Clinical trial NCT00677079: Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Cancer
Advanced Epithelial Ovarian Cancer
Keywords: BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
BRCA-1
BRCA-2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best overall response
timeFrame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
measure: Objective response rate
timeFrame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Secondary outcomes:
measure: Clinical benefit rate
timeFrame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
measure: Progression-Free Survival
timeFrame: until death or study end
measure: Overall Survival
timeFrame: until death or study end
measure: Cancer antigen 125 response (participants with elevated CA125)
timeFrame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Bell-McGuinn KM, Konner JA, Tew WP, Hensley ML, Iasonos A, Charpentier E, Mironov S, Sabbatini P, Aghajanian C. A Phase 2, Single Arm Study of Iniparib in Patients With BRCA1 or BRCA2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Int J Gynecol Cancer. 2016 Feb;26(2):255-60. doi: 10.1097/IGC.0000000000000591.