Status:
COMPLETED
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
Sanofi
Conditions:
Primary Peritoneal Cancer
Advanced Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00677079
Start Date
June 1 2008
End Date
December 1 2008
Last Update
October 1 2013
Active Locations (1)
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1
New York, New York, United States, 10021