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NCT01263886 · ClinicalTrials.gov registry record · Phase 2
Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
NCT01263886: Completed Phase 2 study, sponsored by Sanofi.
NCT01263886 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 176 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263886, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
Study Summary
Primary Objective: * To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC). Secondary Objective: * To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.
Interventions
- DRUG placebo
- DRUG ombrabulin (AVE8062)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT01263886 record still lists
NCT01263886 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01263886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263886 about?
NCT01263886 is a clinical study titled "Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer". Primary Objective: * To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC). Secondary Objective: * To determine overall surviva...
What is the current status of trial NCT01263886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2011-02. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01263886?
The interventions under investigation include: placebo (DRUG), ombrabulin (AVE8062) (DRUG).
Who is sponsoring clinical trial NCT01263886?
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 NCT01263886's enrollment target sits among peer trials
176 394th of 2000 higher than 1,605 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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