A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
Active, no longer recruiting
Phase of Trial: Phase I/II
Latest Information Update: 23 Mar 2018
At a glance
- Drugs Rucaparib (Primary)
- Indications Advanced breast cancer; Carcinoma; Fallopian tube cancer; Lymphoma; Ovarian cancer; Peritoneal cancer; Solid tumours
- Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
- Acronyms Study 10
- Sponsors Clovis Oncology
- 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.
- 21 Feb 2018 According to a Clovis Oncology media release, based on data from two studies (Study 10 and ARIEL2), the CHMP application was submitted during the fourth quarter of 2016 and is currently under review.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History