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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: Completed Phase 3 study, sponsored by Sanofi.
NCT01082549 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 780 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01082549 record still lists
NCT01082549 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which gemcitabine/carboplatin is the first listed.
NCT01082549 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01082549's enrollment target sits among peer trials
780 434th of 2000 higher than 1,563 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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