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NCT00813956 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00813956: Completed Phase 2 study, sponsored by Sanofi.
NCT00813956 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00813956, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. 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 gemcitabine plus carboplatin plus BSI-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00813956 record still lists
NCT00813956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which gemcitabine plus carboplatin plus BSI-201 is the first listed.
NCT00813956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00813956 about?
NCT00813956 is a clinical study titled "A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer". This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. Based on data generated by BiPar/Sanofi, it is concluded that i...
What is the current status of trial NCT00813956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-12. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00813956?
The interventions under investigation include: gemcitabine plus carboplatin plus BSI-201 (DRUG).
Who is sponsoring clinical trial NCT00813956?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00813956's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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