Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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)

Details

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.

Keywords

Ovarian Neoplasm, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasms, Ovarian Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, Nab-paclitaxel 80 mg/m^2, Relacorilant 150 mg once daily (QD), Nab-paclitaxel 100 mg/m^2

Eligibility

Locations

  • Site 014
    San Francisco California 94143 United States
  • Site 278
    San Francisco California 94109 United States
  • Site 150
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corcept Therapeutics
ID
NCT05257408
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 381 people participating
Last Updated