A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase: PHASE2
Conditions: Recurrent Ovarian Cancer, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma
Sponsor: Corcept Therapeutics

Title: A Phase 2, Randomized, Open-Label, 3-Arm Study of Relacorilant in Combination with 
Nab-Paclitaxel for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or 
Primary Peritoneal Cancer 
 
NCT number: NCT03776812 
 
Date: 23 October 2019 

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SYNOPSIS 
Name of Sponsor 
Corcept Therapeutics  
Name of Active Ingredient 
Relacorilant (CORT125134) 
Study Number 
CORT125134-552 
Title of Study  
A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel 
for Patients with Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer 
Study Centers  
Approximately 36 sites in the United States and globally. 
Phase of Development 
Phase 2 
Study Objectives 
For all efficacy objectives and corresponding endpoints listed below, assessment for response and 
disease progression are according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as 
assessed by the Investigator or local radiologist, unless otherwise noted. 
Primary:  
To evaluate progression-free survival (PFS) in patients treated with intermittent or continuous 
regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with 
nab-paclitaxel alone. 
Secondary: 
Efficacy 
• To evaluate objective response rate (ORR) in patients with measurable disease at baseline 
treated with intermittent or continuous regimens of relacorilant in combination with 
nab-paclitaxel compared with patients treated with nab-paclitaxel alone. 
• To evaluate duration of response (DoR) in patients treated with intermittent or continuous 
regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with 
nab-paclitaxel alone. 
• To assess response according to cancer antigen 125 (CA-125) using Gynecologic Cancer 
Intergroup (GCIG) criteria. A combined response endpoint based on both RECIST v1.1 and 
GCIG criteria will also be reported. 
• To evaluate PFS rate at 6 and 12 months in patients treated with intermittent or continuous 
regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with 
nab-paclitaxel alone. 
• To evaluate overall survival (OS) in patients treated with intermittent or continuous regimens of 
relacorilant in combination with nab-paclitaxel compared with patients treated with nab-
paclitaxel alone. 
• To evaluate PFS, ORR, DoR and best overall response (BoR) in patients who receive continuous 
relacorilant in combination with nab-paclitaxel following progression on nab-paclitaxel 
(Crossover).  
• To assess response according to CA-125 using GCIG criteria in those patients who crossover to 
continuous relacorilant + nab-paclitaxel. A combined response endpoint based on both RECIST 
v1.1 and GCIG criteria will also be reported for Crossover patients. 

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Safety 
• To assess the safety of relacorilant treatment in combination with nab-paclitaxel. 
• To model the exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel in each 
treatment arm to recommend a dosing regimen of relacorilant in combination with nab-paclitaxel 
for further development. 
Pharmacokinetics 
• To assess the pharmacokinetics (PK) of relacorilant and nab-paclitaxel following intermittent or 
continuous treatment regimens of relacorilant in combination with nab-paclitaxel compared with 
nab-paclitaxel alone. 
Exploratory 
Pharmacodynamics/Biomarkers  
• To assess the relationship between baseline characteristics of patients that respond to 
intermittent or continuous treatment regimens of relacorilant in combination with nab-paclitaxel 
and patients treated with nab-paclitaxel alone. 
• To assess pharmacodynamic effects of intermittent or continuous treatment regimens of 
relacorilant in combination with nab-paclitaxel and patients treated with nab-paclitaxel alone. 
Patient-Reported Outcomes and Quality of Life 
• To describe changes from baseline of Patient-Reported Outcomes (PRO) and Quality of Life 
(QoL) scores in the study population and to describe differences across treatment arms. 
Population 
Women with recurrent ovarian, primary peritoneal, or fallopian tube cancer following at least one 
treatment and which is resistant and/or refractory to platinum-based chemotherapy, including the 
following histological subtypes:  
• High grade serous carcinoma 
• Carcinosarcoma 
• Endometrioid carcinoma 
Number of Patients Planned 
A total of approximately 177 patients will be randomized in a 1:1:1 ratio to one of the 3 treatment arms 
(approximately 59 patients per arm). 
Methodology 
This is a Phase 2, open-label, randomized, 3-arm study to evaluate the efficacy, safety, PK, 
pharmacodynamics, PRO and QoL of continuous and intermittent dosing of relacorilant in combination 
with nab-paclitaxel compared with nab-paclitaxel alone.  
Screening procedures will be performed within the 28 days prior to the first dose of study treatment.  
Eligible patients will be randomized 1:1:1 to one of the following 3 treatment arms. Patient 
randomization will be stratified by treatment-free interval from most recent taxane (relapse within 
6 months vs >6 months) and presence of ascites (yes vs no).  
• Arm A (continuous relacorilant): relacorilant starting at 100 mg, administered orally, once daily 
every day in combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day 
cycle. 
• Arm B (intermittent relacorilant): relacorilant 150 mg, administered orally, once daily on the day 
before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel, in combination 
with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 

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• Arm C (comparator): nab-paclitaxel 100 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 
Study treatment will start on Cycle 1 Day 1 in all treatment arms.  
Tumor assessments will be conducted using computerized tomography (CT) with contrast or magnetic 
resonance imaging (MRI) scans of the chest, abdomen, and pelvis. A radiographic tumor assessment is 
required within 28 days prior to the first dose of study treatment and then every 8 weeks (±7 days) from 
Cycle 1 Day 1 until unequivocal PD is documented, including in patients who prematurely discontinue 
therapy. Tumor response will be assessed by the Investigator or local radiologist using RECIST v1.1. 
Radiographic scans will be quality checked, anonymized, and stored centrally. 
CA-125 will be assessed within 14 days prior to the first dose of study treatment and then every 
4 weeks from Cycle 1 Day 1 for the first 12 months of study treatment, and CA-125 response will be 
determined according to GCIG criteria.  
Tumor response will be assessed by RECIST v1.1, as described above. A combined response endpoint 
incorporating RECIST v1.1 and GCIG criteria will also be reported.  
Patients will remain on study treatment until unequivocal PD per RECIST 1.1 as determined by the 
Investigator, unmanageable toxicity, or patient refusal, or until meeting other criteria for 
discontinuation of study treatment. Patients will be seen approximately 30 days after the last dose of 
relacorilant or nab-paclitaxel, whichever is latest, for a 30-Day Follow-up Visit.  
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 treatment information (i.e., name[s] of subsequent 
therapy regimen[s], dates of initiation and completion, PD on subsequent therapy and response to 
subsequent therapy) during the Long-Term Follow-up.  
• 
For patients who discontinue treatment before unequivocal PD, subsequent treatment 
information will be collected at the same time as radiographic tumor assessments (i.e., every 
8 weeks) until unequivocal PD. After PD, they will be followed every 3 months for the 
remainder of the Long-Term Follow-up. 
• 
For patients with PD, or for patients who decline further radiographic tumor assessments, 
survival and subsequent treatment information will be collected every 3 months after the last 
dose of study treatment. Long-Term Follow-up will continue until the end point of death, the 
patient is lost to follow-up, or other study exit criteria are met (Section 4.4.2). 
Crossover: Patients in Arm C (comparator) who experience unequivocal PD per RECIST v1.1 will be 
given the opportunity to receive continuous relacorilant in combination with nab-paclitaxel after 
discussion with the Medical Monitor. Radiographic tumor assessments at the time of PD on 
nab-paclitaxel will be considered the final tumor assessment for comparator-only treatment and 
baseline for combination therapy. If more than 28 days have passed since the date of PD and Cycle 1 
Day 1 of the Crossover, then a new baseline radiographic tumor assessment will need to be obtained 
prior to initiating crossover treatment. Tumor assessments will then be performed every 8 weeks (±7 
days) from the first dose of relacorilant until PD. CA-125 will be assessed within 14 days prior to the 
first dose of relacorilant and assessed every 4 weeks for the first 12 months. Study procedures will be 
performed according to the schedule for the Treatment Phase; assessments for the Arm C End-of-
Treatment Visit and the Crossover Cycle 1 Day 1 Visit may be combined into one visit for patients in 
Arm C who crossover from nab-paclitaxel to combination treatment (relacorilant 100 mg, administered 
orally, once daily every day starting on Cycle 1 Day 1; in combination with nab-paclitaxel 80 mg/m2 on 
Days 1, 8, and 15 of each 28-day cycle).  
Pharmacodynamics/Biomarkers 
Optional paired tumor biopsies will be obtained within 6 weeks prior to treatment initiation and at 
Cycle 2 Day 1. A minimum of 6 patients providing biopsies in each of the 3 treatment arms is required. 
If additional patients are enrolled to achieve this target, consent to provide biopsies will become 

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mandatory. Pharmacodynamic markers will include mRNA gene panel (blood and tumor expression 
profiles), cytokines, cancer antigens, tumor biomarker assays (tumor tissue), and other exploratory 
biomarkers. Additionally, the neutrophil-to-lymphocyte ratio will be evaluated as a pharmacodynamic 
marker from the hematology results. 
Pharmacokinetics 
Intensive PK sampling for relacorilant and nab-paclitaxel will take place on Cycle 1 Day 15. 
Patient-Reported Outcomes and Quality of Life 
Baseline PRO and QoL assessments must be collected prior to the first dose of study treatment 
(relacorilant or nab-paclitaxel, whichever is earliest). Post-baseline assessments will be collected every 
other cycle, at the End-of-Treatment Visit, and at the 30-Day Follow-up Visit.  
A detailed description of the study visits and procedures are provided in the schedule of assessments 
(Table 10) and PK (Table 11) and pharmacodynamic (Table 12) schedules of assessments. 
Duration of Treatment and Duration of Study  
Patients will receive treatment until reaching a protocol-defined event of disease progression (PD), 
experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All 
patients will be followed for progression, subsequent therapies (start and end date and response), and 
survival. 
Independent Data Monitoring Committee 
To ensure patient safety, an Independent Data Monitoring Committee (IDMC) will evaluate safety data 
(which will include all patients enrolled in the study) after approximately 40 patients have enrolled and 
met at least one of the following criteria: 
• Received 2 cycles of treatment 
• Reached an event of PD 
• Discontinued treatment due to toxicity 
Subsequent reviews will be based on recommendations from the IDMC, with a minimum frequency 
of approximately every 6 months. A separate IDMC charter will be prepared and agreed by the 
IDMC members. 
Criteria for Inclusion 
Inclusion Criteria  
1. Signed and dated Institutional Review Board/Independent Ethics Committee-approved 
informed consent form prior to study-specific screening procedures.  
2. Female patients aged ≥18 years old at time of consent.  
3. Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary 
peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and 
borderline histologic subtypes are excluded. 
4. Received at least one line of therapy with evidence of cancer progression within 6 months after 
the last dose of platinum-based therapy (i.e., having a platinum-free interval of ≤6 months 
[platinum resistant]), or progressive disease during or immediately after platinum-based 
therapy (i.e., platinum refractory). Patients with primary platinum resistance (progression 
within 6 months of the last dose of first-line platinum-containing chemotherapy) are considered 
eligible.  
Notes: For the calculation of the platinum-free interval, cancer progression must be defined by 
clear evidence of progression, such as radiographic progression per RECIST v1.1. Calculating 
the platinum-free interval on the basis of increased CA-125 is not allowed. 

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5. Measurable or non-measurable disease by RECIST v1.1: 
• 
Previously irradiated lesions are not allowed as measurable disease, unless there is 
documented evidence of progression in the lesions. 
• 
To be eligible with non-measurable disease, patients must have evaluable disease with 
CA-125 of at least twice the upper limit of the reference range (or CA-125 ≥70 U/mL), 
along with radiographically evaluable disease by CT/MRI. 
6. Availability and consent to provide tumor tissue for biomarker assays (archival or recent 
biopsy). 
7. No more than 4 prior chemotherapeutic or myelosuppressive regimens (not including 
maintenance therapy such as single-agent bevacizumab or poly (ADP-ribose) polymerase 
[PARP] inhibitor). Patients with platinum-refractory cancer cannot have had more than 2 prior 
lines of treatment for refractory disease. 
8. Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator. 
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 
10. Adequate organ and bone marrow function meeting the following criteria: 
• 
Absolute neutrophil count (ANC) ≥1,500 cells/mm3. 
• 
Platelet count ≥100,000/mm3. 
• 
Hemoglobin ≥9 g/dL. 
• 
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of 
normal (ULN) (or ≤5×ULN in the context of liver metastasis). 
• 
Total bilirubin ≤1.5×ULN. 
• 
Creatinine clearance ≥45 mL/min/1.73 m2 (measured or estimated). 
• 
Albumin ≥3 g/dL (≥30 g/L). 
11. If patient has undergone surgery of the gastrointestinal or hepatobiliary tract, adequate 
absorption as evidenced by albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if present), 
and lack of malabsorption. 
12. Able to swallow and retain oral medication and does not have uncontrolled emesis. 
13. Able to comply with protocol requirements. 
14. Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential 
must use appropriate precautions to avoid pregnancy, defined as of nonchildbearing potential 
(i.e., postmenopausal or permanently sterilized) or using highly effective contraception with 
low user-dependency, for at least 3 months after the last dose of relacorilant, or per the duration 
indicated in the product label for nab-paclitaxel, whichever is latest. A woman is 
postmenopausal if it is more than 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. Accepted methods of highly effective 
contraception with low user-dependency are: 
• 
An intrauterine device (IUD), provided that the patient has tolerated its use for at least 
3 months before the first dose of study medication and undertakes not to have it removed 
for 1 month after the last dose. 
• 
Abstinence from heterosexual intercourse, when it is in line with the patient’s preferred and 
usual lifestyle. Periodic abstinence and withdrawal are NOT acceptable. 
• 
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. 
• 
Oral hormonal contraceptives are NOT permitted. 
 

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Exclusion Criteria 
1. Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that in the 
opinion of the Investigator has not resolved to Grade 1 or less prior to randomization. 
2. Any major surgery within 4 weeks prior to randomization. If patient received major surgery 
including (curative or palliative surgery), they must have recovered adequately from the 
toxicity and/or complications from the intervention prior to starting therapy.  
3. Treatment with the following prior to randomization: 
• 
Concurrent treatment with other anticancer therapy including other chemotherapy, 
immunotherapy, radiotherapy, chemoembolization, targeted therapy, an investigational 
agent or the non-approved use of a drug or device within 28 days before the first dose of 
study drug. 
• 
Hormonal anticancer therapies within 7 days of the first dose of study drug. 
• 
Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of the first 
dose of study drug. Short courses (≤5 days) for non-cancer-related reasons are allowed if 
clinically required (such as prophylaxis for CT). 
4. Received radiation to more than 25% of marrow-bearing areas. 
5. Toxicities of prior therapies (except alopecia) that have not resolved to National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 ≤ Grade 1. 
6. Requirement for treatment with chronic or frequently used oral corticosteroids for medical 
conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ 
transplantation). 
7. History of severe hypersensitivity or severe reaction to either study drug. 
8. Peripheral neuropathy from any cause > Grade 1. 
9. Pregnant or lactating patients or patients expecting to conceive children within the projected 
duration of the trial, starting with the Screening Visit through at least 3 months after the last 
dose of relacorilant, or per the duration indicated in the product label for nab-paclitaxel, 
whichever is latest. 
10. Human immunodeficiency virus or current chronic/active infection with hepatitis C virus or 
hepatitis B virus, including: 
• 
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 may be 
performed and must be negative for enrollment. 
11. Patient has a clinically significant uncontrolled condition(s) or which in the opinion of the 
Investigator may confound the results of the trial or interfere with the patient’s participation, 
including but not limited to: 
• 
Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months 
before study entry. 
• 
Uncontrolled hypertension (sustained systolic blood pressure >150 mmHg or diastolic 
pressure >100 mmHg despite optimal management). Patients will be considered eligible if 
hypertension is treated and controlled during screening. 
• 
Active infection that requires parenteral antibiotics. 
• 
Bowel obstruction or gastric outlet obstruction. 
• 
Has known psychiatric or substance abuse disorders that would interfere with cooperation 
with the requirements of the trial. 
12. Untreated parenchymal central nervous system metastases. 
13. Any other concurrent cancer or a history of another invasive malignancy within the last 3 years 
that has a likelihood of recurrence of >30% within the next 5 years. Adequately treated 

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non-melanoma skin cancers or non-muscle invasive urothelial cancer or other tumors 
curatively treated with no evidence of disease are permissible. 
14. Are taking a concomitant medication that is a strong CYP3A inhibitor or inducer, or that is a 
substrate of CYP3A with a narrow therapeutic window (Appendix D).  
15. Concurrent treatment with mifepristone or other glucocorticoid receptor (GR) antagonists. 
16. Concurrent treatment on other investigational treatment studies for the treatment of ovarian, 
fallopian tube, or primary peritoneal cancer.  
17. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal 
influenza vaccines for injection are generally inactivated flu vaccines and are allowed; 
however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are 
not allowed. 
Investigational Treatment, Dose, and Mode of Administration 
Study treatment (relacorilant and/or nab-paclitaxel) will be administered according to the assigned 
treatment arm, starting on Cycle 1 Day 1.  
Relacorilant:  
• Formulation: 100-mg yellow, softgel capsules, 50-mg white, hard gelatin capsules, and 25-mg 
brown, softgel capsules 
• Dose and mode of administration:  
• Arm A and Crossover (continuous relacorilant dosing): 100 mg (with upward dose titration 
permitted up to 150 mg), administered orally, once daily every day  
• Arm B (intermittent relacorilant dosing): 150 mg, administered orally, once daily on the 
day before, the day of, and the day after nab-paclitaxel 
Patients should be encouraged to take their relacorilant dose with food and room temperature water. 
Nab-paclitaxel (Abraxane®):  
• Formulation: commercially available and supplied in single dose vials, each containing 100 mg 
paclitaxel and approximately 900 mg of human albumin as stabilizer. 
• Dose and mode of administration: The maximal body surface area used for dose calculations in 
all arms will be 2.0 m2. Nab-paclitaxel will be administered according to the treatment arm as 
follows: 
• Arm A and Crossover: 80 mg/m2 intravenous (IV) infusion over 30–40 minutes on  
Days 1, 8, and 15 of each 28-day cycle 
• Arm B: 80 mg/m2 IV infusion over 30–40 minutes on Days 1, 8, and 15 of each  
28-day cycle  
• Arm C: 100 mg/m2 IV infusion over 30–40 minutes on Days 1, 8, and 15 of each  
28-day cycle 
Additional Study Treatments 
All patients in Arm A (continuous relacorilant), Arm B (intermittent relacorilant), and the Crossover 
will receive prophylactic granulocyte colony-stimulating factor (G-CSF) to reduce the risk of 
neutropenia. Prophylactic G-CSF will consist of at least 1 injection of G-CSF the day after the 
nab-paclitaxel infusion.  

