A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
NCT ID: NCT01173497
Last Updated: 2016-03-17
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
44 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
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Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INIPARIB, irinotecan
INIPARIB + irinotecan
21 day cycle
Interventions
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INIPARIB + irinotecan
21 day cycle
Eligibility Criteria
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Inclusion Criteria
2. ECOG Performance Status of 0-2.
3. Life expectancy of \>12 weeks.
4. No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
5. No active serious infection or other comorbid illness which would impair ability to participate in the trial.
6. Stable or decreasing dose of steroids for ≥ 7 days.
7. Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
8. Patients must have adequate organ function.
Exclusion Criteria
2. Prior allergic reaction to INIPARIB
3. Prior allergic reaction to irinotecan.
4. Evidence of hemorrhage or impending herniation on baseline brain imaging
5. Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
6. Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
7. Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
8. Contraindication to gadolinium-enhanced MRI imaging.
9. Inability to comply with study and/or follow-up procedures.
21 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
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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University of Alabama At Birmingham
Birmingham, Alabama, United States
University of California At San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of North Carolina-CH Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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20100210
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11608
Identifier Type: -
Identifier Source: org_study_id
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