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

Purpose

This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.

Conditions

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Endometrial Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab
In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.
  • Drug: Relacorilant 150 mg once daily (QD)
    Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
    Other names:
    • CORT125134
  • Drug: Nab-paclitaxel 80 mg/m^2
    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Drug: Bevacizumab 10 mg/kg
    Bevacizumab is administered as IV infusion on Days 1 and 15.
Experimental
Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab
In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab.
  • Drug: Relacorilant 150 mg once daily (QD)
    Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
    Other names:
    • CORT125134
  • Drug: Nab-paclitaxel 80 mg/m^2
    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Drug: Bevacizumab 10 mg/kg
    Bevacizumab is administered as IV infusion on Days 1 and 15.
Experimental
Arm C: Relacorilant in Combination with Nab-Paclitaxel
In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.
  • Drug: Relacorilant 150 mg once daily (QD)
    Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
    Other names:
    • CORT125134
  • Drug: Nab-paclitaxel 80 mg/m^2
    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Recruiting Locations

150
Palo Alto 5380748, California 5332921 94304

014
San Francisco 5391959, California 5332921 94143

544
Fort Myers 4155995, Florida 4155751 33901

543
West Palm Beach 4177887, Florida 4155751 33041

518
Minneapolis 5037649, Minnesota 5037779 55404

334
Kansas City 4393217, Missouri 4398678 64132

521
St Louis 4407066, Missouri 4398678 63110

292
Albuquerque 5454711, New Mexico 5481136 97102

304
Centerville 4508204, Ohio 5165418 45459

517
Eugene 5725846, Oregon 5744337 97401

127
Pittsburgh 5206379, Pennsylvania 6254927 15213

522
Fairfax 4758023, Virginia 6254928 22031

300
Norfolk 4776222, Virginia 6254928 23502

121
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID
NCT06906341
Status
Recruiting
Sponsor
Corcept Therapeutics

Study Contact

Corcept Therapeutics
650-684-0171
corceptstudy557@corcept.com

Detailed Description

This study is designed with the goal to add additional arms as new treatments become available. All arms will follow an independent and parallel design. For Arms A and B, study treatment will comprise relacorilant combined with nab-paclitaxel, and bevacizumab and will begin on Cycle 1 Day 1 (C1D1). Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before, the day of, and the day after nab-paclitaxel infusion (in Cycle 1 relacorilant is only given on 2 consecutive days, starting on C1D1), in combination with nab-paclitaxel (80 mg/m^2 intravenously [IV]) administered on Days 1, 8, and 15 of each 28-day cycle. Bevacizumab (10 mg/kg IV once every 2 weeks [Q2W]) will be administered on Days 1 and 15 of each 28-day cycle. Study treatment for Arm C will be similar to Arm A but does not include bevacizumab. Patients will receive treatment until they reach a protocol-defined event of progressive disease (PD), experience an unmanageable toxicity, or until other treatment discontinuation criteria are met.