Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers

Inclusion Criteria

• Inclusion Criteria: Arms A and B - Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma - Arm A Only: Platinum-resistant disease - Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor - Life expectancy of ≥3 months - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Able to swallow and retain oral medication - 1 to 3 lines of prior systemic anticancer therapy - Adequate organ function - Negative pregnancy test for patients of childbearing potential Arm C - Stage III or IV, recurrent, or metastatic endometrial cancer - Life expectancy of ≥3 months - ECOG performance status of 0 or 1 - Able to swallow and retain oral medication - Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD[L]1) antibody - 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer - Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections - Adequate organ function - Negative pregnancy test for patients of childbearing potential Exclusion Criteria: Arm A and B - Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel - Prior enrollment in a clinical trial of relacorilant - Prior anticancer therapy related toxicities not resolved to grade ≤1 - Any surgery within 4 weeks prior to enrollment - 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 - Bowel obstruction ≤12 weeks prior to study entry - Ascites or pleural effusions requiring therapeutic paracentesis - 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 Arm C - Has progressed while receiving weekly paclitaxel or nab-paclitaxel - Prior enrollment in a clinical trial of relacorilant - Prior anticancer therapy related toxicities not resolved to grade ≤1 - Any surgery within 4 weeks prior to enrollment - 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 - Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation - Bowel obstruction ≤12 weeks prior to study entry - Ascites or pleural effusions requiring therapeutic paracentesis - History of other malignancy within 3 years prior to enrollment - Has received a live vaccine within 30 days prior to the study start date - Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.