Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cancer, Advanced Epithelial Ovarian Cancer
In brief
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 Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
Key facts
- Study ID
- NCT00677079
- Run by
- Sanofi
- People needed
- 12
- Starts
- 2008-06-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2013-10-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — New York, New York, United States
Full record on ClinicalTrials.gov
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