A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 05 Dec 2017
At a glance
- Drugs Rucaparib (Primary)
- Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Focus Registrational; Therapeutic Use
- Acronyms ARIEL3
- Sponsors Clovis Oncology
- 05 Dec 2017 According to a Clovis Oncology media release, the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018.
- 01 Nov 2017 According to a Clovis Oncology media release, results from this trial will be presented at the 20th Biennial International Meeting of the European Society for Gynaecological Oncology (ESGO20). The Marketing Authorization Application (MAA) for rucaparib to the European Medicines Agency for an ovarian cancer treatment indication is currently under review. Clovis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) in late 2017.
- 01 Nov 2017 According to a Clovis Oncology media release, comprehensive dataset from this trial was presented at the 2017 European Society for Medical Oncology (ESMO) Congress.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History