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NCT06906341PHASE2Recruiting

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

Corcept Therapeutics

Start Date

4/11/2025

Completion Date

12/1/2026

Summary

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Relacorilant 150 mg once daily (QD)

DRUG

Nab-paclitaxel 80 mg/m^2

DRUG

Bevacizumab 10 mg/kg

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Conditions

Ovarian CancerFallopian Tube CancerPeritoneal NeoplasmsEndometrial Cancer

Locations

004

Birmingham, Alabama 35233

United States

150

Palo Alto, California 94304

United States

014

San Francisco, California 94143

United States

544

Fort Myers, Florida 33901

United States

335

Miami Beach, Florida 33140

United States

543

West Palm Beach, Florida 33041

United States

518

Minneapolis, Minnesota 55404

United States

334

Kansas City, Missouri 64132

United States

521

St Louis, Missouri 63110

United States

292

Albuquerque, New Mexico 97102

United States

304

Centerville, Ohio 45459

United States

517

Eugene, Oregon 97401

United States

127

Pittsburgh, Pennsylvania 15213

United States

522

Fairfax, Virginia 22031

United States

300

Norfolk, Virginia 23502

United States

121

Milwaukee, Wisconsin 53226

United States

328

Aalst, Belgium 9300

Belgium

326

Charleroi, 6000

Belgium

325

Hasselt, 3500

Belgium

108

Leuven, 3000

Belgium

306

Lille, 59000

France

307

Nancy, 54100

France

310

Nice, 06100

France

324

Pierre-Bénite, 69495

France

323

Plérin, 22190

France

308

Toulouse, 31059

France

519

Aachen, 52074

Germany

255

Berlin, 10117

Germany

520

Kempten, 87439

Germany

321

Catania, 95126

Italy

122

Milan, 20141

Italy

516

Milan, 20159

Italy

295

Pavia, 27100

Italy

124

Rome, 00168

Italy

293

Torino, 10128

Italy

319

Treviso, 31100

Italy

341

Gdynia, 81-519

Poland

329

Siedlce, 08-MO

Poland

396

Seoul, Gangnam-gu 06351

South Korea

397

Gyeonggi-do, Goyang-si 10408

South Korea

399

Seoul, Jongno-gu 03080

South Korea

523

Seoul, Seocho-gu 06591

South Korea

398

Seoul, Seodaemun-gu 03722

South Korea

403

Seoul, Songpa-gu 05505

South Korea

349

Badalona, 08916

Spain

115

Barcelona, 08035

Spain

114

Madrid, 28034

Spain

558

Valencia, 46010

Spain

330

Valencia, 46026

Spain