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NCT00540358 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00540358: Completed Phase 2 study, sponsored by Sanofi.
NCT00540358 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00540358, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical benefit compared to treatment with standard chemotherapy alone. Based on data generated by BiPar/Sanofi, it was concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (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.
Primary Outcome
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
Interventions
- DRUG gemcitabine/carboplatin
- DRUG iniparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00540358 record still lists
NCT00540358 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which gemcitabine/carboplatin is the first listed.
NCT00540358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00540358 about?
NCT00540358 is a clinical study titled "A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer". The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer patients improve clinical...
What is the current status of trial NCT00540358?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2007-10. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00540358?
The interventions under investigation include: gemcitabine/carboplatin (DRUG), iniparib (DRUG).
Who is sponsoring clinical trial NCT00540358?
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 NCT00540358's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 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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