NCT03776812

Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, randomized, 3-arm study to evaluate progression-free survival (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer treated with intermittent or continuous regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.

Detailed description

Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy of relacorilant either administered daily (continuous) or on the day prior, the day of, and the day after chemotherapy (intermittent) in combination with nab-paclitaxel in the treatment of platinum-resistant ovarian, fallopian tube, or primary peritoneal cancers compared with nab-paclitaxel alone. The safety, pharmacokinetics (PK), and pharmacodynamic profile of relacorilant in combination with nab-paclitaxel will also be assessed. Eligible patients will be randomized 1:1:1 to one of the following three treatment arms. Patient randomization will be stratified by treatment-free interval from most recent taxane (relapsed within 6 months vs \>6 months) and presence of ascites (yes vs no). * Arm A (Continuous relacorilant): Relacorilant starting at 100 mg, administered orally, once daily every day in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. * Arm B (Intermittent relacorilant): Relacorilant 150 mg, administered orally, on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. * Arm C (Comparator): Nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. Patients will remain on study treatment until reaching a protocol-defined event of disease progression (PD), experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for progression, subsequent therapies, and survival in the long-term follow-up phase. Patients in Arm C who experience unequivocal PD per RECIST v1.1 will be given the opportunity to receive relacorilant in combination with nab-paclitaxel after discussion with the Medical Monitor (Crossover patients).

Conditions

• Recurrent Ovarian Cancer
• Recurrent Fallopian Tube Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant is supplied as capsules for oral dosing.
DRUG	Nab-paclitaxel	Nab-paclitaxel is administered as IV infusion over 30-40 minutes.

Timeline

• Start date: 2019-04-05
• Primary completion: 2021-03-16
• Completion: 2023-07-12
• First posted: 2018-12-17
• Last updated: 2025-10-07
• Results posted: 2025-04-30

Locations

24 sites across 5 countries: United States, Belgium, Canada, Italy, Spain

Regulatory

• FDA-regulated drug study