Pamiparib in metastatic castration-resistant prostate cancer
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm Study of Pamiparib (BGB-290) for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Deficiency (HRD)
IRAS ID
258565
Contact name
Elias Pintus
Contact email
Sponsor organisation
BeiGene, Ltd.
Eudract number
2018-002587-28
Duration of Study in the UK
2 years, 0 months, 15 days
Research summary
Prostate cancer is the second most common cancer in men worldwide, with an estimated 366,000 deaths worldwide. For many men with prostate cancer, treatment is not immediately necessary. However if the disease is diagnosed at a later stage and the cancer has spread to other parts of the body (metastatic cancer) then treatment is focused on prolonging life and relieving symptoms. Male hormones (androgens) stimulate prostate cancer cells to grow therefore hormone therapy is used to suppress these hormones. Patients who have evidence that the disease is progressing while being treated with hormone therapy have castration-resistant prostate cancer (CRPC). For the past decade, the first-line treatment for these patients has been taxane-based treatments in combination with prednisone however most patients develop resistance to these treatments and die within 2-3 years. A number of new therapies have been shown to prolong survival in these patients but there still remains a need for additional approaches that can control disease.
Healthy cells have different ways of repairing their DNA, one of which is to use PARP proteins. Pamiparib is a drug that prevents the PARP DNA-repair function which could therefore result in the death of cancer cells.
This study will look at the effects of pamiparib on the body when it is given to patients with mCRPC who have a DNA repair defect.
Participants will take pamiparib orally daily at home for as long as there is no worsening of the disease or intolerable side effects. Participants will visit their hospital throughout the study for tests and assessments to be performed (eg. physical examination, blood tests, ECGs, scans and questionnaires).
Approximately 100 male patients with mCRPC will take part in this study worldwide.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1001
Date of REC Opinion
30 Aug 2019
REC opinion
Further Information Favourable Opinion