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Patients in Arm C (comparator) will receive G-CSF as per the Investigator’s standard practice. 
Mandatory prophylactic growth factors will be used for patients at high risk for severe neutropenia, 
including the following: 
• 
Age ≥65 years old 
• 
History of febrile neutropenia, previous requirement for G-CSF, or complications of 
neutropenia, or  
• 
Low bone marrow reserve such as a history of extensive disease infiltrating the bone marrow 
or chronic cytopenia considered secondary to bone marrow infiltration.  
Criteria for Evaluation 
Primary Endpoint 
Efficacy 
• Progression free survival: the time from randomization until the date of first documented PD by 
RECIST v1.1 (as determined by the Investigator at the local site) or death due to any cause, 
whichever occurs first. 
Secondary Endpoints 
Efficacy 
• ORR: proportion of patients with measurable disease at baseline who attain complete response 
(CR) or partial response (PR) by RECIST v1.1 (confirmation not required). 
• DoR: time from when response (CR or PR) was first documented to first objectively 
documented PD or death (whichever occurs first). 
• BoR: the best response recorded from the date of randomization until PD/recurrence (or death). 
• CA-125 response will be assessed per GCIG criteria (Rustin 2011) defined as ≥50% reduction in 
CA-125 from a pre-treatment sample and maintained for ≥28 days in patients with a 
pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks 
before starting the treatment. In addition, patients who have a CA-125 response and whose CA 
125 level falls to within the reference range will be classified as CA-125 complete responders.  
• Combined response according to RECIST v1.1 + GCIG criteria. Response will be reported 
separately and combined for RECIST 1.1 and CA-125/GCIG criteria.  
• Progression-free rate (proportion of patients who have not progressed) at 6 and 12 months 
• PFS, ORR, DoR, and BoR in patients who crossover to treatment with continuous relacorilant in 
combination with nab-paclitaxel from the time of PD (baseline for combination therapy) on nab-
paclitaxel alone. 
• Overall survival: time from randomization to death by any cause. 
Safety 
The safety of each treatment group will be assessed by evaluating: 
• Study drug exposure 
• Exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel 
• Incidence of adverse events (AEs), serious AEs (SAEs), treatment-related AEs, AEs by severity, 
and deaths 
• Discontinuation of treatment and study withdrawal due to AEs 
• Dose interruptions and reductions due to AEs 
• Change from baseline in clinical laboratory tests 
• Change from baseline in vital signs (including blood pressure, heart rate) 
• Change from baseline in physical examination 
• Use of growth factors  

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• Change from baseline in ECOG performance status 
Pharmacokinetics 
• 
Primary PK parameters of relacorilant and nab-paclitaxel estimated from intensive PK 
sampling on Cycle 1 Day 15 
Exploratory Endpoints 
Pharmacodynamics 
Baseline assessment of: 
• Tumor immunohistochemistry: GR and immune markers such as 
 
 
• Tumor somatic DNA mutation panel 
• RNA analyses from circulating cells and tumor, where feasible 
• Cancer antigens, such as CA-125, CA15-3, CA19-9 and/or carcinoembryonic antigen (CEA) 
• Cytokines 
Change from baseline of: 
• Tumor immunohistochemistry: GR and immune markers such as 
 
 
• RNA analyses from circulating cells and tumor, where feasible 
• Cancer antigens, such as CA-125, CA15-3, CA19-9 and/or CEA 
• Cytokines 
Patient-Reported Outcomes and Quality of Life 
Changes from baseline of PRO and QoL assessments scores using the Functional Assessment of 
Cancer Therapy Ovarian Symptom Index-18 (FACT NFOSI-18) and EuroQoL 5 Dimensions, 5 Levels 
(EQ-5D-5L/VASc) scales and Patient-Reported Outcomes Measurement Information System 
(PROMIS) Physical Function-Short Form score. 
Statistical Methods  
Analysis Populations 
• Intent-to-Treat (ITT): All randomized patients, analyzed according to the randomized treatment 
arm. This population will be used for analysis of the primary endpoint and all secondary efficacy 
endpoints.  
• Safety Analysis Population (SAF): All randomized patients who received at least 1 dose of study 
treatment, analyzed according to the treatment actually received. This population will be used in 
all analyses of safety endpoints.  
• Pharmacokinetics Analysis Population (PKA): All patients in SAF who have PK data collected 
and available for analysis. 
Statistical Analyses 
Time-to-event endpoints will be summarized using Kaplan-Meier estimates and plots. Event 
probabilities at 6-month and 12-month time point and the median time-to-event (if estimable) will be 
presented. The log-rank test, stratified by stratification variable(s) used at randomization, will be used 
to compare the treatment groups with respect to time-to-event variables. Primary estimates of the 
treatment differences will be obtained using the hazard ratios and 1-sided 95% confidence intervals 
from stratified Cox regression models that includes treatment as a covariate and is stratified by 
stratification variables used at randomization. Response rate endpoints will be summarized by 
providing the point and interval estimates. 
The primary efficacy analysis will be performed on the ITT population. Additional sensitivity analyses 
will be performed to evaluate the robustness of the results.  

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Secondary endpoints will each be tested at a 1-sided 0.05 level of significance, without the adjustment 
for multiplicity of testing. P-values from secondary and exploratory tests will be considered 
descriptive.  
An evaluation of OS will be performed at the time of the primary analysis after 135 PFS events have 
occurred. An additional OS analysis will be performed when at least 120 OS events have occurred, 
which will be used for the purposes of final OS reporting. 
Sample Size 
The assumed median PFS in the current study is 3.8 months in the nab-paclitaxel alone arm (Arm C) 
and 5.4 and 6.8 months, respectively, in Arm B and Arm A. For the comparison between Arm C and 
Arm A, 91 PFS events will provide approximately 79% power for a 1-sided log-rank test at a 
0.05 significance level to detect a hazard ratio [HR]=0.56. Assuming an exponential distribution of 
PFS, this corresponds to an increase in median PFS from 3.8 months in Arm C to 6.8 months in Arm A. 
For the comparison between Arm C and Arm B, 92 PFS events will provide approximately 39% power 
for a 1-sided log-rank test at a 0.05 significance level to detect a HR=0.7. Assuming an exponential 
distribution of PFS, this corresponds to an increase in median PFS from 3.8 months in Arm C to 
5.4 months in Arm B. A total of approximately 177 patients will need to be randomized (1:1:1 ratio), 
assuming approximately 10% drop-out in each study arm.  
Interim Analysis 
No interim efficacy analysis will be performed. 
Patient-Reported Outcomes and Quality of Life 
For the FACT NFOSI-18, 4 subscale scores will be constructed and analyzed: 1) disease-related 
symptoms (DRS) scores, 2) emotional well-being (DRS-E) score, 3) treatment side effect (TSE) score, 
and 4) a functional well-being (FWB) score. For the primary PRO and QoL analysis, the overall mean 
change from baseline for the disease-related symptom (DRS) scores between groups will be assessed, 
using a longitudinal repeated measures model that takes into account the DRS measured at each 
assessment point up to 6 months or PD, whichever is later. Additional analyses based upon PRO 
endpoints will be specified in the statistical analysis plan. 
 

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CONTENTS 
CLINICAL STUDY PROTOCOL CORT125134-552 .................................................................. 1 
SPONSOR SIGNATURE PAGE ................................................................................................... 2 
SYNOPSIS ...................................................................................................................................... 3 
CONTENTS .................................................................................................................................. 13 
List of Tables ................................................................................................................................ 19 
List of Figures ............................................................................................................................... 19 
LIST OF ABBREVIATIONS AND DEFINITIONS ................................................................... 20 
1 
INTRODUCTION, BACKGROUND, AND SCIENTIFIC RATIONALE ..................... 22 
1.1 
Platinum-Resistant/Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer . 22 
1.2 
Therapeutic Hypothesis .................................................................................................... 22 
1.3 
Relacorilant ....................................................................................................................... 23 
1.3.1 Nonclinical Summary ........................................................................................... 23 
1.3.2 Clinical Summary ................................................................................................. 24 
1.4 
Nab-Paclitaxel ................................................................................................................... 25 
1.5 
Rationale for Study Design and Dose Regimen ............................................................... 26 
1.5.1 Design Considerations .......................................................................................... 26 
1.5.2 Rationale for Dose Regimen Selection ................................................................. 27 
1.5.3 Rationale for Dose Selection ................................................................................ 27 
1.5.4 Rationale for Dose Regimen ................................................................................. 27 
1.5.5 Rationale for Study Design ................................................................................... 28 
1.6 
Benefits and Risks............................................................................................................. 28 
2 
STUDY OBJECTIVES ..................................................................................................... 30 
2.1 
Primary Objective ............................................................................................................. 30 
2.2 
Secondary Objectives........................................................................................................ 30 
2.2.1 Secondary Efficacy Objectives ............................................................................. 30 
2.2.2 Safety Objectives .................................................................................................. 30 
2.2.3 Pharmacokinetic Objectives .................................................................................. 31 
2.3 
Exploratory Objectives ..................................................................................................... 31 
2.3.1 Pharmacodynamics/Biomarkers Objectives ......................................................... 31 

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2.3.2 Patient-Reported Outcomes and Quality of Life Objective .................................. 31 
3 
STUDY DESIGN.............................................................................................................. 32 
3.1 
Overall Design .................................................................................................................. 32 
3.1.1 Patient Crossover from Nab-Paclitaxel Treatment ............................................... 34 
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 .................................................................................... 35 
3.2.2.3 Pharmacokinetic Endpoints ................................................................... 36 
3.2.3 Exploratory Endpoints .......................................................................................... 36 
3.2.3.1 Pharmacodynamic Endpoints ................................................................. 36 
3.2.3.2 Patient-Reported Outcomes and Quality of Life Endpoints .................. 36 
3.3 
Number of Patients and Study Participation ..................................................................... 36 
3.3.1 Number of Patients ............................................................................................... 36 
3.3.2 Patient Study Completion ..................................................................................... 36 
3.4 
Definitions: End of Treatment, End of Study, and Study Duration .................................. 37 
3.4.1 End of Treatment .................................................................................................. 37 
3.4.2 End of Study ......................................................................................................... 37 
3.4.3 Study Duration ...................................................................................................... 37 
3.5 
Independent Data Monitoring Committee ........................................................................ 37 
4 
STUDY POPULATION ................................................................................................... 38 
4.1 
Inclusion Criteria .............................................................................................................. 38 
4.2 
Exclusion Criteria ............................................................................................................. 39 
4.3 
Screen Failures .................................................................................................................. 41 
4.4 
Patient Discontinuation of Treatment or Study Completion/Withdrawal......................... 41 
4.4.1 Patient Discontinuation of Study Treatment ......................................................... 41 
4.4.2 Patient Withdrawal from Study/Study Completion .............................................. 42 
5 
STUDY TREATMENTS AND MANAGEMENT .......................................................... 43 
5.1 
Study Drug (Relacorilant) ................................................................................................. 43 
5.1.1 Dose Titration ....................................................................................................... 44 

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5.2 
Nab-Paclitaxel (Abraxane)................................................................................................ 45 
5.3 
Additional Treatments ...................................................................................................... 46 
5.4 
Dose Reductions or Delays ............................................................................................... 46 
5.4.1 Dose Reductions or Delays for Nab-Paclitaxel .................................................... 48 
5.4.2 Dose Reductions or Delays for Relacorilant ......................................................... 49 
5.4.3 Management of Signs of Excessive Glucocorticoid Receptor Antagonism ......... 50 
5.5 
Concomitant Medications and Procedures........................................................................ 50 
5.5.1 Permitted Concomitant Medications ..................................................................... 50 
5.5.2 Permitted and Not Recommended Concomitant Therapy Requiring Caution...... 50 
5.5.3 Prohibited Medications and Foods........................................................................ 51 
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 
Medical and Oncology History ......................................................................................... 54 
6.3 
Safety Measures ................................................................................................................ 55 
6.3.1 Physical Examination and Vital Signs .................................................................. 55 
6.3.2 Pregnancy Test (in Women of Childbearing Potential) ........................................ 56 
6.3.3 Triplicate 12-Lead Electrocardiogram .................................................................. 56 
6.3.4 ECOG Performance Status ................................................................................... 56 
6.3.5 Adverse Events ..................................................................................................... 57 
6.3.6 Clinical Laboratory Assessments .......................................................................... 57 
6.3.6.1 Laboratory Parameters ........................................................................... 57 
6.4 
Measures of Anticancer Activity ...................................................................................... 58 
6.5 
Pharmacokinetic Assessments .......................................................................................... 59 
6.6 
Pharmacodynamic/Biomarker Assessments ..................................................................... 59 
6.6.1 Blood Collection for GC-Related Pathways and Exploratory Biomarkers .......... 60 

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6.6.2 Tumor Biopsy Tissue Collection .......................................................................... 60 
6.7 
Patient-Reported Outcomes and Quality of Life .............................................................. 61 
6.8 
Appropriateness of the Measures ...................................................................................... 61 
7 
STUDY ASSESSMENTS AND PROCEDURES BY STUDY VISIT ............................ 62 
7.1 
Screening........................................................................................................................... 62 
7.2 
Cycle 1 Day 1.................................................................................................................... 63 
7.3 
Treatment Phase ................................................................................................................ 64 
7.4 
End of Treatment (In-clinic Visit) .................................................................................... 65 
7.5 
30-Day Follow-up ............................................................................................................. 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 
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 ......................................................................................................... 70 
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 ....................................................................... 71 
8.2.2.1 Safety Reporting Contact ....................................................................... 71 
8.2.2.2 Suspected Unexpected Serious Adverse Reactions ............................... 72 
8.2.3 Emergency Sponsor Contact ................................................................................. 72 
8.3 
Pregnancy .......................................................................................................................... 72 
8.4 
Treatment of Overdose ..................................................................................................... 72 
9 
STATISTICAL METHODS ............................................................................................. 73 
9.1 
Analysis Populations ......................................................................................................... 73 

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9.2 
General Statistical Considerations .................................................................................... 73 
9.3 
Hypothesis Testing............................................................................................................ 73 
9.4 
Sample Size Calculation ................................................................................................... 74 
9.5 
Analysis Plan .................................................................................................................... 74 
9.5.1 Patient Disposition ................................................................................................ 74 
9.5.2 Demographic and Baseline Data ........................................................................... 74 
9.5.3 Concomitant Medications ..................................................................................... 75 
9.5.4 Efficacy Analyses ................................................................................................. 75 
9.5.4.1 Primary Efficacy Analysis ..................................................................... 75 
9.5.4.2 Secondary Efficacy Analyses ................................................................ 75 
9.5.4.3 Exploratory Efficacy Analyses .............................................................. 76 
9.5.4.4 Interim Analysis ..................................................................................... 76 
9.5.5 Safety Analyses ..................................................................................................... 76 
9.5.6 Pharmacokinetic Analysis ..................................................................................... 77 
9.5.7 Pharmacodynamic Analysis .................................................................................. 77 
9.5.8 Patient-Reported Outcomes/Quality of Life ......................................................... 77 
10 
ETHICAL AND LEGAL CONSIDERATIONS .............................................................. 78 
10.1 
Compliance with Institutional Review Board/Independent Ethics Committee Regulations
........................................................................................................................................... 78 
10.2 
Ethical Conduct of the Study ............................................................................................ 78 
10.3 
Protection of Patients ........................................................................................................ 78 
10.3.1 Compliance with Informed Consent Regulations ................................................. 78 
10.3.2 Patient Confidentiality .......................................................................................... 79 
10.3.3 Patient Privacy ...................................................................................................... 79 
11 
ADMINISTRATIVE CONSIDERATIONS ..................................................................... 80 
11.1 
Study Monitoring .............................................................................................................. 80 
11.2 
Quality Management ......................................................................................................... 80 
11.3 
Documentation .................................................................................................................. 80 
11.3.1 Electronic Case Report Forms and Study Records ............................................... 80 
11.3.2 Access to Source Documentation ......................................................................... 81 
11.3.3 Source Documents ................................................................................................ 81 

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11.3.4 Study Files and Retention of Study Records ........................................................ 81 
11.4 
Sample Collection, Preparation, and Shipping ................................................................. 82 
11.5 
Long-Term Retention of Biological Samples ................................................................... 82 
11.6 
Clinical Supplies ............................................................................................................... 82 
11.6.1 Inventory, Reconciliation, Return, and Disposition of Clinical Supplies ............. 82 
11.6.2 Clinical Supply Inventory ..................................................................................... 82 
11.6.3 Return or Disposal of Study Drug and/or Supplies .............................................. 83 
11.7 
Drug Accountability.......................................................................................................... 83 
11.8 
Post-Trial Care .................................................................................................................. 83 
11.9 
Noncompliance with the Protocol ..................................................................................... 84 
11.10 Financial Disclosure.......................................................................................................... 84 
11.11 Publication and Disclosure Policy .................................................................................... 84 
11.12 Study Termination by Sponsor ......................................................................................... 84 
12 
REFERENCES ................................................................................................................. 86 
Appendix A: Schedules of Assessments and Procedures ............................................................. 88 
Appendix B: Guidance for Identifying High Grade Serous Carcinoma ....................................... 95 
Appendix C: General Chemotherapy Guidelines ......................................................................... 96 
Appendix D: Examples of Medications and Foods that are Prohibited or to be Used with Caution
........................................................................................................................................... 97 
Appendix E: RECIST v1.1 for Disease Assessment .................................................................... 99 
Appendix F: Gynecological Cancer Intergroup Definitions for Response and Progression in 
Ovarian Cancer Clinical Trials ....................................................................................... 103 
Appendix G: Guidance for Counting Prior Lines of Therapy .................................................... 107 
Appendix H: Summary of Changes ............................................................................................ 108 
 

