HRD, Amendment 1, 17-April-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
0179493
Contact name
Marjorie Tano
Contact email
Sponsor organisation
BioMarin Pharmaceutical Inc.
Eudract number
2014-004011-37
Duration of Study in the UK
3 years, months, days
Research summary
This open-label multicenter, multinational study in subjects at least 18 years old explores the potential for HRD score to identify talazoparib responders with advanced or recurrent solid tumors. This study begins in breast and epithelial ovarian cáncer lacking deleterious or pathogenic germline BRCA mutations, and other tumor types may be added to this protocol pending validation of HRD tests in other indications.
Germline BRCA mutation status and HRD score are required to determine study eligibility.
Patients must have acceptable prior reports documenting germline BRCA mutation status or must undergo prospective BRCA germline testing. Patients with deleterious or pathogenic germline BRCA mutation will not be eligible for study participation. The germline BRCA assay and HRD assay may be performed simultaneously. The HRD score for each potential study subject will be determined in archival resected primary ovarian tumor tissue or archival core breast tumor; fresh core breast tumor tissue may be used if archival tissue is not available. The minimum HRD score for study eligibility and treatment will be 42 for breast cancer and 56 for ovarian cáncer.
Approximately 900 patients (600 with breast cancer and 300 with epithelial ovarian cancer) will be screened. The final number of patients screened will depend on obtaining approximately 100 patients (about 50 per tumor type) who have HRD scores within the protocol-defined ranges, and whose tumor biopsy samples are of sufficient quantity and quality.REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1065
Date of REC Opinion
6 Jul 2015
REC opinion
Unfavourable Opinion