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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

Phase 2
18 Years
Not Enrolling
Primary Peritoneal Cancer, Advanced Epithelial Ovarian Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best overall response

Outcome Description:

Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.

Outcome Time Frame:

until treatment discontinuation (assessment at the at the end of each 8-week cycle)

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

September 2010

Related Keywords:

  • Primary Peritoneal Cancer
  • Advanced Epithelial Ovarian Cancer
  • BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • BRCA-1
  • BRCA-2
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



Albany, New York  12208