax 
Time to maximum concentration 
Tmin 
Time of minimum concentration in a dose interval 
tz 
Time after dosing of the last quantifiable concentration 
9.5.7 Pharmacodynamic Analysis 
Pharmacodynamic parameters and biomarker results will be listed and summarized using 
descriptive statistics, as appropriate. Biomarker and pharmacodynamic exploratory analyses will 
be further described in the SAP finalized before database lock. The GC-related gene panel will 
be assessed as defined in the SAP. 
9.5.8 Patient-Reported Outcomes and Quality of Life 
Data collected using the PRO instruments and QoL assessments will be listed and summarized 
using descriptive statistics. 
9.5.9 Interim Analysis 
The IDMC (Section 3.6) will perform an interim assessment of safety and efficacy (which will 
include all patients enrolled in the study) after 40 patients have enrolled and met at least one of 
the following criteria: 
1) Completed at least 12 weeks of treatment, including the second radiographic tumor 
assessment and have at least 1 post-baseline tumor assessment with a result other than 
nonevaluable. 
2) Discontinued the study due to disease progression or toxicity. 


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A total of 40 patients in the Evaluable Population are expected to provide sufficient precision for 
the interval estimates for ORR at the interim analysis in order to allow the IDMC to make an 
informed recommendation.  
The following decision rules are proposed as guidelines for IDMC recommendations: 
1) If the point estimate for ORR as assessed by Investigator is ≥20%, then continue with 
enrollment to a total sample size of 80 patients. 
2) If the point estimate for ORR as assessed by Investigator is ≥10% and <20%, then the 
IDMC will consider the totality of the available evidence for efficacy and safety in 
making a recommendation to continue enrollment in this study. For this purpose, the 
IDMC will be provided with the summaries of the primary and key secondary 
endpoints, together with the summaries on safety endpoints. 
3) If the point estimate for ORR is <10%, then no additional patients will be enrolled and 
the treatment with relacorilant 100 mg once daily and nab-paclitaxel 80 mg/m2 will be 
considered futile. 
Following this initial assessment of safety and efficacy, subsequent reviews of safety will be 
based upon the recommendations from the IDMC, with a minimum frequency of approximately 
every 12 months. 
In reviewing interim trial results, the IDMC will consider the overall risk and benefit to study 
participants and will make recommendations regarding steps to ensure both patient safety and the 
continued ethical integrity of the study. The IDMC may recommend introducing changes in the 
protocol based on futility, toxicity, or compelling evidence of efficacy. 
In making a recommendation to terminate the study for any reason, the IDMC will consider 
information on safety endpoints, as well as consistency of outcomes, secondary endpoints, and 
may consider additional evaluation of efficacy (e.g., calculated predictive probabilities). Further 
details on the interim analysis will be provided in the SAP and IDMC Charter.  


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10 
ETHICAL AND LEGAL CONSIDERATIONS 
10.1 
Compliance with Investigational Review Board Regulations 
This study is to be conducted in accordance with IRB regulations (US 21 CFR Part 56.103) or 
applicable local regulations. The protocol, ICFs, recruitment materials, and all patient materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and the 
consent form must be obtained before any patient is enrolled, and the Investigator must submit 
written approval to the Sponsor, before enrolling any patient. The Investigator is responsible for 
informing the IRB of any amendment to the protocol in accordance with local requirements. The 
protocol must be re-approved by the IRB/IEC on receipt of amendments and annually, as local 
regulations require. 
All changes to the consent form must be approved by the IRB; a determination will be made 
regarding whether previously consented patients need to be re-consented 
The Sponsor 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 the Sponsor or the Sponsor’s designee. 
Progress reports and notifications of serious adverse drug reactions will be provided to the IRB 
according to local regulations and guidelines. 
10.2 
Ethical Conduct of the Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with ICH GCP and applicable regulatory 
requirements. 
 
The Investigator will ensure that the study procedures outlined in this protocol will be conducted 
in accordance with applicable country and local regulations. 
10.3 
Protection of Human Patients 
10.3.1 Compliance with Informed Consent 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 Investigator(s) at each center will ensure that the patient is given full and adequate oral and 
written information about the nature, purpose, possible risk, and benefit of the study. Patients 
must also be notified that they are free to discontinue from the study at any time. The patient 
should be given the opportunity to ask questions and allowed time to consider the information 
provided. 
• The ICF will contain all of the elements required by ICH GCP and any additional 
elements required by local regulations. 
• The ICF must include information about the possible retention of biological samples at 
the conclusion of this study; with the patient’s permission, samples may be retained for 


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future determination of active metabolite concentrations and possible biomarkers related 
to drug response. 
• The patient’s signed and dated ICF must be obtained before conducting any study 
procedures. 
• The Investigator(s) must maintain the original, signed ICF. A copy of the signed ICF 
must be given to the patient. 
• 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 
tissue samples may be retained for future analysis to help identify biomarkers of disease 
or relacorilant treatment.  
10.3.2 Patient Confidentiality 
To maintain patient privacy, all source documents, study reports, and communications will 
identify the patient by initials and the assigned patient number. The Investigator will grant 
monitor(s) and auditor(s) from the Sponsor or their designee and regulatory authority access to 
the patient’s original study records for verification of data gathered on source documents and to 
audit the data collection process. The patient’s confidentiality will be maintained and will not be 
made publicly available to the extent permitted by applicable laws and regulations. 
10.3.3 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 or its designee, regulatory agencies, and the IRB. It is the 
Investigator’s (or designee’s) responsibility to obtain written permission to use protected health 
information per country-specific regulations 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. 


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11 
ADMINISTRATIVE CONSIDERATIONS 
11.1 
Study Monitoring 
Monitoring of the study site (including, but not limited to, reviewing eCRFs for accuracy and 
completeness, and assessing compliance with the protocol and adherence to regulatory and GCP 
requirements) will be performed by the Sponsor’s Clinical Monitor or designee.  
• Monitoring will be performed in accordance with applicable local and country 
regulations and guidance. 
• Monitoring will include regular site visits and communication with the Investigator and 
site staff as appropriate to discuss and answer study questions; ensure compliance with 
the protocol; and ensure quality and integrity of the data.  
• Monitors will ensure the site maintains an adequate supply of investigational products; 
any necessary supplies and ensure that appropriate storage conditions are maintained. 
• Monitoring visits will be conducted according to the US CFR Title 21 parts 50, 56, and 
312; and ICH GCP.  
Monitoring methods, responsibilities, and requirements will be outlined in a study monitoring 
plan. 
11.2 
Quality Management 
As part of quality management based on a risk-based approach per ICH E6(R2): 
Risk reduction activities may be incorporated in protocol design and implementation, monitoring 
plans, agreements between parties defining roles and responsibilities, systematic safeguards to 
ensure adherence to standard operating procedures, and training in processes and procedures.  
Predefined quality tolerance limits should be established, taking into consideration the medical 
and statistical characteristics of the variables as well as the statistical design of the trial, to identify 
systematic issues that can impact subject safety or reliability of trial results. Detection of deviations 
from the predefined quality tolerance limits should trigger an evaluation to determine if action 
is needed.  
Study sites, the study database, and study documentation will be monitored regularly and may be 
subject to a quality assurance audit during the study by the Sponsor or its designee on behalf of 
the Sponsor. In addition, inspections may be conducted by regulatory agencies at their discretion. 
Quality control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/resolution.  
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements (e.g., Good Laboratory Practices, Good Manufacturing 
Practices).  
The investigational site will provide direct access to all trial-related sites, source data/documents, 
and reports for the purpose of monitoring and auditing by the Sponsor, and inspection by local 
and regulatory authorities. 


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11.3 
Documentation 
11.3.1 Electronic Case Report Forms and Study Records 
The Investigator must generate and maintain complete, adequate, accurate, reliable, and 
consistent records to enable full documentation of study conduct. Study data will be captured on 
eCRFs. Investigators must retain all original source documents, and the Sponsor or its designee 
will notify Investigators in writing when the trial-related records are no longer needed. 
11.3.2 Access to Source Documentation 
The Sponsor or its representative will be allowed to conduct site visits to the investigational 
facilities for the purpose of monitoring any aspect of the study. The Investigator agrees to allow 
the monitor to inspect the drug storage area, study drug stocks, drug accountability records, 
patient charts and source documents, and other records relative to study conduct. 
By signing the protocol, the Investigator agrees that, within local regulatory restrictions and 
institutional and ethical considerations, authorized representatives of the Sponsor, a regulatory 
authority, and/or an IRB may visit the site to perform audits or inspections, including the drug 
storage area, study drug stocks, drug accountability records, patient charts and source documents, 
and other records relative to study conduct. The purpose of a Sponsor audit or inspection is to 
systematically and independently examine all study-related activities and documents (e.g., 
laboratory reports, x-rays, workbooks, and patients’ medical records) to determine whether these 
activities were conducted, and data recorded, analyzed, and accurately reported according to the 
protocol, ICH GCP, and any applicable regulatory requirements.  
The Investigator should contact the Sponsor immediately if contacted by a regulatory agency 
regarding an inspection. 
11.3.3 Source Documents 
Source documents are all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Examples 
of these original documents and data records include, but are not limited to, 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 CRFs 
must be substantiated by a source document. 
11.3.4  Study Files and Retention of Study Records 
The Investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified.  
Study documents should be retained for a minimum of 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 until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the study drug. These documents should be retained 
for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the Sponsor, if applicable. It is the responsibility of the Sponsor to 
inform the Investigator when these documents no longer need to be retained. 


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Patient identification codes (patient names and corresponding study numbers) will be retained for 
this same period of time. These documents may be transferred to another responsible party, 
acceptable to the Sponsor, who agrees to abide by the retention policies. Written notification of 
transfer must be submitted to the Sponsor. The Investigator or designee must contact the Sponsor 
before disposing of any study records. 
11.4 
Sample Collection, Preparation, and Shipping 
Instructions for collection, preparation, and shipping of all laboratory samples will be provided 
in the study laboratory manual. 
11.5 
Long-Term Retention of Biological Samples 
No samples will be retained long-term (i.e., beyond end of study and database closure) without 
prior written consent of the patient and IRB approval.  
All long-term, retention samples will be retained by the Sponsor or its designee. The long-term 
retention samples will be coded to allow de-identification according to applicable regulatory 
guidelines. 
If a study patient does not provide consent for the future use of the patient’s samples, that 
patient’s samples will be destroyed. After conclusion of this study, if a study patient provides 
consent, the long-term samples will be held for a period up to 10 years, after which they will be 
destroyed.  
During the conduct of the study, an individual patient can choose to withdraw consent to have 
his or her samples stored for future research.  
It is the responsibility of the trial site to ensure that samples are appropriately labeled in 
accordance with trial procedures to comply with all applicable laws.  
11.6 
Clinical Supplies 
11.6.1 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 Table 1. 
11.6.2 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. 


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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 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 clinical research associate) has confirmed the accountability data and Sponsor has 
approved return or destruction. 
11.6.3  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 the Sponsor or the Sponsor’s designee for destruction. 
Unused study drug may be destroyed on site, per the site’s SOPs, but only after Sponsor has 
granted approval for drug destruction. The study 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.  
Documentation must be provided to the 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 the 
Sponsor upon request. The return of study drug or study drug materials must be accounted for on 
a Study Drug Return Form provided by the Sponsor. 
11.7 
Drug Accountability 
It is the responsibility of the Investigator to maintain drug accountability at the study site and 
ensure that a current record of investigational product disposition is maintained. It is the 
responsibility of the Investigator to ensure that the investigational product is used only in 
accordance with the approved protocol. This includes acknowledgment of receipt of each 
shipment of study product (quantity and condition), patient dispensing records, and returned or 
destroyed study product. Dispensing records will document quantities received from the Sponsor 
or its designee and quantities dispensed to patients, including lot number, date dispensed, patient 
identifier number, patient initials, and the initials of the person dispensing the drug. At the end of 
the study, after final drug inventory reconciliation by the study monitor, the study site will 
dispose of and/or destroy all unused investigational medicinal product supplies, including empty 
containers, according to SOPs. 
11.8 
Post-Trial Care 
There is no provision for continuation of the investigational drug beyond the end of study 
treatment. The Sponsor will work with the Investigator to ensure that study participants continue 
to receive appropriate care, which may include referral to an ongoing clinical trial, with this or 
another investigational treatment or may involve transition to medical management outside the 
research context. 
11.9 
Noncompliance with the Protocol 
Prospective approval of deviations from the inclusion and exclusion criteria, also known as 
protocol waivers or exemptions, is not permitted. 


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A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or manual of 
procedures requirements. The noncompliance may be either on the part of the patient, the 
Investigator, or the study site staff. As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly. These practices are consistent with ICH E6.  
The Investigator should not implement any deviation from the protocol without prior review and 
agreement by the Sponsor in writing and in accordance with the IRB and local regulations, 
except when necessary to eliminate an immediate hazard to study patients. When a deviation 
from the protocol is deemed necessary for an individual patient, the Investigator must obtain 
approval in writing from the Sponsor. 
Such contact must be made as soon as possible to permit a review by the Sponsor to determine 
the impact of the deviation on the patient and/or the study. 
Any significant protocol deviations affecting patient eligibility and/or safety must be reviewed 
and/or approved by the IRB and regulatory authorities, as applicable, prior to implementation. 
11.10  Financial Disclosure 
Investigators will be required to disclose any financial equity interests in the Sponsor and any 
conflicts of interest, as defined by the Sponsor.  
11.11 Publication and Disclosure Policy 
Corcept, as the Sponsor, has a proprietary interest in this study.  
No individual publications will be allowed before publication of the multicenter results except as 
agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the 
Sponsor for review before submission to the publisher. 
The Sponsor will comply with the requirements for publication of study results and 
determination of authorship in accordance with standard editorial and ethical practice and with 
the International Committee of Medical Journal Editors requirements.  
 


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12 
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Tempero MA, Malafa MP, Al-Hawary M, Asburn H, Bain A, Behrman SW, et al. 2017. 
Pancreatic adenocarcinoma, version 2. NCCN clinical practice guidelines in oncology. J 
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and positron emission tomography: review and 1999 EORTC recommendations. 
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APPENDIX A: SCHEDULES OF ASSESSMENTS 
 


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Table 13 
Schedule of Clinical Assessments and Procedures 
Study Period 
Screening 
Treatment Period 
EOT 
Visit 
30-day 
Post-
Treatment 
Follow-Up a  
Long-Term 
Follow-Up b 
(Every 
3 months 
after EOT) 
Cycle 1 
Cycle 2 + 
Clinic Visit 
 
(see Note below table for windows) 
Within 
21 days prior 
to the first  
dose of 
relacorilant 
Day 1 
Day 2 
Day 8 
Day 15 
Day 1 
Day 8 
Day 15 
Informed Consent 
X 
X 
 
 
 
 
 
 
 
 
 
Review Inclusion and Exclusion 
Criteria 
X 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
Medical/Oncologic History 
X 
 
 
 
 
 
 
 
 
 
 
Prior and Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Serum/Urine Pregnancy Test c 
X 
 
 
 
 
X c 
 
 
 
 
 
Tumor Biopsy d 
X 
 
 
 
 
 
 
 
 
 
 
Tumor and Sarcopenia 
(% Skeletal Muscle Mass) 
Assessment by CT or MRI e 
X 
Every 6 wks until 24 wks, then every 8 wks e 
X 
 
 
FDG-PET scan 
X 
 
 
 
 
X  
[6 wks only] 
 
 
 
 
 
CA19-9, CA-125, and CEA f 
X 
X 
 
 
 
X 
 
 
X f 
 
 
Karnofsky Performance Status 
X 
X 
 
 
 
X 
 
 
X 
X 
 
Physical Examination g 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Vital Signs 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Hematology h 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Coagulation (aPTT and INR) 
X 
 
 
 
 
 
 
 
 
X 
 


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Study Period 
Screening 
Treatment Period 
EOT 
Visit 
30-day 
Post-
Treatment 
Follow-Up a  
Long-Term 
Follow-Up b 
(Every 
3 months 
after EOT) 
Cycle 1 
Cycle 2 + 
Clinic Visit 
 
(see Note below table for windows) 
Within 
21 days prior 
to the first  
dose of 
relacorilant 
Day 1 
Day 2 
Day 8 
Day 15 
Day 1 
Day 8 
Day 15 
Serum Chemistry i 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Urinalysis j 
X 
 
 
 
 
 
 
 
X 
X 
 
Hepatitis B and C Serologies 
and HIV 
X 
 
 
 
 
 
 
 
 
 
 
12-lead ECG (Triplicate) 
X 
 
 
 
 
 
 
 
X 
 
 
Provide Dose Diary Card 
 
X 
 
 
 
X 
 
 
 
 
 
Nab-paclitaxel Dosing (IV) 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
Dispense Relacorilant 
 
X 
 
 
 
X 
 
 
 
 
 
Relacorilant Dosing (Once 
Daily, by Mouth) 
 
 
 
 
 
Assess Treatment Compliance k 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
PK Sampling l 
 
X 
X 
 
X 
 
 
 
 
 
 
Pharmacodynamic Sampling m 
 
X 
X 
 
X 
X  
 
 
X 
 
 
Patient-Reported Outcomes and 
Quality of Life n 
X 
 
 
 
 
X 
 
 
X 
X 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Long-Term Follow-Up 
 
 
 
 
 
 
 
 
 
 
X 
aPTT, activated partial thromboplastin time; CA-125, cancer antigen 125; CA19-9, cancer antigen 19-9; CEA, carcinoembryonic antigen; CT, computed 
tomography; ECG, electrocardiogram; EOT, End-of-Treatment; FDG-PET, fluorodeoxyglucose-positron emission tomography; GR, glucocorticoid receptor; 
HIV, human immunodeficiency virus; INR, international normalized ratio; IV, intravenously; PK, pharmacokinetics; wks, weeks. 
Visit Window Note: Study visits will align with nab-paclitaxel infusion days during the Treatment Period. Refer to Appendix C for acceptable treatment 
windows for nab-paclitaxel based on scheduling, and Section 5.4.3 for dose delays due to toxicity. 
Procedural Window Note: Screening hematology and chemistry laboratory tests can be used for Cycle 1 Day 1 values if collected within 48 hours of the first 
dose of relacorilant. For all other visits, pre-dose laboratory procedures can be conducted up to 72 hours prior to the study visit/nab-paclitaxel infusion. 
FDG-PET scan can be performed within a 7-day window. 


