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

September 23, 2013 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response
Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
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.
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate
Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
until treatment discontinuation (assessment at the at the end of each 8-week cycle)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit rate
Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.
until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Progression-Free Survival
Time Frame: until death or study end

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.
until death or study end
Overall Survival
Time Frame: until death or study end

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.
until death or study end
Cancer antigen 125 response (participants with elevated CA125)
Time Frame: until treatment discontinuation (assessment at the at the end of each 8-week cycle)
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.
until treatment discontinuation (assessment at the at the end of each 8-week cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD11489
  • 20080105 (Other Identifier: BiPar)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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