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List of Tables 
Table 1 
Relacorilant: Formulation, Administration, Packaging, and Storage ....................43 
Table 2 
Nab-Paclitaxel: Formulation, Administration, Packaging, and Storage ................45 
Table 3  
Dose Reductions or Delays Due to Adverse Events ..............................................47 
Table 4 
Nab-Paclitaxel Dose Reductions............................................................................49 
Table 5 
Relacorilant Dose Level Summary ........................................................................49 
Table 6 
ECOG Performance Status ....................................................................................56 
Table 7 
Clinical Laboratory Variables Evaluated During the Study ..................................58 
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 
Schedule of Assessments and Procedures..............................................................88 
Table 11 
Pharmacokinetic Schedule of Assessments ...........................................................92 
Table 12 
Pharmacodynamic Schedule of Assessments ........................................................93 
Table 13 
Evaluation of Best Overall Response in Patients Without Initial Measurable 
Disease and Who are Evaluable by CA-125 (GCIG Criteria) .............................104 
Table 14 
Best Overall Response in Patients with Measurable Disease and Who are also 
Evaluable by CA-125 (GCIG Criteria) ................................................................105 
Table 15 
Example of Reporting Response According to RECIST v1.1, CA-125 (GCIG 
Criteria), and Combined Response ......................................................................106 
Table 16 
Summary of Changes in Protocol CORT125134-552 Amendment 1 .................109 
 
List of Figures 
Figure 1 
CORT125134-552 Study Design ...........................................................................33 
 

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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 
AUC 
Area under the curve 
BoR 
Best overall response 
CA-125 
Cancer antigen 125 
CEA 
Carcinoembryonic antigen 
CI 
Confidence interval 
CR 
Complete response 
CT 
Computerized tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DoR 
Duration of response 
DRS 
Disease-related symptom 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EQ-5D-5L/VASc 
EuroQoL 5 Dimensions, 5 Levels 
EU 
European Union 
FACT NFOSI-18 
Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 
G-CSF 
Granulocyte colony-stimulating factor 
GCIG 
Gynecologic Cancer Intergroup 
GCP 
Good Clinical Practice 
GR 
Glucocorticoid receptor 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
IND 
Investigational new drug 
INR 
International normalized ratio 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IV 
Intravenously 

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Abbreviation 
Definition 
IVRS/IWRS 
Interactive voice/web response system 
MedDRA 
Medical Dictionary for Regulatory Affairs 
MRI 
Magnetic resonance imaging 
mRNA 
Messenger ribonucleic acid 
NCI 
National Cancer Institute 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events  
ORR 
Objective response rate 
OS 
Overall survival 
PD 
Disease progression (progressive disease per RECIST v1.1) 
PFS 
Progression-free survival 
PK 
Pharmacokinetics 
PKA 
Pharmacokinetic Analysis Population  
PR 
Partial response 
PRO 
Patient-reported outcomes 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PS 
Performance status 
PT 
Prothrombin time 
QC 
Quality control 
QoL 
Quality of life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RSI 
Reference Safety Information 
SAE 
Serious adverse event 
SAF 
Safety analysis population 
SAP 
Statistical analysis plan 
SD 
Stable Disease 
SOD 
Sum of the diameters 
SOP 
Standard operating procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
Treatment-emergent adverse events 
ULN 
Upper limit of normal 
 

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2 
STUDY OBJECTIVES 
For all efficacy objectives listed below, as well as the corresponding endpoints (see Section 3.2), 
assessment for response and disease progression are according to RECIST v1.1 as assessed by 
the Investigator or local radiologist, unless otherwise noted. 
2.1 
Primary Objective 
To evaluate progression-free survival (PFS) in patients treated with intermittent or continuous 
regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with 
nab-paclitaxel alone. 
2.2 
Secondary Objectives 
2.2.1 Secondary Efficacy Objectives 
• To evaluate objective response rate (ORR) in patients with measurable disease treated 
with intermittent or continuous regimens of relacorilant in combination with 
nab-paclitaxel compared with patients treated with nab-paclitaxel alone. 
• To evaluate duration of response (DoR) in patients treated with intermittent or continuous 
regimens of relacorilant in combination with nab-paclitaxel compared with patients 
treated with nab-paclitaxel alone. 
• To assess response according to cancer antigen 125 (CA-125) using GCIG criteria. A 
combined response endpoint based on both RECIST v1.1 and GCIG criteria will also be 
reported. 
• To evaluate PFS rate at 6 and 12 months in patients treated with intermittent or 
continuous regimens of relacorilant in combination with nab-paclitaxel compared with 
patients treated with nab-paclitaxel alone. 
• To evaluate overall survival (OS) in patients treated with intermittent or continuous 
regimens of relacorilant with nab-paclitaxel compared with patients treated with nab-
paclitaxel alone. 
• To evaluate PFS, ORR, DoR and best overall response (BoR) in patients who receive 
continuous relacorilant in combination with nab-paclitaxel following progression on 
nab-paclitaxel (Crossover). 
• To assess response according to CA-125 using GCIG criteria in those patients who 
crossover to continuous relacorilant + nab-paclitaxel. A combined response endpoint 
based on both RECIST v1.1 and GCIG criteria will also be reported for Crossover 
patients. 
2.2.2 Safety Objectives 
• To assess the safety of relacorilant treatment in combination with nab-paclitaxel. 
• To model the exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel 
in each treatment arm to recommend a dosing regimen of relacorilant in combination 
with nab-paclitaxel for further development. 

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2.2.3 Pharmacokinetic Objectives 
To assess the PK of relacorilant and nab-paclitaxel following intermittent or continuous regimens 
of relacorilant in combination with nab-paclitaxel compared with nab-paclitaxel alone. 
2.3 
Exploratory Objectives 
2.3.1 Pharmacodynamics/Biomarkers Objectives 
• To assess the relationship between baseline characteristics of patients that respond to 
intermittent or continuous treatment regimens of relacorilant in combination with 
nab-paclitaxel and patients treated with nab-paclitaxel alone. 
• To assess pharmacodynamic effects of intermittent or continuous treatment regimens of 
relacorilant in combination with nab-paclitaxel and patients treated with nab-paclitaxel 
alone. 
2.3.2 Patient-Reported Outcomes and Quality of Life Objective 
To describe changes from baseline of PRO and QoL scores in the study population and to 
describe differences across treatment arms. 

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3 
STUDY DESIGN 
3.1 
Overall Design 
This is a Phase 2, open-label, randomized, 3-arm study to evaluate the efficacy, safety, PK, 
pharmacodynamics, PRO and QoL of continuous and intermittent dosing of relacorilant in 
combination with nab-paclitaxel compared with nab-paclitaxel alone. 
Eligible patients will be randomized 1:1:1 to one of the following 3 treatment arms. Patient 
randomization will be stratified by treatment-free interval from most recent taxane (relapse 
within 6 months vs >6 months) and presence of ascites (yes vs no).  
• Arm A (continuous relacorilant): relacorilant starting at 100 mg, administered orally, 
once daily every day, in combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 
of each 28-day cycle.  
• Arm B (intermittent relacorilant): relacorilant 150 mg, administered orally, once daily on 
the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel, in 
combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 
• Arm C (comparator): nab-paclitaxel 100 mg/m2 on Days 1, 8, and 15 of each 28-day 
cycle. 
The study consists of the following phases: 
• Screening: Patients will undergo screening procedures within 28 days prior to the first 
dose of study treatment (relacorilant or nab-paclitaxel, whichever is earliest). 
• Treatment Phase: Study treatment will start on Cycle 1 Day 1 for all treatment arms and 
continue until disease progression, unacceptable toxicity, or other treatment 
discontinuation criteria are met. Patients in Arm C who experience unequivocal PD per 
RECIST v1.1 will be given the opportunity to crossover to the continuous regimen of 
relacorilant in combination with nab-paclitaxel after discussion with the Medical Monitor 
(Section 3.1.1). 
• 30-Day Follow-up and Post-Treatment Follow-up: Patients will return for a 30-Day 
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 every 8 weeks (±7 days) until unequivocal PD. 
• Long-Term Follow-up: All patients will be followed after their final dose of study 
treatment to document survival as well as response/outcomes to subsequent anticancer 
treatment (Section 7.6). 
See Figure 1 for an illustration of the study design. 

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Figure 1 
CORT125134-552 Study Design 
 
 
A detailed description of the study visits and procedures are provided in the schedule of 
assessments (Table 10) and PK (Table 11) and pharmacodynamic (Table 12) schedules of 
assessments.  
All data will be recorded in an electronic case report form (eCRF). 
Measures of Anticancer Activity 
Tumor assessments will be conducted using computerized tomography (CT) with contrast or 
magnetic resonance imaging (MRI) scan of the chest, abdomen, and pelvis. A radiographic 
tumor assessment is required within 28 days prior to the first dose of study treatment and then 
every 8 weeks (±7 days) from Cycle 1 Day 1 until unequivocal PD is documented, including in 
patients who prematurely discontinue therapy. Tumor response will be assessed by the 
Investigator or local radiologist using RECIST v1.1. Radiographic scans will be quality checked, 
anonymized, and stored centrally. 
CA-125 will be assessed within 14 days prior to the first dose of study treatment and then every 
4 weeks from Cycle 1 Day 1 for the first 12 months of study treatment, and CA-125 response 
will be determined according to GCIG criteria. 
Tumor response will be assessed by RECIST v1.1, as described above. A combined response 
endpoint incorporating RECIST v1.1 and GCIG criteria will also be reported.  
Pharmacodynamics/Biomarkers 
Optional paired tumor biopsies will be obtained in this study. For patients who consent to 
provide these, the first tumor biopsy will be collected within 6 weeks prior to treatment initiation 
(this can be the same pre-treatment biopsy used to meet eligibility criteria) and the second tumor 

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biopsy will be collected at Cycle 2 Day 1. In order to assess the study endpoints, paired biopsies 
from a minimum of 6 patients per treatment arm are needed. If additional patients have to be 
enrolled to achieve this target, consent to provide paired biopsies will become mandatory for 
enrollment in the study.  
Pharmacodynamic markers will include mRNA gene panel (blood and tumor expression 
profiles), cytokines, cancer antigens, tumor biomarker assays (tumor tissue), and other 
exploratory biomarkers. Additionally, the neutrophil-to-lymphocyte ratio will be evaluated as a 
pharmacodynamic marker from the hematology results. 
Intensive pharmacodynamic sampling (Table 12) will be performed on a subset of patients, 
comprising at least the first 20 patients enrolled in Arm A (Section 6.6.1). In order to achieve 
20 pharmacodynamic-evaluable patients, additional patients in Arm A may undergo intensive 
pharmacodynamic sampling if some patients are not evaluable.  
Pharmacokinetics 
Intensive pharmacokinetic sampling for relacorilant and nab-paclitaxel will take place on Cycle 1 
Day 15. 
Patient-Reported Outcomes and Quality of Life 
Baseline PRO and QoL assessments must be collected prior to the first dose of study treatment 
(relacorilant or nab-paclitaxel, whichever is earliest). Post-baseline assessments will be collected 
every other cycle, at the End-of-Treatment Visit, and at the 30-Day Follow-up Visit. To 
minimize bias, PRO and QoL assessments are to be completed prior to discussing the results of 
tumor assessments or disease-related clinical changes with the patient (Section 6.7). 
3.1.1 Patient Crossover from Nab-Paclitaxel Treatment 
Patients in Arm C (comparator) who experience unequivocal PD per RECIST v1.1 will be given 
the opportunity to receive the continuous regimen of relacorilant in combination with nab-
paclitaxel after discussion with the Medical Monitor. Patients will receive relacorilant 100 mg, 
administered orally, once daily every day with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of 
each 28-day cycle. Radiographic tumor assessments at the time of PD on nab-paclitaxel will be 
considered the final tumor assessment for comparator-only treatment and baseline for 
combination therapy. If the most recent radiographic tumor assessment has occurred >28 days 
from Cycle 1 Day 1 of the Crossover, then a new baseline radiographic tumor assessment will 
need to be obtained prior to starting crossover treatment. Radiographic tumor assessments will 
then be performed every 8 weeks (±7 days) from the first dose of relacorilant until PD. CA-125 
will be assessed within 14 days prior to the first dose of relacorilant and assessed every 4 weeks 
for the first 12 months. Study procedures will be performed according to the schedule for the 
Treatment Phase; assessments for the Arm C End-of-Treatment Visit and the Crossover Cycle 1 
Day 1 Visit may be combined into 1 visit for patients in Arm C who crossover to combination 
treatment with continuous relacorilant and nab-paclitaxel.  

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3.2 
Study Endpoints 
3.2.1 Primary Efficacy Endpoint 
The primary efficacy endpoint will be PFS, i.e., the time from the date of randomization until the 
date of first documented PD by RECIST v1.1 (as determined by the Investigator at the local site) 
or death from any cause, whichever occurs first. 
3.2.2 Secondary Endpoints 
3.2.2.1 
Secondary Efficacy Endpoints 
•
Objective Response Rate (ORR): proportion of patients with measurable disease at
baseline who attain CR or PR by RECIST v1.1 (confirmation not required).
•
Duration of Response (DoR): time from when response (CR or PR) was first documented
to first objectively documented PD or death (whichever occurs first).
•
Best Overall Response (BoR): the best response recorded from the date of randomization
until PD/recurrence (or death).
•
CA-125 response will be assessed per GCIG criteria (Rustin et al. 2011) defined as ≥50%
reduction in CA-125 from a pre-treatment sample and maintained for ≥28 days in patients
with a pretreatment sample that is at least twice the upper limit of the reference range and
within 2 weeks before starting the treatment. In addition, patients who have a CA-125
response and whose CA-125 level falls to within the reference range will be classified as
CA-125 complete responders.
•
Combined response according to RECIST v1.1 + GCIG criteria. Response will be
reported separately and combined for RECIST v1.1 and CA-125/GCIG criteria.
•
Progression-free rate (proportion of patients who have not progressed) at 6 and
12 months.
•
PFS, ORR, DoR, and BoR in patients who crossover to the continuous treatment regimen
of relacorilant in combination with nab-paclitaxel from the time of PD (baseline for
combination therapy) on nab-paclitaxel alone.
•
Overall survival: time from randomization to death by any cause.
3.2.2.2 
Safety Endpoints 
The safety of each treatment group will be assessed by evaluating: 
•
Study drug exposure
•
Exposure-toxicity and exposure-response of relacorilant and nab-paclitaxel
•
Incidence of AEs, serious AEs (SAEs), treatment-related AEs, AEs by severity, and
deaths
•
Discontinuation of treatment and study withdrawal due to AEs
•
Dose interruptions and reductions due to AEs
•
Change from baseline in clinical laboratory tests
•
Change from baseline in vital signs (including blood pressure, heart rate)
•
Change from baseline in physical examination
•
Use of growth factors

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•
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance
status (PS)
3.2.2.3 
Pharmacokinetic Endpoints 
Primary PK parameters of relacorilant and nab-paclitaxel estimated from intensive PK sampling 
on Cycle 1 Day 15 will be assessed. 
3.2.3 Exploratory Endpoints 
3.2.3.1 
Pharmacodynamic Endpoints 
Baseline assessment of: 
•
Tumor immunohistochemistry: GR and immune markers such as 
•
Tumor somatic DNA mutation panel
•
RNA analyses from circulating cells and tumor, where feasible
•
Cancer antigens, such as CA-125, CA15-3, CA19-9 and/or CEA
•
Cytokines
Change from baseline of: 
•
Tumor immunohistochemistry: GR and immune markers such as 
•
RNA analyses from circulating cells and tumor, where feasible
•
Cancer antigens, such as CA-125, CA15-3, CA19-9 and/or carcinoembryonic antigen
(CEA)
•
Cytokines
3.2.3.2 
Patient-Reported Outcomes and Quality of Life Endpoints 
Changes from baseline of PRO and QoL scores using the Functional Assessment of Cancer 
Therapy Ovarian Symptom Index-18 (FACT NFOSI-18) (Jensen et al. 2011) and EuroQoL 
5 Dimensions, 5 Levels (EQ-5D-5L/VASc) scales (EuroQoL 1990) and Patient-Reported 
Outcomes Measurement Information System (PROMIS) Physical Function-Short Form score 
(Cella et al. 2007, Rose et al. 2008, Rose et al. 2014) will be assessed. 
3.3 
Number of Patients and Study Participation 
3.3.1 Number of Patients 
A total of approximately 177 patients will be randomized in a 1:1:1 ratio to one of the 
3 treatment arms (approximately 59 patients per arm).  
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). 

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3.4 
Definitions: End of Treatment, End of Study, and Study Duration  
3.4.1 End of Treatment 
Refer to Section 4.4 for reasons for treatment discontinuation. 
The end of treatment is defined as the date on which the patient received her last treatment of 
relacorilant or nab-paclitaxel, whichever is latest. 
3.4.2 End of Study 
The end of study is defined as the date of last contact (visit, telephone, email) with the last study 
patient. Corcept will ensure that the Institutional Review Board (IRB)/Independent Ethics 
Committee (IEC) and the regulatory authority are notified that the study has finished according 
to Corcept’s standard operating procedures (SOPs) and/or local or national regulations.  
3.4.3 Study Duration 
The assumed median PFS is 3.8 months in the comparator arm (Arm C), and 6.8 and  
5.4 months, respectively, in Arm A and Arm B. Patients will receive treatment until reaching a 
protocol-defined event of PD, experiencing unmanageable toxicity, or until other treatment 
discontinuation criteria are met. 
The total patient accrual duration is expected to be 24 months, with an overall expected study 
duration of 43 months. 
All patients will be followed for progression, subsequent therapies (start and end date and 
response) and survival.  
3.5 
Independent Data Monitoring Committee  
To ensure patient safety, an Independent Data Monitoring Committee (IDMC) will evaluate 
safety data (which will include all patients enrolled in the study) after approximately 40 patients 
have enrolled and met at least one of the following criteria: 
• Received 2 cycles of treatment 
• Reached an event of PD 
• Discontinued treatment due to toxicity 
Subsequent reviews will be based on recommendations from the IDMC, with a minimum 
frequency of approximately every 6 months. A separate IDMC charter will be prepared and 
agreed by the IDMC members. 
 

