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
Participants were treated for at least one 8-week cycle, with additional cycles as long as
they had stable or responding disease (per RECIST criteria) and wished to remain on study.
Participants had a final follow-up visit within 4 weeks following the last dose of iniparib,
after which time they were contacted by study staff every 3 months for the first year and
every 6 months thereafter to assess disease status and survival.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best overall response
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.
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Clinical Sciences & Operations
United States: Food and Drug Administration
|Albany, New York 12208|