Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 176 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01263886
The ClinicalTrials.gov registry entry for NCT01263886 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 176 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 placebo is the first listed.
NCT01263886 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.