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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. Signed and dated IRB/IEC-approved informed consent form (ICF) prior to study-specific
screening procedures. Note: standard of care assessments completed before the ICF is
signed can be used for eligibility if done within the 28-day Screening Period.
2. Female patients aged ≥18 years old at time of consent.
3. Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary
peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and
borderline histologic subtypes are excluded. Guidelines for identifying high grade serous
carcinoma are provided in Appendix B.
4. Received at least one line of therapy with evidence of cancer progression within 6 months
after the last dose of platinum-based therapy (i.e., having a platinum-free interval of
≤6 months [platinum resistant]), or progressive disease during or immediately after
platinum-based therapy (i.e., platinum refractory). Patients with primary platinum
resistance (progression within 6 months of the last dose of first-line platinum-containing
chemotherapy) are considered eligible.
Notes: For the calculation of the platinum-free interval, cancer progression must be
defined by clear evidence of progression, such as radiographic progression per
RECIST v1.1. Calculating the platinum-free interval on the basis of increased CA-125 is
not allowed.
5. Measurable or non-measurable disease by RECIST v1.1:
•
Previously irradiated lesions are not allowed as measurable disease, unless there is
documented evidence of progression in the lesions.
•
To be eligible with non-measurable disease, patients must have evaluable disease
with CA-125 of at least twice the upper limit of the reference range (or CA-125
≥70 U/mL), along with radiographically evaluable disease by CT/MRI.
6. Availability and consent to provide tumor tissue for biomarker assays (archival or recent
biopsy).
7. No more than 4 prior chemotherapeutic or myelosuppressive regimens (not including
maintenance therapy such as single-agent bevacizumab and poly (ADP-ribose)
polymerase [PARP] inhibitors). Patients with platinum-refractory cancer cannot have had
more than 2 prior lines of treatment for refractory disease. Guidance for counting prior
lines of therapy are provided in Appendix G.
8. Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator.
9. ECOG performance status 0 or 1.
10. Adequate organ and bone marrow function meeting the following criteria at the
Screening Visit:
•
Absolute neutrophil count (ANC) ≥1,500 cells/mm3.
•
Platelet count ≥100,000/mm3.
•
Hemoglobin ≥9 g/dL.

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• AST or alanine aminotransferase (ALT) ≤2.5× upper limit of normal (ULN) (or 
≤5×ULN in the context of liver metastasis). 
• Total bilirubin ≤1.5×ULN.  
• Creatinine clearance ≥45 mL/min/1.73 m2 (measured or estimated). 
• Albumin ≥3 g/dL (≥30 g/L).  
11. If patient has undergone surgery of the gastrointestinal or hepatobiliary tract, adequate 
absorption as evidenced by albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if 
present), and lack of malabsorption. 
12. Able to swallow and retain oral medication and does not have uncontrolled emesis. 
13. Able to comply with protocol requirements. 
14. Negative pregnancy test for patients of childbearing potential. Patients of childbearing 
potential must use appropriate precautions to avoid pregnancy, defined as of 
nonchildbearing potential (i.e., postmenopausal or permanently sterilized) or using highly 
effective contraception with low user-dependency, for at least 3 months after the last dose 
of relacorilant, or per the duration indicated in the product label for nab-paclitaxel, 
whichever is latest. A woman is postmenopausal if it is more than 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. Accepted methods of highly effective contraception with low user-
dependency are: 
• An intrauterine device (IUD), provided that the patient has tolerated its use for at least 
3 months before the first dose of study medication and undertakes not to have it 
removed for 1 month after the last dose. 
• Abstinence from heterosexual intercourse, when it is in line with the patient’s 
preferred and usual lifestyle. Periodic abstinence and withdrawal are NOT acceptable. 
• 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. 
• Oral hormonal contraceptives are NOT permitted. 
4.2 
Exclusion Criteria 
Patients who meet any of the following criteria will not be permitted entry to the study: 
1. Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that 
in the opinion of the Investigator has not resolved to Grade 1 or less prior to 
randomization. 
2. Any major surgery within 4 weeks prior to randomization. If the patient received major 
surgery including (curative or palliative surgery), they must have recovered adequately 
from the toxicity and/or complications from the intervention prior to starting therapy.  
3. Treatment with the following prior to randomization: 
• Concurrent treatment with other anticancer therapy including other chemotherapy, 
immunotherapy, radiotherapy, chemoembolization, targeted therapy, an 
investigational agent, or the non-approved use of a drug or device within 28 days 
before the first dose of study drug. 

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• Hormonal anticancer therapies within 7 days of the first dose of study drug. 
• Systemic, inhaled, or prescription strength topical corticosteroids within 21 days of 
the first dose of study drug. Short courses (≤5 days) for non-cancer-related reasons 
are allowed if clinically required (such as prophylaxis for CT). 
4. Received radiation to more than 25% of marrow-bearing areas. 
5. Toxicities of prior therapies (except alopecia) that have not resolved to National Cancer 
Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) 
≤ Grade 1. 
6. Requirement for treatment with chronic or frequently used oral corticosteroids for 
medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after organ 
transplantation). 
7. History of severe hypersensitivity or severe reaction to either study drug. 
8. Peripheral neuropathy from any cause > Grade 1. 
9. Pregnant or lactating patients or patients expecting to conceive children within the 
projected duration of the trial, starting with the Screening Visit through at least 3 months 
after the last dose of relacorilant, or per the duration indicated in the product label for 
nab-paclitaxel, whichever is latest. 
10. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis 
C virus or hepatitis B virus including: 
• 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 may be performed and must be negative for enrollment. 
11. Patient has a clinically significant uncontrolled condition(s) or which in the opinion of 
the Investigator may confound the results of the trial or interfere with the patient’s 
participation, including but not limited to: 
• Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 
6 months before study entry. 
• Uncontrolled hypertension (sustained systolic blood pressure >150 mmHg or diastolic 
pressure >100 mmHg despite optimal management). Patients will be considered 
eligible if hypertension is treated and controlled during screening. 
• Active infection that requires parenteral antibiotics. 
• Bowel obstruction or gastric outlet obstruction. 
• Has known psychiatric or substance abuse disorders that would interfere with 
cooperation with the requirements of the trial. 
12. Untreated parenchymal central nervous system metastases. 
13. Any other concurrent cancer or a history of another invasive malignancy within the last 
3 years that has a likelihood of recurrence of >30% within the next 5 years. Adequately 
treated non-melanoma skin cancers or non-muscle invasive urothelial cancer or other 
tumors curatively treated with no evidence of disease are permissible. 
14. Are taking a concomitant medication that is a strong CYP3A inhibitor or inducer, or that 
is a substrate of CYP3A with a narrow therapeutic window (Appendix D).  
15. Concurrent treatment with mifepristone or other GR antagonists.  
16. Concurrent treatment on other investigational treatment studies for the treatment of 
ovarian, fallopian tube, or primary peritoneal cancer.  

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17. Has received a live vaccine within 30 days of planned start of study therapy. Note: 
Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are 
allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated 
vaccines, and are not allowed.  
4.3 
Screen Failures 
Screen failures are defined as patients who consent to participate in the clinical study but are not 
subsequently randomized to study treatment.  
A patient who has failed screening due to a reason that is temporary and expected to resolve 
(e.g., mild intercurrent infection) may be re-screened. 
The reason for screen failure should be recorded. 
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 
refuse further study procedures, the patient should be asked if she is willing to continue with 
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 to 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 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 Patient 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 schedule of assessments.  
Reasons for study treatment discontinuation may include the following:  
• Disease progression as defined by RECIST v1.1 
• Unacceptable toxicity 
• Adverse event 
• Patient refuses further 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, including a non-protocol-specified 
anticancer therapy 
– The patient is not compliant with protocol requirements 

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– Global deterioration of health status requiring treatment discontinuation 
• The patient is pregnant 
• Any of the criteria listed in Section 4.4.2, as patients who withdraw/complete the study 
will also discontinue treatment 
Patients who discontinue study treatment early should be encouraged to come to the clinic for an 
End-of-Treatment Visit, return for a 30-Day Follow-up Visit approximately 30 days after the 
patient’s final dose of study treatment (Table 10), and should report any AEs, including SAEs, 
according to Section 8.1.2. For patients who elect to discontinue treatment, every effort should 
be made to determine whether the decision to discontinue treatment was related to an AE or a 
specific aspect of the study.  
Patients who discontinue treatment before unequivocal PD will continue radiographic tumor 
assessments until unequivocal PD, and subsequent treatment information will be collected, every 
8 weeks (±7 days) (Section 7.6). For patients with PD, or for patients who decline further 
radiographic tumor assessments, survival and subsequent treatment information will be collected 
every 3 months (±7 days) after the last dose of study treatment. Long-Term Follow-up will 
continue until the end point of death, the patient is lost to follow-up, or other study exit criteria 
are met (Section 4.4.2). 
The date when the patient discontinues treatment and the reason for discontinuation must be 
recorded on the eCRF. The Investigator should notify the Sponsor within 48 hours if a patient 
discontinues study treatment.  
For guidelines regarding temporary interruption of treatment or treatment modifications, see 
Section 5.3. 
4.4.2 Patient Withdrawal from Study/Study Completion 
Patients may withdraw voluntarily from the study at any time. As noted above, if a patient 
wishes to withdraw consent to further participation in the study entirely, including Long-Term 
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 (eCRF). If the patient withdraws from the 
study and also withdraws consent for disclosure of future information, no further evaluations 
should be performed, and no additional data should be collected.  
Reasons for study exit may include the following medical or administrative reasons: 
• Withdrawal of consent for further follow-up by the patient or legal guardian 
• Completed study (Section 3.3.2) 
• Adverse event 
• Death 
• Early termination of the study by the Sponsor 
• Lost to follow-up 
The date the patient is withdrawn from the study and the primary reason for withdrawal must be 
recorded on the eCRF. 
The Investigator should notify the Sponsor within 48 hours if a patient withdraws from the study. 

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5 
STUDY TREATMENTS AND MANAGEMENT 
Study drug is defined as relacorilant. The comparator/co-administered drug is defined as 
nab-paclitaxel. 
Study treatment is defined as the treatment administered according to randomization, and will 
begin on Cycle 1 Day 1: 
• Arm A (continuous relacorilant): relacorilant 100 mg, administered orally, once daily 
every day in combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 
28-day cycle. Upon the completion of Cycle 1 or 2, the dose of relacorilant may be 
increased in 25-mg increments per 28-day cycle to a maximum relacorilant dose of 
150 mg once daily (see Section 5.1).  
• Arm B (intermittent relacorilant): relacorilant 150 mg, administered orally, once daily on 
the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel, in 
combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle 
• Arm C (comparator): nab-paclitaxel 100 mg/m2 on Days 1, 8, and 15 of each 28-day 
cycle 
Patients in Arm C who experience unequivocal PD according to RECIST v1.1 will be given the 
opportunity to crossover, in consultation with the Medical Monitor, to treatment with relacorilant 
100 mg, administered orally, once daily every day starting on Cycle 1 Day 1 (continuous 
regimen); and nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. See 
Section 3.1.1. 
5.1 
Study Drug (Relacorilant) 
Relacorilant dose and regimen, formulation, packaging, and storage, are described in Table 1.  
The current IB for relacorilant will be provided to Investigators. 
Table 1 
Relacorilant: Formulation, Administration, Packaging, and Storage 
Specifications 
Study Drug  
Relacorilant (CORT125134) 
Description 
For each capsule, relacorilant (CORT125134) is prepared as a 200 mg/g 
formulation
 
. 
Unit dose strength(s) and 
appearance 
Relacorilant is presented as 100-mg yellow, softgel capsules, 50-mg white, hard 
gelatin capsules, and 25-mg brown, softgel capsules. 
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. 

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Specifications 
Study Drug  
Relacorilant (CORT125134) 
Dose and regimen  
Arm A and Crossover (continuous relacorilant): relacorilant 100 mg (dose 
titration permitted up to 150 mg), administered orally, once daily every day  
Arm B (intermittent relacorilant): relacorilant 150 mg, administered orally, 
once daily on the day before (excluding Cycle 1 Day -1), the day of, and the day 
after nab-paclitaxel 
Arm C (comparator): no relacorilant 
Patients should make every effort to take their dose of relacorilant at the same 
time each day; however, a 6-hour window will be allowed. 
Patients should be encouraged to take their relacorilant dose 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 CYP3A or 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 treatment 
Dispense to patients according to their visit schedule. 
Packaging and labeling 
Relacorilant 100-mg softgel capsules capsule will be provided in bottles 
containing 30 capsules each.  
Relacorilant 50-mg hard capsules will be provided in blister packaging with 
7 capsules per blister pack and 2 blister packs per carton. 
Relacorilant 25-mg softgel capsules will be provided in bottles containing 
30 capsules each.  
Each blister pack/carton and 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)  
• Out of reach and sight of children 
Manufacturer 
Corcept Therapeutics  
Note: Procedures for inventory, reconciliation, and destruction or return of study drug are provided in Section 11.6. 
5.1.1 Dose Titration 
For patients receiving the continuous relacorilant regimen (Arm A and Crossover), the 
relacorilant dose will start at 100 mg daily on Cycle 1 Day 1.  
Cycle 2 Day 1 
If during the first cycle no intolerable Grade 2 nor any Grade 3 or 4 toxicities require dose 
reduction or omission of either relacorilant or nab-paclitaxel, then the relacorilant dose will be 
escalated to 125 mg once daily, beginning on Cycle 2 Day 1.  

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Cycle 3 Day 1 
For patients who escalate the relacorilant dose 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 will be escalated to 150 mg once daily, beginning on 
Cycle 3 Day 1.  
If the dose was not escalated at 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. 
5.2 
Nab-Paclitaxel (Abraxane) 
Nab-paclitaxel dose and regimen, formulation, packaging, and storage are described 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.  
Appearance 
White to off-white sterile lyophilized powder for reconstitution before use  
Administration  
Administer reconstituted formulation as an intravenous infusion over  
30-40 minutes on Days 1, 8, and 15 of each 28-day cycle for all patients. 
Nab-paclitaxel infusions must be no less than 7 days apart.  
Dose and regimen 
Arm A (continuous relacorilant), Arm B (intermittent relacorilant), and 
Crossover: nab-paclitaxel, 80 mg/m2 IV infusion over 30–40 minutes on Days 1, 
8, and 15 of each 28-day cycle 
Arm C (comparator): nab-paclitaxel, 100 mg/m2 intravenous infusion over  
30–40 minutes on Days 1, 8, and 15 of each 28-day cycle 
The maximal body surface area used for dose calculations will be 2.0 m2. 
Nab-paclitaxel infusions must be no less than 7 days apart. 
Restrictions 
Start of infusion must be within 15 minutes after relacorilant dose on Cycle 1 
Day 15 (day for intensive pharmacokinetic sampling). 
Missed doses 
Refer to Appendix C and Section 5.4. 
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 between 20–25 °C (68–77 °F) in its 
carton  
• Vials should be stored in their original cartons. Use reconstituted 
nab-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 in Arm A (continuous) and Arm B (intermittent), and patients participating in the 
Crossover, with the exception of patients with ANC >10,000/mm3, will receive prophylactic 
G-CSF to reduce the risk of neutropenia. Prophylactic G-CSF will consist of at least 1 injection 
of G-CSF the day after the nab-paclitaxel infusion.  
Patients in Arm C (comparator) will receive G-CSF as per standard practice, with mandatory 
prophylactic growth factors for patients at high risk for severe neutropenia, including the 
following: 
• Age ≥65 years old,  
• History of febrile neutropenia, previous requirement for G-CSF, or complications of 
neutropenia, or  
• Low bone marrow reserve such as a history of extensive disease infiltrating the bone 
marrow or chronic cytopenia considered secondary to bone marrow infiltration. 
Prophylactic treatment with filgrastim 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.  
For patients receiving prophylactic G-CSF, filgrastim (5 µg/kg/day) will be administered at least 
24 hours after completion of dosing with nab-paclitaxel with the last dose of filgrastim at least 
24 hours prior to the next treatment with nab-paclitaxel.  
Biosimilars of filgrastim and pegfilgrastim are permitted. 
5.4 
Dose Reductions or Delays  
If a patient experiences an AE that results in a delay in starting a cycle or requires that study 
regimen is delayed or interrupted during a cycle (Table 3), the patient will complete the planned 
activities per the schedule of assessments (Table 10) until resuming treatment.   
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 

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have resolved to Grade 1 or to baseline. Tumor assessments (CT or MRI and CA-125) and 
PRO/QoL assessments should continue per the schedule of assessments (Table 10). 
General chemotherapy dosing guidelines are provided in Appendix C. 
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) 
Cycle Day 1:  
• Delay Day 1 nab-paclitaxel until ANC is 
1,500 or higher 
Cycle Day 8 or 15: 
• No change 
• Withhold dose until ANC is 
1,500 or higher 
• Reinitiate at same dose level 
Neutropenia:  
(ANC <1,000) 
Cycle Day 1:  
• Delay Day 1 nab-paclitaxel until ANC is 
1,500 or higher.  
• Reduce 1 dose level 
Cycle Day 8 or 15: 
• 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 <100,000) 
Cycle Day 1:  
• Delay Day 1 nab-paclitaxel until platelet is 
100,000 or higher 
Cycle Day 8 or 15: 
• Platelets 50,000 to 99,000: No change  
• Platelets < 50,000 omit dose and then 
reduce nab-paclitaxel by 1 dose level 
• No change 
Peripheral neuropathy: 
Intolerable Grade 2  
• Reduce 1 dose level 
• No change 
Peripheral neuropathy: 
Grade 3 
• Delay dose until symptoms improve to 
Grade 2 or better 
• Reduce 1 dose level 
• No change 
Peripheral neuropathy: 
Grade 4 
• Discontinue nab-paclitaxel 
• Discontinue relacorilant 
Cystoid macular edema 
• Discontinue nab-paclitaxel 
• Discontinue relacorilant 

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Adverse Event 
Nab-Paclitaxel Dose Modification 
Relacorilant Dose Modification 
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 
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 adverse event:  
Grade 3 or 4 
• Withhold dose until severity of adverse 
event improves to Grade 1 or lower, or to 
baseline if Grade 2 toxicity was present at 
study entry 
• Reduce 1 dose level 
• For adverse events attributable 
only to nab-paclitaxel, continue 
relacorilant unchanged. 
• For adverse events attributable 
to relacorilant, withhold dose 
until severity of adverse event 
improves to Grade 1 or lower 
(or to baseline if Grade 2 
toxicity was present at study 
entry) and reduce relacorilant 
by 1 dose level 
Abbreviation: ANC, absolute neutrophil count  
 
5.4.1 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 (Table 4) should be made based on observed toxicities secondary 
to treatment, as indicated in Table 3. Sequential dose reductions may be made at the discretion of 
the Investigator. A maximum of 2 dose reductions are allowed. When a dose reduction is 

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required, no dose re-escalation will be permitted. If nab-paclitaxel is discontinued, then 
relacorilant will also be discontinued. 
Table 4 
Nab-Paclitaxel Dose Reductions 
 
Arms A and B, and Crossover 
Arm C 
Starting Dose 
80 mg/m2 
100 mg/m2 
Dose Level -1 
60 mg/m2 
80 mg/m2 
Dose Level -2 
60 mg/m2 biweekly  
(on Days 1 and 15 of each cycle) 
60 mg/m2 
Note: Nab-paclitaxel administered on Days 1, 8, and 15 of each 28-day cycle unless otherwise noted. 
 
