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

NCT06906341 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CORT125134-557
• Study Type: interventional
• Target: 270
• Locations: 8 countries
• Sites: 49

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms; Endometrial Cancer

Keywords

Genital Neoplasms, Female; Neoplasms by Site; Fallopian Tube Diseases; Ovarian Diseases; Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Paclitaxel; Albumin-Bound Paclitaxel; Ovarian; Peritoneal or Advanced Fallopian Tube Cancer; High Grade; Platinum Resistant; Relacorilant; Bella; Nab-paclitaxel; Bevacizumab; Endometrial Neoplasm; Endometrial

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.

  Date of first dose until PD or death, up to 18 months

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Date of first dose until PD or death, up to 18 months

• Best Overall Response Rate (BOR)

  Date of first dose until PD or death, up to 18 months

• Duration of Response (DOR)

  Time of first objective response until PD or death, up to 18 months

• Clinical Benefit Rate (CBR)

  Week 24

• Overall Survival (OS)

  Date of first dose up to 6, 12, and 18 months

Study Arms (3)

Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab

EXPERIMENTAL

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); Drug: Nab-paclitaxel 80 mg/m^2; Drug: Bevacizumab 10 mg/kg

Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab

EXPERIMENTAL

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); Drug: Nab-paclitaxel 80 mg/m^2; Drug: Bevacizumab 10 mg/kg

Arm C: Relacorilant in Combination with Nab-Paclitaxel

EXPERIMENTAL

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); Drug: Nab-paclitaxel 80 mg/m^2

Interventions

Relacorilant 150 mg once daily (QD) DRUG

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.

Also known as: CORT125134

Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab; Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab; Arm C: Relacorilant in Combination with Nab-Paclitaxel

Nab-paclitaxel 80 mg/m^2 DRUG

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

Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab; Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab; Arm C: Relacorilant in Combination with Nab-Paclitaxel

Bevacizumab 10 mg/kg DRUG

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

Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab; Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (49)

004

Birmingham, Alabama, 35233, United States

RECRUITING

150

Palo Alto, California, 94304, United States

RECRUITING

014

San Francisco, California, 94143, United States

RECRUITING

544

Fort Myers, Florida, 33901, United States

RECRUITING

335

Miami Beach, Florida, 33140, United States

RECRUITING

543

West Palm Beach, Florida, 33041, United States

RECRUITING

518

Minneapolis, Minnesota, 55404, United States

RECRUITING

334

Kansas City, Missouri, 64132, United States

RECRUITING

521

St Louis, Missouri, 63110, United States

RECRUITING

292

Albuquerque, New Mexico, 97102, United States

RECRUITING

304

Centerville, Ohio, 45459, United States

RECRUITING

517

Eugene, Oregon, 97401, United States

RECRUITING

127

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

522

Fairfax, Virginia, 22031, United States

RECRUITING

300

Norfolk, Virginia, 23502, United States

RECRUITING

121

Milwaukee, Wisconsin, 53226, United States

RECRUITING

328

Aalst, 9300, Belgium

RECRUITING

326

Charleroi, 6000, Belgium

RECRUITING

325

Hasselt, 3500, Belgium

RECRUITING

108

Leuven, 3000, Belgium

RECRUITING

306

Lille, 59000, France

RECRUITING

307

Nancy, 54100, France

RECRUITING

310

Nice, 06100, France

RECRUITING

324

Pierre-Bénite, 69495, France

RECRUITING

323

Plérin, 22190, France

RECRUITING

308

Toulouse, 31059, France

RECRUITING

519

Aachen, 52074, Germany

RECRUITING

255

Berlin, 10117, Germany

RECRUITING

520

Kempten, 87439, Germany

RECRUITING

321

Catania, 95126, Italy

RECRUITING

122

Milan, 20141, Italy

RECRUITING

516

Milan, 20159, Italy

RECRUITING

295

Pavia, 27100, Italy

RECRUITING

124

Rome, 00168, Italy

RECRUITING

293

Torino, 10128, Italy

RECRUITING

319

Treviso, 31100, Italy

RECRUITING

341

Gdynia, 81-519, Poland

RECRUITING

329

Siedlce, 08-MO, Poland

RECRUITING

396

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

397

Gyeonggi-do, Goyang-si, 10408, South Korea

RECRUITING

399

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

523

Seoul, Seocho-gu, 06591, South Korea

RECRUITING

398

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

403

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

349

Badalona, 08916, Spain

RECRUITING

115

Barcelona, 08035, Spain

RECRUITING

114

Madrid, 28034, Spain

RECRUITING

558

Valencia, 46010, Spain

RECRUITING

330

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Endometrial Neoplasms; Genital Neoplasms, Female; Neoplasms by Site; Fallopian Tube Diseases; Ovarian Diseases; Neoplasms

Interventions

relacorilant; 130-nm albumin-bound paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Uterine Neoplasms; Uterine Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sachin Pai, MD, MS

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Corcept Therapeutics

CONTACT

650-684-0171; corceptstudy557@corcept.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 2, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); KR (6); PL (2); US (16); IT (7); DE (3); FR (6); ES (5)