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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relacorilant 150 mg once daily (QD) — DRUG
    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 80 mg/m^2 — DRUG
    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Bevacizumab 10 mg/kg — DRUG
    Bevacizumab 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 Bevacizumab
    In 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 Bevacizumab
    In 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-Paclitaxel
    In 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

Locations (16)

FacilityCityStateZIPSite coordinators
004BirminghamAlabama35233-
150Palo AltoCalifornia94304-
014San FranciscoCalifornia94143-
544Fort MyersFlorida33901-
335Miami BeachFlorida33140-
543West Palm BeachFlorida33041-
518MinneapolisMinnesota55404-
334Kansas CityMissouri64132-
521St LouisMissouri63110-
292AlbuquerqueNew Mexico97102-
304CentervilleOhio45459-
517EugeneOregon97401-
127PittsburghPennsylvania15213-
522FairfaxVirginia22031-
300NorfolkVirginia23502-
121MilwaukeeWisconsin53226-

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