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

RecruitingPhase 2

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)

Who can join

Ages 18 and older · Women

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Corcept Therapeutics · Participants: 270 · Started: Apr 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06906341

Locations in the U.S.

Alabama004, Birmingham
California150, Palo Alto
014, San Francisco
Florida544, Fort Myers
335, Miami Beach
543, West Palm Beach
Minnesota518, Minneapolis
Missouri334, Kansas City
521, St Louis
New Mexico292, Albuquerque
Ohio304, Centerville
Oregon517, Eugene
Pennsylvania127, Pittsburgh
Virginia522, Fairfax
300, Norfolk
Wisconsin121, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.