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a  The Follow-Up Visit should be performed 30 days after the patient receives their final dose of study treatment (relacorilant or nab-paclitaxel, whichever is 
latest).  
b  Long-Term Follow-Up: survival information (i.e., the date and cause of death) and subsequent treatment information (i.e., date/duration of treatment, response, 
and disease progression on subsequent therapy). Follow-up will continue every 3 months until the endpoint of death, the patient is lost to follow-up, or until 
2 years following the final dose of study treatment in the final patient enrolled. 
c  A serum or urine pregnancy test for female patients of childbearing potential prior to the first dose of relacorilant (48-hour window from the first dose) and 
then every 12 weeks ±7 days. 
d  Patients will be requested to provide an archival or recent tumor biopsy, if available. Patients will also have the option to consent to provide an additional on-
study biopsy obtained during a procedure conducted as part of their standard of care. 
e  CT/MRI scans will be performed within 21 days prior to the first dose of relacorilant and then every 6 to 8 weeks (±7 days) from Cycle 1 Day 1 (irrespective 
of treatment delays) until unequivocal disease progression is documented, including in patients who prematurely discontinue therapy. The same method should 
be used for each assessment for a particular patient. The same images (CT or MRI) acquired for tumor assessments will undergo additional evaluation for 
changes in skeletal muscle mass to determine the presence of sarcopenia. The details for analysis of sarcopenia will be documented in the imaging charter. 
f  Available measurements of CA19-9 (or CEA and CA-125 in non-CA19-9 elevated tumors) are required within 14 days prior to first dose of relacorilant. 
During the Treatment Period, circulating tumor markers (i.e., CA19-9 in patients with elevated CA19-9 at baseline, or CEA and CA-125 in those without 
elevated CA19-9) will be assessed every 4 weeks from Cycle 1 Day 1 for the first 12 months of treatment.  
g  A comprehensive physical examination will be performed at Screening, Cycle 1 Days 1 and 15, and Day 1 of each subsequent cycle, and at the End-of-
Treatment Visit. A targeted physical examination will be performed at Days 8 and 15 of each cycle. 
h  Hematology assessments to include complete blood count with differential within 72 hours of study visit/nab-paclitaxel infusion. 
i  Serum chemistry assessments will include those listed in the clinical laboratory assessments table. 
j  Urinalysis at Screening, End-of-Treatment Visit, and 30-day Post-Treatment Follow-Up Visit. Microscopy is required only to follow-up clinically significant 
urine dipstick findings. Urinalysis assessments are listed in the clinical laboratory assessments table. 
k  Patient compliance will be assessed by reconciliation of the used and unused study drug.  
l Pharmacokinetics will be characterized after dosing with the combination of nab-paclitaxel and relacorilant, on Cycle 1 Days 1, 2, and 15. Details are provided 
in Table 14. 
m  At Cycle 1 Day 1, samples will be collected pre-dose and at 4 hours post-dose. All other collections will be pre-dose. Details are provided in Table 15. 
n  Baseline patient-reported outcome assessments must be collected prior to the first dose of relacorilant. Post-baseline assessments will be collected every cycle 
starting with Cycle 2 Day 1, at the End-of-Treatment Visit, and at the 30-day Post-Treatment Follow-Up Visit. Patient-reported outcome assessments should be 
completed prior to discussing the results of tumor assessments with the patient. 
 


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Table 14 
Pharmacokinetic Schedule of Assessments 
PK Sample 
Day 
Nominal Time 
Window 
Relacorilant and nab-paclitaxel 
 
Cycle 1 Day 1 a 
 
Pre-dose 
<1 hour before relacorilant 
4 hours 
 
From the start of nab-paclitaxel  
infusion ±10 minutes 
Cycle 1 Day 2 a 
Pre-dose 
<1 hour before relacorilant and within 
30 minutes from the start of nab-paclitaxel 
infusion 
Cycle 1 Day 15 
Pre-dose 
<1 hour before relacorilant and within 
30 minutes from the start of nab-paclitaxel 
infusion 
0.5 hour 
 
From the start of nab-paclitaxel  
infusion ±10 minutes 
 
0.75 hour 
1 hour 
2 hours 
4 hours 
6 hours 
PK, pharmacokinetics. 
a PK assessments on Cycle 1 Day 1 and Cycle 1 Day 2 are paired with identically scheduled biomarker assessments. 


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Table 15 
Pharmacodynamic Schedule of Assessments 
Procedure/Assay 
Tissue 
Source 
Visit Schedule 
Cycle Day 
Methodology; Examples of 
Biomarkers 
HOMA-IR 
Blood 
Fasting, pre-dose (preferably 7-9 am) at:  
Cycle 1 Day 1, plus an additional collection 4 hours post-dose 
Cycle 1 Day 2 
Cycle 1 Day 15 
Cycle 3 Day 1 
Every 3 cycles from Cycle 3a 
EOT 
Disease progression c 
Fasting blood glucose and insulin  
Immune, tumor, and GC-related 
gene panel including COX2 and 
DUSP1 
Blood 
Fasting, pre-dose (preferably 7-9 am) at:  
Cycle 1 Day 1, plus an additional collection 4 hours post-dose 
Cycle 1 Day 2 
Cycle 1 Day 15 
Cycle 3 Day 1  
Every 3 cycles from Cycle 3 a 
EOT 
Disease progression c  
mRNA expression by technologies 
such as Nanostring 
Exploratory cytokines, circulating 
tumor markers, and/or markers of 
sarcopenia or cachexia 
Blood 
Fasting, pre-dose (preferably 7-9 am) at:  
Cycle 1 Day 1, plus an additional collection 4 hours post-dose 
Cycle 1 Day 2 
Cycle 1 Day 15 
Cycle 3 Day 1  
Every 3 cycles from Cycle 3 a 
EOT 
Disease progression c 
Immunoassay panel for cytokines 
related to immune and GC function, 
markers of sarcopenia or cachexia 
(such as CRP and IL-6), and/or 
circulating tumor markers 


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Procedure/Assay 
Tissue 
Source 
Visit Schedule 
Cycle Day 
Methodology; Examples of 
Biomarkers 
Immune, tumor, and GC-related 
gene panel including COX2 and 
DUSP1  
Tumor biopsy 
sample b 
As provided (optional) b 
Formalin fixed, paraffin embedded 
tissue sample; microdissection and 
assessment of mRNA expression of 
genes involved in tumor GR-signaling, 
chemotherapy resistance, tumor 
immune response, apoptosis, and 
metabolism 
Immunohistochemistry for 
immune infiltrate, PD-L1, and 
other exploratory markers  
Tumor biopsy 
sample b 
As provided (optional) b 
Formalin fixed, paraffin embedded 
tissue sample; assessment of immune 
infiltrate, PD-L1 IHC assay, and/or 
other histological methods 
Mutation and homologous 
recombination deficiency 
assessment d 
Tumor biopsy 
sample b 
As provided (optional) 
Formalin fixed, paraffin embedded 
tissue sample; DNA sequencing 
analysis, such as FoundationOne 
CDxTM panel 
COX2, cyclooxygenase 2; CRP, C-reactive protein; DUSP1, dual-specificity phosphatase 1; EOT, End-of-Treatment; GC, glucocorticoid; HOMA-IR, 
homeostatic model assessment of insulin resistance; IHC, immunohistochemistry; IL-6, interleukin 6; PD-L1, programmed death-ligand 1. 
a After 1 year, the sampling frequency will decrease to every 6 months. 
b Patients will be requested to provide an archival or recent tumor biopsy, if available, for GR immunohistochemistry and other exploratory markers relevant to 
pancreatic cancer or the mechanism of action. Patients will also have the option to consent to provide an additional on-study biopsy obtained during a 
procedure conducted as part of their standard of care. 
c If a patient discontinues treatment for reasons other than disease progression, a sample will be collected upon disease progression. 
d If FoundationOne or comparable DNA mutation assay has been completed, de-identified data from biopsy is requested. 
 


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APPENDIX B: RESPONSE CRITERIA 
Tumor response and assessment according to Response Evaluation Criteria in Solid Tumors 
(RECIST) v1.1 is described below. This appendix is not exhaustive and the source 
(Eisenhauer et al. 2009) should be referred to for further detail.  
Measurement of Lesions 
All measurements should be recorded in metric notation, using calipers if clinically assessed. All 
baseline evaluations should be performed as close as possible to the treatment start and never 
more than 4 weeks before the beginning of the treatment. 
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up. Imaging based evaluation should 
always be done rather than clinical examination unless the lesion(s) being followed cannot be 
imaged but are assessable by clinical exam. 
Clinical lesions: Clinical lesions will only be considered measurable when they are superficial 
and ≥10 mm diameter as assessed using calipers (e.g., skin nodules). For the case of skin lesions, 
documentation by color photography including a ruler to estimate the size of the lesion is 
suggested. As noted above, when lesions can be evaluated by both clinical exam and imaging, 
imaging evaluation should be undertaken since it is more objective and may also be reviewed at 
the end of the study. 
Computed tomography (CT) is the best currently available and reproducible method to measure 
lesions selected for response assessment. CT (with intravenous and oral contrast) should be 
performed with cuts of 5 mm or less in slice thickness contiguously. Magnetic resonance 
imaging (MRI) can be performed if required but should have Sponsor approval. 
For accurate objective response evaluation, ultrasound should not be used to measure tumor 
lesions. 
Measurable Tumors 
Tumor lesions must be accurately measured in at least one dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of: 
• 10 mm on the long axis for non-nodal lesions by CT/MRI scan (slice thickness no 
greater than 5 mm).  
• 15 mm on short axis for nodal disease by CT/MRI scan (slice thickness no greater 
than 5 mm) 
• 10 mm caliper measurement by clinical exam (lesions which cannot be accurately 
measured with calipers should be recorded as nonmeasurable). 
Nonmeasurable Tumors 
All other lesions, including small lesions (longest diameter <10 mm or pathological lymph nodes 
with ≥10 to <15 mm short axis) as well as truly nonmeasurable lesions. Lesions considered truly 
nonmeasurable include: leptomeningeal disease, ascites, pleural or pericardial effusion, 
inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 


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masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques. 
Special Considerations Regarding Lesion Measurability 
Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular 
comment: 
Bone Lesions: 
• Bone scan, PET scan or plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. 
• Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, 
that can be evaluated by cross sectional imaging techniques such as CT or MRI can be 
considered as measurable lesions if the soft tissue component meets the definition of 
measurability described above. 
• Blastic bone lesions are nonmeasurable. 
Cystic Lesions: 
• Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor nonmeasurable) since they are, 
by definition, simple cysts. 
• ‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable 
lesions, if they meet the definition of measurability described above. However, if 
noncystic lesions are present in the same patient, these are preferred for selection as 
target lesions. 
Lesions with Prior Local Treatment: 
• Tumor lesions situated in a previously irradiated area, or in an area subjected to other 
loco-regional therapy, are not considered measurable unless there has been demonstrated 
progression in the lesion.  
Tumor Response Evaluation 
Assessment of Overall Tumor Burden and Measurable Disease 
To assess objective response or future progression, it is necessary to estimate the overall tumor 
burden at baseline and use this as a comparator for subsequent measurements.  
Patients with measurable or nonmeasurable disease are eligible. Measurable disease is defined as 
above, by the presence of at least one measurable lesion.  
Baseline Documentation of ‘Target’ and ‘Nontarget’ Lesions 
When more than one measurable lesion is present at baseline all lesions up to a maximum of 
5 lesions total (and a maximum of 2 lesions per organ) representative of all involved organs 
should be identified as target lesions and will be recorded and measured at baseline. 
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 


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reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does 
not lend itself to reproducible measurement in which circumstance the next largest lesion which 
can be measured reproducibly should be selected. 
Response criteria as defined below should be used: 
• Evaluation of Target Lesions 
– Complete Response (CR): Disappearance of all target lesions. Any pathological 
lymph nodes (whether target or nontarget) must have reduction in short axis to 
<10 mm. 
– Partial Response (PR): At least a 30% decrease in the sum of the diameters (SOD) of 
target lesions, taking as reference the baseline SOD. 
– Progressive Disease (PD): At least a 20% increase in the SOD of target lesions, 
taking as reference the smallest sum recorded since the treatment started or the 
appearance of one or more new lesions. In addition to the relative increase of 20%, 
the sum must also demonstrate an absolute increase of at least 5 mm. The 
development of unequivocal new lesions (not attributed to differences in scanning 
technique, imaging modality, or flare/healing of pre-existing lesions) will also be 
considered PD. 
– Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase 
to qualify for PD, taking as reference the smallest SOD since the treatment started. 
• Special Notes on the Assessment of Target Lesions 
– Lymph nodes identified as target lesions should always have the actual short axis 
measurement recorded (measured in the same anatomical plane as the baseline 
examination), even if the nodes regress to below 10 mm on study. This means that 
when lymph nodes are included as target lesions, the ‘sum’ of lesions may not be zero 
even if CR criteria are met, since a normal lymph node is defined as having a short 
axis of <10 mm. Case report forms or other data collection methods may therefore be 
designed to have target nodal lesions recorded in a separate section where, to qualify 
for CR, each node must achieve a short axis <10 mm. For PR, stable disease and PD, 
the actual short axis measurement of the nodes is to be included in the sum of target 
lesions. 
• Evaluation of Nontarget Lesions 
– CR: Disappearance of all nontarget lesions and normalization of tumor marker level. 
– Incomplete Response/Stable Disease (non-CR/non-PD): Persistence of one or more 
nontarget lesion(s) or/and maintenance of tumor marker level above the normal 
limits. 
– PD: Appearance of one or more new lesions and/or unequivocal progression of 
existing nontarget lesions. 
• Special Notes on Assessment of Progression of Nontarget Disease 
– To achieve ‘unequivocal progression’ on the basis of the nontarget disease, there 
must be an overall level of substantial worsening in nontarget disease such that, even 
in presence of stable disease or PR in target disease, the overall tumor burden has 
increased sufficiently to merit discontinuation of therapy.  


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– A modest increase in the size of one or more nontarget lesions is usually not 
sufficient to qualify for unequivocal disease progression. In the absence of PD by 
CT/MRI per RECIST v1.1, an increase in uptake and metabolism of [18F]-FDG 
is not sufficient to declare disease progression and should not be the basis for 
treatment discontinuation. Clinical deterioration or changes on FDG-PET that may 
be indicative of disease progression, including new “hot spots” suggestive of new 
lesions, should be confirmed by biopsy or CT/MRI scan per RECIST v1.1. 


