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NCT01033123 · ClinicalTrials.gov registry record · Phase 2
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT01033123 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 41 participants.
The verdict
NCT01033123, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 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-sensitive 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 | 41 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01033123
The ClinicalTrials.gov registry entry for NCT01033123 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 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 BSI-201 is the first listed.
NCT01033123 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01033123 about?
NCT01033123 is a clinical study titled "A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer". The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive 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 NCT01033123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2009-12. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01033123?
The interventions under investigation include: BSI-201 (DRUG).
Who is sponsoring clinical trial NCT01033123?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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