673-203 HRD Study, Amendment 3, 10-August-2015
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label, Exploratory Biomarker Study of Talazoparib (BMN 673) Monotherapy in Patients with Recurrent or Metastatic Solid Tumors
IRAS ID
179493
Contact name
Marjorie Tano
Contact email
Sponsor organisation
BioMarin Pharmaceutical Inc.
Eudract number
2014-004011-37
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of the HRD test is to work out whether your cancer might be sensitive to the study drug. Some tumour cells cannot repair certain types of damage to their DNA, but these cells can continue to live. One way that cells can repair their DNA is by homologous recombination. Cancer that cannot repair their DNA with homologous recombination may be sensitive to the study drug talazoparib. Talazoparib may kill tumour cells that may not have a working homologous recombination repair pathway, but have little effect on normal cells in the body. The study drug comes from a group of drugs know as PARP inhibitors. The HRD test, or homologous recombination deficiency test, is one way to see if your cancer cannot repair DNA, and therefore is sensitive to the study drug. If the HRD test is positive you may be eligible for the study. The HRD test is limited to investigational use as specified by country regulations.
The primary endpoint is to evaluate objective tumour response to talazoparib treatment. The study will assess if there is an association between HRD score and tumor response and to identify an HRD score range that correlates with high response rate. Approximately 600 patients with breast cancer and 300 patients with epithelial ovarian cancer will be screened to obtain approximately 50 patients per tumour type.REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1422
Date of REC Opinion
23 Nov 2015
REC opinion
Further Information Favourable Opinion