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APPENDIX C: GENERAL CHEMOTHERAPY GUIDELINES 
• A patient will be permitted to have a new cycle of chemotherapy delayed up to 7 days 
(without this being considered to be a protocol deviation) for major life events (e.g., 
serious illness in a family member, major holiday, vacation which is unable to be 
re-scheduled). Documentation to justify this decision should be provided. 
• It will be acceptable for nab-paclitaxel doses to be delivered within a 1-day window after 
the scheduled date of treatment, except if the treatment due date is a Friday. In that case, 
if the patient cannot be treated on the Friday, then the acceptable window for treatment 
would include the following Monday (Day 3 past due).  
For example:  
– “Day 8 chemotherapy” can be delivered on Day 8 or Day 9, unless Day 9 is a 
Saturday and then Day 8 chemotherapy can be delivered on Day 11 
– “Day 15 chemotherapy” can be given on Day 15 or Day 16, unless Day 16 is a 
Saturday and then Day 15 chemotherapy can be delivered on Day 18 
• Chemotherapy doses can be “rounded” according to institutional standards without being 
considered a protocol deviation (most institutions use a rule of approximately ±5% of the 
calculated dose). 
• Chemotherapy doses are required to be recalculated if the patient has a weight change of 
greater than or equal to 10%. Patients are permitted to have chemotherapy doses 
recalculated for <10% weight changes. 
• If a patient has a dose interruption for >7 days, subsequent study visits/procedures may 
be omitted upon discussion with the Medical Monitor. Study assessments should be 
obtained and reviewed prior to the patient resuming study treatment. Radiographic tumor 
assessments should continue every 6 to 8 weeks, independent of treatment delays or 
interruptions, and AEs should be recorded during this time period according to Section 8. 


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APPENDIX D: EXAMPLES OF PROHIBITED MEDICATIONS OR MEDICATIONS 
TO BE USED WITH CAUTION 
The following medications are examples (not a comprehensive list) of prohibited medications or 
medications to be used with caution or avoided, if possible, during the study: 
 
Prohibited 
Permitted but Use with Caution 
or Avoid if Possible 
CYP3A Inducers 
St. John’s wort, rifampin 
Bosentan, efavirenz, etravirine, 
modafinil, nafcillin 
Carbamazepine, phenytoin 
CYP3A Inhibitors 
Grapefruit and Seville oranges (including 
marmalade and juices made from these fruits) 
Boceprevir, clarithromycin, conivaptan, indinavir, 
itraconazole, ketoconazole, lopinavir/ritonavir, 
mibefradil, nefazodone, nelfinavir, posaconazole, 
ritonavir, saquinavir, telaprevir, telithromycin, 
voriconazole 
Amprenavir, aprepitant, atazanavir, 
ciprofloxacin, darunavir/ritonavir, 
diltiazem, erythromycin, 
fluconazole, fosamprenavir, 
verapamil 
CYP3A Substrates 
Alfentanil, aprepitant, astemizole, budesonide, 
buspirone, cisapride, conivaptan, cyclosporine, 
darifenacin, darunavir, dasatinib, 
dihydroergotamine, dronedarone, eletriptan, 
eplerenone, ergotamine, everolimus, felodipine, 
fentanyl, indinavir, fluticasone, lopinavir, 
lovastatin, lurasidone, maraviroc, midazolam, 
nisoldipine, pimozide, quetiapine, quinidine, 
saquinavir, sildenafil, simvastatin, sirolimus, 
tacrolimus, terfenadine, tolvaptan, tipranavir, 
triazolam, ticagrelor, vardenafil 
-- 
CYP2C8 Inhibitors 
Gemfibrozil 
Glimepiride, tolbutamide a 
Corticosteroids or 
GR Modulators 
Mifepristone or other GR antagonists 
Topical or oral corticosteroids 
Abbreviations: CYP, cytochrome P450; GR, glucocorticoid receptor. 
a   For patients receiving sulfonylureas, conduct close glucose monitoring to assess for diabetic control. 
Note: The table of examples above is not comprehensive. For additional information, see the prescribing information 
of the respective medications and the following websites for information on drug interactions: 
http://www fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm
080499.htm; http://medicine.iupui.edu/clinpharm/ddis/main-table/  


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APPENDIX E: SUMMARY OF CHANGES 
Significant changes in Amendment 1 dated 20 January 2020 of the protocol compared with the 
Original Protocol dated 08 July 2019 are summarized below with additional details provided in 
Table 16. Minor editorial or stylistic changes made for consistency are not shown in the redline 
version of the amendment.  
This protocol amendment was written to: 
• Change the study phase from Phase 2 to Phase 3 and adjust sample size estimates 
accordingly. 
• Change inclusion criteria from “histologically confirmed mPDAC” to “histologically 
confirmed PDAC with metastatic” to clarify that histology from metastatic site is not 
necessary. 
• Change in inclusion criteria so that prior lines of therapy could have occurred in any 
disease setting and are not restricted to the metastatic setting. 
• Change timing of radiographic tumor assessments: 
– Post-baseline CT/MRI scans will now be conducted every 6 weeks (±7 days) from 
Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent CT/MRI scans will then be 
obtained every 8 weeks (±7 days). 
– A post-baseline FDG-PET scan will now be obtained 6 weeks (±7 days) from Cycle 1 
Day 1. 
• Add additional decision rules as proposed guidelines for IDMC recommendations at 
Interim Analysis. 
 


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Table 16 
Summary of Changes in Protocol CORT125134-553 Amendment 1  
Section 
Revision 
Global changes made but not 
shown in the redline 
version 
Incorporated editorial and stylistic changes as appropriate (e.g., corrected typos, 
added hyphens, and defined acronyms). 
Updated the table of contents and the lists of tables and figures. 
Updated all table, figure, and section numbers. 
Global changes made and 
shown in the redline 
version 
For the version of the protocol, changed “Original” to “Amendment 1” and 
changed the date from 08 July 2019 to 20 January 2020. 
Updated study title to reflect the study name “RELIANT.” 
Deleted text referring to Independent Ethics Committees (IECs) because this 
study will be conducted in the United States only. 
Updated citations and references, as appropriate. 
Updated study phase: Phase 23 
Updated number of patients: 7180 patients 
Updated periodicity of CT/MRI scans: every 6 to 8 weeks 
Updated timing of post-baseline FDG-PET scan: 68 weeks (±7 days) from 
Cycle 1 Day 1 
Added “radiographic” before tumor assessments, where appropriate, to clarify 
intent. 
Revised “last dose” to “final dose”, where appropriate, to clarify intent. 
Revised text for consistency in using the term “the Sponsor” to indicate Corcept. 
Cover Page 
 and added 
 as Medical Monitor. 
Removed EudraCT number as the study will be conducted in the US only. 
Synopsis 
Updated the text in the synopsis to align with the changes in the following 
sections of the body of the protocol. 
1 Introduction: Background 
Information and Scientific 
Rationale 
Revised the last paragraph of this section: 
This Phase 2 3 study (RELacorilant In Pancreatic Adenocarcinoma with 
Nab-PacliTaxel [RELIANT]) is designed to evaluate the efficacy, safety, 
pharmacokinetics (PK), and pharmacodynamics, of relacorilant in combination 
with nab-paclitaxel in patients with metastatic pancreatic ductal 
adenocarcinoma (mPDAC). Patients must have histologically confirmed 
mpancreatic ductal carcinoma (PDAC) with metastatic disease and have 
received at least 2 prior lines of therapy for pancreatic ductal 
adenocarcinoma (PDAC)and documented disease progression on nab
paclitaxel to participate. 
1.1 Pancreatic Cancer 
Revised the last sentence of this section to align with the updated statistical 
methodology: 
…the lower bound of the 95% CI for ORR will be evaluated to exclude 510% 
(Section 9.4). 
1.1.1 Therapeutic Hypothesis 
Revised the text to align with the updated inclusion criteria. 
1.2.1.2 In Vivo Studies 
Replaced Figure 1 to remove “GR antagonist” from figure legend. 
1.2.2 Clinical Summary 
Updated the text related to safety and efficacy data in Study CORT125134-550 
to align with the current version of the relacorilant Investigator’s Brochure 
(Edition 7). 
1.4 Rationale for Study 
Design and Dose Regiment 
Revised text to align with updated inclusion criteria. 
1.4.1 Differences Statement 
Revised text to align with updated inclusion criteria. 


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Section 
Revision 
1.4.2 Rationale for Study 
Design 
Revised text to align with updated inclusion criteria. 
1.4.3 Rationale for Dose 
Selection 
Added text to reflect current efficacy data from Study CORT125134-550: 
Tumor response has also been observed in patients receiving relacorilant 
in combination with nab-paclitaxel in the Phase 1 Study CORT125134 
550, including in patients who have previously received taxane treatment. 
1.4.4 Rationale for Dose 
Regimen 
 
Modified text to reflect updated approach related to dosing: 
In the current study, relacorilant will be administered at 100 mg once daily 
(continuous dosing), with a possible increase to a maximum dose of 150 mg 
once daily (Section 5.1.1), based on preliminary efficacy and safety results 
from Study CORT125134-550. In this study, disease control of 16 weeks or 
greater has been observed in 7 patients with PDAC, including 4 patients with 
PDAC having PR on this combined treatment regimen (). Three of these 
patients achieved PR despite having progressed on 2 or more prior lines of 
therapy before entering the study (Section 1.2.2.1). 
Added rationale for the dose regimen: 
The initial starting dose of nab-paclitaxel in Study CORT125134-550 was 
80 mg/m2 when dosed with continuous relacorilant (100 mg) to account for 
the expected CYP3A-mediated drug-drug interaction resulting in 
increased nab-paclitaxel exposure. Overall, the toxicities observed with 
the dosing regimen were largely consistent with those of nab-paclitaxel 
monotherapy and were manageable in a similar fashion to weekly nab 
paclitaxel. Across all dose levels and dosing regimens, dose-limiting 
toxicities (DLTs) as defined by Grade 3 or higher toxicities leading to 
greater than 1 week delay of nab-paclitaxel during the first cycle of 
treatment consisted of neutropenia, febrile neutropenia, rash, 
thrombocytopenia, hand/foot syndrome, peripheral neuropathy, colitis, 
diarrhea, and mucositis, with AEs of neutropenia constituting the 
majority of the DLTs. Due to the DLTs of neutropenia, primary 
prophylaxis with G-CSF was mandated and neutropenia was manageable 
with this implementation. For the continuous relacorilant schedule, the 
dose regimen selected for further clinical evaluation was relacorilant 
100 mg and nab-paclitaxel 80 mg/m2 (administered on Days 1, 8, and 15 of 
a 28-day cycle) with G-CSF. Of the 13 evaluable patients at this dose level, 
4 patients experienced DLTs (neutropenia [2], colitis, and peripheral 
neuropathy). The feasibility of this dose regimen was further evaluated in 
patients with previously treated pancreatic adenocarcinoma and was 
determined to be suitable for evaluation in this patient population. The 
highest starting relacorilant dose level tested in Study CORT125134-550 
with the continuous regimen was relacorilant 150 mg in combination with 
nab-paclitaxel 80 mg/m2. The single patient enrolled to the pancreatic 
cohort at this dose level experienced a DLT of Grade 3 rash; 1 of the 
3 patients enrolled to the advanced solid tumor cohort at this dose level 
experienced a DLT of Grade 3 febrile neutropenia that led to greater than 
1 week interruption of study drugs. This dose level was closed to further 
enrollment as an alternative dosing strategy of upward titration from a 
starting daily dose of relacorilant 100 mg was considered to be more 
favorable than starting at the higher dose. The pharmacodynamic effect of 
a GR antagonist for a given dose or exposure varies among individuals. 
Similarly, glucocorticoid hormone response is known to vary among 
individuals as well as within the same individual and has presented a 
challenge to scientists and clinicians when using GR agonists. In order to 
optimize the dose for each individual in the presence of by-patient 
variability in PK and sensitivity to GR antagonism and to minimize the  




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Section 
Revision 
2.2.1 Efficacy Objectives 
Modified the objectives to: 
• To evaluate the duration of response (DOR) according to the Investigator and 
BICR 
• To evaluate DCR (CR, PR, or stable disease) at 1618 weeks, as assessed by the 
Investigator 
• To evaluate PFS rate at 2, 4, 3, 6, and 12 months 
• To evaluate OS rate at 4, 3, 6, and 12 months 
• To assess tumor response based on changes in fluorodeoxyglucose-positron 
emission tomography (FDG-PET) scan at 8 6 weeks per European 
Organization for Research and Treatment of Cancer (EORTC) criteria, 
according to BICR 
• To evaluate the time to progression (TTP) on study treatment (relacorilant + 
nab-paclitaxel). The duration of disease control and TTP on prior nab-
paclitaxel therapy (if applicable), and on the most recent therapy will also be 
described. 
2.3 Exploratory Objectives 
Added an objective for KPS score, which is now an exploratory efficacy 
endpoint: 
• To assess changes in Karnofsky performance status (KPS) score. 
Revised the following exploratory objective to reflect the intent of capturing 
PRO and QoL endpoints: 
• To assess PRO and QoL in terms of physical function, symptoms, and 
utilization of health care resources. 
3.1 Overall Design 
Modified the text to reflect the increased number of study sites: 
Patients will enroll at approximately 25 30 centers in the US and globally. 
Modified text to reflect updated inclusion criteria: 
Patients with mPDAC who have received at least 2 prior lines of therapy for 
PDAC in any setting, including at least 1 prior gemcitabine-based therapy 
and at least 1 prior fluoropyrimidine-based therapyand who had 
documented disease progression on nab paclitaxel will be eligible to enroll in 
the study. 
Modified the text related to the timing of radiographic tumor assessments 
Subsequent CT/MRI scans will be obtained every 8 6 weeks (±7 days) from 
Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent CT/MRI scans will 
then be obtained every 8 weeks (±7 days). CT/MRI scans will continue per 
this schedule until unequivocal disease progression is documented, including 
in patients who prematurely discontinue therapy. 
Replaced Figure 2 to reflect the updates to timing for CT/MRI and FDG-PET 
scans. 
Removed GR IHC under Pharmacodynamics/Biomarkers. 
Added the following text under Pharmacokinetics: 
Blood samples will be collected for determination of plasma PK 
parameters of relacorilant and/or its metabolites (CORT125336; 
CORT125337; CORT125295). Blood samples will be also be collected for 
determination of plasma PK parameters of nab-paclitaxel. 
3.2.1 Primary Efficacy 
Endpoint 
Updated the wording: 
The primary efficacy endpoint is ORR, defined as the percentage of patients with 
measurable disease at baseline who achieve confirmed CR or PR per RECIST 
v1.1, according to BICR of tumor scans. 


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Section 
Revision 
3.2.2.1 Secondary Efficacy 
Endpoints 
Modified the text to add DOR per BICR as an efficacy endpoint and updated the 
endpoints to align with updated the timing of radiographic tumor assessments: 
• DOR as measured from the data that the criteria are met for CR and PR 
until the first date that PD is objectively documented and determined by 
BICR 
• DCR, defined as the percentage of patients who have achieved CR, PR, or 
stable disease for ≥1618 weeks, as determined by the Investigator 
• PFS rate (proportion of patients who have not progressed) at 2, 43, 6, and 12 
months 
• OS rate (proportion of patients surviving) at 43, 6, and 12 months 
• Tumor response assessed by FDG-PET at 86 weeks per EORTC criteria, 
according to BICR 
3.2.2.2 Safety Endpoints 
Removed the KPS score endpoint (now an exploratory efficacy endpoint): 
• Change from baseline in Karnofsky performance status (KPS) score 
3.2.3.1 Exploratory Efficacy 
Endpoints 
Added an exploratory efficacy endpoint: 
• Change from baseline in KPS score 
3.2.3.2 Pharmacodynamic 
Endpoints 
Removed GR from the markers listed. 
3.2.3.3 Patient-Reported 
Outcomes and Quality-of-
Life Endpoints 
Added EuroQoL 5 Dimensions 5 Levels to the endpoints, and formatted 
endpoints as bullets. 
3.3.2 Patient Study 
Completion 
Added definition of study completion. 
3.4.2 End of Treatment 
Revised text to clarify last treatment is relacorilant or nab-paclitaxel, whichever 
is latest. 
3.6 Independent Data 
Monitoring Committee 
Added the following statement: 
Enrollment will be paused such that the interim assessment can be 
conducted by the IDMC before additional patients are enrolled. 
4.1 Inclusion Criteria 
Revised the inclusion criteria: 
3. Have histologically confirmed mPDAC with metastatic disease. 
4. Have received at least 2 prior lines of therapy for mPDAC in any setting, 
but no more than 4 prior lines of cytotoxic or myelosuppressive therapy for 
mPDAC. All adjuvant and neo adjuvant therapies within the past 12 months 
will be counted toward the maximum lines of therapy including at least 1 
prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-
based therapy. 
5. Have received at least 1 prior gemcitabine based therapy and at least 1 prior 
fluorouracil based therapy no more than 4 prior lines of cytotoxic or 
myelosuppressive therapy for PDAC.  
6. Have documented disease progression on nab paclitaxel or within 90 days 
of the last dose of nab paclitaxel therapy. Radiographic reports must be 
made available for documentation of disease progression. 
12. Have stable pain symptoms. Pain symptoms should not require 
modifications in analgesic management prior to enrollment. 


