Drug-Drug interaction study with ARN509 and abiraterone
Research type
Research Study
Full title
A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer
IRAS ID
155407
Contact name
Johann de Bono
Contact email
Sponsor organisation
Aragon Pharmaceuticals
Eudract number
2014-001426-14
Research summary
The sponsor of the study is Janssen-Cilag International (NV). The purpose of this study is to determine what the effect of ARN509 (JNJ-56021927) is on the blood levels of Abiraterone in subjects with Metastatic Castration-Resitant Prostate Cancer (mCRPC) during a combination treatment of JNJ-56021927, Abiraterone and prednisone. Further the safety and efficacy of the combination of JNJ-56021927, Abiraterone and Prednisone is studied.
Patients will only be able to participate if they meet the study specific criteria.
The study is global and is running in the USA, Canada, the Netherlands and UK. In the UK the study is running at one site: the Royal Marsden.
Each patient recruited in the study will be taling part as long as it is benificial to the patients. The study is open-label which means both the study docter and the patient will be aware of the medication they are receiving each time they are dosed. Each patient will receive 1000 mg Abiraterone daily and 5 mg prednisone twice daily from Cycle 1 Day 1 onwards. From Cycle 1, Day 8 onwards they will also receive 240 mg JNJ-56021927 daily.REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1163
Date of REC Opinion
6 Aug 2014
REC opinion
Further Information Favourable Opinion