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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)

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Trial Profile

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, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Sep 2025

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At a glance

  • Drugs Paclitaxel (Primary) ; Relacorilant (Primary)
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ROSELLA
  • Sponsors Corcept Therapeutics

Most Recent Events

  • 01 Aug 2025 According to a Corcept Therapeutics media release, submission of European Marketing Authorization Application (MAA) expected this quarter
  • 14 Jul 2025 According to a Corcept Therapeutics media release, the company has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. NDA filing is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials.
  • 02 Jun 2025 According to a Corcept Therapeutics media, data from the study were presented at the ASCO 2025 (American Society of Clinical Oncology) Annual Meeting and The Lancet.

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