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4.1 Inclusion Criteria 
17. 15. Patients of childbearing potential must use appropriate precautions to 
avoid pregnancy:  
a. Women who are postmenopausal or permanently sterilized are considered 
of nonchildbearing potential. A woman is postmenopausal if it has been 
≥12 months since her last menstruation, without an alternative medical 
cause. Accepted methods of permanent sterilization methods are 
hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy.  
b. Women of childbearing potential must use a highly effective contraception 
with low user-dependency throughout the study and then for at least 
6 months after the final dose of relacorilant or nab-paclitaxel, 
whichever is latest after the last dose of study treatment. Accepted 
methods of highly effective contraception with low user-dependency 
are:… 
c. Oral hormonal contraceptives are NOT permitted. 
d. Male patients should agree to use an adequate method of contraception 
starting with the first dose of study treatment through 120 days3 months 
after the last final dose of study treatment (relacorilant or nab-
paclitaxel, whichever is latest). Male patients should not father a 
child while receiving study treatment (including refraining from 
sperm donation). 
4.2 Exclusion Criteria 
Revised the exclusion criteria: 
1. Have pancreatic neuroendocrine tumors, lymphoma of the pancreas, acinar 
pancreatic cancer, or ampullary cancer. 
5. Have taken the following medications prior to enrollment: 
a. 
An investigational product, cytotoxic chemotherapy or targeted agent 
within 21 14 days or 5 half lives, whichever is longer. 
b. Radiotherapy within 21 days. 
c. 
Palliative radiotherapy within 2 1 weeks of Cycle 1 Day 1, or if 
toxicities from radiotherapy are Grade 2 severity or higher or have 
not recovered to baseline. If palliative radiation therapy included the 
pelvis, a minimum of 3 weeks is required between palliative radiotherapy 
and enrollment. 
d. Systemic, inhaled, or prescription strength topical corticosteroids for the 
purposes of treating a chronic nononcologic indication within 21 days.  
6. Have a requirement for treatment with chronic or frequently used oral or 
inhaled corticosteroids for medical conditions or illnesses (e.g., rheumatoid 
arthritis, asthma, or immunosuppression after organ transplantation). 
7. Are taking a concomitant medication that is a strong and moderate CYP3A 
or CYP2C8 inhibitor or inducer, or a strong and moderate CYP3A 
inducer, or that is highly dependent ona substrate metabolism byof CYP3A 
or CYP2C8 and has a narrow therapeutic window (See Appendix D).  
8. Concurrent treatment with mifepristone or other GR antagonists. 
8. Are women who are pregnant, lactating, or who intend to become pregnant 
within 3 months after the last dose of study treatment. 
11.Have had endoscopic retrograde cholangiopancreatography within 7 days 
prior to enrollmentwith persistence of any of the following: 
a. Bilirubin ≥1.5 × ULN 
b. Amylase >2 × ULN and abdominal pain or amylase >3 × ULN (with 
or without symptoms) 
c. 
Fever or signs of infection 
d. Decreasing hemoglobin or signs of blood loss 


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Section 
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4.2 Exclusion Criteria 
(continued) 
13. Have a rapid decline in KPS score or serum albumin (≥20%), or have 
progressive pain symptoms indicative of rapid clinical deterioration in the 
opinion of the Investigator, prior to enrollment. These patients will become 
ineligible if rapid decline is observed during the Screening Period. 
4.4 Patient Discontinuation 
of Treatment or Study 
Completion/Withdrawal 
Wording in this section was revised to clearly indicate what should happen when 
a patient discontinues treatment, completes the study, or withdraws consent. 
4.4.1 Discontinuation 
of Study Treatment 
Reasons for treatment discontinuation were revised for clarity. 
 
4.4.2 Patient Withdrawal 
from Study/Study 
Completion 
Reasons a patient may exit from the study were revised for clarity. 
 
4.4.3 Long Term Survival 
Follow Up 
Removed this section as it is redundant with Section 7.6.  
4.6 Restrictions During Study 
Removed cranberry as a restricted food. 
5.1 Relacorilant 
Revised the text in Table 1 for consistency with the label provided on study drug. 
Added the recommendation to take relacorilant with food. 
Added information related to the permitted temperature excursions for study drug 
storage. 
5.1.1 Relacorilant Dose 
Titration 
Added text to reflect that the relacorilant dose can be increased to 150 mg, if 
tolerated. 
5.2 Nab-Paclitaxel 
Deleted text in row “Administration” which was redundant with the row 
“Regimen”. 
5.4 Dose-Adjustment Criteria 
Revised the text in this section and added a table to specify the appropriate dose 
modifications for nab-paclitaxel and relacorilant, in case of toxicities. 
5.4.1 Dose Modifications 
Reductions or Delays for 
Relacorilant 
Revised the text and added a table of relacorilant dose levels (up to 150 mg and 
down to 100 mg) to provide guidance in case dose modification is needed. 
5.4.2 Management of Signs 
of Excessive 
Glucocorticoid Receptor 
Antagonism 
Modified the text to clarify that symptoms of GR antagonism could occur due to 
relacorilant treatment: 
There is the possibility thatFor patients treated with relacorilant, could 
experience signs or symptoms related to excessive GR antagonism may 
develop. 
5.4.3 Dose Modifications 
Reductions or Delays for 
Nab-Paclitaxel 
Revised the text and added a table of nab-paclitaxel dose levels in case dose 
reductions are needed to provide clarification on what to do if the starting dose 
(80 mg/m2) is not tolerated. 
5.5 Concomitant Medications 
and Procedures 
Revised the text to reflect: 
• Systemic corticosteroids are permitted if clinically required, for example as a 
premedication to a contrast agent 
• Marijuana is permitted but should be used with caution with relacorilant 
• Other GR antagonists are prohibited 
• Align text to the changes made to Appendix D (Examples of Prohibited 
Medications or Medications to be Used with Caution) 
6.4.5 Triplicate 12-Lead 
Electrocardiogram 
Revised the header and text to clarify that ECGs should be performed in 
triplicate. 


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Section 
Revision 
6.4.6 Karnofsky Performance 
Status Score 
Moved to Section 6.6 Exploratory Efficacy Measures, as this is now an 
exploratory efficacy endpoint. 
6.4.9 6.4.8 Clinical 
Laboratory Assessments 
Removed mean corpuscular volume, prothrombin time, and C-peptide and from 
the planned laboratory assessments. 
Modified the text in Table 6 for clarity: Serum or urine β-HCGpregnancy test 
6.5 Measures of Anticancer 
Activity 
Added text to clarify approach for areas of suspected metastatic disease: 
Imaging for other areas of suspected metastatic disease (e.g. neck, brain 
or bones) not covered by the required imaging should also be performed. 
Modified the text to reflect the updated periodicity of radiographic tumor 
assessments: 
Subsequent post-treatment CT/MRI scans are required every 8 6 weeks (±7 
days) from Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent 
CT/MRI scans will then be obtained every 8 weeks (±7 days). CT/MRI 
scans will continue per this schedule, irrespective of treatment delays, until 
unequivocal PD is documented, including in patients who discontinue 
treatment prematurely. 
6.7.2 Evaluation of 
Sarcopenia 
Moved to Section 6.6 Exploratory Efficacy Measures, as this is an exploratory 
efficacy endpoint. 
6.7.1 6.8.1 Blood Collection 
for Glucocorticoid-Related 
Pathways and Exploratory 
Biomarkers 
Removed C-peptide from the list of assessments. 
Added the following text: 
In order to permit future bridging studies to other potential GC-related 
gene panel assays, 2 additional tubes of blood must be obtained from all 
patients to be tested at a future date. 
6.9 Patient-Reported 
Outcomes and Quality of 
Life 
Added EQ-5D-5L/VASc 
7 Study Assessments and 
Procedures by Study Visit 
Revised the text to align with the study schedule. 
7.6 Long-Term Follow-Up 
Assessment of Survival 
Revised text to provide details on the Long-Term Follow-Up Assessments. 
8 Safety Event 
Documentation and 
Reporting 
Revised text to clarify that clinically significant (rather than all) abnormal 
laboratory findings classify as AEs. 
Revised the text to specify that after the 30-day follow-up period AEs which 
worsen or SAEs, which are considered related to study treatment, should be 
recorded. 
Added text to indicate that any deaths considered related to study treatment 
occurring greater than 30 days after the final dose of study treatment should 
also be recorded. 
Removed Table 5 Follow-up Recording of AEs and Deaths as it was redundant 
with the text. 
Added text to section 8.1.4 and modified text in Table 9 to provide clarity on 
causality relationship.  
 Relationship to study treatment (relacorilant and/or nab-paclitaxel) will 
be assessed for all AEs. 
Added the Safety Reporting Contact as Section 8.2.2.1. 
9.1 Analysis Populations 
Clarified the definition of the ITT Population. 


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Section 
Revision 
9.4 Sample Size Calculation 
Revised the text to reflect the primary analysis will be in the ITT Population. 
Revised the text to align with the updated number of planned participants 
(changed from 71 to 80 patients) and timing of radiographic tumor assessments 
(changed from every 8 weeks to every 6 weeks). 
Revised the method for estimating CIs from Blaker to Clopper-Pearson method. 
Revised the expected number of OS events in Table 11 based on the updated 
statistical considerations. 
9.5.3 Prior and Concomitant 
Medications 
Revised text considering updated inclusion criteria (prior nab-paclitaxel therapy 
is no longer required). 
9.5.4.1 Analysis of Primary 
Efficacy Endpoint 
Revised the text to reflect the primary analysis will be in the ITT Population, 
with supportive analysis in the Evaluable Population. 
9.5.4.1 Analysis of 
Secondary Efficacy 
Endpoints 
Revised the text to reflect the data will be analyzed in the ITT and Evaluable 
Populations. 
9.5.4.1 Analysis of 
Exploratory Endpoints 
Revised the text to reflect the data will be analyzed in the ITT and Evaluable 
Populations. 
Replaced Blaker method with Clopper-Pearson method. 
9.5.4.3.1 Subgroup Analyses 
Added the following to the planned subgroup analyses: 
• Prior progression on/after nab-paclitaxel-based therapy 
9.5.6 Pharmacokinetic 
Analysis 
Revised the text to clearly indicate which analyses are planned. 
Removed AUCglucose from the table of PK parameters. 
9.5.7 Pharmacodynamic 
Analysis 
Revised the text to clearly indicate which analyses are planned. 
9.5.8 Patient-Reported 
Outcomes and Quality of 
Life 
Added a subsection to cover the analysis of PRO and QoL endpoints. 
9.5.8 9.5.9 Interim Analysis 
Added decision rules for IDMC recommendations and reflected update to the 
sample size (from 71 to 80 patients) and efficacy endpoints. 
11.2 Quality Management 
Added a paragraph regarding a risk-based approach per ICH E6(R2), which is 
aligned with the current Corcept protocol template. 
11.5 Long-Term Retention of 
Biological Samples 
Revised the text to reflect the intended approach for the future use of patient 
samples. 
12 References 
Updated the references to match citations used in the text. 
Appendix A 
Revised Table 13 to align with updated the timing for radiographic tumor 
assessments, revisions to the clinical laboratory assessments, and for 
consistency with the changes in the protocol. 
Revised Table 15 to align with the changes in the protocol. 
Appendix D 
Updated Appendix D table to clarify which medications are prohibited or to be 
used with caution or avoid if possible, aligned with the prescribing information 
for nab-paclitaxel. 
β-HCG, beta human chorionic gonadotropin; AE, adverse event; AUC, area under the curve; BICR, blinded 
independent central review; Cmax, maximum concentration; CI, confidence interval; CR, complete response; CT, 
computed tomography; DCR, disease control rate; DLT, dose-limiting toxicity; DOR, duration of response; ECG, 
electrocardiogram; EORTC, European Organization for Research and Treatment of Cancer; EudraCT, European 
Union Drug Regulating Authorities Clinical Trials Database; FDA, Food and Drug Administration; FDG-PET, 
fluorodeoxyglucose-positron emission tomography; G-CSF, granulocyte colony-stimulating factor; ICH, 
International Council for Harmonisation; IDMC, Independent Data Monitoring Committee; ITT, Intent-to-Treat; 
KPS, Karnofsky performance status; mPDAC, metastatic pancreatic ductal adenocarcinoma; MRI, magnetic 


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resonance imaging; ORR, objective response rate; OS, overall survival; PD, progressive disease; PDAC, 
pancreatic ductal carcinoma; PFS, progression-free survival; PK, pharmacokinetics; PR, partial response; PRO, 
patient-reported outcomes; QoL, quality of life; SAE, serious AE; TTP, time to progression; ULN, upper limit of 
normal; US, United States. 
Note: In this table, strike-through text indicates a deletion, bold text indicates an addition. 

