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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 355 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00699517
The ClinicalTrials.gov registry entry for NCT00699517 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 355 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.
NCT00699517 reports 0 study locations.
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.
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