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This single-arm study evaluates the drug Iniparib (BSI-201) in patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer associated with BRCA1 or BRCA2 changes. Women aged 18 and older with confirmed BRCA1 or BRCA2 status who had received at least one prior platinum/taxane-based therapy could take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Female, age 18 or older; * Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV); * At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies); * Confirmed BRCA1 or BRCA2 status; * One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI)); * Karnofsky performance status ≥70%; * Estimated life expectancy of at least 16 weeks. Exclusion Criteria: * Normal clinical laboratory values; * Any anti-cancer therapy within 21 days prior to study start; * Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer; * Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection; * Active central nervous system or brain metastases; * History of seizures or current treatment with anti-epileptic medication; * Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.