At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 781 enrolled
Drug / intervention
AFLIBERCEPT AVE0005 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Single Arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Quality of Life of Aflibercept in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen
In Brief
A Phase 3 clinical trial evaluating AFLIBERCEPT AVE0005 and FOLFIRI for Colorectal Cancer Metastatic. Completed, enrolled 781 participants across 179 sites in 23 countries.
Detailed Summary
Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer Metastatic
CountriesBelgium, Brazil, Canada, Chile, Czechia, Denmark, Finland, Germany, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Russia, Spain, Sweden, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartMay 2012
Primary CompletionJan 2017
TodayJul 2026
First PostedApr 5, 2012
Enrollment StartMay 30, 2012
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 14.2 years ago
Interventions
AFLIBERCEPT AVE0005drug
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
FOLFIRIdrug
irinotecan, 5-FU and leucovorin