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NCT00422682 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
NCT00422682 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 136 participants.
The verdict
NCT00422682, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors. 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 + topotecan
- DRUG bsi-201 + temozolomide
- DRUG bsi-201 + gemcitabine
- DRUG bsi-201 + carboplatin/paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422682
The ClinicalTrials.gov registry entry for NCT00422682 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 136 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 4 interventions - of which bsi-201 + topotecan is the first listed.
NCT00422682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00422682 about?
NCT00422682 is a clinical study titled "A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors". The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors. Based on data generated by BiPar/Sanofi, it is conclu...
What is the current status of trial NCT00422682?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2007-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00422682?
The interventions under investigation include: bsi-201 + topotecan (DRUG), bsi-201 + temozolomide (DRUG), bsi-201 + gemcitabine (DRUG), bsi-201 + carboplatin/paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00422682?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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