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NCT00687687 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00687687 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 22 participants.
The verdict
NCT00687687, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas. 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 carboplatin
- DRUG paclitaxel
- DRUG BSI-201 (Iniparib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00687687
The ClinicalTrials.gov registry entry for NCT00687687 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 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 3 interventions - of which carboplatin is the first listed.
NCT00687687 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00687687 about?
NCT00687687 is a clinical study titled "Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma". To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanis...
What is the current status of trial NCT00687687?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2008-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00687687?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), BSI-201 (Iniparib) (DRUG).
Who is sponsoring clinical trial NCT00687687?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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