NCT05257408

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As there are no currently approved therapies or effective standard of care for heavily pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy and/or bevacizumab, the combination of intermittently administered relacorilant and nab-paclitaxel may demonstrate a substantial improvement without increased toxicity compared with nab-paclitaxel. Patients will receive study treatment until confirmed progressive disease (PD) or unacceptable toxicity. All patients will be followed for the collection of study endpoints, inclusive of disease progression and survival.

Conditions

• Ovarian Neoplasm
• Fallopian Tube Neoplasms
• Peritoneal Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-29
• Primary completion: 2025-03-24
• Completion: 2026-03-01
• First posted: 2022-02-25
• Last updated: 2025-04-16

Locations

117 sites across 14 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Hungary, Israel, Italy, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study