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)
Corcept Therapeutics
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 A…
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)
- 004Birmingham, Alabama
- 150Palo Alto, California
- 014San Francisco, California
- 544Fort Myers, Florida
- 335Miami Beach, Florida
- 543West Palm Beach, Florida