Trial Profile
A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 06 Apr 2018
At a glance
- Drugs Rucaparib (Primary)
- Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Focus Registrational; Therapeutic Use
- Acronyms ARIEL2
- Sponsors Clovis Oncology
- 06 Apr 2018 Results published in the Media Release
- 23 Mar 2018 Accoprding to a Clovis Oncology media release, formal approval from the European Commission is anticipated in second quarter 2018.
- 23 Mar 2018 Accoprding to a Clovis Oncology media release, CHMP adopted a positive opinion recommending the granting of a conditional marketing authorisation for rucaparib as a monotherapy for adult patients with platinum sensitive, relapsed or progressive, BRCA-mutant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.