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

NCT05257408 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2025-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Ovarian Neoplasm
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Interventions

DRUG

Nab-paclitaxel 80 mg/m^2

Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.

DRUG

Relacorilant 150 mg once daily (QD)

Relacorilant is administered as capsules for oral dosing.

DRUG

Nab-paclitaxel 100 mg/m^2

Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sachin Pai, MD · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2025-03-24
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257408 on ClinicalTrials.gov