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)
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.
Arms & 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.
Outcome measures
Primary
Progression-Free Survival (PFS)
To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.
Time frame: Date of first dose until PD or death, up to 18 months
Secondary
Objective Response Rate (ORR)
Time frame: Date of first dose until PD or death, up to 18 months
Best Overall Response Rate (BOR)
Time frame: Date of first dose until PD or death, up to 18 months
Duration of Response (DOR)
Time frame: Time of first objective response until PD or death, up to 18 months
Clinical Benefit Rate (CBR)
Time frame: Week 24
Overall Survival (OS)
Time frame: Date of first dose up to 6, 12, and 18 months
Number of patients with one or more adverse events
Time frame: Date of first dose up to 30 days after last dose
Area under the plasma concentration-time curve (AUC) of relacorilant
Time frame: On Cycle 1 Day 8 (each cycle is 28 days)
Maximum plasma concentration (Cmax) of relacorilant
Time frame: On Cycle1 Day 8 (each cycle is 28 days)
Trough plasma concentrations (Cmin) of relacorilant
Time frame: On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days)
Eligibility criteria
Study locations (16)
004
Birmingham, Alabama, 35233
150
Palo Alto, California, 94304
014
San Francisco, California, 94143
544
Fort Myers, Florida, 33901
335
Miami Beach, Florida, 33140
543
West Palm Beach, Florida, 33041
518
Minneapolis, Minnesota, 55404
334
Kansas City, Missouri, 64132
521
St Louis, Missouri, 63110
292
Albuquerque, New Mexico, 97102
304
Centerville, Ohio, 45459
517
Eugene, Oregon, 97401
127
Pittsburgh, Pennsylvania, 15213
522
Fairfax, Virginia, 22031
300
Norfolk, Virginia, 23502
121
Milwaukee, Wisconsin, 53226