Open-label Extension Study for Participants with Prostate Cancer
Research type
Research Study
Full title
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
IRAS ID
213632
Contact name
Johann de Bono
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2016-001694-32
Duration of Study in the UK
4 years, 1 months, 16 days
Research summary
Enzalutamide is currently approved by the European Medicines Agency for the treatment of men with metastatic castration resistant prostate cancer but it has not been approved for the treatment of other types of prostate cancer. It works by blocking the action of the androgen receptor (AR) which is a cell receptor. Cell receptors are a type of protein that act like locks on the surface of a cell and can cause further chemical reaction inside of a cell. Sometimes in cancer, there are too many of these receptors compared to normal cells or these reactions happen more often than normal and lead to tumour cell growth. Blocking of the androgen receptor has been important in prostate cancer to delay tumours from growing.
This study is a phase 2 open-label extension study for patients with prostate cancer, who previously participated in an Enzalutamide clinical study. Patients that could benefit from continued use of the study drug (as determined by their study doctor) will be provided with continued treatment with enzalutamide and the safety of the treatment will be monitored. Participants will continue to receive the treatment until any of the discontinuation criteria are met.
Approximately 270 participants will take part in this study from North America, Latin America, Europe, Russia, South Africa, and Asia Pacific.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/0017
Date of REC Opinion
7 Mar 2017
REC opinion
Further Information Favourable Opinion