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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Corcept Therapeutics
Study ID
NCT03776812
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 17, 2018
Start date
Apr 5, 2019
Status verified
Apr 2025
Primary completion
Mar 16, 2021
Completion
Jul 12, 2023

Study Design

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

Arms

  • Experimental: Arm A: Continuous Relacorilant Dosing
    Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
  • Experimental: Arm B: Intermittent Relacorilant Dosing
    Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
  • Active Comparator: Arm C: Nab-paclitaxel Comparator
    Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Baseline and up to 15 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator #004BirminghamAlabama35249-
Site Reference ID/Investigator #038ScottsdaleArizona85258-
Site Reference ID/Investigator #032DenverColorado80045-
Site Reference ID/Investigator #001ChicagoIllinois60637-
Site Reference ID/Investigator #106BostonMassachusetts02215-
Site Reference ID/Investigator #128BostonMassachusetts02215-
Site Reference ID/Investigator #051New YorkNew York10065-
Site Reference ID/Investigator #169New YorkNew York10065-
Site Reference ID/Investigator #170New YorkNew York10065-
Site Reference ID/Investigator #127PittsburghPennsylvania15213-
Site Reference ID/Investigator #135CharlottesvilleVirginia22908-
Site Reference ID/Investigator #121MilwaukeeWisconsin53226-

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