Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05257408 | Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 381 | — | — | Jun 29, 2022 | Mar 1, 2026 | Apr 16, 2025 | 117 | United States, Argentina +12 |
Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first
Time from randomization to death by any cause
| Arm | Type | Description |
|---|---|---|
| Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg | EXPERIMENTAL | Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1. |
| Nab-paclitaxel 100 mg/m^2 | ACTIVE_COMPARATOR | Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Nab-paclitaxel 80 mg/m^2 | DRUG | Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle. |
| Relacorilant 150 mg once daily (QD) | DRUG | Relacorilant is administered as capsules for oral dosing. |
| Nab-paclitaxel 100 mg/m^2 | DRUG | Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle. |
Inclusion Criteria: * Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures. * Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carc...