This is a single institution, single arm study of BSI-201 in patients with advanced BRCA-1
or BRCA-2 associated epithelial ovarian, fallopian tube, or primary peritoneal cancer.
BSI-201 is a small molecule inhibitor of poly ADP-ribose polymerase-1 (PARP-1). The goal of
this study is to determine if BSI-201 is efficacious in this patient population. Eligible
patients will have received initial treatment with platinum/taxane combination therapy and
have no curative options as determined by their physician. There will be no limit on the
number of prior therapies. A maximum of 35 patients will be treated in this study using a
Simon two-stage optimal design.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess
characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been
fully elucidated, however based on experiments on tumor cells performed in the laboratory,
iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of
DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell
lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell
lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
- Female, age 18 or older.
- Histologically or cytologically confirmed advanced epithelial ovarian cancer,
fallopian tube cancer or primary peritoneal cancer (stage III or IV).
- Patients must have received at least one regimen of platinum/taxane therapy.
- Confirmed BRCA1 or BRCA2 status.
- One or more measurable lesions, at least 10mm in longest diameter by spiral CT scan
or 20mm in longest diameter when measured with conventional techniques (palpation,
plain x-ray, CT or MRI).
- Karnofsky performance status ≥70%.
- Estimated life expectancy of at least 16 weeks.
- Normal clinical laboratory values:
- Any anti-cancer therapy within 21 days prior to day 1.
- Any other malignancy within 3 years of day 1, 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.