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Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
NCT06906341 · Corcept Therapeutics
In plain English
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Official title
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)
About this study
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
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
Enrollment target: 270 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-11
Estimated completion: 2026-12
Last updated: 2026-04-14
Interventions
Drug: Relacorilant 150 mg once daily (QD)Drug: Nab-paclitaxel 80 mg/m^2Drug: Bevacizumab 10 mg/kg
Primary outcomes
- • Progression-Free Survival (PFS) (Date of first dose until PD or death, up to 18 months)
Sponsor
Corcept Therapeutics · industry
Contacts & investigators
ContactCorcept Therapeutics · contact · corceptstudy557@corcept.com · 650-684-0171
InvestigatorSachin Pai, MD, MS · study_director, Corcept Therapeutics
All locations (49)
004Recruiting
Birmingham, Alabama, United States
150Recruiting
Palo Alto, California, United States
014Recruiting
San Francisco, California, United States
544Recruiting
Fort Myers, Florida, United States
335Recruiting
Miami Beach, Florida, United States
543Recruiting
West Palm Beach, Florida, United States
518Recruiting
Minneapolis, Minnesota, United States
334Recruiting
Kansas City, Missouri, United States
521Recruiting
St Louis, Missouri, United States
292Recruiting
Albuquerque, New Mexico, United States
304Recruiting
Centerville, Ohio, United States
517Recruiting
Eugene, Oregon, United States
127Recruiting
Pittsburgh, Pennsylvania, United States
522Recruiting
Fairfax, Virginia, United States
300Recruiting
Norfolk, Virginia, United States
121Recruiting
Milwaukee, Wisconsin, United States
328Recruiting
Aalst, Belgium
326Recruiting
Charleroi, Belgium
325Recruiting
Hasselt, Belgium
108Recruiting
Leuven, Belgium
306Recruiting
Lille, France
307Recruiting
Nancy, France
310Recruiting
Nice, France
324Recruiting
Pierre-Bénite, France
323Recruiting
Plérin, France
308Recruiting
Toulouse, France
519Recruiting
Aachen, Germany
255Recruiting
Berlin, Germany
520Recruiting
Kempten, Germany
321Recruiting
Catania, Italy
122Recruiting
Milan, Italy
516Recruiting
Milan, Italy
295Recruiting
Pavia, Italy
124Recruiting
Rome, Italy
293Recruiting
Torino, Italy
319Recruiting
Treviso, Italy
341Recruiting
Gdynia, Poland
329Recruiting
Siedlce, Poland
396Recruiting
Seoul, Gangnam-gu, South Korea
397Recruiting
Gyeonggi-do, Goyang-si, South Korea
399Recruiting
Seoul, Jongno-gu, South Korea
523Recruiting
Seoul, Seocho-gu, South Korea
398Recruiting
Seoul, Seodaemun-gu, South Korea
403Recruiting
Seoul, Songpa-gu, South Korea
349Recruiting
Badalona, Spain
115Recruiting
Barcelona, Spain
114Recruiting
Madrid, Spain
558Recruiting
Valencia, Spain
330Recruiting
Valencia, Spain