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NCT01173497 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01173497 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 44 participants.
The verdict
NCT01173497, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study 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.
Interventions
- DRUG INIPARIB + irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01173497
The ClinicalTrials.gov registry entry for NCT01173497 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INIPARIB + irinotecan is the first listed.
NCT01173497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01173497 about?
NCT01173497 is a clinical study titled "A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis". 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 ...
What is the current status of trial NCT01173497?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2010-07. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01173497?
The interventions under investigation include: INIPARIB + irinotecan (DRUG).
Who is sponsoring clinical trial NCT01173497?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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