Janssen 67652000PCR1001 Phase I-Nira FDC
Research type
Research Study
Full title
An open-label, randomized study to assess the relative bioavailability (BA) and bioequivalence (BE) of fixed-dose combination (FDC) formulations of niraparib plus abiraterone acetate (AA) compared to niraparib and AA co-administered as single agents in men with prostate cancer
IRAS ID
286668
Contact name
Robert Chandler
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-000137-39
Duration of Study in the UK
3 years, 7 months, 15 days
Research summary
15% to 20% of men affected by metastatic castration-resistant prostate cancer (mCRPC) showed abnormalities in mechanisms involved in DNA-repair. \nNiraparib is used to treat cancers where DNA-repair events are present. The compound is used to treat prostate cancer, ovarian cancer, some types of breast cancer and non-small lung cancer. Abiraterone acetate known as Zytiga® is a molecule that blocks the production of androgens. Androgens are hormones produced by the testis, adrenal glands and ovaries. Androgens are known as “male hormones” as mostly synthesized by the testis and play a role in prostate cancer since they are stimulating prostate cancer cells to grow. Abiraterone acetate inhibits the androgens production ad interferes with the prostate tumor growth. \nThere is early evidence that the combination of Niraparib and abiraterone may be more effective than either drug given in isolation.\nThese patients are taking the two drugs as single agents; taking pills of Niraparib and pills of abiraterone acetate. The Sponsor would like to run this study testing a new formulation where Niraparib and abiraterone acetate are made in the same tablet reducing the pill burden for patients taking these two medications. Sponsor defined this tablet of Niraparib and abiraterone acetate as Fixed Dose Combination (FDC) and would like to test the efficacy and safety of this tablet compared to patients taking Niraparib and abiraterone acetate as single pill. If the study will be successful and the new formulation of Niraparib and abiraterone acetate in the same tablet will be able to support the same response of the two drugs taken as single tablet, then the new therapy can be adopted by patients with mCRPC with a reduction of 6 pills to be taken per day.\nThis will help patients in being compliant and will reduce the stress of taking several pills during the day.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0335
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion