Niraparib in men with mCRPC and DNA-repair anomalies
Research type
Research Study
Full title
A phase 2, efficacy and safety study of niraparib in men with metastatic castration-resistant prostate cancer and DNA-repair anomalies
IRAS ID
214004
Contact name
Amit Bahl
Contact email
Sponsor organisation
Janssen Cilag-International NV
Eudract number
2016-002057-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 14 days
Research summary
This is a study in men over the age of 18 with advanced prostate cancer. Specifically, the condition is metastatic castration resistant prostate cancer (mCRPC) with deoxyribonucleic acid (DNA) repair anomalies, meaning prostate cancer that has spread to a part of the body other than the prostate, and which is able to grow despite treatment.
Such advanced prostate cancer is a serious condition, and is currently treated with chemotherapy and hormone therapy. However, some men do not respond to these treatments at the start of treatment, or stop responding whilst receiving treatment. For such men, there are no approved treatment options, and so there is a clear unmet medical need for new treatment options. Niraparib may be a new treatment option for such men.
Niraparib is a new treatment for mCRPC with DNA repair anomalies, which is not approved by any regulatory authority in the world, and so can only be used in a research study. The purpose of the study is to find out if niraparib is useful in the treatment of this cancer, and to study the safety of niraparib.
The study is conducted in 4 phases: pre-screening, screening, treatment and follow-up. Pre-screening is conducted to check whether patients are eligible for participation. To determine this, blood and tumour samples will be used to determine the different substances making up the cancer. Screening will then be conducted to check further conditions to see if patients are eligible for participation, and will be completed within 35 days. Treatment is given in 28 day cycles, and will continue for as long as the treatment continues to help the participant. During treatment, participants will swallow 3x capsules of niraparib per day. Follow-up will be conducted by telephone calls every 3 months.
100 patients will be involved across the world.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0446
Date of REC Opinion
5 Dec 2016
REC opinion
Further Information Favourable Opinion