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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
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:
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR