PCR2002 Niraparib Combination Therapies for Prostate Cancer
Research type
Research Study
Full title
A Phase 1b-2 Study of Niraparib and JNJ-63723283 for the Treatment of Metastatic Castration-Resistant Prostate
IRAS ID
239387
Contact name
Johann DeBono
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2017-003552-23
Duration of Study in the UK
2 years, 5 months, 14 days
Research summary
This is a phase 1b/2 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 in combincation with JNJ-63723283 may be a new treatment option for such men.
Niraparib and JNJ-63723283 are new treatments 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 in combination with JNJ-63723283 is useful in the treatment of this cancer, and to study the safety of the combination.
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 and have JNJ-63723283 IV infusion. Follow-up will be conducted by telephone calls every 3 months.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0095
Date of REC Opinion
10 May 2018
REC opinion
Further Information Favourable Opinion