A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer
NCT ID: NCT00540358
Last Updated: 2012-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2007-10-31
2010-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm G/C
Standard chemotherapy with gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s)
gemcitabine/carboplatin
Gemcitabine and carboplatin administered according to instructions in the package inserts.
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)
gemcitabine/carboplatin
Gemcitabine and carboplatin administered according to instructions in the package inserts.
iniparib
Body weight adjusted dose
1 hour intravenous infusion
Interventions
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gemcitabine/carboplatin
Gemcitabine and carboplatin administered according to instructions in the package inserts.
iniparib
Body weight adjusted dose
1 hour intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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BiPar Sciences
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Denver, Colorado, United States
Research Site
Torrington, Connecticut, United States
Research Site
Ocoee, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Henderson, Nevada, United States
Research Site
Hooksett, New Hampshire, United States
Research Site
Raleigh, North Carolina, United States
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
Research Site
Fairfax, Virginia, United States
Research Site
Vancouver, Washington, United States
Research Site
Yakima, Washington, United States
Countries
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References
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O'Shaughnessy J, Osborne C, Pippen JE, Yoffe M, Patt D, Rocha C, Koo IC, Sherman BM, Bradley C. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011 Jan 20;364(3):205-14. doi: 10.1056/NEJMoa1011418. Epub 2011 Jan 5.
Other Identifiers
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20070102
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11485
Identifier Type: -
Identifier Source: org_study_id