drugset / Trial / NCT01571284

Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

NCT01571284

Phase 3 Completed 781 enrolled Sanofi Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2012-05-30
Primary completion
2017-01-31
Completion
2017-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 4 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications