NCT06906341

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-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.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Neoplasms
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Relacorilant 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.
DRUG	Nab-paclitaxel 80 mg/m^2	Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
DRUG	Bevacizumab 10 mg/kg	Bevacizumab is administered as IV infusion on Days 1 and 15.

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-04-02
• Last updated: 2026-04-14

Locations

49 sites across 8 countries: United States, Belgium, France, Germany, Italy, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study