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NCT00699517 · ClinicalTrials.gov registry record · Phase 3
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 355
- Enrollment target
NCT00699517: Completed Phase 3 study, sponsored by Sanofi.
NCT00699517 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 355 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00699517, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 355 participants
- Enrollment target
Study Summary
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms The secondary objectives of the study are : * To compare the overall survival in the 2 treatment arms * To compare the objective response rate in the 2 treatment arms * To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy) * To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.
Interventions
- DRUG Placebo
- DRUG OMBRABULIN (AVE8062)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2008-06 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT00699517 record still lists
NCT00699517 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00699517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00699517 about?
NCT00699517 is a clinical study titled "A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies". The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms The secondary objectives of the study are : * To compare the overall survival in the 2 treatment arms * To compare the objective response rate in the 2 treatment arms * To assess the safety...
What is the current status of trial NCT00699517?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 355 participants. The study started on 2008-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00699517?
The interventions under investigation include: Placebo (DRUG), OMBRABULIN (AVE8062) (DRUG).
Who is sponsoring clinical trial NCT00699517?
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 NCT00699517's enrollment target sits among peer trials
355 1025th of 2000 higher than 975 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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