For patients in Arm B, if a patient took relacorilant the day before and is not able to receive her 
scheduled nab-paclitaxel infusion, it is acceptable for the patient to receive up to 2 extra once-
daily doses of relacorilant while awaiting her next infusion. 
5.4.2 Dose Reductions or Delays for Relacorilant  
See Section 5.1.1 for information on upward dose titration. 
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 at 1 dose level lower than the current 
level (Table 5).  
For toxicities that are known risks of nab-paclitaxel, nab-paclitaxel should be preferentially dose 
reduced and relacorilant continued at the current dose level.  
A maximum of 3 dose reductions of relacorilant will be allowed. The minimum dose of 
relacorilant to be administered is 50 mg. In the event that relacorilant is discontinued, treatment 
with nab-paclitaxel will continue until disease progression, unmanageable toxicity, or other 
treatment discontinuation criteria are met. 
Table 5 
Relacorilant Dose Level Summary 
 
Relacorilant Dosing Regimen 
 
Continuous 
Intermittent 
Dose Level -3 
-- 
50 mg 
Dose Level -2 
50 mg 
75 mg 
Dose Level -1 
75 mg 
100 mg 
Starting Dose 
100 mg 
150 mg 
Dose Level +1 (Cycle 2 Day 1) 
125 mg 
-- 
Dose Level +2 (Cycle 3 Day 1) 
150 mg 
-- 

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5.4.3 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, altered mental status, or 
hypoglycemia 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 last dose of relacorilant, supplemental 
glucocorticoids and appropriate medical care may be needed to prevent excessive GR 
antagonism that may arise due to increased cortisol requirements in the perioperative period. 
5.5 
Concomitant Medications and Procedures 
5.5.1 Permitted Concomitant Medications  
The 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 American Society of Clinical 
Oncology guidelines. Patients do not require and should not receive premedication with 
dexamethasone prior to nab-paclitaxel infusion, as hypersensitivity reactions are not expected. 
Initial anti-emetic prophylaxis is allowed with ondansetron or other therapies, as appropriate, but 
should not include dexamethasone.  
Permitted treatments also include standard therapies for concurrent medical conditions.  
Patients must be instructed to notify the investigational site about any new medications they take 
after the start of the 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 
page in the 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 and Not Recommended Concomitant Therapy Requiring Caution 
Permitted medications to be used with caution from 1 week before first dose of study treatment 
(relacorilant or nab-paclitaxel, whichever is earliest) through the 30-Day Follow-up Visit are as 
follows: 
• Warfarin, if its use cannot be avoided. If used, conduct additional international 
normalized ratio (INR) monitoring.  
• Sulfonylureas. If used, conduct close glucose monitoring to assess for changes in diabetic 
control. 

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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, treatments, and foods 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 of the resected area from that point forward and will continue to be followed for disease 
progression in all other target areas. The concomitant surgery should be noted on the 
corresponding eCRF. 
Concomitant radiotherapy for the disease under study is not allowed. Radiotherapy for non-
study-related lesions should be documented on the corresponding eCRF. 
5.6 
Method of Treatment Assignment and Randomization 
All patients will be centrally assigned to randomized study treatment using an interactive 
voice/web response system (IVRS/IWRS). Before the study is initiated, the telephone number 
and call-in directions for the IVRS and/or the log-in information and directions for the IWRS 
will be provided to each site. 
Once screening procedures are complete eligible patients will be randomized 1:1:1 to one of the 
3 treatment arms. Patient randomization will be stratified by treatment-free interval from most 
recent taxane (relapse within 6 months vs >6 months) and presence of ascites (yes vs no).  
Study treatment will be dispensed at the study visits summarized in the schedule of assessments 
(Table 10).  
Returned study treatment should not be re-dispensed to patients. 
5.7 
Blinding 
This is an open-label study; however, the specific treatment to be taken by a patient will be 
assigned using an IVRS/IWRS. The site will use the IVRS/IWRS to register the patient before 
the start of study treatment administration for each patient. The site will record the treatment 
assignment on the applicable eCRF, if required.  
5.8 
Dose Diary 
A dose diary card will be provided to patients receiving relacorilant, and patients will be 
instructed to return all unused relacorilant and the dose diary card during the patient visits as 
indicated in the schedule of assessments (Table 10). Patients should complete an entry in the 
diary for each self-administered dose of relacorilant and note doses of any concomitant 

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medications taken. Entries will include the number of capsules as well as the date and time of 
relacorilant administration. On visit days when pre-dose samples are to be collected for PK 
(Table 11) or pharmacodynamics (Table 12), 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 schedule of assessments (Table 10).  
The Investigator and Sponsor will conduct the study in accordance with International Council on 
Harmonisation (ICH) Good Clinical Practice (GCP) and local regulations. Adherence to the 
study design requirements, including those specified in the schedule of assessments, 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 schedule of 
assessments. 
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/IEC, must be signed by the patient 
before any protocol-directed procedures are performed. The ICF must also be signed before 
any prohibited medications are withheld from patient in order for the patient to participate in 
the study. 
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.  
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 
met the protocol-specified criteria and were performed within the time frame defined in the 
schedule of assessments (Table 10). Screening laboratory samples can be used for Cycle 1 Day 1 
Visit if taken within 48 hours of the first dose of study treatment.  
6.2 
Medical and Oncology 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 
the Screening Period. Any new or clinically significant changes in the patient’s medical or 
oncologic history between signing of the IRB/IEC-approved ICF and the first dose of study 
treatment will be recorded on the AE eCRF.  
The following information will be collected: 
• Complete medical history, including documentation of any clinically significant medical 
condition. 
• History of tobacco and alcohol use. 
• Presence and severity of any symptoms/conditions associated with ovarian cancer. 
• Detailed oncology history, including but not limited to: 
– Date of primary cancer diagnosis 
– Pathology (histology or cytology) of primary tumor 
– Surgical history, including residual disease at the completion of surgery 

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– Anticancer and radiation treatments administered (including initiation and completion 
dates, type of modality, response, and reason for discontinuation and platinum-free 
interval, if applicable) 
– Metastasis information (including the location 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 cancer and may include testing for defects in 
homologous recombination (such as BRCA1 or BRCA2 mutation), TP53 mutation 
testing, and molecular profiling. Where possible, a comprehensive report would be 
preferred to a summary or notes on the results. 
– Any new or clinically significant changes in the patient’s medical or oncologic 
history between signing of the IRB/IEC-approved ICF and the first dose of study 
treatment will be recorded on the AE eCRF. 
6.3 
Safety Measures 
Safety will be determined by evaluating study drug exposure, AEs, SAEs, all deaths, changes in 
laboratory determinations, and vital sign parameters. Vital signs, laboratory tests, and 
performance status assessment will be performed according the schedule of assessments 
(Table 10).  
6.3.1 Physical Examination and Vital Signs  
Physical examinations will be performed according to the schedule of assessments (Table 10).  
A full physical examination will be performed at Screening, Day 1 of each cycle, at the 
End-of-Treatment Visit, and at the 30-Day Follow-up Visit. A targeted physical examination will 
be performed at Days 8 and 15 (or the day before) of each cycle. The performance of the 
physical examination will be recorded in the appropriate eCRF by the Investigator or designee.  
Targeted physical examinations will include assessment of skin, heart, lungs, and abdomen, in 
addition to symptom-directed assessment of other organ systems. Note: all clinically significant 
abnormalities occurring before signature of informed consent should be recorded in the Medical 
History and/or Oncology History section of the eCRF; all abnormalities occurring or worsening 
after signature of informed consent should be recorded in the AE section of the eCRF.  
Weight will be reported at each visit where a physical examination is performed. Height will be 
recorded at the Screening Visit only. Height and weight (without shoes) will be measured using 
an appropriate measuring device. Historical patient information and/or patient reports should not 
be used for either measurement.  
Vital signs will be measured as noted in the schedule of assessments (Table 10) and include 
resting heart rate, blood pressure, respiratory rate, and body temperature. Systolic and diastolic 
blood pressure will be measured after patients have been at rest (seated) for at least 3 minutes. 
Blood pressure will be recorded in mmHg. Heart rate (beats per minute) will be measured after 
the patient has been in a resting state (seated) for at least 3 minutes. Heart rate should be 
recorded over 30 seconds or longer. 

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Unscheduled assessments of vital signs can be performed as necessary.  
6.3.2 Pregnancy Test (in 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 study treatment and reviewed prior 
to randomization. Pregnancy tests will be repeated every 12 weeks, or more frequently according 
to country requirements. Patients considered not of childbearing potential must be documented 
as being surgically sterile or postmenopausal (amenorrheic for at least 12 months). 
If pregnancy test results are equivocal (e.g., false positive due to β-human chorionic 
gonadotropin being a tumor marker) 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. 
6.3.3 Triplicate 12-Lead Electrocardiogram  
A resting 12-lead ECG will be performed in triplicate per the schedule of assessments 
(Table 10). 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 each 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. Each original ECG tracing or copy with physician’s 
assessment will be retained in the patient’s records at the study site. 
6.3.4 ECOG Performance Status 
ECOG performance status (Table 6) will be assessed at visits according to the schedule of 
assessments (Table 10). 
Table 6 
ECOG Performance Status 
ECOG 
Performance 
Status 
Description 
0 
Fully active, able to carry on all pre-disease activities without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature (light housework, office work) 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and 
about more than 50% of waking hours 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
Abbreviation: ECOG, Eastern Cooperative Oncology Group 
Source: Oken et al. 1982 

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6.3.5 Adverse Events 
Details on definitions and reporting of AEs are provided in Section 8. 
6.3.6 Clinical Laboratory Assessments 
6.3.6.1 
Laboratory Parameters 
Blood samples will be collected for the analysis of safety in all patients at the times indicated in 
the schedule of assessments (Table 10). Laboratory samples will be analyzed at central or local 
laboratories as noted in Section 7.  
A complete blood count and differential and blood chemistry will be obtained on Days 1, 8, and 
15 of each cycle while the patient is on therapy, with other laboratory blood testing obtained 
prior to each 28-day treatment cycle.  
Local laboratory data will be used for immediate treatment decisions and for safety assessment. 
Local laboratory CA-125 data will also be used to derive CA-125 response via GCIG criteria. 
The Investigator will review all local laboratory reports, evaluate the results, and sign/date the 
report.  
Laboratory tests to be performed are listed in Table 7 and should be performed according to the 
schedule provided the schedule of assessments (Table 10). 
Instructions for collection, preparation, and shipping of laboratory samples will be provided in 
the study laboratory manual. 

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Table 7 
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 
Aspartate aminotransferase 
Glucose  
 
Alanine aminotransferase 
Bilirubin 
Coagulation 
Glucose, document whether fasting 
Leukocyte esterase 
International normalized ratio  
   or non-fasting 
Hormone 
Activated partial thromboplastin time Blood urea nitrogen 
Serum or urine human chorionic  
Prothrombin time 
Bicarbonate 
   gonadotropin, if applicable 
Tumor Markers 
Total protein 
Pharmacodynamic 
Cancer antigen 125 
Other b 
See Table 12 for details. 
 
HIV immunoassay c 
 
 
Hepatitis B/C serology d 
 
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. 4th 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. 
6.4 
Measures of Anticancer Activity  
Tumors will be assessed radiologically and response to treatment will be determined by using 
RECIST v1.1 (Eisenhauer 2009; Appendix E). 
A CT or MRI scan of the chest, abdomen, and pelvis will be used to evaluate disease status per 
RECIST v1.1. A radiographic tumor assessment is required within 28 days prior to the first dose 
of study treatment and subsequent scans are required every 8 weeks (±7 days) from Cycle 1 
Day 1 irrespective of treatment delays until unequivocal PD is documented, including in patients 
who discontinue treatment prematurely. At the End-of-Treatment Visit, a final radiographic 
tumor assessment will be done if ≥4 weeks have elapsed since the last radiographic tumor 
assessment, unless there is documented PD. The same method of assessment and the same 

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technique should be used at baseline and throughout the study. Radiographic scans will be 
quality checked, anonymized, and stored centrally. 
CA-125 response will be assessed per GCIG criteria (Rustin et al. 2011; Appendix F). CA-125 
will be assessed within 14 days prior to the first dose of study treatment and then every 4 weeks 
from Cycle 1 Day 1 for the first 12 months of study treatment. If Investigators collect CA-125 
beyond 12 months as per their standard of care, this information will be documented in the 
eCRF. In addition, other tumor markers collected as standard practice (such as cancer antigens 
CA15-3 and CA19-9, and CEA) will be documented in the eCRF. Pharmacodynamic and 
biomarker collections are described in Section 6.6. 
Patients who discontinue treatment at any time (Section 4.4.1) will continue to be followed for 
study endpoints (Section 7.6) after the last dose of study treatment until the endpoint of death, 
the patient is lost to follow-up, or until other study exit criteria are met (Section 4.4.2). 
As described in Section 3.1.1, patients in Arm C (comparator) who experience unequivocal PD 
per RECIST v1.1 may be eligible to receive relacorilant in combination with nab-paclitaxel, after 
discussion with the Medical Monitor. Radiographic tumor assessments will be collected at the 
time of PD on nab-paclitaxel and be considered the final tumor assessment for comparator-only 
treatment and baseline for combination therapy. If more than 28 days have passed since the date 
of PD and Cycle 1 Day 1, then a new baseline radiographic tumor assessment will be obtained 
prior to initiating crossover treatment. Radiographic tumor assessments will then be performed 
every 8 weeks (±7 days) from the first dose of relacorilant until PD. CA-125 will be assessed 
within 14 days prior to the first dose of relacorilant and assessed every 4 weeks for the first 12 
months. Study procedures will be performed according to the schedule for the Treatment Phase. 
6.5 
Pharmacokinetic Assessments 
Intensive PK sampling for relacorilant and nab-paclitaxel will take place on Cycle 1 Day 15 and 
will consist of a total of 5 samples collected at the following time points: pre-dose (0 hour) and at 
1, 2, 4, and 6 hours post-dose (Table 11).  
Refer to Section 9.5.6 for a description of variables to be analyzed. 
6.6 
Pharmacodynamic/Biomarker Assessments 
The development and improvement of therapies increasingly depends on insights gained from 
analysis of biomolecules. During this study and with the consent of patients (see Section 10.3.1), 
biological samples (e.g., blood, plasma, serum, or tumor tissue) 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 via a central laboratory using a variety of techniques (e.g., 
immunohistochemistry 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 12. 

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6.6.1 Blood Collection for GC-Related Pathways and Exploratory Biomarkers 
Blood will be collected by venipuncture. Samples are to be obtained pre-dose, fasting, and 
between 7–9 am at the time points outlined (Table 12). On Cycle 1 Day 15, samples are to be 
collected in conjunction with the PK time point, if possible. The collection, processing and 
storage should be performed as described in the study-specific manual.  
Intensive sampling is required from a subset of 20 patients (from Arm A only) for RNA analysis 
at additional time points: Cycle 1 Day 1 (4 hours post-dose), Cycle 1 Day 2, Cycle 1 Day 3, 
Cycle 1 Day 5, and Cycle 1 Day 10 (Table 12). At a minimum, the first 20 patients enrolled in 
Arm A will be included in this subset. In order to achieve 20 pharmacodynamic-evaluable 
patients, additional patients in Arm A may undergo intensive pharmacodynamic sampling if 
some patients are not evaluable. As this is a randomized study, it is unknown at the beginning of 
the study which sites will have patients who participate in the pharmacodynamic sampling. All 
sites/patients will be expected to participate until the Sponsor notifies the sites that the required 
number of patients has been reached.  
6.6.2 Tumor Biopsy Tissue Collection 
For patients enrolling in the study, consent and availability to archived tissue biopsy are required 
for eligibility. If archived tissue is not available, a fresh tumor biopsy should be obtained. 
Specimens obtained closest to the time of study enrollment are preferred, but not required. In 
addition, optional biopsies may be obtained if collected during standard-of-care procedures 
during the study or at the time of disease progression and with consent of the patient. 
Optional paired pre- and post-treatment tumor biopsies will be collected within 6 weeks prior to 
treatment initiation and on Cycle 2 Day 1 (±7-day window) for determination of GR status and 
exploratory biomarkers. While these paired tumor biopsies are optional, a minimum of 6 patients 
per treatment arm are required to submit paired tumor biopsies. For these optional paired 
biopsies, archival biopsies collected >6 weeks prior to treatment initiation are not allowed to 
serve as the pre-treatment biopsy.  
For patients in whom fresh tumor biopsy is mandatory for enrollment (because archival tissue is 
not available), patients must have at least 1 lesion accessible that is safely accessible for biopsy 
to be eligible for enrollment. Tissue acquisition, with or without anesthesia, must be considered 
of low risk to the patient. Biopsy of lesions that pose an undue risk to the patient, such as 
mediastinal lymph nodes, will not be performed as part of this study. In the case where biopsy 
samples are unable to be obtained for a given patient, the patient will remain on study, receive 
study medication and all study procedures will be performed. Please contact the Medical Monitor 
if any of the specimens are not feasible to collect. 
Samples collected during screening should be fixed in formalin and embedded in paraffin 
(FFPE) according to standard institutional procedures. Tumor samples should be stored 
according to institutional procedures until shipment to the central laboratory. Overfixation in 
formalin for >24 hours should be avoided where possible. While sending FFPE blocks is 
preferred, slides prepared by the local pathology laboratory are acceptable and should be 
prepared as described in the study-specific laboratory manual. A minimum of 15 FFPE slides 
will be required for each tumor tissue collection (tissue block preferred). Refer to the study 
laboratory manual for complete instructions. 

