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
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
Inclusion Criteria20
- 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
- Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\[L\]1) antibody
- 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 Criteria31
- 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
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(45)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06906341
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