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A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2008-06 |
| Completion | 2008-12 |
Conditions
- Primary Peritoneal Cancer
- Advanced Epithelial Ovarian Cancer
Interventions
- Iniparib
Primary outcomes
- Best overall response — until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. - Objective response rate — until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
Countries
United States