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6.7 
Patient-Reported Outcomes and Quality of Life 
PRO and QoL assessments will be performed according to the schedule of assessments 
(Table 10). QoL will be assessed using FACT NFOSI-18 (Jensen et al. 2011), EQ-5D-5L/VASc 
scales (EuroQoL 1990), and PROMIS Physical Function-Short Form score (Cella et al. 2007, 
Rose et al. 2008, Rose et al. 2014). A healthcare utilization questionnaire will also be 
administered at these visits.  
The FACT NFOSI-18 consists of 18 items and separates disease-related symptoms from 
treatment-related side effects, in 4 subscales: 1) disease-related symptoms (DRS) (9 items), 
2) emotional well-being (1 item), 3) treatment side-effects (5 items), and 4) functional well-being 
(3 items). The EQ-5D-5L is a generic preference instrument that has been validated in numerous 
populations. The 5 dimensions of the EQ-5D-5L (mobility, self-care, usual activities, 
pain/discomfort and anxiety/depression) will be measured on a 5-level scale. The EQ-5D-5L also 
contains a visual analog score (VAS) to assess the patient’s overall health. 
Baseline PRO and QoL assessments will be performed prior to the first dose of study treatment 
(relacorilant or nab-paclitaxel, whichever is earliest), at the Screening Visit. At this visit, patients 
will also be asked to answer the following 2 questions to assess for patient bias that could 
influence the PRO/QoL assessments in this open-label study: 
1. Do you expect to have side effects? (Yes/No) 
2. Do you expect to have benefit? (Yes/No)  
Post-baseline assessments will be performed every other cycle starting with Cycle 2 Day 1, at the 
End-of-Treatment Visit, and at the 30-Day Follow-up Visit.  
Patients will be asked to complete the FACT NFOSI-18 first, followed by the EQ-5D-5L. PRO 
and QoL assessments will be completed prior to discussing the results of tumor assessments or 
disease-related clinical changes 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 the patient cannot self-administer the forms, the 
forms can also be administered by interview format (person-to-person and over the telephone). If 
a patient is not able to come to the site, the questionnaires may be sent with a request to complete 
them and return to the site as instructed by the site staff, or by telephone interview. 
6.8 
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 
A schedule of assessments with scheduled visit dates and acceptable visit windows is provided in 
Table 10. A schedule of PK assessments is provided in Table 11. A schedule of 
pharmacodynamic assessments is provided in Table 12. 
Patients should come to the clinic in a fasted state (no eating or drinking [other than water] for 
≥8 hours beforehand) for pre-dose pharmacodynamic assessments as follows: 
• All patients: Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1, 
End of Treatment 
• The first 20 patients in Arm A (subset for intensive pharmacodynamic sampling 
[Section 6.6.1]): Screening, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 1 
Day 5, Cycle 1 Day 10, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1, End of Treatment  
7.1 
Screening  
Screening will be within 28 days before the first dose of study treatment (relacorilant or 
nab-paclitaxel, whichever is earliest) and may take place on more than 1 day within the 4-week 
Screening Period. If a patient was screened more than 4 weeks before the date of their first 
administration of study treatment (e.g., if the study is delayed or the patient was initially 
screened as a standby patient for an earlier cohort), that patient must be re-screened. A patient 
who has failed screening due to a reason that is temporary and expected to resolve (e.g., mild 
intercurrent infection) may be re-screened. 
At the start of screening, 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). Each patient 
who receives study treatment will be assigned a patient number that will be used on patient 
documentation throughout the study. 
A CT or MRI scan of the chest, abdomen, and pelvis will be performed within 28 days prior to 
the first dose of study treatment to evaluate disease status per RECIST v1.1. CA-125 will be 
assessed within 14 days prior to the first dose of study treatment. 
The following screening procedures will also be performed: 
• Record baseline demographics 
• Record medical/oncologic history 
• Record prior and concomitant medications 
• A serum or urine pregnancy test for female patients of childbearing potential will be 
performed prior to the first dose of study treatment (48-hour window from the first dose 
of study treatment, and then every 12 weeks ±7 days) 
• Tumor biopsy prior to initiating study treatment (availability and consent to provide an 
archival or recent tumor biopsy for biomarkers is required for patient inclusion in the 
study) 

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• ECOG PS 
• Complete physical examination 
• Measure height 
• Measure body weight 
• Record vital signs 
• 12-lead ECGs (performed in triplicate) 
• Local laboratory tests (CA-125, hematology, chemistry, urinalysis, prothrombin time 
(PT), activated partial thromboplastin time (aPTT), INR; see Table 7 for details) 
• Hepatitis B and C serologies and HIV immunoassay 
• Baseline PRO and QoL must be collected prior to the first dose of study treatment 
• Pharmacodynamic sampling (see Table 12 for details) 
• AEs are to be recorded from the time written informed consent is obtained 
7.2 
Cycle 1 Day 1 
Following confirmation that the patients continue to meet Inclusion and Exclusion Criteria, the 
patients will be randomized (Section 4). Eligible patients will be randomized 1:1:1 to one of the 
following 3 treatment arms: 
• Arm A (continuous): relacorilant 100 mg, administered orally, once daily every day, in 
combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle.  
• Arm B (intermittent): relacorilant 150 mg, administered orally, once daily on the day 
before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel, in 
combination with nab-paclitaxel 80 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 
• Arm C (comparator): nab-paclitaxel 100 mg/m2 on Days 1, 8, and 15 of each 28-day 
cycle. 
Study treatment will start on Cycle 1 Day 1 for all treatment arms.  
Patients should receive their first dose of study treatment on the same day as randomization 
wherever possible, and with a minimum of delay where unavoidable.  
The following procedures will also be performed at the Cycle 1 Day 1 Visit: 
• A serum or urine pregnancy test for female patients of childbearing potential will be 
performed and reviewed prior to the first dose of study treatment (48-hour window from 
the first dose of study treatment) and then every 12 weeks ±7 days 
• Record concomitant medications 
• Patients in Arm A, Arm B, or the Crossover should receive their first dose of relacorilant 
and be dispensed adequate relacorilant according to their dose regimen 
• Provide a dose diary card to all patients receiving relacorilant 
• Pharmacodynamic sampling (see Table 12 for details) 
• Record AEs (any since the last visit) 
Screening laboratory samples can be used for the Cycle 1 Day 1 Visit if taken within 48 hours of 
the first dose of study treatment. 

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7.3 
Treatment Phase 
Visits will be conducted on Day 1, 8, and 15 of each cycle, starting with Cycle 1 and continuing 
until the End-of-Treatment Visit is complete. The acceptable visit window for scheduling 
conflicts during the Treatment Phase is +1 day for all visits unless the window spans a weekend, 
in which case the acceptable window extends to the following Monday (Day 3 past due). This 
acceptable visit window also applies to pharmacodynamic sampling. Visit windows are relative 
to the most recent infusion of nab-paclitaxel (Appendix C). Refer to Section 5.4 for delays that 
may occur due to toxicity. 
Study procedures at each visit will be performed according to the schedule of assessments 
(Table 10).  
A serum or urine pregnancy test for female patients of childbearing potential will be performed 
and reviewed prior to the first dose of study treatment (48-hour window from the first dose of 
study treatment) and then every 12 weeks ±7 days while on study treatment. 
All patients will receive their first dose of nab-paclitaxel on Cycle 1 Day 1.  
All patients will receive dosing with nab-paclitaxel on Days 1, 8, and 15 of each cycle. Patients 
receiving relacorilant will also receive their relacorilant dose in the clinic at visits when pre-dose 
samples for PK (Table 11) or pharmacodynamics (Table 12) are scheduled to be collected.  
Radiographic tumor assessments will be performed every 8 weeks (±7 days) from Cycle 1 Day 1 
irrespective of treatment delays until unequivocal PD is documented. The same method should 
be used for each assessment for a particular patient.  
Availability and consent to provide an archival or recent tumor biopsy (pre-treatment tumor 
biopsy) is required for patient inclusion in the study. For patients who consent to provide 
optional paired (pre-treatment and post-treatment) tumor biopsies, biopsies will be obtained 
within 6 weeks prior to treatment initiation (this can be the same pre-treatment biopsy used to 
meet eligibility criteria) and at Cycle 2 Day 1 (±7 days).  
Pharmacodynamic sampling will occur as described in the schedule provided in Table 12. 
Pharmacodynamic markers will include mRNA gene panel (blood and tumor expression 
profiles), cytokines, cancer antigens, tumor biomarker assays (tumor tissue), and other 
exploratory biomarkers. Additionally, the neutrophil-to-lymphocyte ratio will be evaluated as a 
pharmacodynamic marker from the hematology results. 
CA-125 will be assessed within 14 days prior to the first dose of study treatment, and every 
4 weeks from Cycle 1 Day 1 for the first 12 months of study treatment.  
PK sampling will occur as described in Table 11. 
The following procedures should be performed on only Day 1 of each cycle according to 
Table 10: 
• ECOG PS 
• Measure weight 
• Provide new dose diary card to all patients receiving relacorilant 
• Patients in Arm A, Arm B, or the Crossover should be dispensed adequate relacorilant, 
according to their dose regimen, to self-administer until their next visit 

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• PRO and QoL assessments will be collected every other cycle (-7-day window) starting 
with Cycle 2 Day 1, prior to discussing the results of tumor assessments or disease-
related clinical changes with the patient 
The following procedures should be performed at all study visits during the Treatment Phase 
according to Table 10. 
• Record concomitant medications 
• Assess treatment compliance. Patients receiving relacorilant will be instructed to return 
all unused study drug and their dose diary card at each study visit.  
• Physical examinations (full examination on Day 1 of each cycle, targeted examinations 
on Days 8 and 15 [or the day before] of each cycle) 
• Vital signs 
• Record AEs 
• Local laboratory tests (hematology and chemistry. See Table 7 for details  
7.4 
End of Treatment (In-clinic Visit)  
The following assessments should be performed during the End-of-Treatment Visit according to 
the schedule of assessments (Table 10): 
• Tumor assessments by RECIST v1.1: a final radiographic tumor assessment will be done 
if ≥4 weeks have elapsed since the last radiographic tumor assessment, unless there is 
documented PD. Note: Patients who discontinue before PD will continue radiographic 
tumor assessments every 8 weeks (±7 days) until equivocal disease progression. 
• ECOG PS 
• Record concomitant medications 
• Complete physical examination 
• Record vital signs 
• Measure body weight 
• 12-lead ECGs (performed in triplicate) 
• Local laboratory tests (hematology, chemistry and urinalysis; see Table 7 for details) 
• Assess treatment compliance per dose diary card and returned unused study drug (for 
patients receiving relacorilant) 
• PRO and QoL assessments 
• Record AEs 
• Pharmacodynamic sampling (Table 12) 
If treatment discontinuation occurs during a regularly scheduled study visit, that visit may serve 
as the End-of-Treatment Visit. All required assessments will be combined for the regularly 
scheduled study visit and the End-of-Treatment Visit. Assessments that overlap between these 
2 visits do not have to be repeated if the visits are combined; however, all assessments unique to 
each visit must be performed. 
7.5 
30-Day Follow-up 
The following assessments should be performed 30 days (±3 days) after the patient’s final dose 
of study treatment according to the schedule of assessments (Table 10): 

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• ECOG PS 
• Record concomitant medications 
• Complete physical examination 
• Record vital signs 
• Measure body weight 
• Local laboratory tests (hematology, chemistry, urinalysis, PT, aPTT, and INR; see 
Table 7 for details) 
• PRO and QoL assessments 
• Record AEs 
7.6 
Long-Term Follow-up Assessment of Survival  
During the Long-Term Follow-up, 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 
treatment information (i.e., name[s] of subsequent therapy regimen[s], dates of initiation and 
completion, PD on subsequent therapy, and response to subsequent therapy).  
• For patients who discontinue treatment before PD, subsequent treatment information will 
be collected at the same time as radiographic tumor assessments (i.e., every 8 weeks 
[±7 days]) until unequivocal PD. After PD, they will be followed every 3 months 
(±7 days) for the remainder of the Long-Term Follow-up. 
• For patients who discontinue treatment at the time of PD, or for patients who decline 
further radiographic tumor assessments, long-term follow-up information will be 
collected every 3 months (±7 days) after the last dose of study treatment.  
Long-term follow-up for survival and subsequent therapies will continue per this schedule (or as 
requested by the Sponsor to support data analysis), until the endpoint of death, the patient is lost 
to follow-up, or other study exit criteria are met (Section 4.4). Study staff will consult public 
records for survival status if the patient is lost to follow-up.  
7.7 
Unscheduled Visits 
As appropriate, assessments deemed clinically necessary by the Investigator may be performed 
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 relevant 
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 last dose of relacorilant or nab-paclitaxel, whichever is latest. Any worsening 
AEs or any SAEs that occur more than 30 days after the last 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 last 
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 last dose of study treatment will be 
considered TEAEs. Adverse events reported more than 30 days after the last dose of study 
treatment will be considered post-treatment AEs. 

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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 8.1.3) 
4. Relationship to study treatment (see Section 8.1.4) 
5. Seriousness criteria if applicable (see Section 8.2.1) 
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 lab 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 discontinuation. 
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 8.2.2 for details on 
SAE reporting). 
All SAEs that are related to study treatment and unexpected (not reported in the 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/IEC as required by the IRB/IEC, local regulations, and the governing health 
authorities (see Section 8.2.2.2). 
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 criteria v5.0 
(NCI-CTCAE 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 adverse event 
Source: National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 
(NCI CTCAE 2017). 
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 non-serious). 
Table 9 
Causal Attribution Guidance for Adverse Events 
Not related to study drug  
An AE that is judged to be clearly due only to extraneous 
causes such as diseases, environment, and the like or for 
which it is temporally implausible to be related to use of the 
study drug. The cause must be noted on the AE eCRF 
Possibly related to study drug An AE that might be due to the use of the drug. The 
relationship in time is reasonable; therefore, a causal 
relationship cannot be excluded. An alternative explanation is 
inconclusive (e.g., concomitant drugs, concurrent diseases) 
Probably related to study 
drug 
An AE that might be due to the use of the drug. The 
relationship in time is suggestive. An alternative explanation 
is less likely (e.g., concomitant drugs or concurrent diseases) 
Abbreviations: AE, adverse event; eCRF, electronic case report form. 

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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. 
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 the 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. 

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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 last dose of study treatment 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 
be followed and the outcomes reported. The Investigator must supply the Sponsor and the 
IRB/IEC 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 1 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 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 last 
administration 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 last 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/IEC of all serious, 
unexpected, drug-related events that occur at his or her site or per the IRB/IEC 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/IEC as required by the IRB/IEC, 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.  
8.2.2.1 
Safety Reporting Contact 
 is the vendor for this study to report SAEs to and can be contacted via the following: 
• 
  
• 
 

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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 most current version of the IB for relacorilant and the current 
US package insert or Summary of Product Characteristics for nab-paclitaxel. 
8.2.3 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 investigational product), study site 
personnel will apply appropriate medical intervention according to current standards of care and 
contact the Medical Monitor. 
8.3 
Pregnancy 
All pregnancies occurring during the study and within 30 days of the last dose of study treatment 
should be immediately reported to Corcept. The outcome of any conception occurring from the 
date of the first dose of study treatment through within 30 days of the last dose of study treatment 
will 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. Corcept 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. 

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9 
STATISTICAL METHODS 
This section outlines the statistical design consideration, analyses and descriptive summaries to 
be performed on the collected data. Further details of the statistical analyses and methods will be 
provided in a Statistical Analysis Plan, to be completed prior to the study database lock.  
9.1 
Analysis Populations 
Analysis populations for this study are: 
• Intent-to-Treat (ITT): All randomized patients, analyzed according to the randomized 
treatment arm. This population will be used for analysis of the primary endpoint and all 
secondary efficacy endpoints.  
• Safety Analysis Population (SAF): All randomized patients who received at least 1 dose 
of study treatment, analyzed according to the treatment actually received. This population 
will be used in all analyses of safety endpoints.  
• Pharmacokinetics Analysis Population (PKA): All patients in the SAF who have PK data 
collected and available for analysis. 
9.2 
General Statistical Considerations 
The statistical analysis will be conducted by the Sponsor and/or their designee. Detailed 
descriptions of all analyses and statistical methods will be prespecified and documented in a 
Statistical Analysis Plan (SAP), to be finalized before database lock. 
All summaries will be presented by starting dose group (as randomized), regardless of the actual 
dose level at the time point associated with the data collection. In addition, data will be tabulated 
for all patients combined. 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 level 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, median, minimum, and maximum values. Categorical variables 
will be summarized by the number and percentage of patients in each category. 
The baseline value will be defined as the most recent value prior to the first dose of study 
treatment (relacorilant or nab-paclitaxel, whichever occurs earliest).  
9.3 
Hypothesis Testing 
The primary efficacy endpoint will each be tested at a 1-sided 0.05 level of significance to test 
the null hypothesis of no difference in PFS between 2 study treatment groups. Hochberg step-up 
procedure will be applied in order to control for multiplicity of testing when comparing the 
2 relacorilant-containing arms (Arms A and B) vs the nab-paclitaxel-only control (Arm C).  
Secondary endpoints will be tested at a 1-sided 0.05 level of significance, with no additional 
adjustment for multiplicity of testing. P-values from secondary and exploratory tests will be 
considered descriptive. 

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9.4 
Sample Size Calculation 
In order to estimate the total sample size and the number of events needed in this study, estimates 
of median PFS were considered from previous studies for the treatment of recurrent or persistent 
platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. In a single arm study of 
nab-paclitaxel alone (Coleman et al. 2011), where a majority of 47 evaluable patients had a 
recurrence within 6 months of treatment completion, the observed median PFS was 4.5 months 
(95% confidence interval [CI]: 2.2–6.7). In a Phase 3 study of bevacizumab in combination with 
chemotherapy for platinum-resistant recurrent ovarian cancer (Pujade-Lauraine et al. 2014), the 
observed median PFS was 3.4 months with chemotherapy alone (95% CI: 2.2–3.7) vs 6.7 months 
with bevacizumab-containing therapy (95% CI: 5.7–7.9).  
Based on these data, the assumed median PFS in the current study is 3.8 months in the 
nab-paclitaxel alone arm (Arm C) and 5.4 and 6.8 months, respectively, in Arm B and Arm A. 
For the comparison between Arm C and Arm A, 91 PFS events will provide approximately 79% 
power for a 1-sided log-rank test at a 0.05 significance level to detect a hazard ratio [HR]=0.56. 
Assuming an exponential distribution of PFS, this corresponds to an increase in median PFS 
from 3.8 months in Arm C to 6.8 months in Arm A. For the comparison between Arm C and 
Arm B, 92 PFS events will provide approximately 39% power for a 1-sided log-rank test at a 
0.05 significance level to detect a HR=0.7. Assuming an exponential distribution of PFS, this 
corresponds to an increase in median PFS from 3.8 months in Arm C to 5.4 months in Arm B. A 
total of approximately 177 patients will need to be randomized (1:1:1 ratio), assuming 
approximately 10% drop-out in each study arm.  
The total accrual duration is expected to be 24 months, with expected study duration of 
43 months. 
Assuming a median survival of 13.3 months in the control group, and 16.6 and 17.4 months in 
Arms B and A, respectively, approximately 120 OS events can be expected to be observed 
during the 43 months of study duration. This will provide 33% global power for the comparison 
of time to OS among the 3 treatment arms.  
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 
discontinuation. 
9.5.2 Demographic and Baseline Data 
Demographics baseline data will include frequency and percentages for categorical variables, 
and mean, standard deviation, median, minimum, and maximum for continuous variables. 
Demographic and baseline characteristics will be summarized by treatment regimen dose group, 
and overall. 

