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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: Completed Phase 3 study, sponsored by Sanofi.
NCT00561470 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,226 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportiona
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 |
What the finished NCT00561470 record still lists
NCT00561470 is an interventional study that assigns participants to a tested intervention. Its 1,226 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00561470 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00561470's enrollment target sits among peer trials
1,226 214th of 2000 higher than 1,787 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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