MDV3800-06 Talazoparib in Men with MCRPC
Research type
Research Study
Full title
A Phase 2, Open-Label, 2-Arm, Response Rate Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)
IRAS ID
212853
Contact name
Johann De Bono
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2016-002036-32
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is an international, phase 2, open-label, 2-arm, response rate study of a drug called talazoparib in men with DNA repair defects and metastatic castration-resistant prostate cancer who have previously received Taxane-Based chemotherapy and progressed on at Least 1 novel hormonal agent (Enzalutamide and/or Abiraterone Acetate/Prednisone). "Metastasic” means the cancer has spread to other parts of the body, “Castration resistant” means cancer of the prostate that is getting worse despite receiving therapies that lower the male sex hormone testosterone.
Talazoparib may stop the normal activity of certain specific proteins that are found in all cells, normal and cancerous, and are involved in the repair of DNA - the genetic material found in every cell. These proteins are needed to repair any mistakes that may happen in the DNA when cells divide. Talazoparib interferes with the repair activity of these proteins, which can lead to increased amounts of DNA defects and cell death, including cancer cell death. In clinical trials, the use of talazoparib and other compounds having a similar action have shown that these types of drugs can reduce tumour size and slow tumour growth in some patients who have defects in DNA damage repair proteins.
Approximately 150 patients will be enrolled and assigned to 2 overlapping cohorts of approximately 110 patients each. All participants will receive talazoparib.
Treatment will be in the form of tablets which will be taken daily until radiographic progression of the disease.
The study will comprise of the following periods, pre-screening (optional), screening, treatment, safety follow-up, and long-term follow-up. Safety follow-up after permanent discontinuation of study drug treatment will occur approximately 30 days after the last dose of study drug or before initiation of a new antineoplastic or investigational therapy, whichever occurs first. Long-term follow-up will occur every 12 weeks after safety follow-up.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1779
Date of REC Opinion
15 Nov 2016
REC opinion
Further Information Favourable Opinion