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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
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.
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab is administered as IV infusion on Days 1 and 15.
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
Objective Response Rate (ORR)
To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1.
Time frame: Date of first dose until PD or death, up to 18 months
Best Overall Response Rate (BOR)
To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death
Time frame: Date of first dose until PD or death, up to 18 months
Duration of Response (DOR)
To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first.
Time frame: Time of first objective response until PD or death, up to 18 months
Clinical Benefit Rate (CBR)
To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1.
Time frame: Week 24
Overall Survival (OS)
To evaluate the probability of OS survival at 6, 12, and 18 months.
Time frame: Date of first dose up to 6, 12, and 18 months
Number of patients with one or more adverse events
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150
Palo Alto, California, United States
RECRUITING014
San Francisco, California, United States
RECRUITING544
Fort Myers, Florida, United States
RECRUITING543
West Palm Beach, Florida, United States
RECRUITING518
Minneapolis, Minnesota, United States
RECRUITING334
Kansas City, Missouri, United States
RECRUITING521
St Louis, Missouri, United States
RECRUITING292
Albuquerque, New Mexico, United States
RECRUITING304
Centerville, Ohio, United States
RECRUITING517
Eugene, Oregon, United States
RECRUITING...and 35 more locations
Time frame: Date of first dose up to 30 days after last dose