A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Completed · Phase 2
Conditions studied: Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT01173497
- Run by
- Sanofi
- People needed
- 44
- Starts
- 2010-07-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2016-03-17
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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