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.

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.