Primary Peritoneal Cancer Clinical Trial
Official title:
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.
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
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