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

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.