Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00677079
First received: May 9, 2008
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Primary Peritoneal Cancer
Advanced Epithelial Ovarian Cancer
Drug: Iniparib
Phase 2

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Best overall response [ Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle) ] [ Designated as safety issue: No ]
    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 [ Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle) ] [ Designated as safety issue: No ]
    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 [ Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle) ] [ Designated as safety issue: No ]
    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 [ Time Frame: until death or study end ] [ Designated as safety issue: No ]

    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 [ Time Frame: until death or study end ] [ Designated as safety issue: No ]

    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) [ Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle) ] [ Designated as safety issue: No ]
    Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.


Enrollment: 12
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iniparib
Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles
Drug: Iniparib

Body weight adjusted dose

1 hour intravenous infusion

Other Names:
  • BSI-201
  • SAR240550

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677079

Locations
United States, New York
New York, New York, United States, 10021
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00677079     History of Changes
Other Study ID Numbers: ARD11489, 20080105
Study First Received: May 9, 2008
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
BRCA-1
BRCA-2

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014