Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT05257408
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Neoplasms
  • Ovarian Neoplasm
  • Peritoneal Neoplasms

Eligibility Criteria

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

Interventions

  • 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.

Study Details

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Key Dates

First listed
Feb 25, 2022
Start date
Jun 29, 2022
Status verified
Apr 2025
Primary completion
Mar 24, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
381 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
    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.
  • Active Comparator: Nab-paclitaxel 100 mg/m^2
    Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.

Primary Outcome Measure

Progression-free Survival as Assessed by BICR [ Time Frame: Up to 24 months from enrollment of the last patient ]

Locations (44)

FacilityCityStateZIPSite coordinators
Site 318PhoenixArizona85016-
Site 277TucsonArizona85719-
Site 350IrvineCalifornia92618-
Site 364La JollaCalifornia92093-
Site 150Palo AltoCalifornia94304-
Site 014San FranciscoCalifornia94143-
Site 278San FranciscoCalifornia94109-
Site 316SolvangCalifornia93463-
Site 032AuroraColorado80045-
Site 335Miami BeachFlorida33140-
Site 042WestonFlorida33331-
Site 009AtlantaGeorgia30322-
Site 272AtlantaGeorgia30342-
Site 372GainesvilleGeorgia30548-
Site 291SavannahGeorgia31405-
Site 315EvanstonIllinois60201-
Site 314HinsdaleIllinois60521-
Site 346UrbanaIllinois61801-
Site 339IndianapolisIndiana46260-
Site 200Overland ParkKansas66211-
Site 334Overland ParkKansas66211-
Site 279LouisvilleKentucky40241-
Site 128BostonMassachusetts02114-
Site 288New BrunswickNew Jersey08901-
Site 292AlbuquerqueNew Mexico87131-
Site 275FlushingNew York11355-
Site 298CincinnatiOhio45242-
Site 304CincinnatiOhio45459-
Site 049PortlandOregon97239-
Site 280PortlandOregon97210-
Site 317PortlandOregon97213-
Site 337BethlehemPennsylvania18015-
Site 127PittsburghPennsylvania15213-
Site 276Rapid CitySouth Dakota57701-
Site 368GermantownTennessee38138-
Site 281NashvilleTennessee37203-
Site 229AustinTexas78731-
Site 312BedfordTexas76022-
Site 297Fort WorthTexas76104-
Site 392San AntonioTexas78240-
Site 301The WoodlandsTexas77380-
Site 300NorfolkVirginia23502-
Site 365RichmondVirginia23298-
Site 121MilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Site 318· Phoenix, AZSite 277· Tucson, AZSite 350· Irvine, CASite 364· La Jolla, CASite 150· Palo Alto, CASite 014· San Francisco, CA

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