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Spots Global Cancer Trial Database for A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

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Trial Identification

Brief Title: A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Official Title: A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Study ID: NCT01173497

Study Description

Brief Summary: The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan. 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.

Detailed Description:

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama At Birmingham, Birmingham, Alabama, United States

University of California At San Francisco, San Francisco, California, United States

Georgetown University, Washington, 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

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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