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9.5.3 Concomitant Medications 
Verbatim terms on the eCRFs will be mapped to Anatomical/Therapeutic Chemical class and 
Generic Drug Names using the most current version of the World Health Organization Drug 
Dictionary. Concomitant medications will be summarized for all treatment patients by treatment 
regimen dose group and overall. 
9.5.4 Efficacy Analyses 
Time-to-event variables will be summarized using Kaplan-Meier estimates and plots. Event 
probabilities at 6-month and 12-month time points and the median time-to-event (if estimable) 
will be presented. The log-rank test, stratified by stratification variable(s) used at randomization, 
will be used to compare the treatment groups with respect to time-to-event variables.  
Primary estimates of the treatment differences will be obtained using the hazard ratios and 
1-sided 95% CIs from stratified Cox regression model that includes treatment as a covariate and 
are stratified by stratification variables used at randomization.  
Response rate endpoints will be summarized by providing the point and interval estimates. 
9.5.4.1 
Primary Efficacy Analysis 
The primary endpoint is defined in Section 3.2.1. 
The primary efficacy analysis will be performed on the ITT population as described in 
Section 9.1. Additional sensitivity analyses will be performed to evaluate the robustness of the 
primary efficacy analysis. 
PFS is defined as the time from the date of randomization to the date of first documented PD by 
RECIST v1.1 (Appendix E), or death due to any cause. All events of disease progression (as 
determined by the Investigator) or death will be included, regardless of whether the event 
occurred while the patient was still taking study drug or had previously discontinued study drug. 
However, if a disease progression event occurs after a patient misses 2 or more consecutive 
tumor assessments, this patient will be censored at the last tumor assessment prior to the missing 
assessments. If a patient has not progressed or died before the analysis cutoff date, PFS will be 
censored at the date of last adequate tumor assessment.  
Additional sensitivity analyses will be completed where patients receiving other anticancer 
therapies are censored at the time other anticancer treatment is initiated. 
Hochberg’s step-up procedure will be used for the control of multiplicity of testing in the 
primary efficacy analysis. 
9.5.4.2 
Secondary Efficacy Analyses 
The secondary efficacy endpoints are defined in Section 3.2.2. 
Analysis of the secondary efficacy endpoints will be performed on the ITT population as 
described in Section 9.1. Time-to-event type secondary endpoints will be analyzed in the same 
manner as the primary efficacy endpoint, unless otherwise pre-specified in the SAP. Each 
secondary endpoint will be evaluated at the 0.05 level of significance without the additional 
adjustment for multiplicity of testing across secondary analyses.  

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ORR is defined as the proportion of patients with measurable disease at baseline who attain CR 
or PR by RECIST v1.1. Confirmation is not required to be counted toward ORR. 
DoR is defined as the time from the date response was documented (whichever came first) until 
first observation of PD or death due to any cause. DoR will be assessed only in patients who 
have a response at any time on study. If a patient does not have documented PD or death before 
the analysis cutoff date, DoR will be censored at the date of last study visit. 
BoR is defined as the best response recorded from the date of randomization until PD/recurrence 
(or death). BoR will be summarized for the following types of responses: CR, PR, SD, and PD, 
categorically and graphically with a waterfall plot. 
OS is defined as the time from the date of randomization to the date of death due to any cause. If 
a patient has not died before the analysis cutoff date, OS will be censored at the date of last 
contact.  
An evaluation of OS will be performed at the time of the primary analysis after 135 PFS events 
have occurred. An additional OS analysis will be performed when at least 120 OS events have 
occurred, which will be used for the purposes of final OS reporting. 
DoR, PFS, and OS will be analyzed and presented using the Kaplan-Meier method (for PFS and 
OS), along with the estimated median (in months) with 95% CIs, 25th and 75th percentiles. 
PFS, ORR, and BoR will also be evaluated among patients who were in Arm C and Crossover to 
continuous relacorilant + nab-paclitaxel (Section 3.1.1) following unequivocal PD. Additional 
sensitivity analyses will be performed to evaluate the impact of various assumptions on the 
evaluation of efficacy when considering this treatment switch following PD.  
9.5.4.3 
Exploratory Efficacy Analyses 
Exploratory efficacy endpoints are defined in Section 3.2.3. 
Analysis of the exploratory efficacy endpoints will be performed on the ITT population as 
described in Section 9.1. 
9.5.4.4 
Interim Analysis 
No interim efficacy analysis will be performed. 
9.5.5 Safety Analyses 
Safety analyses will be conducted on the SAF 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 last 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. 

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The following AEs will be summarized separately: AEs leading to discontinuation of study 
treatment (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 overall and for each treatment regimen dose group by parameter, visit, and time 
point using descriptive statistics. 
By-patient safety listings will be provided. 
9.5.6 Pharmacokinetic Analysis 
Intensive PK sampling for relacorilant and nab-paclitaxel will take place on Cycle 1 Day 15 and 
will consist of a total of 5 samples collected at the following time points: pre-dose (0 hour) and at 
1, 2, 4, and 6 hours post-dose. 
Standard PK parameters will be included. Further details of the PK analyses will be described in 
the SAP finalized before database lock. 
Pharmacokinetic analyses will be performed on the PKA population as described in Section 9.1.  
9.5.7 Pharmacodynamic Analysis 
Biomarker and pharmacogenomic exploratory analyses will be described in the SAP finalized 
before database lock. 
9.5.8 Patient-Reported Outcomes/Quality of Life 
For the FACT NFOSI-18, 4 subscale scores will be constructed and analyzed: 1) disease-related 
symptoms (DRS) scores, 2) emotional well-being (DRS-E) score, 3) treatment side effect (TSE) 
score, and 4) a functional well-being (FWB) score. For the primary PRO and QoL analysis, the 
overall mean change from baseline for the DRS scores between groups will be assessed, using a 
longitudinal repeated measures model that takes into account the DRS measured at each 
assessment point up to 6 months or PD, whichever is later. Additional analyses based upon PRO 
endpoints will be specified in the SAP. 

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10 
ETHICAL AND LEGAL CONSIDERATIONS 
10.1 
Compliance with Institutional Review Board/Independent Ethics Committee 
Regulations 
This study is to be conducted in accordance with IRB regulations (US 21 CFR Part 56.103), IEC 
regulations, or applicable local regulations. The protocol, ICFs, recruitment materials, and all 
patient materials will be submitted to the IRB/IEC 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/IEC 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/IEC; a determination will be made 
regarding whether previously consented patients need to be re-consented 
Corcept is to be notified immediately if the responsible IRB/IEC has been disqualified or if 
proceedings leading to disqualification have begun. Copies of all IRB/IEC correspondence with 
the Investigator should be provided to Corcept. 
Progress reports and notifications of serious adverse drug reactions will be provided to the 
IRB/IEC 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 Principal 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 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 Principal 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 Principal 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 obtained for future analysis to help identify biomarkers of disease 
or relacorilant treatment. 
• The informed consent process should be documented in the patient’s record. 
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, regulatory agencies, and IRB/IEC/Research Ethics Board. 
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 federal 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 monitoring plan. 
11.2 
Quality Management 
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. 
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 Corcept or its designee will 
notify Investigators in writing when the trial-related records are no longer needed. 

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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 original source documents, and other records relative to study conduct. 
By signing the protocol, the Principal Investigator agrees that, within local regulatory restrictions 
and institutional and ethical considerations, authorized representatives of the Sponsor, a 
regulatory authority, and/or an IRB/IEC 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 eCRFs 
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 investigational product. 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. 
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. 

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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/IEC approval.  
All long-term, retention samples will be retained by Corcept or designee. The long-term 
retention samples will be coded to allow de-identification according to applicable regulatory 
guidelines. 
After conclusion of this study, the long-term samples will be held for a period up to 10 years, 
after which they will be destroyed. If a study patient does not provide consent for future use, that 
patient’s samples will be destroyed.  
During the conduct of the study, an individual patient can choose to withdraw consent to have 
her samples stored for future research. However, withdrawal of consent with regard to biological 
sample storage will not be possible after the study is completed.  
It is the responsibility of the trial site to ensure that samples are appropriately labelled in 
accordance with the trial procedures to comply with all applicable laws, which may include but 
are not limited to European Directives 95/46/EC and 2002/58/EC and any legislation and/or 
regulation implementing or made pursuant to them, or which amends, replaces, re-enacts, or 
consolidates any of them (including the General Data Protection Regulation [EU] 2016/679), and 
all other applicable laws relating to processing of personal data and privacy that may exist in any 
relevant jurisdiction. Biological samples collected from participants as part of this trial will be 
transported, stored, accessed and processed in accordance with all applicable laws relating to the 
use and storage of human tissue for research purposes and such activities shall at least meet the 
requirements as set out in the 2004 Human Tissue Act and the 2006 Human Tissue (Scotland) 
Act. 
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/government health authorities 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.  

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Unused study drug must be kept in a secure location for accountability and reconciliation by the 
study monitor. The Investigator or designee must provide an explanation for any destroyed or 
missing study drug or study materials. 
The Investigator or designee is responsible for maintaining accurate records (including dates and 
quantities) of study drug(s) received, patients to whom study drug is dispensed (patient 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 
(onsite 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 returned to Corcept or Corcept 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 Corcept or 
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 patients 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. 

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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. 
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 IEC/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 IEC/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 Corcept. The Investigator agrees to submit all manuscripts or abstracts to Corcept 
for review before submission to the publisher. 
Corcept 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. 
11.12 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 

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Study termination and follow-up will be performed in compliance with applicable regulations. 

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12 
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Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. 2008. Evaluation of a preliminary physical 
function item bank supports the expected advantages of the Patient-Reported 
Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 61:17–33. 
Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware Jr JE. 2014. The PROMIS Physical 
Function Item Bank Was Calibrated to a Standardized Metric and Shown to Improve 
Measurement Efficiency. J Clin Epidemiol. 67(5):516–526. 
Rustin GJ, Vergote I, Eisenhauer E, Pujade-Lauraine E, Quinn M, Thigpen T, et al. 2011. 
Definitions for response and progression in ovarian cancer clinical trials incorporating 
RECIST 1.1 and CA-125 agreed by the Gynecological Cancer Intergroup (GCIG). Int J 
Gynecol Cancer. 21(2):419–423. doi: 10.1097/IGC.0b013e3182070f17. 
Skor MN, Wonder E, Kocherginsky M, et al. 2013. Glucocorticoid receptor antagonism as a 
novel therapy for triple negative breast cancer. Clin Cancer Res. 19(22):6163–6172. 
Stringer EM, Saha P, Swoboda A, Kocherginsky M, Baker G, Olberkyte S, et al. 2017. A phase I 
trial of mifepristone (M), carboplatin (C), and gemcitabine (G) in advanced breast and 
ovarian cancer. J Clin Oncol. 35:15_suppl, 1083–1083. 
Stringer-Reasor EM, Baker GM, Skor MN, et al. 2015. Glucocorticoid receptor activation 
inhibits chemotherapy-induced cell death in high-grade serous ovarian carcinoma. 
Gynecolog Oncol. 138(3):656–662. 
 

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Appendix A: Schedules of Assessments and Procedures 
Table 10 
Schedule of Assessments and Procedures 
Study Period/  
Visit 
Screening 
Treatment Phase 
EOT a 
30-Day 
Follow-up b  
Long-Term 
Follow-up c 
Cycle 1 
Cycle 2 and Subsequent Cycles 
Day 
 
(See Note below table for windows) 
Within 
28 days 
prior to 
first dose 
of study 
treatment 
Day 1 
Day 8 
Day 15 
Day 1 
Day 8 
Day 15 
 
30 days after 
final 
treatment 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Inclusion and Exclusion Criteria 
X 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical/Oncologic History 
X 
 
 
 
 
 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Serum/Urine Pregnancy Test d 
X 
X 
 
 
X d 
 
 
 
 
 
Tumor Biopsy e 
X 
 
 
 
X 
 
 
 
 
 
Tumor Assessment (CT/MRI) f 
X 
Every 8 weeks (±7 days) from Cycle 1 Day 1 f 
X f 
 
 
CA-125 g 
X 
X 
 
 
X 
 
 
X g 
 
 
ECOG PS 
X 
X 
 
 
X 
 
 
X 
X 
 
Randomization h 
 
X 
 
 
 
 
 
 
 
 
Physical Examination i 
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 
 
Hematology j 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

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Study Period/  
Visit 
Screening 
Treatment Phase 
EOT a 
30-Day 
Follow-up b  
Long-Term 
Follow-up c 
Cycle 1 
Cycle 2 and Subsequent Cycles 
Day 
 
(See Note below table for windows) 
Within 
28 days 
prior to 
first dose 
of study 
treatment 
Day 1 
Day 8 
Day 15 
Day 1 
Day 8 
Day 15 
 
30 days after 
final 
treatment 
PT/aPTT/INR 
X 
 
 
 
 
 
 
 
X 
 
Biochemistry k 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Urinalysis l 
X 
 
 
 
 
 
 
X 
X 
 
Hepatitis B and C Serologies & 
HIV 
X 
 
 
 
 
 
 
 
 
 
12-lead ECG (in triplicate) 
X m 
 
 
 
 
 
 
X 
 
 
Patients in Arm A or B, or Crossover: 
Provide dose diary card  
 
X 
 
 
X 
 
 
 
 
 
Dispense relacorilant 
 
X 
 
 
X 
 
 
 
 
 
Relacorilant dosing (oral) n 
 
Refer to Section 5 for details of continuous and intermittent dose 
schedules 
 
 
 
Assess treatment compliance  
 
 
X 
X 
X 
X 
X 
X 
 
 
Nab-Paclitaxel Dosing (IV) 
 
X 
X 
X 
X 
X 
X 
 
 
 
Intensive PK Blood Sampling o 
 
 
 
X 
 
 
 
 
 
 
Pharmacodynamic Sampling p 
X 
X 
 
X 
X p 
 
X 
X 
 
 
PRO and QoL Assessments q 
X 
 
 
 
X q 
 
 
X 
X 
 
Record AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Follow-up 
 
 
 
 
 
 
 
 
 
X 
Abbreviations: AE, Adverse event; aPTT, activated partial thromboplastin time; CA-125, cancer antigen 125; CEA, carcinoembryonic antigen; CR, complete 
response; CT, computerized tomography; ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology Group; EOT, End of Treatment; GR, glucocorticoid 

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receptor; HIV, human immunodeficiency virus; INR, international normalized ratio; IV, intravenously; MRI, magnetic resonance imaging; OS, overall 
survival; PD, disease progression (progressive disease per RECIST v1.1); PK, pharmacokinetic; PRO=patient-reported outcomes; PS, performance status; PT, 
prothrombin time; QoL=quality of life; SAE, serious adverse event. 
Visit Window Note: Study visits will align with nab-paclitaxel infusion days during the Treatment Phase. Refer to Appendix C for acceptable treatment windows 
for nab-paclitaxel for scheduling conflicts. For dose delays of nab-paclitaxel due to toxicity see Section 5.4.  
Procedural Window Note: 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 chemistry assessments can be conducted up to 72 hours prior to the study visit/nab-paclitaxel 
infusion. Post-baseline PRO and QoL assessments can be performed up to 7 days early. 
a. Patients who discontinue treatment prior to disease progression will continue radiographic tumor assessments every 8 weeks (±7 days) until unequivocal 
disease progression. 
b. Follow-up Visit should be performed 30 days (±3 days) after the patient receives their final dose of study treatment (relacorilant or nab-paclitaxel, whichever is 
latest). 
c. Long-Term Follow-up: For patients who discontinue before PD, subsequent treatment information will be collected at the same time as radiographic tumor 
assessments (i.e., every 8 weeks [±7 days]), until unequivocal PD, after which they will be followed every 3 months (±7 days). For patients who discontinue 
treatment at the time of PD, or for those who decline further radiographic tumor assessments, survival and subsequent treatment information will be collected 
every 3 months (±7 days) from the last dose of study treatment (Section 7.6).  
d. A serum or urine pregnancy test for female patients of childbearing potential will be performed prior to the first dose of study treatment (48-hour window from 
the first dose of study treatment) and then every 12 weeks ±7 days. 
e. Availability and consent to provide an archival or recent (pre-treatment) tumor biopsy for biomarkers are required for patient inclusion in the study. Optional 
paired tumor biopsies will be obtained within 6 weeks prior to treatment initiation (this can be the same pre-treatment biopsy used to meet eligibility criteria) 
and at Cycle 2 Day 1. In order to assess the study endpoints, paired biopsies from a minimum of 6 patients per treatment arm are needed. If additional patients 
are enrolled to achieve this target, consent to provide biopsies will become mandatory for enrollment in the study. Refer to Table 12 for further details of 
pharmacodynamic assessments. 
f. Tumor assessments will be performed within 28 days prior to the first dose of study treatment and then every 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. At the EOT visit, a final radiographic tumor assessment will be done if ≥4 weeks have 
elapsed since the last radiographic tumor assessment, unless there is documented PD. 
g. CA-125 will be assessed by the local laboratory within 14 days prior to the first dose of study treatment and every 4 weeks from Cycle 1 Day 1 for the first 
12 months of treatment. If Investigators collect CA-125 beyond 12 months as per their standard of care, this information will be documented in the eCRF. 
h. Randomization to be performed prior to administration of study medication. Patients should receive their first dose of study treatment on the same day as 
randomization wherever possible, and with a minimum of delay where unavoidable.  
i. A full physical examination will be performed at Screening, Cycle 1 Day 1 of each cycle, and at the End-of-Treatment Visit. A targeted physical examination 
will be performed at Days 8 and 15 of each cycle (or the day before). 
j. Hematology assessments are listed in Table 7. On Cycle 1 Day 1, hematology samples should be collected pre-dose and 4 hours post-dose. For Arms A and B, 
and Crossover, the nominal time for this sample collection is relative to the dose of relacorilant. For Arm C, the nominal time for this sample collection is 
relative to the start of the nab-paclitaxel infusion. 
k. Biochemistry assessments are listed in Table 7. 
l. Urinalysis assessments are listed in Table 7. Microscopy is required only to follow-up clinically significant urine dipstick findings. 

