Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Corcept Therapeutics
- Study ID
- NCT06906341
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Neoplasms
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Relacorilant 150 mg once daily (QD) — DRUGRelacorilant 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 80 mg/m^2 — DRUGNab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
- Bevacizumab 10 mg/kg — DRUGBevacizumab is administered as IV infusion on Days 1 and 15.
Study Details
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.
Key Dates
- Start date
- Apr 11, 2025
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 270 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Relacorilant in Combination with Nab-paclitaxel and BevacizumabIn Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.
- Experimental: Arm B: Relacorilant in Combination with Nab-Paclitaxel and BevacizumabIn Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab.
- Experimental: Arm C: Relacorilant in Combination with Nab-PaclitaxelIn Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.
Primary Outcome Measure
Progression-Free Survival (PFS) [ Time Frame: Date of first dose until PD or death, up to 18 months ]
Central Contacts
- Corcept Therapeutics650-684-0171
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| 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 | - |
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