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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
February 2011
NCT00561470Uploaded 04-24-2015
Available for Download
PDS UID: Colorec_SanofiU_2007_131
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen
Provider Information
Provider Data DescriptionPrimary objective: -To demonstrate improvement in overall survival (OS) with aflibercept by comparison to placebo in patients with colorectal cancer treated with FOLFIRI as second line treatment for metastatic disease. Secondary objectives: -To compare progression free survival (PFS) in the 2 treatment arms -To evaluate overall response rate (RR) in the 2 treatment arms -To evaluate the safety profile in the 2 treatment arms -To assess the pharmacokinetics of IV aflibercept -To assess immunogenicity of IV aflibercept
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset1226
# of Patients Control610
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/xw2z-zv42
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsColorectal Neoplasms
Neoplasm Metastasis
Intervention TypeDrug: Placebo
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Drug(s)Drug: Placebo
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Total Enrolled1226
RandomizationRandomized
Blinding MethodTriple
Arms InterventionPlacebo/FOLFIRI - Placebo Comparator
Aflibercept/FOLFIRI - Experimental
Secondary IDEudraCT 2007-000820-42
PubMed (PMID)34789774
32168980
28807738
28761750
26706237
24140268
22949147
Collaborator(s)Regeneron Pharmaceuticals
NSABP Foundation Inc
Region(s)United States
Argentina
Australia
Austria
Belgium
Brazil
Chile
Czech Republic
Denmark
Estonia
France
Germany
Greece
Italy
Korea, Republic of
Netherlands
New Zealand
Norway
Poland
Puerto Rico
Romania
Russian Federation
South Africa
Spain
Sweden
Turkey
Ukraine
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLSanofi_AVE0005_EFC10262_protocol.pdf
CRFSanofi_AVE0005_EFC10262_CRF.pdf
DATA DICTIONARYSanofi_AVE0005_EFC10262_data_discriptors.xlsx
DATA (COMPARATOR ARM)Sanofi_AVE0005_EFC10262_data_files_and_discriptors.zip
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