SAP_001.pdf: 
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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
AST 
asparate aminotransferase 
ATC 
Anatomical-Therapeutic-Chemical 
BICR 
blinded independent central review 
BOR 
best overall response 
BSA 
Body surface area 
CA-125 
cancer antigen 125 
CA19-9 
cancer antigen 19-9 
CEA 
carcinoembryonic antigen 
CFR  
Code of Federal Regulations 
CI 
confidence interval 
Cmax 
maximum concentration 
COX2 
cyclooxygenase 2 
CR 
complete response 
CNS 
central nervous system 
CT 
computed tomography 
CYP 
cytochrome P450 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
disease control rate 
DOR 
duration of response 
DLT 
dose-limiting toxicity 
DUSP1 
dual-specificity phosphatase 1 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EORTC 
European Organization for Research and Treatment of Cancer 
FACT 
functional assessment of cancer therapy 
FDA 
food and drug administration 


  
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Abbreviation 
Definition 
FDG 
fluorodeoxyglucose 
FDG-PET 
fluorodeoxyglucose-positron emission tomography 
FOLFIRINOX 
folinic acid, fluorouracil, irinotecan, and oxaliplatin 
FOLFOX 
folinic acid, fluorouracil, and oxaliplatin 
GC 
Glucocorticoid 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony-stimulating factor 
GR 
glucocorticoid receptor 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HOMA-IR 
homeostatic model assessment of insulin resistance 
IA 
Interim assessment 
IA1 
Interim assessment during the Open-Label Treatment Period (Part 1) 
IB 
Investigator’s Brochure 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IDMC 
Independent Data Monitoring Committee 
IHC 
Immunohistochemistry 
IND 
Investigational New Drug 
INR 
international normalized ratio 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
Ki 
inhibition constant 
KPS 
Karnofsky performance status 
MedDRA 
Medical Dictionary for Regulatory Activities 
mPDAC 
metastatic pancreatic ductal adenocarcinoma 
MRI 
magnetic resonance imaging 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
NFHSI 
NCCN/FACT hepatobiliary-pancreatic symptom index 
OR 
objective response 
ORR 
objective response rate 


  
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Abbreviation 
Definition 
OS 
overall survival 
PD 
progressive disease 
PDAC 
pancreatic ductal adenocarcinoma 
PD-L1 
programmed death-ligand 1 
PET 
positron emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PR 
partial response 
PRO 
patient-reported outcomes 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PT 
Preferred term 
QoL 
quality of life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious AEs 
SAP 
statistical analysis plan 
SAS 
Statistical analysis software 
SOC 
System organ class 
SD 
stable disease 
SI 
standard international 
SUV 
standardized uptake value 
TEAE 
treatment-emergent AEs 
TTP 
time to progression 
ULN 
upper limit of normal 
US 
United States 
WHO 
World Health Organisation 
WHODD 
WHO drug dictionary 
 


  
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CONTENTS 
STATISTICAL ANALYSIS PLAN (SAP) .................................................................................... 1 
APPROVAL SHEET ...................................................................................................................... 2 
LIST OF ABBREVIATIONS ......................................................................................................... 3 
CONTENTS .................................................................................................................................... 6 
List of Tables .................................................................................................................................. 8 
List of Figures ................................................................................................................................. 9 
1 
INTRODUCTION ............................................................................................................ 10 
2 
STUDY OVERVIEW ....................................................................................................... 10 
2.1 
Overall Design .................................................................................................................. 10 
2.2 
Study Phases or Treatment Periods................................................................................... 12 
3 
STUDY OBJECTIVES ..................................................................................................... 12 
3.1 
Primary Objectives............................................................................................................ 12 
3.2 
Secondary Objectives........................................................................................................ 12 
3.2.1 Efficacy Objectives ............................................................................................... 12 
3.2.2 Safety Objectives .................................................................................................. 13 
3.2.3 Pharmacokinetic Objectives .................................................................................. 13 
3.3 
Exploratory Objectives ..................................................................................................... 13 
3.3.1 Pharmacodynamics/Biomarkers Objective ........................................................... 13 
3.3.2 Patient-Reported Outcomes/Quality-of-Life Objective ........................................ 13 
4 
STUDY ENDPOINTS ...................................................................................................... 14 
4.1 
Primary Efficacy Endpoint ............................................................................................... 14 
4.2 
Secondary Endpoints ........................................................................................................ 14 
4.2.1.1 Secondary Efficacy Endpoints ............................................................... 14 
4.2.1.2 Safety Endpoints .................................................................................... 14 
4.2.1.3 Pharmacokinetic Endpoints ................................................................... 15 
4.3 
Exploratory Endpoints ...................................................................................................... 15 
4.3.1.1 Exploratory Efficacy Endpoints ............................................................. 15 
4.3.1.2 Pharmacodynamic Endpoints ................................................................. 15 
4.3.1.3 Patient-Reported Outcomes and Quality-of-Life Endpoints.................. 16 


  
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5 
SAMPLE SIZE CONSIDERATIONS .............................................................................. 16 
6 
ANALYSIS POPULATIONS .......................................................................................... 16 
6.1 
Intent-To-Treat Population/ Safety Analysis Population .................................................. 16 
6.2 
Evaluable Population ........................................................................................................ 17 
6.3 
Pharmacokinetic Analysis Population .............................................................................. 17 
7 
DEFINITIONS, COMPUTATIONS AND CONVENTIONS ......................................... 17 
7.1 
Definitions......................................................................................................................... 17 
7.2 
Reporting Conventions ..................................................................................................... 18 
7.3 
Conventions for Dates....................................................................................................... 19 
7.4 
Treatment Group Presentation .......................................................................................... 19 
7.5 
Handling of Missing Data ................................................................................................. 19 
7.6 
Visit Windows .................................................................................................................. 20 
8 
TIMING OF ANALYSES ................................................................................................ 22 
9 
STATISTICAL METHODS ............................................................................................. 22 
9.1 
Patient Disposition ............................................................................................................ 22 
9.2 
Protocol Deviations ........................................................................................................... 23 
9.3 
Demographic Characteristics ............................................................................................ 23 
9.4 
Disease Characteristics and Previous Therapies ............................................................... 23 
9.5 
Medical History ................................................................................................................ 24 
9.6 
Concomitant Medications and Subsequent Therapies ...................................................... 24 
9.7 
Extent of Exposure and Study Drug Compliance ............................................................. 25 
9.8 
Efficacy Analyses ............................................................................................................. 26 
9.8.1 Multiplicity Adjustment for Efficacy Analyses .................................................... 27 
9.8.2 Primary Efficacy Endpoint ................................................................................... 27 
9.8.2.1 Primary Analysis .................................................................................... 27 
9.8.2.2 Sensitivity Analyses ............................................................................... 27 
9.8.3 Secondary Efficacy Endpoints .............................................................................. 27 
9.8.3.1 ORR per RECIST v1.1 according to investigator assessments ............. 27 
9.8.3.2 Best overall response according to BICR .............................................. 27 
9.8.3.3 Best overall response according to Investigator assessment.................. 28 


  
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9.8.3.4 Duration of Response as determined by the Investigator ...................... 28 
9.8.3.5 Duration of Response as determined by BICR ...................................... 29 
9.8.3.6 Disease Control Rate.............................................................................. 29 
9.8.3.7 Progression Free Survival ...................................................................... 29 
9.8.3.8 Overall Survival ..................................................................................... 30 
9.8.3.9 PFS rate at 3, 6, and 12 months ............................................................. 30 
9.8.3.10 OS rate at 3, 6 and 12 months ................................................................ 30 
9.8.3.11 Change in CA19-9 from baseline at 8 and 16 weeks ............................. 30 
9.8.3.12 CA19-9 response at 8 and 16 weeks ...................................................... 30 
9.8.3.13 Tumor response assessed by FDG-PET at 6 weeks per EORTC criteria, 
according to BICR ................................................................................. 30 
9.8.3.14 Time to progression on study treatment, as determined by the 
Investigator ............................................................................................ 31 
9.8.4 Exploratory Efficacy Endpoints ............................................................................ 31 
Pharmacodynamic Analysis .................................................................................. 31 
9.8.5 Subgroup Analyses ............................................................................................... 32 
9.9 
Pharmacokinetic Analyses ................................................................................................ 32 
9.10 
Safety Analyses ................................................................................................................. 33 
9.10.1 Adverse Events ..................................................................................................... 33 
9.10.1.1 Identified Risks and General Safety Topics........................................... 35 
9.10.2 Deaths ................................................................................................................... 35 
9.10.3 Clinical Laboratory Tests ...................................................................................... 35 
9.10.4 Vital Signs and Weight ......................................................................................... 37 
9.10.5 Electrocardiograms ............................................................................................... 37 
9.10.6 Physical Examination............................................................................................ 37 
10 
REFERENCES ................................................................................................................. 38 
11 
APPENDIX ....................................................................................................................... 38 
 
List of Tables 
Table 1  
Two-Sided 95% Confidence Intervals of Objective Response Rates with 
40 Patients Treated with Relacorilant+Nab-Paclitaxel in the Intent-to-Treat 
Population ..............................................................................................................16 


  
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Table 2 
Analysis Visit Windows for Safety Assessments ..................................................21 
Table 3 
Censoring Rules for analysis of DOR ....................................................................28 
Table 4 
Censoring Rules for the Analysis of PFS ..............................................................29 
Table 5 
Selected TEAEs .....................................................................................................35 
Table 6 
Clinical Laboratory Variables Evaluated During the Study ..................................36 
 
List of Figures 
Figure 1 
CORT125134-553 Study Design ...........................................................................11 
 


  
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1 
INTRODUCTION 
This statistical analysis plan (SAP) contains definitions of analysis populations and endpoints, 
outlines the timing of statistical analyses, and provides a comprehensive description of 
statistical analyses to be implemented to assess the clinical efficacy and safety of protocol 
CORT125134-553, amendment 1, dated 20 January 2020: A Phase 3 Study of Relacorilant in 
Combination with Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma 
(RELIANT).  
This SAP will be developed and approved prior to database lock and data analysis. Any 
deviations from the SAP will be documented as such in the clinical study report.  
2 
STUDY OVERVIEW 
2.1 
Overall Design 
This is a Phase 3, single-arm, open-label multicenter study to assess the safety and effectiveness 
of relacorilant in combination with nab-paclitaxel in patients with metastatic pancreatic ductal 
adenocarcinoma (mPDAC). 
This is an open-label single-arm study in which patients are treated with relacorilant in 
combination with nab-paclitaxel to evaluate the efficacy, safety, pharmacokinetics (PK), 
pharmacodynamics, patient-reported outcomes (PRO) and quality of life (QoL). There is a pre-
planned interim assessment after approximately 40 patients have enrolled. 
Patients who have received at least 2 prior lines of therapy for PDAC in any setting, including at 
least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy, and 
have metastatic disease are eligible for the study. Patients will enroll at approximately 30 centers 
in the US. 
Radiographic tumor assessments will be conducted using computed tomography (CT) with 
contrast of the chest, abdomen, and pelvis using standard multiphasic (pancreas) CT imaging 
protocol guidelines. Magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis is 
acceptable, with Medical Monitor approval, if CT with contrast cannot be done. Imaging for 
other areas of suspected metastatic disease (e.g. neck, brain or bones) not covered by the required 
imaging should also be performed. The same method should be used for each assessment for a 
particular patient. Prior to initiating therapy, a baseline tumor scan is required within 21 days 
prior to the first dose of study treatment. This includes brain CT/MRI for patients enrolled with 
brain metastasis/central nervous system (CNS) metastasis disease and for patients with 
symptoms that may be indicative of CNS metastasis. Subsequent CT/MRI scans will be obtained 
every 6 weeks (±7 days) from Cycle 1 Day 1 for 24 weeks. After Week 24, subsequent CT/MRI 
scans will then be obtained every 8 weeks (±7 days). CT/MRI scans will continue per this 
schedule until unequivocal disease progression is documented, including in patients who 
prematurely discontinue therapy. In addition, a baseline fluorodeoxyglucose-positron emission 
tomography (FDG-PET) scan will be obtained prior to initiating therapy and a post-baseline 
FDG-PET scan will be obtained 6 weeks (±7 days) from Cycle 1 Day 1. 


  
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Tumor response will be assessed by blinded independent central review (BICR), and by the 
Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete 
response (CR) and partial response (PR) will be confirmed with a subsequent scan at least 
4 weeks from the first response. Tumor response by FDG-PET at 6 weeks will be assessed by 
BICR only per European Organization for Research and Treatment of Cancer (EORTC) criteria. 
Patients will remain on treatment until unequivocal progressive disease (PD) per RECIST v1.1, 
as determined by the Investigator, or until meeting other criteria for discontinuation of the study 
regimen. Patients will return for a Post-Treatment Follow-Up Visit approximately 30 days 
after the patient’s final dose of relacorilant or nab-paclitaxel, whichever is latest, for a final 
visit. Patients will be followed for survival information (i.e., date and cause of death) and 
information on subsequent treatments (i.e., date/duration of treatment, response, and subsequent 
PD). Survival follow-up will continue every 3 months until the endpoint of death, the patient 
is lost to follow-up, or until 2 years following the final dose of study treatment in the final 
patient enrolled. 
Figure 1 
CORT125134-553 Study Design  
 
CT, computed tomography; FDG-PET, fluorodeoxyglucose-positron emission tomography; MRI, magnetic 
resonance imaging; PK, pharmacokinetic. 
a  Patients will return for a Post-Treatment Follow-Up Visit approximately 30 days after the patient’s final dose of 
study treatment. Patients who discontinue treatment prior to disease progression will continue radiographic tumor 
assessments (CT/MRI) every 6 to 8 weeks until unequivocal disease progression. Patients will continue to be 
followed for survival information every 3 months. 
b  Patients will have CT/MRI scans every 6 weeks (±7 days) from Cycle 1 Day 1 for 24 weeks. After Week 24, 
subsequent CT/MRI scans will then be obtained every 8 weeks (±7 days). 


  
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2.2 
Study Phases or Treatment Periods 
The study consists of the following study periods: 
x Screening Period: Within 21 days prior to the first dose of study treatment. 
x Treatment Period: Both relacorilant and nab-paclitaxel will be administered during the 
Treatment Period, starting on Cycle 1 Day 1 and continuing until disease progression, 
unacceptable toxicity, or other treatment discontinuation criteria are met. Relacorilant 
(starting dose 100 mg, titrated in increments of 25 mg per cycle to a potential maximum 
dose of 150 mg) will be taken once daily in the morning and nab-paclitaxel 80 mg/m2 
will be administered on Days 1, 8, and 15 of each 28-day cycle.  
All patients, with exception of patients with absolute neutrophil count 
(ANC) >10,000/mm3, will receive prophylactic G-CSF to reduce the risk of neutropenia 
starting 1 day after each nab-paclitaxel infusion. A minimum of 2 doses of granulocyte 
colony-stimulating factor (G-CSF) (filgrastim [5 μg/kg/day]) is recommended. 
x Safety Follow-Up Period: Patients will return for a Post-Treatment Follow-Up Visit 
approximately 30 days after the patient’s final dose of study treatment. Patients who 
discontinue treatment prior to disease progression will continue radiographic tumor 
assessments per the Schedule of Assessments (SoA) (every 6 to 8 weeks) until 
unequivocal disease progression. 
x Long-Term Survival Follow-Up Period: All patients will be followed every 3 months 
after the end of treatment, (to document dates and responses to subsequent treatment, and 
for survival). Per protocol Section 7.6, survival information and post-therapy information 
will be collected at 3 month intervals (or as requested by the Sponsor to support data 
analysis) beginning on the date of progression and continuing until the endpoint of death, 
the patient is lost to follow-up, or until 2 years following the final dose of study treatment 
in the final patient enrolled.  
 
 
3 
STUDY OBJECTIVES 
All study objectives apply to patients with mPDAC treated with relacorilant in combination with 
nab-paclitaxel. 
3.1 
Primary Objectives 
To evaluate the objective response rate (ORR), defined as the percentage of patients with 
measurable disease at baseline who achieve confirmed CR or PR per RECIST v1.1, according to 
BICR 
3.2 
Secondary Objectives 
3.2.1 Efficacy Objectives 
x To evaluate the ORR per RECIST v1.1, as assessed by the Investigator  


  
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x To evaluate best overall response per RECIST v1.1 according to BICR and 
Investigator assessment 
x To evaluate the duration of response (DOR) according to the Investigator and BICR 
x To evaluate disease control rate (DCR) (CR, PR, or stable disease [SD]) at 18 weeks, as 
assessed by the Investigator  
x To evaluate progression-free survival (PFS), as assessed by the Investigator  
x To evaluate overall survival (OS) 
x To evaluate PFS rate at 3, 6 and 12 months 
x To evaluate OS rate at 3, 6 and 12 months 
x To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks, in patients who have 
elevated CA19-9 at baseline 
x To assess tumor response based on changes in FDG-PET scan at 6 weeks per EORTC 
criteria, according to BICR 
x To evaluate the time to progression (TTP) on study treatment (relacorilant + 
nab-paclitaxel). The duration of disease control on prior nab-paclitaxel therapy (if 
applicable), and on the most recent therapy will also be described. 
3.2.2 Safety Objectives 
x To characterize the exposure-toxicity of relacorilant in combination with nab-paclitaxel 
x To assess the safety and tolerability of relacorilant in combination with nab-paclitaxel 
3.2.3 Pharmacokinetic Objectives 
x To assess the PK of relacorilant in combination with nab-paclitaxel 
3.3 
Exploratory Objectives 
x To assess the impact of relacorilant in combination with nab-paclitaxel on body 
composition, via CT/ MRI scans for sarcopenia  
x To integrate changes in CA19-9 with tumor response rates by FDG-PET scan, in patients 
who have elevated CA19-9 at baseline 
x To assess the changes in carcinoembryonic antigen (CEA) and cancer antigen 125 
(CA-125) at 8 and 16 weeks in patients who do not have elevated CA19-9 at baseline 
x To assess changes in Karnofsky performance status (KPS) score 
3.3.1 Pharmacodynamics/Biomarkers Objective 
x To explore molecular, cellular, and soluble markers in peripheral blood and/or tumor 
tissue that have possible relevance to the mechanism of action of, or response/resistance 
to, relacorilant in combination with nab-paclitaxel 
3.3.2 Patient-Reported Outcomes/Quality-of-Life Objective 
x To assess PRO and QoL in terms of physical function, symptoms, and utilization of 
health care resources 


