# 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

> **NCT00561470** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 1226 (actual)

## Conditions studied

- Colorectal Neoplasms
- Neoplasm Metastasis

## Interventions

- **DRUG:** Placebo
- **DRUG:** Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
- **DRUG:** FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- **DRUG:** FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

## Key facts

- **NCT ID:** NCT00561470
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-11
- **Primary completion:** 2011-02
- **Final completion:** 2012-06
- **Target enrollment:** 1226 (ACTUAL)
- **Last updated:** 2012-09-28

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00561470

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00561470, "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". Retrieved via AI Analytics 2026-08-18 from https://api.ai-analytics.org/clinical/NCT00561470. Licensed CC0.

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