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NCT00561470 · ClinicalTrials.gov registry record · Phase 3
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,226
- Enrollment target
NCT00561470 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,226 participants.
The verdict
NCT00561470, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,226 participants
- Enrollment target
Study Summary
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
Interventions
- DRUG Placebo
- DRUG FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- DRUG Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,226 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00561470
The ClinicalTrials.gov registry entry for NCT00561470 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,226 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 3 interventions - of which Placebo is the first listed.
NCT00561470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00561470 about?
NCT00561470 is a clinical study titled "Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen". The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin base...
What is the current status of trial NCT00561470?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,226 participants. The study started on 2007-11. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00561470?
The interventions under investigation include: Placebo (DRUG), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) (DRUG), Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (DRUG).
Who is sponsoring clinical trial NCT00561470?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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