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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
21 day cycle
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
...and 3 more locations
Efficacy
AS measured by intra or extra cranial time to progression (TTP)
Time frame: 12 months
Response Rate
as measured by RECIST
Time frame: 12 months
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