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m. Triplicate ECG-measurements should be performed prior to the first dose of study treatment. If not performed at Screening, ECGs can be done at Cycle 1 
Day 1. 
n. For patients in Arm A (continuous) or the Crossover, the first dose of relacorilant will be Cycle 1 Day 1 and will then continue to be administered once daily 
through the Treatment Phase. For patients in Arm B (intermittent), the first dose of relacorilant is to be administered on Cycle 1 Day 1 and then will continue 
to be administered on the day prior, the day of, and the day following nab-paclitaxel. Nab-paclitaxel will be administered on Day 1, 8, and 15 for all arms. See 
Section 5 for full details of dosing for both relacorilant and nab-paclitaxel. 
o. Intensive PK sampling for relacorilant and nab-paclitaxel to take place on Cycle 1 Day 15 and will consist of a total of 5 samples collected at the following 
time points: pre-dose (0 hour) and at 1, 2, 4, and 6 hours post-dose (Table 11). 
p. A schedule of pharmacodynamic assessments is provided in Table 12, this includes timing of blood samples and timing of paired tumor biopsies.  
q. Baseline PRO and QoL assessments must be collected prior to the first dose of study treatment (relacorilant or nab-paclitaxel, whichever occurs earlier). Post-
baseline assessments will be collected every other cycle (-7-day window) starting with Cycle 2 Day 1, at the End-of-Treatment Visit, and at the 30-Day 
Follow-up Visit. PRO and QoL assessments should be completed prior to discussing the results of tumor assessments or disease-related clinical changes with 
the patient. 
 
 

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Table 11 
Pharmacokinetic Schedule of Assessments 
PK Sample 
Day 
Nominal Time a 
Window 
Relacorilant & nab-paclitaxel 
Cycle 1 Day 15 
0 hr, pre-dose 
Within 15 minutes before the relacorilant 
dose 
1 hr 
±10 minutes 
2 hr 
4 hr 
6 hr 
Abbreviation: PK, pharmacokinetic 
a For Arms A and B, and Crossover, the nominal time of PK sample collection is relative to the dose of relacorilant. For Arm C, the nominal time for the PK 
sample collection is relative to the start of the nab-paclitaxel infusion. 
 

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Table 12 
Pharmacodynamic Schedule of Assessments 
Procedure/Assay 
Tissue Source 
Visit Schedule  
Cycle Day 
Methodology; Examples of Biomarkers 
Immune, tumor, and GC-
related gene panel including 
 
Blood 
Fasting, pre-dose (between 7-9 am) at: 
Screening 
Cycle 1 Day 1 
Cycle 1 Day 15 
Cycle 3 Day 1 
Cycle 6 Day 1 
EOT a  
Disease progression a 
mRNA expression by technologies 
such as NanoString 
 
For a subset of 20 patients enrolled into Arm A, an 
intensive collection schedule will be followed: 
Fasting, pre-dose (between 7-9 am) at: 
Screening 
Cycle 1 Day 1 
Cycle 1 Day 2 
Cycle 1 Day 3 
Cycle 1 Day 5 
Cycle 1 Day 10 
Cycle 1 Day 15 
Cycle 3 Day 1 
Cycle 6 Day 1 
EOT a  
Disease progression a 
Post-dose (between 11 am-1 pm), fasting not required 
(please note whether fasting or not fasting): 
Cycle 1 Day 1 

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Procedure/Assay 
Tissue Source 
Visit Schedule  
Cycle Day 
Methodology; Examples of Biomarkers 
Exploratory cytokines 
Blood 
Fasting, pre-dose (between 7-9 am) at: 
Screening 
Cycle 1 Day 1 
Cycle 1 Day 15 
Immunoassay panel for cytokines related to 
immune and GC function 
Cancer antigens  
Blood 
Pre-dose (between 7-9 am): 
Screening,  
Every 6-8 weeks to coincide with radiographic 
assessments.  
Analytes measured by technologies such as 
immunoassay; Antigens such as CA15-3, 
CA19-9, or carcinoembryonic antigen (CEA) 
Immune, tumor, and GC-
related gene panel including 
 
Pre-treatment and 
post-treatment 
(when available) 
tumor biopsies 
Screening 
Cycle 2 Day 1 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 GR 
and/or other exploratory 
markers  
Pre-treatment and 
post-treatment 
(when available) 
tumor biopsies 
Screening 
Cycle 2 Day 1 b 
Formalin fixed, paraffin embedded tissue 
sample; CLIA-validated IHC assay for GR 
and/or other IHC or IF methods  
Mutation and homologous 
recombination deficiency 
assessment 
Pre-treatment 
tumor biopsy 
Screening 
Formalin fixed, paraffin embedded tissue 
sample; DNA sequencing analysis, such as 
 
Footnotes for Table 12 
Abbreviations: CA-125, cancer antigen 125; CA15-3, cancer antigen 15-3; CA19-9, cancer antigen 19-9; CLIA, Clinical Laboratory Improvement Amendments; 
DNA, deoxyribonucleic acid; EOT, End of Treatment; 
 GC, glucocorticoid; GR, 
glucocorticoid receptor; IF, immunofluorescence; IHC, immunohistochemistry; mRNA, messenger RNA; PD, disease progression. 
a If a patient discontinues treatment for reasons other than PD, a sample will be collected upon PD. 
b Availability and consent to provide an archival or recent tumor biopsy (pre-treatment tumor biopsy) for tumor biomarker assays are required for patient 
inclusion in the study. Optional paired (pre-treatment and post-treatment) tumor biopsies will be obtained within 6 weeks prior to treatment initiation (this can 
be the same pre-treatment biopsy used to meet eligibility criteria) and at Cycle 2 Day 1 (±7 days). Patients will also have the option to provide an additional 
on-study biopsy (1) obtained during procedure conducted as standard of care; or (2) at the time of PD.  
 

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Appendix B: Guidance for Identifying High Grade Serous Carcinoma 
The following should be considered when determining a diagnosis of high grade serous 
carcinoma: 
• Diagnosed as Grade 2 or Grade 3 serous carcinoma using Shimizu-Silverberg grading 
scheme. 
• Wide spectrum of architectural patterns, including solid, glandular, and cribriform 
patterns, and patterns resembling transitional cell carcinoma. At least focal papillae and 
micropapillae with gaping and slit-like architectural features are present. 
• Histologic variants such as transitional cell carcinoma or serous carcinoma with 
microcystic features. 
• High nuclear grade, with extreme nuclear size variability (>5×). 
• More than 10 mitotic figures per 10 high power fields. 
• Typically disseminated at presentation. WT1 expression should be sought for Stage I 
tumors. 
• WT1, p53, and/or pl6 overexpression may be sought if the differential diagnosis includes 
low grade serous carcinoma, endometrioid carcinoma, or clear cell carcinoma. 
• Can be distinguished from serous borderline tumor by the presence of high nuclear grade 
if obvious stromal invasion is not identified after examination of multiple sections. 
 

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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. 

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Appendix D: Examples of Medications and Foods that are Prohibited or to be 
Used with Caution 
The following medications and foods are examples of prohibited medications/foods or 
medications/foods to be used with caution during the study: 
 
Prohibited 
Not Recommended 
Use with Caution 
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 
QT-prolonging 
Medications 
-- 
-- 
Substitute or eliminate QT-
prolonging medications, when 
possible 
(https://www.crediblemeds.org/) 
Abbreviations: CYP, cytochrome P450; GR, glucocorticoid receptor. 

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a. For patients receiving sulfonylureas, conduct close glucose monitoring to assess for diabetic control. 
The table of examples above is not comprehensive. For additional information or to review specific medications, 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/uc
m080499.htm 
http://medicine.iupui.edu/clinpharm/ddis/main-table/  
 
 

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Appendix E: RECIST v1.1 for Disease Assessment 
Tumor response and assessment according to RECIST v1.1 is described below. This appendix is 
not exhaustive and the source (Eisenhauer 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. 
CT is the best currently available and reproducible method to measure lesions selected for 
response assessment. CT (with IV and oral contrast) should be performed with cuts of 5 mm or 
less in slice thickness contiguously. 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 1 dimension (longest diameter in the plane 
of measurement is to be recorded) with a minimum size of: 
• 10 mm on 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 non-measurable). 
Non-measurable 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 non-measurable lesions. Lesions considered truly 
non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, 
inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 
masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques. 

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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 non-measurable. 
Cystic Lesions: 
• Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) 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 
non-cystic 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 non-measurable disease are eligible. Measurable disease is defined 
as above, by the presence of at least 1 measurable lesion.  
Baseline Documentation of ‘Target’ and ‘Nontarget’ Lesions 
When more than 1 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 
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. 

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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 / Disease Progression (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 1 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 (SD): 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.  
– All lesions at baseline should have their actual measurements recorded at each 
subsequent evaluation, even when very small (<5 mm). If the lesion is believed to be 
present, but too small to measure, a default value of 5 mm should be assigned (as 
derived from the 5 mm CT slice thickness). If it is the opinion of the radiologist that 
the lesion has likely disappeared, the measurement should be recorded as 0 mm. 
• Evaluation of Nontarget Lesions 
– Complete Response (CR): Disappearance of all nontarget lesions and normalization 
of tumor marker level. 
– Incomplete Response/Stable Disease (non-CR/non-PD): Persistence of 1 or more 
nontarget lesion(s) or/and maintenance of tumor marker level above the normal 
limits. 
– Progressive Disease / Disease Progression (PD): Appearance of 1 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 SD or PR in target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy. A modest increase in the size of 1 or more nontarget 
lesions is usually not sufficient to qualify for unequivocal disease progression. In the 

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absence of radiographic or clinical evidence of progressive disease, a rise in CA-125 
alone is not sufficient to declare progression. 
New lesions 
• The appearance of new lesions denotes disease progression. The findings of a new lesion 
should be unequivocal; i.e., not attributable to differences in scanning technique, timing 
of scanning, phase of contrast administration, change in imagining modality, or finding 
thought to represent something other than tumor. A lesion identified on a follow-up study 
in an anatomical location that was not scanned at baseline is considered a new lesion and 
will indicate disease progression. 
• If a new lesion is equivocal, continue therapy and follow-up evaluation will clarify if it 
represents new disease. If repeat scans confirm there is a new lesion, then progression 
should be declared using the date of the initial scan. 
 

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Appendix F: Gynecological Cancer Intergroup Definitions for Response and Progression in 
Ovarian Cancer Clinical Trials 
Tumor response and assessment according to GCIG criteria is described below. This appendix is 
not exhaustive and the source (Rustin 2011) should be referred to for further detail. 
Definition of Response 
A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a pretreatment 
sample. The response must be confirmed and maintained for at least 28 days. Patients can be 
evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the 
upper limit of the reference range and within 2 weeks before starting the treatment. 
To calculate CA-125 responses accurately, the following rules apply: 
• Intervening samples and the 28-day confirmatory sample must be less than or equal to 
(within an assay variability of 10%) the previous sample. 
• Variations within the reference range of CA-125 levels will not interfere with the 
response definition. 
• For each patient, the same assay method must be used, and the assay must be tested in a 
quality control scheme. 
• Patients are not evaluable by CA-125 if they have received mouse antibodies (unless the 
assay used has been shown not to be influenced by human antimouse antibody) or if there 
has been medical and/or surgical interference with their peritoneum or pleura during the 
previous 28 days (e.g., paracentesis). If assessing therapy that includes 2 treatment 
modalities for relapse (e.g., surgery and chemotherapy), any CA-125 response results 
from both treatment modalities. CA-125 cannot distinguish between the effects of the 
2 treatments. 
The date when the CA-125 level is first reduced by 50% is the date of the CA-125 response. To 
calculate response per GCIC criteria, an intent-to-treat analysis will be used that includes all 
patients with an initial CA-125 level of at least twice the upper limit of the reference range as 
eligible and evaluable. In addition, as a separate analysis, those patients who have a CA-125 
response and whose CA-125 level falls to within the reference range can be classified as CA-125 
complete responders. In Table 13 and Table 14 where CA-125 is stated as normalized or normal, 
means within the reference range. 
Evaluation of Best Overall Response in Patients without Initial Measurable Disease and 
Evaluable by CA-125 (GCIG Criteria) 
CA-125 may be used to evaluate response in patients without initial measurable disease either 
because no measurable disease is evident on radiological imaging or because appropriate 
imaging has not been performed as demonstrated in Table 13. 

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Table 13 
Evaluation of Best Overall Response in Patients Without Initial Measurable 
Disease and Who are Evaluable by CA-125 (GCIG Criteria) 
CA-125 
Nontarget  
Lesions a  
New Lesions  
Overall 
Response 
Best Response for 
This Category Also 
Requires 
Response and Normalized 
CR 
No 
CR 
Confirmed and 
maintained for at 
least 28 days 
Response 
Non-PD 
No 
PR 
Normalized but no response  
Non-CR/Non-PD 
No 
SD 
Non-PR/non-PD 
Non-PD 
No 
SD 
 
PD 
Any 
Yes or No 
PD 
 
Any 
PD b 
Yes or No 
PD 
 
Any 
Any 
Yes 
PD 
 
Abbreviations: CA-125, cancer antigen 125; CR, Complete response; PD, progressive disease; PR, partial response; 
SD, stable disease. 
a Nontarget lesions include ascites and peritoneal thickening, which are not measurable according to RECIST. 
b Unequivocal progression in nontarget lesions may be accepted as disease progression.  
 
Evaluation of Best Overall Response in Patients with Initial Measurable Disease and Who 
are Also Evaluable by CA-125 (GCIG Criteria) 
A report that combines both CA-125 and RECIST v1.1 is likely to include patients who are 
measurable by one or both of the criteria and who may have events at different time points. It 
should be determined according to Table 14. In patients who have measurable disease by both 
criteria, the date of response will be the date of the earlier of the 2 events if this approach to 
combined response reporting is to be used. In the combined assessment of CA-125 and RECIST 
v1.1 response, the following algorithm applies when determining the best overall response. If 
patients have progressive disease (PD) according to RECIST v1.1 within 28 days of CA-125 
response, they are classified as having PD. If the PD according to RECIST v1.1 is longer than 
28 days before or after the CA-125 response, they are classified as having partial response. 
Patients whose best response according to RECIST v1.1 is stable disease but who have a CA-125 
response are classified as CA-125 responders. 

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Table 14 
Best Overall Response in Patients with Measurable Disease and Who are also 
Evaluable by CA-125 (GCIG Criteria) 
Target Legion a 
Nontarget b 
New Lesion 
CA-125 c 
Best Overall 
Response 
CR 
CR 
No 
Normal  
CR 
CR 
Non-CR Non-PD 
No 
Not PD 
PR 
CR 
CR 
No 
PR but not normal 
PR 
CR 
NE 
No 
PR 
PR 
PR 
Non-PD or NAE 
No 
Not PD 
PR 
NAE 
Non-PD 
No 
PR 
PR 
PD or New >28 days from CA-125 PR d 
PR 
PR 
SD 
Non-PD 
No 
PR 
PR 
SD 
Non-PD or NAE 
No 
Not PR and not PD 
SD 
PD or New ≤28 days from CA-125 PR d 
PR 
PD 
PD 
Any 
Yes or No 
Any 
PD 
Any 
PD 
Yes or No 
Any 
PD 
Any 
Any 
Yes 
Any 
PD 
Any 
Any 
Yes or No 
PD 
PD 
Abbreviations: CA-125, cancer antigen 125; CR, Complete response; NE, not evaluated; NAE, not all evaluated; 
PD, progressive disease; PR, partial response; SD, stable disease. 
a Target lesions include up to 5 measurable lesions (2 per organ) as deﬁned by RECIST v1.1.  
b Nontarget lesions include ascites and peritoneal thickening which are not measurable according to RECIST v1.1. 
c CA-125 response must be confirmed and maintained for at least 28 days. 
d Patients who have a CA-125 response that occurs more than 28 days from PD according to RECIST v1.1 are 
considered a PR, according to best response, but PD if the RECIST v1.1 PD is within 28 days of CA-125 
response.  
 
Reporting of Response According to both RECIST v1.1 and CA-125 (GCIG Criteria) 
In this study, responses will be reported separately for both tumor response per RECIST v1.1 and 
CA-125 response per GCIG criteria as shown in the hypothetical example in Table 15. A 
combined response endpoint based on both RECIST v1.1 and GCIG criteria will also be 
reported. Tumor response will be assessed by the Investigator or local radiologist using RECIST 
v1.1. CA-125 response and the combined response will be derived based upon local CA-125 
results. 

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Table 15 
Example of Reporting Response According to RECIST v1.1, CA-125 (GCIG 
Criteria), and Combined Response 
Bolded numbers, CA-125 responders; bolded and italicized numbers, both RECIST and 
CA-125 responders; italicized numbers, RECIST responders. 
 
CA-125 Response 
RECIST 
Yes 
No or PD 
NE 
Total RECIST 
CR a  
4 
0 
0 
4 
PR 
3 
1 
1 
5 
SD 
3 
12 
1 
16 
PD 
0 
8 
2 
10 
NE 
3 
5 
2 
10 
Total CA-125 
13 
26 
6 
Total entered = 45 
Abbreviations: CA-125, cancer antigen 125; CR, complete response; GCIG, Gynecologic Cancer Intergroup; NE, 
not evaluated; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid 
Tumors. 
Note: In the above example, the RECIST v1.1 response rate is 9 (25.7%) of 35 patients evaluable by RECIST 
v1.1, the CA-125 response rate is 13 (33%) of 39 patients evaluable by CA-125, and the combined overall 
response rate (either RECIST or CA-125 response) is 15 (35%) of 43 patients total. 
a RECIST v1.1 includes normalization of CA-125 to achieve CR (Table 14). 
 

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Appendix G: Guidance for Counting Prior Lines of Therapy 
The following guidance applies with respect to counting the number of prior lines of anticancer 
therapy for each patient: 
• Line of therapy includes therapy that was given in any setting (adjuvant or neoadjuvant 
treatment or for recurrent disease). 
• If a treatment was initiated after disease progression or discontinuation of a previous 
regimen due to toxicity, then the treatment should be considered a separate line of 
therapy, with exception of the following: 
– If 1 component of a regimen/planned treatment duration was transitioned to a similar 
class/regimen due to toxicity, then the continuation of doublet therapy should be 
considered as 1 line of therapy. For example, adjuvant treatment with carboplatin and 
paclitaxel, with a change from paclitaxel to docetaxel after 3 cycles due to toxicity, to 
complete the planned 6 cycles of treatment, would be considered 1 line of therapy. 
Similarly, if the same patient received maintenance treatment with bevacizumab 
following completion of carboplatin and paclitaxel/docetaxel, all therapies would be 
considered as 1 line of therapy. 
• If a patient completed a planned course of treatment, subsequent treatments should be 
considered as a new line of therapy. 
• Maintenance therapy is not considered a separate regimen and should be counted as part 
of the line of therapy most recently completed.