RecruitingPhase 2NCT06906341

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

An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)

Sponsor

Corcept Therapeutics

Enrollment

270 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Endometrial Cancer Fallopian Tube Cancer Peritoneal Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing relacorilant — a drug that blocks the stress hormone cortisol — in combination with standard chemotherapy or targeted therapy for women with recurrent gynecological cancers (ovarian, fallopian tube, peritoneal, or endometrial cancer). **You may be eligible if...** - You have been diagnosed with epithelial ovarian, primary peritoneal, or fallopian tube cancer, OR stage III/IV or recurrent endometrial cancer - You have had 1 to 3 prior lines of cancer treatment - Your cancer either stopped responding to platinum chemotherapy (platinum-resistant) or progressed while on a PARP inhibitor (platinum-sensitive), or you have recurrent endometrial cancer - Your overall health is good (ECOG 0–1) and you can swallow oral medications - You are expected to live at least 3 more months **You may NOT be eligible if...** - You have had more than 3 prior lines of treatment - You have serious organ problems or uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelacorilant 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.

DRUGNab-paclitaxel 80 mg/m^2

Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

DRUGBevacizumab 10 mg/kg

Bevacizumab is administered as IV infusion on Days 1 and 15.

Locations(49)

004

Birmingham, Alabama, United States

150

Palo Alto, California, United States

014

San Francisco, California, United States

544

Fort Myers, Florida, United States

335

Miami Beach, Florida, United States

543

West Palm Beach, Florida, United States

518

Minneapolis, Minnesota, United States

334

Kansas City, Missouri, United States

521

St Louis, Missouri, United States

292

Albuquerque, New Mexico, United States

304

Centerville, Ohio, United States

517

Eugene, Oregon, United States

127

Pittsburgh, Pennsylvania, United States

522

Fairfax, Virginia, United States

300

Norfolk, Virginia, United States

121

Milwaukee, Wisconsin, United States

328

Aalst, Belgium

326

Charleroi, Belgium

325

Hasselt, Belgium

108

Leuven, Belgium

306

Lille, France

307

Nancy, France

310

Nice, France

324

Pierre-Bénite, France

323

Plérin, France

308

Toulouse, France

519

Aachen, Germany

255

Berlin, Germany

520

Kempten, Germany

321

Catania, Italy

122

Milan, Italy

516

Milan, Italy

295

Pavia, Italy

124

Rome, Italy

293

Torino, Italy

319

Treviso, Italy

341

Gdynia, Poland

329

Siedlce, Poland

396

Seoul, Gangnam-gu, South Korea

397

Gyeonggi-do, Goyang-si, South Korea

399

Seoul, Jongno-gu, South Korea

523

Seoul, Seocho-gu, South Korea

398

Seoul, Seodaemun-gu, South Korea

403

Seoul, Songpa-gu, South Korea

349

Badalona, Spain

115

Barcelona, Spain

114

Madrid, Spain

558

Valencia, Spain

330

Valencia, Spain

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NCT06906341

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