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

Open to females ages 18 years and up

• 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/mm³.
  2. Platelet count ≥100,000/mm³.
  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.
• Ascites or pleural effusions requiring therapeutic paracentesis or 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.