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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Body weight adjusted dose 1 hour intravenous infusion
Unnamed facility
New York, New York, United States
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.
Time frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
Time frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Clinical benefit rate
Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.
Time frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Progression-Free Survival
Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first. In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.
Time frame: until death or study end
Overall Survival
Overall Survival was defined as the time interval from study entry until death due to any cause. In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.
Time frame: until death or study end
Cancer antigen 125 response (participants with elevated CA125)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.
Time frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
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