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NCT01082549 · ClinicalTrials.gov registry record · Phase 3
Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 780
- Enrollment target
NCT01082549 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 780 participants.
The verdict
NCT01082549, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 780 participants
- Enrollment target
Study Summary
To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. 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 gemcitabine/carboplatin
- DRUG gemcitabine/carboplatin plus Iniparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01082549
The ClinicalTrials.gov registry entry for NCT01082549 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 780 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 2 interventions - of which gemcitabine/carboplatin is the first listed.
NCT01082549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01082549 about?
NCT01082549 is a clinical study titled "Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)". To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP...
What is the current status of trial NCT01082549?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 780 participants. The study started on 2010-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01082549?
The interventions under investigation include: gemcitabine/carboplatin (DRUG), gemcitabine/carboplatin plus Iniparib (DRUG).
Who is sponsoring clinical trial NCT01082549?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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