CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 381 enrolled
Drug / intervention
Nab-paclitaxel 80 mg/m^2 +2 moredrug
Likely dose
Nab-paclitaxel 80 mg/m^2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05257408
NCT05257408Phase 3Active
CompareCT.gov

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

Corcept Therapeutics·interventional·Posted Feb 25, 2022·Updated Apr 16, 2025

In Brief

A Phase 3 clinical trial evaluating Nab-paclitaxel 80 mg/m^2, Relacorilant 150 mg once daily (QD), and 1 other intervention for Ovarian Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 381 participants across 117 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasm, Fallopian Tube Neoplasms, Peritoneal Neoplasms
CountriesArgentina, Australia, Belgium, Brazil, Canada, France, Hungary, Israel, Italy, Poland, South Korea, Spain, United Kingdom, United States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 3ActiveOverdue
2023202420252026
First PostedFeb 25, 2022
Enrollment StartJun 29, 2022
Primary CompletionMar 24, 2025
Study CompletionMar 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.4 years ago

Interventions

Nab-paclitaxel 80 mg/m^2drug

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^2drug

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