  
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4 
STUDY ENDPOINTS 
4.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is ORR, defined as the percentage of patients with measurable 
disease at baseline who achieve confirmed CR or PR per RECIST v1.1, according to BICR.  
4.2 
Secondary Endpoints 
4.2.1.1 
Secondary Efficacy Endpoints 
Efficacy will be assessed by evaluating the following endpoints: 
x ORR per RECIST v1.1, according to Investigator assessment 
x Best overall response (BOR), defined as the best response recorded from the date of 
enrollment across all time points during study observation period, per RECIST v1.1 
according to BICR  
x BOR per RECIST v1.1 according to Investigator assessment 
x DOR as measured from the date that the criteria are met for CR or PR until the first date 
that PD is objectively documented and determined by the Investigator 
x DOR as measured from the date that the criteria are met for CR and PR until the first date 
that PD is objectively documented and determined by BICR 
x DCR, defined as the percentage of patients who have achieved CR, PR, or SD for ≥18 
weeks, as determined by the Investigator and BICR 
x PFS, defined as the time from the date of enrollment to the date the patient experiences 
unequivocal disease progression per RECIST v1.1, as determined by the Investigator, 
or death (all causes of mortality). Disease progression as determined by BICR will 
also be assessed.  
x OS, defined as the time from date of enrollment until the date of death from any cause 
x PFS rate (proportion of patients who have not progressed) at 3, 6, and 12 months 
x OS rate (proportion of patients surviving) at 3, 6 and 12 months 
x Change in CA19-9 from baseline at 8 weeks and 16 weeks in patients who have elevated 
CA19-9 (CA19-9 > upper limit of normal [ULN]) at baseline 
x CA19-9 response, at 8 weeks and 16 weeks, defined as the percentage of patients with 
elevated CA19-9 at baseline who have ≥50% reduction in CA19-9 
x Tumor response assessed by FDG-PET at 6 weeks per EORTC criteria, according 
to BICR  
x TTP on study treatment, defined as the time from enrollment to disease progression 
per RECIST v1.1 as determined by the Investigator 
4.2.1.2 
Safety Endpoints 
Safety will be assessed by evaluating the following endpoints:  
x Study drug exposure 
x Exposure-toxicity exposure-response of relacorilant and nab-paclitaxel 


  
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x Adverse events (AEs) (including frequency, severity, and relationship to study treatment) 
and deaths 
x Change from baseline in clinical laboratory tests 
x Change from baseline in vital signs (including blood pressure, heart rate) 
x Interpretation of electrocardiogram (ECG) assessments (normal, abnormal clinically 
insignificant, or abnormal clinically significant) 
x Physical examination findings 
4.2.1.3 
Pharmacokinetic Endpoints 
PK will be assessed by evaluating the following: 
x Primary PK parameters of relacorilant and nab-paclitaxel estimated from PK sampling on 
Cycle 1 Days 1, 2, and 15 
4.3 
Exploratory Endpoints 
4.3.1.1 
Exploratory Efficacy Endpoints 
x Presence of sarcopenia by CT/MRI scans of body composition (i.e., skeletal muscle 
mass) 
x Change in CEA and CA-125 from baseline in patients who do not have elevated CA19-9 
at baseline 
x Change from baseline in KPS score 
4.3.1.2 
Pharmacodynamic Endpoints 
Baseline assessment of:  
x Homeostatic model assessment of insulin resistance (HOMA-IR) 
x Immune and GC function-related cytokines 
x Markers of sarcopenia or cachexia 
x Hematology parameters, such as differential complete blood count 
x RNA analyses from circulating cells and tumor tissue of immune, tumor, and GC-related 
genes such as cyclooxygenase 2 (COX2) and dual-specificity phosphatase 1 (DUSP1) 
x Tumor somatic DNA mutation panel 
x Tumor IHC: immune infiltrate, programmed death-ligand (PD-L1) and other exploratory 
markers 
Change from baseline of:  
x HOMA-IR 
x Immune and GC function-related cytokines 
x Markers of sarcopenia or cachexia 
x Hematology parameters, such as differential complete blood count 
x RNA analyses from circulating cells of immune, tumor, and GC-related genes such as 
COX2 (PTGS2) and DUSP1 


  
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4.3.1.3 
Patient-Reported Outcomes and Quality-of-Life Endpoints  
Changes from baseline of PRO and QoL scores according to the following instruments:  
x National Comprehensive Cancer Network/FACT-hepatobiliary-pancreatic symptom 
index (NFHSI-18) (Butt et al. 2012)  
x Patient-Reported Outcomes Measurement Information System (PROMIS) (Cella et al. 
2007) short form  
x EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L/VASc) 
x A questionnaire for healthcare service utilization 
5 
SAMPLE SIZE CONSIDERATIONS 
In this estimation study, the efficacy analysis will include the calculation of a 95% Confidence 
Interval (CI) around the ORR point estimate in the Intent-to-Treat (ITT) Population treated with 
relacorilant + nab-paclitaxel.  
A total of approximately 80 patients in the ITT Population treated with relacorilant + nab-
paclitaxel are expected in this study to provide sufficient precision for the interval estimates 
for the ORR. The Independent Data Monitoring Committee (IDMC) will perform an interim 
assessment of safety and efficacy after 40 patients have enrolled and either (1) completed at least 
12 weeks of treatment, including the second radiographic tumor assessment and have at least 1 
post-baseline tumor assessment with a result other than nonevaluable; or (2) discontinued the 
study due to disease progression or toxicity. Decision rules for the interim assessment, as 
described in the IDMC charter, were based on a sample size of 40 patients. 
In Table 1, the 95% CI estimates around ORR were obtained using the Clopper-Pearson method 
(Clopper and Pearson 1934) for the interim assessment. Patients with no post-baseline 
radiographic tumor assessments available will be considered non-responders.  
Table 1 Two-Sided 95% Confidence Intervals of Objective Response Rates with 40 Patients 
Treated with Relacorilant+Nab-Paclitaxel in the Intent-to-Treat Population 
Number of ORs 
ORR Estimate (%) 
95% CI of ORR (%) 
4 
10.0 
2.8 – 23.7  
7 
17.5 
7.3 – 32.8  
8 
20.0 
9.1 – 35.6 
Abbreviations: CI, (Clopper-Pearson) confidence interval; OR, objective response; ORR, objective response rate. 
6 
ANALYSIS POPULATIONS  
6.1 
Intent-To-Treat Population/ Safety Analysis Population 
ITT / Safety Analysis Population: ITT /Safety population will include all patients enrolled and 
treated with at least 1 dose of study treatment. This population will be used for all safety 
endpoints of the study. 


  
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6.2 
Evaluable Population 
Evaluable Population (Evaluable): Evaluable population will include all patients in the ITT 
Population who have at least one post-baseline radiographic tumor assessment (with results other 
than non-evaluable). 
6.3 
Pharmacokinetic Analysis Population 
Pharmacokinetic Analysis Population (PK Population) will include all enrolled patients who 
have PK data collected and available for analysis. 
7 
DEFINITIONS, COMPUTATIONS AND CONVENTIONS 
The statistical principles applied in the design and planned analyses of this study are consistent 
with International Council for Harmonisation (ICH) E9 guidelines (ICH 1998) and the Food and 
Drug Administration (FDA) Guidance for Industry: Clinical Trial Endpoints for the Approval of 
Cancer Drugs and Biologics (2018). All statistical analyses detailed in this SAP will be 
conducted using SAS version 9.4 or higher. 
7.1 
Definitions 
Enrollment date: Enrollment date is the date of first dose of study treatment (relacorilant+ nab-
paclitaxel), i.e., Cycle 1 Day 1. 
Study day: Study day for safety will be calculated in reference to the date of the first dose of 
relacorilant (study treatment). For assessments conducted on or after the date of the first dose of 
study drug, study day will be calculated as (assessment date - date of first dose of study drug 
+ 1). For assessments conducted before the date of the first dose of study drug, study day is 
calculated as (assessment date - date of first dose of study drug). There is no study day 0. 
Treatment-emergent period: The treatment-emergent period is defined as the period of time from 
the date and time of the first dose of study drug (relacorilant or nab-paclitaxel whichever is 
earliest) through 30 days after the final dose of study drug (relacorilant or nab-paclitaxel 
whichever is latest).  
The treatment-emergent period will be used in the summaries of treatment-emergent adverse 
events (TEAEs). 
Baseline and postbaseline value: Unless otherwise specified, a baseline value is defined as the 
most recent value prior to the first dose of study treatment including baseline characteristics. A 
postbaseline value is defined as an assessment obtained after the first dose of study treatment. 
Baseline and postbaseline value for safety analyses: Unless otherwise specified, a baseline value 
for safety analyses is defined as the last value before the date/time of first dose of study 
treatment for laboratory tests, vital sign assessments, and ECG data. A postbaseline value for 
safety analyses is defined as a measurement taken after the date/time of first dose of study 
treatment. If multiple toxicity grades are present for the same date, the worst toxicity grade will 
be used in the summaries of toxicity grade by laboratory tests. For triplicate measurements of 
ECG, average of these values will be used in the summaries presented by visit. For all other 


  
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safety parameters, if multiple measurements are present for the same date, latest available value 
will be considered for summaries. 
Last dose date: Last dose date is defined as the date of last dose of study treatment (relacorilant 
or nab-paclitaxel, whichever is last) from the end of treatment – relacorilant and nab-paclitaxel 
electronic case report forms (eCRFs).  
7.2 
Reporting Conventions 
Unless otherwise specified, the following conventions will be applied to all analyses:  
x Mean and median values will be formatted to 1 more decimal place than the measured 
value. Standard deviation values will be formatted to 2 more decimal places than the 
measured value; minimum and maximum values will be presented to the same number of 
decimal places as the measured value.  
x Percentages will be rounded to 1 decimal place. Number and percentage values will be 
presented as xx (xx.x%). 
x Listings will be presented for relacorilant + nab-paclitaxel and will be sorted for 
presentation in order of patient identifier and date of procedure or event.  
x Analysis and summary tables will have the analysis population sample size (ie, number 
of patients).  
x Laboratory data will be reported using standard international (SI) units; as local 
laboratories are used for this study, conversion factors from conventional units will be 
listed in the clinical study report.  
For example 1 inch = 2.54 cm.  
x Time-to-event or duration of event endpoints will be based on the actual date the 
radiographic scan was obtained rather than the associated visit date.  
x For by-visit observed data analyses, percentages will be calculated based on the number 
of patients with non-missing data as the denominator unless otherwise specified.  
x For time-to-event right-censored data, the summary statistics and descriptions will 
include Kaplan-Meier plots and/or life tables.  
x For other continuous endpoints, the summary statistics will include mean, standard 
deviation, median, and range (minimum and maximum).  
x For categorical endpoints, the summary statistics will include frequency counts and 
percentages.  
x Confidence intervals (CIs), when presented, will generally be constructed at the 95% 
level. For binomial variables, exact methods will be employed unless otherwise specified.  
x Medical history and adverse events will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) v 23.0. Adverse event severity will be evaluated using 
the National Cancer Institute Common Terminology Criteria for Adverse Events 
(CTCAE v.5.0).  
x Prior therapies and concomitant medications will be coded using the World Health 
Organization (WHO) Drug Dictionary and summarized by Anatomical Therapeutic 
Chemical (ATC) therapeutic subgroup and preferred drug names. 


  
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7.3 
Conventions for Dates 
Conventions for calculations with dates are as follows:  
x Dates will be stored as numeric variables in the statistical analysis software (SAS) 
analysis files and reported in DDMMMYYYY format (ie, the Date9. datetime format 
in SAS).  
x Dates recorded in comment fields will not be imputed or reported in any specific format.  
x Intervals that are presented in weeks will be transformed from days to weeks by using the 
following conversion formula, and rounding to 1 decimal place:  
WEEKS = DAYS / 7  
x Intervals that are presented in months will be transformed from days to months by using 
the following conversion formula, and rounding to 1 decimal place:  
MONTHS = DAYS / 30.4375 
7.4 
Treatment Group Presentation 
Patient disposition, protocol deviations, demographics and baseline characteristics, medical 
history, prior medications and procedures, efficacy and safety data summaries will be presented 
using ITT population.  
7.5 
Handling of Missing Data 
Missing data will not be imputed unless otherwise specified. 
In safety analyses, for incomplete date of last dose of study drug or incomplete start date of 
a new antitumor treatment that are 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.  
Adverse Events and Concomitant Medications  
Missing dates or partially missing dates will be imputed conservatively for adverse events and 
prior/concomitant medications/procedures. 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:  
x If both month and day are missing and year = year of treatment start date, then set to 
treatment start date  
x If both month and day are missing and year ≠ year of treatment start date, then set to 
January 01  
x If day is missing and month and year = month and year of treatment start date, then set to 
treatment start date  


  
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x If day is missing and month and year ≠ month and year of treatment start date, then set to 
first of the month  
x If only year is missing or 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:  
x If both month and day are missing, then set to December 31  
x If only day is missing, then set to last day of the month  
x If only year is missing or 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:  
x If both month and day are missing, then set to January 01  
x If only day is missing, then set to the first of the month  
If end date of a medication is partially missing, impute as follows:  
x If both month and day are missing, then set to December 31  
x If only day is missing, then set to last day of the month  
If only year is missing or start date or end date of a medication is completely missing, do 
not impute.  
Primary Cancer Diagnosis 
If the diagnosis date of primary cancer is partially missing, the following rules will be applied to 
impute partial dates: 
x If both month and day are missing and year = year of treatment start date, then set to 
treatment start date. 
x If both month and day are missing and year ≠ year of treatment start date, then set to 
December 31. 
x If day is missing and month and year = month and year of treatment start date, then set to 
treatment start date. 
x If day is missing and month and year ≠ month and year of treatment start date, then set to 
the last day of the month. 
7.6 
Visit Windows 
Visit windows will be used to associate assessments with a scheduled visit for summarizing data 
by visit.  
Study visits will align with nab-paclitaxel infusion days during the Treatment Phase. Screening 
hematology and chemistry laboratory tests can be used for the Cycle 1, Day 1 values if collected 
within 48 hours of the first dose of study treatment. For all other visits, hematology and 


  
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chemistry should be performed within the prior 24 hours (relative to the study visit/nab-
paclitaxel infusion).  
The Follow-up Visit should be performed 30 days (±3 days) after the patient receives their final 
dose of relacorilant or nab-paclitaxel, whichever is latest. 
The Long-term follow-up assessments should be done every 3 months (±7 days) until the 
endpoint of death, the patient is lost to follow-up, or until 2 years following the final dose of 
study treatment in the final patient enrolled. 
For efficacy assessments and AEs, data from both planned visits and unscheduled visits will be 
assessed and summarized.  
For all other by-visit safety assessments, unscheduled visits will be mapped into analysis visit 
windows as shown in Table 2. If more than one assessment occurs within a given analysis visit 
window, (1) the planned visit will be always used in summaries for the given visit; (2) if all visits 
are unscheduled visits, the assessment closest to the target date will be used.  
 
