Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Eligibility Criteria

• * Histologic diagnosis of high-grade serous/endometrioid, epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma.
• * Platinum-resistant disease (defined as progression \<183 days from the last dose of platinum).
• * At least 1 measurable (target) lesion per RECIST version 1.1.
• * Life expectancy of ≥3 months.
• * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• * Able to swallow and retain oral medication and does not have uncontrolled emesis.
• * 1 to 3 lines of prior systemic anticancer therapy for ovarian cancer.
• 1. ≥1 prior line of platinum-based therapy.
• 2. Prior treatment with bevacizumab allowed.
• * Adequate organ function meeting the following laboratory-test criteria:
• 1. Absolute neutrophil count (ANC) ≥1500 cells/mm\^3.
• 2. Platelet count ≥100,000/mm\^3.
• 3. Hemoglobin ≥9 g/dL.
• 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN if liver metastases.
• 5. Total bilirubin ≤1.5 × ULN.
• 6. Albumin ≥2.5 g/dL.
• 7. Calculated creatinine clearance ≥35 mL/min.
• 8. Urine protein \<2+ by dipstick; if ≥2+, 24-hour urine \<1 g of protein.
• * Negative pregnancy test for patients of childbearing potential.
• * Has progressed while receiving weekly (every week or 3 out of 4 weeks) paclitaxel or nab-paclitaxel in the platinum-resistant ovarian cancer (PROC) setting.
• * Prior anticancer therapy related toxicities not resolved to grade ≤1.
• * Any surgery within 4 weeks prior to enrollment.
• * Prior treatment as follows:
• 1. Chemotherapy, immunotherapy, investigational agent etc. within 5 times the half-life of the prior therapy, or 28 days if 5 times the half-life of the prior therapy is \>28 days, before the first dose of study treatment.
• 2. Radiotherapy not completed ≤2 weeks prior to first dose of study treatment.
• 3. Hormonal anticancer therapies within 7 days of first dose of study treatment.
• 4. Corticosteroids used within a period equivalent to 5 times the half-life of the corticosteroid prior to first dose of study treatment.
• * Wide-field radiation to more than 25% of marrow-bearing areas.
• * Medical conditions requiring chronic or frequent treatment with corticosteroids.
• * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
• * Peripheral neuropathy from any cause \>Grade 1.
• * Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic.
• * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation, including unstable angina, myocardial infarction within 6 months prior to the first dose of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication, severe/advancing cirrhosis, active infectious disease requiring IV therapy within 2 weeks prior to the first dose of study treatment, gastric-outlet obstruction, acute renal failure, known psychiatric disorder that would interfere with trial compliance.
• * Bowel obstruction ≤12 weeks prior to study entry.
• * Ascitic or pleural thoracentesis within the 30 days prior to study entry or anticipated within 30 days of C1D1.
• * Non-healing wound, ulcer, or bone fracture.
• * History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to C1D1.
• * Evidence of recto-sigmoid involvement by ovarian cancer.
• * Anticoagulants or thrombolytic agents use for therapeutic purpose within 10 days prior to study treatment start.
• * Active infection with HIV, hepatitis C or hepatitis B virus.
• * Untreated or symptomatic central nervous system metastases.
• * History of other malignancy within 3 years prior to enrollment.
• * Has received a live vaccine within 30 days prior to the study start date.