A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Public ClinicalTrials.gov record NCT01173497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01173497
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 44 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Sep 30, 2012
- Completion
- Jun 30, 2013
- Last update posted
- Mar 16, 2016
2010 – 2013
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama At Birmingham | Birmingham | Alabama | — | — |
| University of California At San Francisco | San Francisco | California | — | — |
| Georgetown University | Washington D.C. | District of Columbia | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | — | — |
| Johns Hopkins University | Baltimore | Maryland | — | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | — | — |
| University of Michigan | Ann Arbor | Michigan | — | — |
| University of North Carolina-CH Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599-7295 | — |
| Duke University | Durham | North Carolina | — | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | — | — |
| Vanderbilt University | Nashville | Tennessee | — | — |
| MD Anderson Cancer Center | Houston | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01173497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2016 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01173497 live on ClinicalTrials.gov.