Table 2 
Analysis Visit Windows for Safety Assessments  
Visit Name 
Start Day 
Target Day 
End Day 
Baseline/Cycle 1 Day 1 
---- 
1 
---- 
Cycle 1 Day 8 
2 
8 
11 
Cycle 1 Day 15 
12 
15 
22 
Cycle 2 Day 1 
23 
29 
32 
Cycle 2 Day 8 
33 
36 
39 
Cycle 2 Day 15 
40 
43 
50 
Cycle 3 Day 1 
51 
57 
60 
Cycle 3 Day 8 
61 
64 
67 
Cycle 3 Day 15 
68 
71 
78 
---- 
---- 
---- 
---- 
EOT 
 
Study Day of Final Dose 
of Study drug 
 
Follow-up 
>Study Day of Final Dose of 
Study Drug (relacorilant or 
nab-paclitaxel, whichever is 
latest) 
Study Day of Final Dose 
of Study Drug + 30 
Study Day of Final Dose 
of Study Drug + 31 


  
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8 
TIMING OF ANALYSES 
An Independent Data Monitoring Committee (IDMC) will be established to conduct periodic and 
ad hoc medical and/or statistical reviews of available data to protect the safety and ethical 
interest of patients and protect the scientific validity of the study. The IDMC will comprise 
independent consultants (medical and statistical) with relevant expertise. The IDMC will be 
provided with data from this study, including safety and efficacy variables, for periodic review. 
The IDMC will review data as follows. 
1) An interim assessment will occur after approximately 40 patients have enrolled and have 
met at least one of the following criteria:  
1. Completed at least 12 weeks of treatment, including the second radiographic tumor 
assessment and have at least 1 post-baseline tumor assessment with a result other than 
nonevaluable. 
2. Discontinued the study due to disease progression or toxicity. 
Enrollment will be paused such that the interim assessment can be conducted by the IDMC 
before additional patients are enrolled. 
Subsequent reviews of safety will occur as specified by the IDMC, with a minimum frequency of 
approximately every 12 months. The IDMC may recommend changes in the protocol based on 
futility, toxicity, or compelling evidence of efficacy. 
Final analyses will be performed after completion of safety follow-up of the final patient enrolled 
in the study. 
9 
STATISTICAL METHODS 
Analysis populations will be specified for each of the endpoints. 
9.1 
Patient Disposition 
Patient populations will be summarized for all patients enrolled and will include the number and 
percentage of patients in the ITT/safety, evaluable and PK populations.  
Disposition summaries will present number of patients enrolled, number treated, and among 
those treated, number who completed and discontinued treatment. Primary reason for 
discontinuation of treatments (relacorilant or nab-paclitaxel), including any of the following, will 
be summarized: 
x Adverse event 
x Disease progression as defined by RECIST 1.1  
x Clinical disease progression  
x Non-compliance with study drug  
x Patient decision to discontinue treatment  
x Patient withdrew consent for study  
x Physician decision 
x Lost to follow-up  


  
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x Protocol deviation  
x Pregnancy  
x Study terminated by sponsor  
x Death 
x COVID-19  
x Other 
Counts and percentages of patients who complete the study and those who discontinue for any of 
the following reasons will also be calculated: 
x Death  
x Protocol non-compliance  
x Withdrawal of consent for study  
x Investigator decision  
x Pregnancy  
x Lost to follow-up 
x Termination of study by sponsor  
x COVID-19 
x Other 
9.2 
Protocol Deviations 
Protocol deviations will be categorized as “Important” or “Other” according to the protocol 
deviation specification document. Important protocol deviations that occur during the study will 
be summarized by deviation category for all patients in the ITT population. A by-patient listing 
of all deviations will be provided. 
Patient eligibility including inclusion and exclusion criteria that were not met will be 
summarized for all patients in the ITT population. 
9.3 
Demographic Characteristics 
The following patient characteristics collected will be presented in data listings and summarized 
for the ITT Population: 
x Age (in years) at informed consent (continuous and categorical variables: < 50, 50 to 65, 
> 65; <65 and ≥65) will be summarized 
x Sex  
x Of childbearing potential (Yes/No) 
x Ethnicity 
x Race 
9.4 
Disease Characteristics and Previous Therapies 
Disease characteristics at baseline will be listed including date and stage at study entry, presence 
of regional nodal metastasis, sites of metastatic disease along with other relevant data collected 
in the eCRF. Sites of visceral disease (liver, lung, peritoneum, and brain) and number of 


  
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metastatic sites (1, 2, 3, >3) will be summarized. Laboratory tumor markers including CA19-9, 
CA-125 and CEA will also be summarized. 
Prior cancer treatments include surgeries, systemic and radiation therapies will be summarized 
for ITT population. 
Prior cancer surgeries: Number of patients reporting at least one prior surgery will be 
summarized and listed which include type and date of surgeries. 
Prior systemic therapies: Number of patients reporting systemic therapies, line of therapies 
number, line of therapy setting and best overall response, reason for discontinuation will be 
summarized. Number of prior systemic lines (2, 3, >3), prior taxane, and prior nab-paclitaxel will 
be summarized. Listings include all relevant data including start/stop dates and medications 
included in the prior systemic therapy collected in the eCRF. 
Prior Radiotherapy: A listing will display all entries for prior radiotherapies received by date of 
first dose. Patients who received at least one prior radiotherapy, tumor location, total dose 
received, and disease progressed in the area will be summarized.  
9.5 
Medical History 
Medical History: All medical history verbatim terms will be coded using the MedDRA 
version 23.0 and ordered by system organ class (SOC) and preferred term (PT). At each level 
of summation (SOC, PT), patients reporting more than one medical condition will be counted 
only once. All surgeries that are not related to the cancer under study will be listed and 
summarized separately. 
Oncology History: For each patient, date and stage of initial diagnosis, primary location of 
primary tumor, histologic features and grade, and current extent, site of metastatic disease along 
with other relevant data collected in the eCRF will be listed. A summary table will summarize 
these disease history characteristics. Patients with prior pancreatectomy and biliary stent will 
also be summarized. 
Cancer mutation: All data collected under “Cancer mutations” form will be listed. 
History of tobacco and alcohol use: Patient history of tobacco and alcohol use as noted on the 
Demographics eCRF during screening will be listed and summarized. 
All medical history summaries will be based on ITT population. 
9.6 
Concomitant Medications and Subsequent Therapies 
Any concomitant medication used by patients will be recorded on eCRF. Indication for use, 
whether taken for medical history or AE, start and end date, ongoing, dose, dose formulation, 
frequency, and route of administration will be noted. Medications are considered concomitant if 
exposure occurs during the treatment-emergent period (as defined in Section 7.1). A patient 
reporting use of the same medication more than once will be counted once in the calculation of 
the number and percentage of patients who received that medication.  


  
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The imputation rules for missing start and end date of a concomitant medication are described 
in Section 7.5. 
Verbatim terms from the eCRF will be mapped to ATC class and Generic drug names using the 
WHODD Global B3 August 2020 coding dictionary.  
A listing will display all entries for medications received by a patient, ordered by “Start date”. 
The listing will display the recorded term from the eCRF and, adjacent to that, the ATC level 2 
class (therapeutic subgroup) and the preferred drug name. 
A summary table will be organized to display the therapeutic subgroup (2nd level) and preferred 
drug name. It will include counts and percentages of patients who reported using at least one 
medication in each therapeutic subgroup.  
A data listing will be provided for all concomitant procedures and/or surgeries.  
Post-treatment radiotherapy, systemic therapies and subsequent anticancer therapies and 
surgeries received will be listed and summarized.  
All summaries will be based on ITT population. 
The duration of treatment on the prior nab-paclitaxel regimen (if applicable) and on the most 
recent treatment regimen will be calculated and presented in the listing. 
9.7 
Extent of Exposure and Study Drug Compliance 
All recorded information on dosing of relacorilant, including date, time and dose administered 
(or relevant reason if not administered), actual dose, as well as drug accountability will be 
presented in a data listing by date of administration. 
A separate data listing and summary table will present data collected on nab-paclitaxel 
administered via an IV infusion. Planned dose level, planned dose, actual dose, whether infusion 
was interrupted and reason, will be included. 
Relacorilant exposure 
Following summaries will be provided using relacorilant exposure data. 
x Number of cycles of treatment: The number of cycles of treatment will be presented 
based on the last visit when the patient received treatment. 
x Duration of exposure: The duration of exposure for the study drug will be presented in 
days and calculated as the date of last dose of study drug minus the date of the first dose 
of study drug, plus one. 
x Total dose received: The total dose received for the study drug will be the sum of the 
actual dose administered for the duration of exposure. For patients where their dose 
received is either zero or missing, a received dose of zero is included in the total dose 
received derivation. 
x Total dose expected: Expected dose of relacorilant for each patient is set to 100 mg in 
Cycle 1, 125 mg in Cycle 2 and 150 mg in Cycle 3 irrespective of the actual dose 
increase. Relacorilant is expected to be taken daily starting at Cycle1 Day 1. A patient 


  
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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 patients where their 
dose received is either zero or missing, an associated expected dose is included in the 
total dose expected derivation.  
x Relative dose intensity: Relative dose intensity is calculated for the study drug as the total 
dose received divided by the total dose expected, multiplied by 100. 
Nab-Paclitaxel exposure 
Following summaries will be presented using nab-paclitaxel exposure data. 
x Numbder of cycles of treatment: The number of cycles of treatment will be presented 
based on the last visit when the patient received treatment. 
x Number of infusions: The cumulative number of nab-paclitaxel infusions will be 
presented. 
x Duration of exposure: The duration of exposure to the study drug will be presented in 
days and calculated as the date of last dose of study drug minus the date of the first dose 
of study drug, plus one.  
x Total dose expected: nab-paclitaxel is expected to be taken on Day 1, 8, and 15 of 
each cycle. The planned nab-paclitaxel dose is calculated from the field “Planned 
Nab-Paclitaxel dose” of eCRF “Nab-Paclitaxel administration” page. Total dose expected 
is the sum of planned dose divided by the body surface area (BSA). BSA will be 
calculated using height and weight value captured in the eCRF nearest and prior to the 
drug administration date. 
x Relative dose intensity: Relative dose intensity is calculated for the study drug as the total 
dose received divided by the total dose expected, multiplied by 100. The actual Nab-
paclitaxel dose is calculated from the field “Actual Nab-Paclitaxel dose administered” of 
eCRF “Nab-Paclitaxel administration” page. Total dose received is the sum of actual 
dose divided by BSA. 
Data on G-CSF therapy include therapy name, indication, start date, end date, dose level, 
dose, route and frequency of therapy. A summary table and a listing will be provided for G-
CSF therapies. 
9.8 
Efficacy Analyses 
The ITT population as defined in Section 6, will be used to address the primary, secondary and 
exploratory efficacy objectives of the study. Evaluable population will also be used to provide 
summaries for all efficacy endpoints. Disease response and progression assessed according to 
RECIST v1.1 by the Investigator or BICR will provide the basis for efficacy endpoints. 
At all scheduled visits, data recorded for target, non-target, and new lesions, and Investigator 
response assessment will be presented in by-patient listings. Summary tables and figures will be 
provided for endpoints as described in the following sections. 
Response rate endpoints will be summarized by providing the point and interval estimates. 
Time-to-event variables will be summarized using Kaplan-Meier estimates and plots.  


  
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9.8.1 Multiplicity Adjustment for Efficacy Analyses 
No multiplicity adjustments were required for efficacy analyses. 
9.8.2 Primary Efficacy Endpoint 
ORR is defined as the percentage of patients with measurable disease at baseline who achieve 
confirmed CR or PR per RECIST v1.1, according to BICR. Patients in the ITT Population with 
no valid post-baseline radiographic tumor assessments will be considered as non-responders.  
If patients discontinue earlier than 12 weeks with progressive disease, they will be considered 
non-responders.  
9.8.2.1 
Primary Analysis 
The primary analysis of ORR per BICR will be performed in the ITT Population. The point 
estimate and 95% CI will be provided using the Clopper-Pearson method (Clopper and 
Pearson 1934).  
ORR will also be analyzed in the Evaluable Population, as a supportive analysis to the primary 
endpoint analysis. 
9.8.2.2 
Sensitivity Analyses 
In a sensitivity analysis of the primary endpoint of ORR per Investigator, patients in the ITT 
population who receive prohibited concomitant medications will be excluded. 
9.8.3 Secondary Efficacy Endpoints 
Unless stated, all the secondary endpoints will be evaluated in patients treated with relacorilant + 
nab-paclitaxel. 
9.8.3.1 
ORR per RECIST v1.1 according to investigator assessments  
ORR according to investigator assessments will be summarized similar to primary efficacy 
endpoint analysis.  
9.8.3.2 
Best overall response according to BICR  
For each patient, BOR will be derived from the date of enrollment across all time points during 
study observation period, per RECIST v1.1 according to BICR. Patients who have a post-
baseline scan that cannot be evaluated because of the quality of the image or other reasons will 
have “non-evaluable” recorded as their response at that visit. If all post-baseline scans are non-
evaluable, the patient will have “non-evaluable” recorded as their best response. 
BOR rates will be summarized by the number and percentage of patients within each response 
category (CR, PR, SD, PD, or non-evaluable).  
Waterfall plots will visually illustrate the best percent change in tumor burden (sum of longest 
diameter for all non-nodal target lesions and shortest diameter for nodal target lesions) measured 


  
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on a post-baseline scan. On the y-axis, a positive value represents increase in tumor burden, and 
a negative value represent maximum decreases in tumor burden. The vertical bars will also 
indicate (through different colors) the BOR of CR, PR, SD or PD. Waterfall plots will include all 
patients in the ITT population with measurable disease at baseline and at least one post baseline 
measurement. 
9.8.3.3 
Best overall response according to Investigator assessment  
BOR per RECIST v1.1 according to Investigator assessments will be summarized similar to 
BOR analysis according to BICR assessment. 
9.8.3.4 
Duration of Response as determined by the Investigator  
DOR is defined as the time from the date that the criteria are met for CR or PR until the first date 
that PD is objectively documented and determined by the Investigator. Patients who do not 
experience PD and are alive as of the analysis cutoff date will be censored at the date of last 
adequate tumor assessment. Censoring rule is described in Table 3. 
DOR (months) = (date of progression, death, or censoring – date of first documented 
objective response + 1)/30.4375  
Estimates of median DOR with 95% CIs will be computed using the Kaplan-Meier method. 
Kaplan-Meier graphs will visually display DOR. 
Table 3 
Censoring Rules for analysis of DOR 
Censoring Categories 
Date of Censoring 
Patients who did not have documented progression and 
did not die  
Date of the last adequate tumor assessment  
Patients who did not have documented progression as 
determined by the investigator on or before initiation of a 
new anticancer therapy and did not die on or before the 
data cutoff date 
Date of the last adequate tumor assessment on or 
before initiation of a new anticancer therapy and 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  
Patients who did not have documented progression and 
died more than 112 days from most recent tumor 
assessment. 
Date of the last adequate tumor assessment 
 
If a patient meets the criteria for more than 1 censoring rule, the earliest censoring date will be 
considered.  


  
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9.8.3.5 
Duration of Response as determined by BICR  
DOR per BICR will be assessed as measured from the date of the tumor scan documenting CR or 
PR until the date of first documented PD or death, whichever comes first.  
9.8.3.6 
Disease Control Rate  
DCR is defined as the percentage of patients who have achieved CR, PR, or SD for ≥18 weeks, 
as determined by the Investigator and BICR. Patients in the ITT Population with no valid post-
baseline radiographic tumor assessment will be considered non-responders. 
The point estimate and 95% CI will be calculated using the Clopper-Pearson method.  
Summaries will also be presented based on BICR assessments. 
Exploratory DCR will be calculated for ≥6 weeks and for ≥12 weeks, respectively. 
9.8.3.7 
Progression Free Survival  
PFS is defined as the time from the date of enrollment to the date the patient experiences 
unequivocal disease progression per RECIST v1.1, as determined by the Investigator, or death 
(all causes of mortality), whichever comes first. Both BICR and Investigator assessments will be 
considered and analyzed separately. 
PFS (months) = (first documented date of progression, death, or censoring – date of 
enrollment + 1)/30.4375  
All events of disease progression or death will be counted regardless of whether the event 
occurred while the patient was on study drug or had previously discontinued treatment. Patients 
who do not experience disease progression or death will be censored at the date of last adequate 
tumor assessment. Censoring rules in Table 4 will be applied.  
Table 4 
Censoring Rules for the Analysis of PFS 
Censoring Categories 
Date of Censoring 
Patients who did not have baseline or post-baseline tumor 
assessments and did not die  
Enrollment date +1 
Patients who did not have unequivocal progression and 
did not die  
Date of the last adequate tumor assessment  
Patients who did not have documented progression as 
determined by the investigator on or before initiation of a 
new anticancer therapy and did not die on or before the 
data cutoff date 
Date of the last adequate tumor assessment on or 
before initiation of a new anticancer therapy and on 
or before the data cutoff date  
Patients who had 2 or more consecutive missed 
scheduled tumor assessments immediately prior to 
unequivocal disease progression 
Date of the last adequate tumor assessment without 
evidence of unequivocal disease progression before 
the 2 missed tumor assessments  
Patients who did not have documented progression and 
died more than 112 days from last tumor assessment. 
Date of the last adequate tumor assessment 


  
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Estimates of median PFS with 95% CIs will be computed using the Kaplan-Meier method. 
Kaplan-Meier graphs will visually display PFS. 
9.8.3.8 
Overall Survival  
OS is defined as the time from enrollment until the date of death from any cause. If a patient is 
alive or no known death date, OS will be censored at the date of last contact. 
OS (months) = (date of death or censoring – date of enrollment + 1)/30.4375 
Median, 25th and 75th percentiles of OS, in months, with 95% CIs will be summarized and 
plotted graphically using the Kaplan-Meier estimates.  
9.8.3.9 
PFS rate at 3, 6, and 12 months  
The proportion of patients who are progression-free (as defined above) at 3, 6 and 12 months 
will be summarized using Kaplan-Meier estimates. 
9.8.3.10 
OS rate at 3, 6 and 12 months  
The proportion of patients surviving (as defined above) at 3, 6 and 12 months will be 
summarized using Kaplan-Meier estimates.  
9.8.3.11 
Change in CA19-9 from baseline at 8 and 16 weeks 
Change in CA19-9 from baseline in patients who have elevated CA19-9 at baseline (baseline 
CA19-9 >ULN) will be reported. Descriptive statistics will be provided at each of the time points 
during the observation period. 
9.8.3.12 
CA19-9 response at 8 and 16 weeks 
CA19-9 response is defined as the percentage of patients with elevated CA19-9 at baseline 
(baseline CA19-9 >ULN) who have ≥50% reduction in CA19-9. CA19-9 response rate at 
8 weeks and 16 weeks will be reported. The point estimate and the 95% CI using the 
Clopper-Pearson method will be presented.  
9.8.3.13 
Tumor response assessed by FDG-PET at 6 weeks per EORTC criteria, 
according to BICR  
FDG-PET tumor response will be summarized at 6 weeks. FDG-PET response will be reported 
as the number and percentages of patients achieving complete metabolic response, partial 
metabolic response, stable metabolic disease, and progressive metabolic disease according to 
BICR assessment of changes in standardized uptake values (SUVs) from the baseline FDG-PET 
scan to the post-baseline (6-week) scan using EORTC criteria (Young et al. 1999). The SUVs 
obtained from FDG-PET scans will be summarized by visit in a table and presented graphically 
in waterfall plots. 


