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A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00540358
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : December 28, 2012
Sponsor:
Collaborator:
BiPar Sciences
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone.

Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: gemcitabine/carboplatin Drug: iniparib Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:
Patients were treated until disease progression, unacceptable toxicity, Investigator's decision to discontinue, or withdrawal of consent. After treatment discontinuation, all patients were evaluated every 90 days after last dose of gemcitabine/carboplatin with or without iniparib, for up to 3 years or death or end of study, which ever occurred first.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
Study Start Date : October 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm G/C
Standard chemotherapy with gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s)
 Drug: gemcitabine/carboplatin
Gemcitabine and carboplatin administered according to instructions in the package inserts.
Experimental: Arm G/C/I
Standard chemotherapy with gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s)
 Drug: gemcitabine/carboplatin
Gemcitabine and carboplatin administered according to instructions in the package inserts.

Drug: iniparib

Body weight adjusted dose

1 hour intravenous infusion

Other Names:
  • BSI-201
  • SAR240550


Outcome Measures
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Primary Outcome Measures :
  1. Clinical benefit rate [ Time Frame: until cut-off date established so that all patients were evaluable for primary outcome measure ]
    Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: until cut-off date established so that all patients were evaluable for primary outcome measure ]
    Objective response rate was defined as the percentage of patients with confirmed partial response or complete response

  2. Progression-free survival [ Time Frame: until cut-off date established so that all patients were evaluable for primary outcome measure ]
    Progression-free survival was defined as the time interval from the date of randomization to the date of disease progression or the date of death due to any cause, whichever came first.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age;
  • Metastatic breast cancer (Stage IV) with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
  • 0-2 prior chemotherapy regimens in the metastatic setting;
  • Histologically documented (either primary or metastatic site) breast cancer that was ER-negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplification by fluorescence in situ hybridization (FISH);
  • Completion of prior chemotherapy at least 2 weeks prior to trial entry and recovery from toxicity of prior chemotherapy;
  • Radiation therapy must have been completed at least 2 weeks prior to trial entry, and radiated lesions may not have served as measurable disease;
  • Patient may have had central nervous system (CNS) metastases if he/she did not require steroids, whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were clinically stable without symptomatic progression;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Adequate organ function defined as: absolute neutrophil count (ANC)≥1,500/mm3, platelets ≥100,000/mm3, creatinine clearance >50mL/min, ALT and AST <2.5 x upper limit of normal (ULN) (or <5 x ULN in case of liver metastases); total bilirubin <1.5 mg/dL.
  • Tissue block (primary or metastatic) available for PARP and PG studies was recommended, although its absence did not exclude subjects from participating;
  • Woman of child bearing potential must have had documented negative pregnancy test within two weeks of trial entry and agreed to acceptable birth control during the duration of the trial therapy;
  • Signed, IRB approved written informed consent.

Exclusion Criteria:

  • Lesions identifiable only by positron emission tomography (PET);
  • Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib;
  • Major medical conditions that might have affected trial participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection);
  • Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that was either symptomatic or asymptomatic but with decreased ejection fraction <45%;
  • Other significant comorbid condition which the investigator felt might compromise effective and safe participation in the trial;
  • Patient enrolled in another investigational device or drug trial, or was receiving other investigational agents;
  • Concurrent or prior (within 7 days of trial day 1) anticoagulation therapy (low dose for port maintenance allowed);
  • Concurrent radiation therapy was not permitted throughout the course of the trial;
  • Inability to comply with the requirements of the trial;
  • Pregnant or lactating woman;
  • Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540358


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Connecticut
Research Site
Torrington, Connecticut, United States
United States, Florida
Research Site
Ocoee, Florida, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Nevada
Research Site
Henderson, Nevada, United States
United States, New Hampshire
Research Site
Hooksett, New Hampshire, United States
United States, North Carolina
Research Site
Raleigh, North Carolina, United States
United States, Texas
Research Site
Bedford, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Tyler, Texas, United States
United States, Virginia
Research Site
Fairfax, Virginia, United States
United States, Washington
Research Site
Vancouver, Washington, United States
Research Site
Yakima, Washington, United States
Sponsors and Collaborators
Sanofi
BiPar Sciences
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Publications of Results:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00540358    
Other Study ID Numbers: TCD11485
20070102 ( Other Identifier: BiPar )
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: December 28, 2012
Last Verified: December 2012
Keywords provided by Sanofi:
Triple negative breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Gemcitabine
 Iniparib
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors