Open label Phase 1b Qt/QTc study of ARN-509 in CR Prostate Cancer
Research type
Research Study
Full title
An Open-label Phase 1b QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Castration-Resistant Prostate Cancer.
IRAS ID
191886
Contact name
Prof. Johann de Bono
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2015-004044-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
The purpose of this study is to evaluate the effect of a single dose of JNJ-56021927 on the heart’s electrical activity and to see how the body processes the study drug in subjects with Castration-Resistant Prostate Cancer.
This is an open-label Phase 1b QT/QTc Study of JNJ-56021927 (ARN-509) in Subjects With Castration- Resistant Prostate Cancer. This study will investigate the effect of JNJ-56021927 on ventricular repolarization and other electrocardiogram (ECG) parameters at a dose level of 240 mg daily in men with castration-resistant prostate cancer. It will also evaluate the pharmacokinetics profile of JNJ-56021927, determine a potential relationship between plasma concentrations of JNJ-56021927 and QT interval, and evaluate the safety of JNJ-56021927.
Approximately 42 male subjects ≥18 years of age with non-metastatic CRPC (NM-CRPC) or metastatic CRPC (mCRPC) will be enrolled to ensure that at least 38 subjects complete the study. The study will consist of a 28-day Screening Phase, an open-label Treatment Phase where subjects will be monitored for safety
(including cardiac safety) and pharmacokinetics, and a Follow-up Phase. JNJ-56021927 will be administered orally at a dose level of 240 mg daily in cycles of 28 days. Dose modification is allowed for the management of toxicities.REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1825
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion