Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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.