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NCT01033292 · ClinicalTrials.gov registry record · Phase 2
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01033292: Completed Phase 2 study, sponsored by Sanofi.
NCT01033292 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033292, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin. 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 BSI-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01033292 record still lists
NCT01033292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which BSI-201 is the first listed.
NCT01033292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01033292 about?
NCT01033292 is a clinical study titled "A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer". The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typica...
What is the current status of trial NCT01033292?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2009-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01033292?
The interventions under investigation include: BSI-201 (DRUG).
Who is sponsoring clinical trial NCT01033292?
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 NCT01033292's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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