  
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9.8.3.14 
Time to progression on study treatment, as determined by the Investigator  
TTP is defined as the time from enrollment to disease progression per RECIST v1.1 as 
determined by the Investigator. TTP will be analyzed using Kaplan-Meier estimates. Censoring 
rules in Table 4 will be applied as well. 
9.8.4 Exploratory Efficacy Endpoints 
Presence of sarcopenia by CT/MRI scans of body composition (i.e., skeletal muscle mass) 
The percent change in skeletal muscle mass from baseline will be summarized. Summary 
statistics will be provided at each of the post-baseline time points during the observation period. 
Change in CEA and CA-125 from baseline in patients who do not have elevated CA19-9 at 
baseline: Change in CEA and CA-125 from baseline, in patients who do not have elevated 
CA19-9 at baseline, will be reported for each time point using summary statistics during the 
observation period. 
The percentage of patients with elevated CEA (≥2.5 ng/mL) who have ≥50% reduction in CEA, 
at 8 weeks and 16 weeks, will be reported for ITT and evaluable populations, respectively. Point 
estimates and 95% CIs using Clopper-Pearson method will be provided. 
The percentage of patients with elevated CA-125(>35 U/mL) who have ≥50% reduction in 
CA-125, at 8 weeks and 16 weeks, will be reported for ITT and evaluable populations, 
respectively. Point estimates and 95% CIs using the Clopper-Pearson method will be provided. 
Change from baseline in KPS score: KPS score will be assessed by two observers. If the values 
obtained by each observer are discrepant, the one with the lowest assessment will be considered. 
Summary statistics will be provided for KPS score at screening, baseline and at each of the 
post-baseline time points during the observation period. The changes of KPS score from baseline 
will be summarized by post-baseline visits. Patient data will be listed.  
Pharmacodynamic Analysis 
Analyses of pharmacodynamic parameters will be described in a separate document.  
Patient Reported Outcomes and Quality of Life Assessment 
PRO and QoL will be assessed in this study using the NFHSI-18 questionnaire (Butt et al. 2012), 
PROMIS (Cella et al. 2007) short form, EQ-5D-5L/VASc (Herdman et al. 2011), and a 
questionnaire for healthcare service utilization.  
NFHSI-18 questionnaire data will be listed and summarized. 
Baseline PRO and QoL assessments will be collected at Screening prior to the first dose of study 
treatment. Post-baseline assessments will be collected every cycle starting with Cycle 2 Day 1, at 
the End-of-Treatment Visit, and at the 30-Day Post-Treatment Follow-Up Visit. 
PROMIS Physical Function: Self-reported measure of physical capability, including functioning 
of upper extremities (dexterity), lower extremities (walking or mobility), central regions (neck, 


  
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back), as well as instrumental activities of daily living such as running errands, will be obtained 
at scheduled visits. 
EQ-5D-SL/VASc: The five dimensions of this instrument, mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression, along with a visual analog score for overall health will 
be assessed at designated visits. The same will be listed and summarized. 
PRO and QoL will be analyzed in the ITT Population and summarized for patients experiencing 
clinical benefit (response and/or disease control ≥18 weeks). Summary statistics will be provided 
for baseline and observed values at all post-baseline timepoints during the observation period. 
Data collected using the PRO instruments and QoL assessments will be listed. 
Data from healthcare utilization form will be summarized and listed including data on urgent 
care visits, emergency department visits and use of inpatient hospital services. 
9.8.5 Subgroup Analyses 
BOR and DCR per Investigator assessment will be analyzed for the following subgroups of the 
ITT and Evaluable Populations: 
x Prior lines of therapy (2 vs. ≥3) 
x KPS score (≥70 to <90 vs. ≥90 to 100, 70 vs 80+) 
x Site of metastatic disease (lung and lymph nodes only vs. liver vs. diffuse disease) 
x Time since diagnosis of pancreatic ductal adenocarcinoma to time of informed consent 
(<=12 months vs. > 12 months)  
x Duration of last treatment 
x Duration of last prior nab-paclitaxel 
x Prior systemic therapy 
Forest plot of DCR for SD ≥6 Weeks and SD ≥12 Weeks will be generated for age (<65, ≥65), 
sex, KPS, prior lines of therapy (2, 3, 4), metastatic disease at baseline, CA19-9 at baseline and 
prior nab-paclitaxel for ITT and evaluable populations respectively. 
9.9 
Pharmacokinetic Analyses 
The PK of relacorilant and nab-paclitaxel will be assessed in the PK population. Intensive PK 
sampling will occur on Cycle 1 Day 15 and will consist of a total of 7 samples collected at the 
following time points: pre-dose (0 hour), 0.5, 0.75, 1, 2, 4, and 6 hours post-dose. Where 
possible, the following PK parameters will be calculated:  
x AUC0-6h: AUC values from time 0 to 6 hours post-dose.  
x AUC0-24h: AUC values from time 0 to 24 hours post-dose.  
x AUClast: AUC values from time 0 to time of last measurable concentration.  
x Cmax: Maximum concentration.  
x Clast: Minimum concentration from time 0 to time of last measurable concentration.  
x Tmax: Time to maximum concentration. 
x Tlast: Time after dosing of the last quantifiable concentration.  


  
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x λz: Apparent terminal rate constant. 
PK parameters will be listed and summarized using descriptive statistics. 
9.10 
Safety Analyses 
All safety analyses will be performed on the safety analysis population. Data collected on study 
drug exposure, adverse events, deaths, clinical lab assessments, concomitant medications and 
therapies, physical examination, vital signs, 12-lead ECG will be presented in data listings and 
summary tables. 
9.10.1 Adverse Events 
AEs will be collected immediately following signing of informed consent and will continue until 
30 days after the last dose of relacorilant or nab-paclitaxel, whichever is latest. An abnormal 
laboratory value that leads to a dose modification/interruption, treatment discontinuation, or 
patient withdrawal from the study will be recorded as an AE. Adverse events reported more than 
30 days after the last dose of study treatment will be considered post-treatment AEs.  
Incidence of AEs will be listed and summarized using the Medical Dictionary for Regulatory 
Activities (MedDRA) version 23.0 by system organ class and preferred term. A hierarchical 
listing will display the MedDRA system organ classes represented in the data, and within each 
system organ class, the listing will display each unique preferred term ordered alphabetically. 
Adverse event listings will show missing relationship as missing. Tabular summaries with 
numbers and percentages of patients that have the following adverse events will be provided: 
x Overview of TEAEs  
x Summary of TEAEs: 
– by SOC and PT 
– by decreasing incidence of PT 
– by SOC, PT, and maximum severity 
x Summary of TEAEs related to relacorilant by investigator assessment: 
– by decreasing incidence of PT 
x Summary of TEAEs related to nab-paclitaxel by investigator assessment: 
– by decreasing incidence of PT 
x Summary of treatment-emergent serious adverse events: 
– by SOC and PT 
– by decreasing incidence of PT 
– by SOC, PT, and maximum severity 
– Related to relacorilant per investigator by SOC and PT 
– Related to nab-paclitaxel per investigator by SOC and PT 
x Summary of TEAEs with action taken of permanent discontinuation of relacorilant: 
– by decreasing incidence of PT 
x Summary of TEAEs with action taken of permanent discontinuation of nab-paclitaxel: 


  
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– by decreasing incidence of PT 
x TEAEs by SOC and PT occurring in at least 10% of the Safety Population 
– Related to relacorilant per investigator by SOC and PT 
– Related to nab-paclitaxel per investigator by SOC and PT 
x TEAEs with fatal outcome  
– by SOC and PT 
– by decreasing incidence of PT 
– Related to relacorilant per investigator by SOC and PT 
– Related to relacorilant per investigator by decreasing frequency of PT 
– Related to nab-paclitaxel per investigator by SOC and PT 
– Related to nab-paclitaxel per investigator by decreasing frequency of PT 
x Grade 3 or higher TEAE by SOC and PT  
– by SOC and PT  
– by decreasing incidence of PT 
x Grade 3 or higher TEAEs related to relacorilant by investigator assessment 
– by SOC and PT  
– by decreasing incidence of PT 
x Grade 3 or higher TEAEs related to nab-paclitaxel by investigator assessment 
– by SOC and PT  
– by decreasing incidence of PT  
x TEAEs leading to dose reductions for relacorilant 
– by SOC and PT  
– by decreasing incidence of PT 
x TEAEs leading to dose interruptions for relacorilant 
– by SOC and PT  
– by decreasing incidence of PT 
x TEAEs leading to dose reductions for nab-paclitaxel 
– by SOC and PT  
– by decreasing incidence of PT 
x TEAEs leading to dose interruptions for nab-paclitaxel 
– by SOC and PT  
– by decreasing incidence of PT 
x TEAEs reported due to COVID-19 by SOC and PT 
x TE Neutropenia by decreasing incidence of PT 
At each level of summarization (e.g., any AE, SOC, and PT), patients experiencing more than 
one AE will be counted only once within each dose level or follow-up period. In the summary of 
TEAEs by severity grade, patients will be counted once at the highest severity reported at each 


  
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level of summarization; in the summary of TEAEs by relationship, patients will be counted once 
at the closest relationship to study drug.  
Adverse events that are associated with infections due to SARS-CoV-2, including adverse 
events reported as COVID-19, will be summarized to assess the impact of the 2020 pandemic 
on the results. 
9.10.1.1 
Identified Risks and General Safety Topics 
Neutropenia incidence and severity will be examined as described in Section 9.10.1: 
TE Neutropenia by decreasing incidence of PT 
In addition, following combined categories of TEAEs will be analyzed (Table 5).  
Table 5 
Selected TEAEs 
Selected TEAEs 
Preferred Terms 
Neutropenia-1 
neutropenia, neutrophil count decreased 
Neutropenia-2 
neutropenia, neutrophil count decreased, leukopenia, white blood cell count decreased 
Neutropenia-3 
neutropenia, neutrophil count decreased, leukopenia, white blood cell count decreased 
and febrile neutropenia 
Anemia 
anemia, hemoglobin decreased 
Thrombocytopenia 
thrombocytopenia, platelet count decreased 
Pancytopenia 
pancytopenia, neutropenia, neutrophil count decreased, leukopenia, white blood cell 
count decreased, febrile neutropenia, anemia, hemoglobin decreased, 
thrombocytopenia, platelet count decreased 
Abdominal pain 
abdominal pain, abdominal pain upper, abdominal lower 
Fatigue 
asthenia, fatigue 
Peripheral neuropathy 
peripheral sensory neuropathy, peripheral neuropathy, neuropathy peripheral, 
peripheral motor neuropathy, peripheral sensorimotor neuropathy, neurotoxicity, 
hypoesthesia, dysesthesia 
 
9.10.2 Deaths 
All deaths, date and primary cause, whether they occurred during treatment or after 30-day 
follow-up, and whether an autopsy report is available will be listed and summarized. 
9.10.3 Clinical Laboratory Tests 
Screening Hepatitis B and C serologies and HIV, and other clinical laboratory tests for safety 
(hematology, chemistry, coagulation, urinalysis) will be performed according to the study 
schedule, data processed by local laboratories, and entered directly into the electronic data 
capture by site users. The table below lists all laboratory variables evaluated during the study. 
All results, along with abnormal values where relevant, and normal ranges will be presented in 


  
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data listings. If there are several measurements performed within the single visit window period, 
the measurement nearest to the planned visit date will be considered. 
Table 6 
Clinical Laboratory Variables Evaluated During the Study 
Hematology 
Serum Chemistry 
Urinalysis (dipstick) 
Red blood cell count  
Sodium  
Bacteria 
Hemoglobin  
Potassium  
Blood 
Hematocrit  
Calcium  
Urobilinogen 
Platelet count 
Chloride  
Nitrites 
White blood cell count (WBC) 
Phosphorus a  
Color 
WBC with 5-part differential: 
Magnesium a  
Clarity 
Neutrophils 
Serum creatinine 
pH 
Lymphocytes 
Total bilirubin 
Specific gravity 
Monocytes 
Albumin  
Ketones 
Eosinophils 
Alkaline phosphatase 
Protein  
Basophils 
Lactate dehydrogenase  
Glucose 
Coagulation 
   (at Screening only) 
Bilirubin 
International normalized ratio  
Aspartate aminotransferase 
Leukocyte esterase 
Activated partial thromboplastin time Alanine aminotransferase 
Hormone 
Prothrombin time 
Glucose, document whether fasting 
Serum or urine human chorionic  
Tumor Markers 
   or non-fasting 
   gonadotropin, if applicable 
CA19-9 
Blood urea nitrogen 
Other b 
CA-125 c 
Uric acid 
HIV immunoassay d 
CEA c 
Bicarbonate 
Hepatitis B/C serology e 
 
Total protein 
 
a  Magnesium and phosphorus at Screening and Day 1 of each cycle only. 
b  Must be confirmed as negative prior to randomization and first dose of study drug. 
c  CA-125 and CEA will only be measured in those patients who do not have elevated CA19-9 at Screening. 
d  4th generation immunoassay that detects HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen. 
e  Serologic assays for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), 
antibody to hepatitis B surface antigen (anti-HBs), and anti-hepatitis C antibodies. 
 
For safety lab panels, summaries of actual values and change from baseline will be presented at 
each assessment time point. Change from baseline will be calculated as the post-baseline minus 
the baseline measurement. If either value is missing, the observation will not be included in the 
summary statistics.  


  
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For parameters that can be graded using NCI-CTCAE v5.0, shift tables that summarize counts 
and percentages of patients by severity grade at baseline and worst post-baseline result will also 
be constructed.  
Results from a serum or urine pregnancy test for patients of childbearing potential, performed 
prior to start of study treatment and subsequently every 12 weeks, will be listed. 
9.10.4 Vital Signs and Weight 
At designated visits, vital signs will be recorded and will include weight, systolic and diastolic 
blood pressure, resting heart rate, body temperature, and respiratory rate. A listing of all vital 
signs will be provided. Additionally, data will be summarized using descriptive statistics at 
baseline, each study evaluation, and change from baseline to evaluation. Change from baseline 
will be calculated as the post-baseline minus the baseline measurement. If either value is 
missing, the observation will not be included in the summary statistics. 
9.10.5 Electrocardiograms 
At Screening and End of Treatment visits, 12-lead ECG data, obtained in triplicate, will be 
classified as normal, abnormal but not clinically significant, or abnormal and clinically 
significant by the Investigator or qualified designee. All recorded results will be included in 
a listing, and results averaging the triplicate reading at screening and end of study will be 
summarized as an absolute value and change from baseline. 
9.10.6 Physical Examination 
Any abnormalities observed during physical examination are captured as AEs or Medical History 
as appropriate. 


  
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APPENDIX