A Phase 2 study of Enzalutamide in Advanced Hepatocellular
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects with Advanced Hepatocellular Carcinoma
IRAS ID
184963
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2014-004283-37
Duration of Study in the UK
2 years, 4 months, 2 days
Research summary
The purpose is to see if enzalutamide is effective in prolonging survival in patients with Hepatocellular carcinoma (HCC), who already received sorafenib or anti-VEGF medicine, but their disease has progressed. Approximately 144 patients will take part in this study; from Europe, Asia and North America.
Enzalutamide blocks the action of the androgen receptor (AR). Androgen receptor is often found in HCC. Studies done on liver cancer cells show that drugs that block androgen receptor slow tumour cell growth. The study will consist of a Screening, Treatment and a Follow-up period. The screening period occurs within 21 days prior to patients starting study drug. Patients are randomly assigned to two treatment groups, enzalutamide vs placebo, there is a two in three chance that patients will receive enzalutamide. For the first month on study drug, patients will be asked to return to the clinic every 2 weeks then after that it will be every 4 weeks until end of treatment. Throughout the treatment period, procedures will be performed to find out if patients are eligible to remain on the study, to see how their disease is responding to treatment and whether they have any side effects. Within 7 days after patients discontinue study medication, they will have an end of treatment visit. A 30 day follow-up visit will be performed to find out if patients experienced any side effects. After the follow-up visit, patients will enter the long-term follow-up period where study staff will contact patients about every 30 days up to 2 years to ask questions about current treatments and medications. The study will last approximately 2 years.
Patients will receive a dose of 160 mg of Enzalutamide each day. Tests will be conducted by the doctor during this time to monitor health.A pharmaceutical company is funding this research.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0671
Date of REC Opinion
23 Sep 2015
REC opinion
Further Information Favourable Opinion