Back to resultsSingle Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Primary Purpose
Primary Peritoneal Cancer, Advanced Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iniparib
Sponsored by
About this trial
This is an interventional treatment trial for Primary Peritoneal Cancer focused on measuring BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, BRCA-1, BRCA-2
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iniparib
Arm Description
Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles
Outcomes
Primary Outcome Measures
Best overall response
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.
Objective response rate
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
Secondary Outcome Measures
Clinical benefit rate
Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.
Progression-Free Survival
Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first.
In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.
Overall Survival
Overall Survival was defined as the time interval from study entry until death due to any cause.
In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.
Cancer antigen 125 response (participants with elevated CA125)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00677079
Brief Title
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iniparib
Arm Type
Experimental
Arm Description
Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles
Intervention Type
Drug
Intervention Name(s)
Iniparib
Other Intervention Name(s)
BSI-201, SAR240550
Intervention Description
Body weight adjusted dose
1 hour intravenous infusion
Primary Outcome Measure Information:
Title
Best overall response
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.
Time Frame
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Title
Objective response rate
Description
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
Time Frame
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Secondary Outcome Measure Information:
Title
Clinical benefit rate
Description
Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.
Time Frame
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Title
Progression-Free Survival
Description
Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first.
In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.
Time Frame
until death or study end
Title
Overall Survival
Description
Overall Survival was defined as the time interval from study entry until death due to any cause.
In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.
Time Frame
until death or study end
Title
Cancer antigen 125 response (participants with elevated CA125)
Description
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.
Time Frame
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26745694
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.
Results Reference
derived
Learn more about this trial
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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