Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
Status:
Terminated
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by
comparison to placebo in increasing the overall survival (OS) in participants with metastatic
pancreatic cancer, treated with gemcitabine.
The secondary objectives were to evaluate progression free survival, clinical benefit,
overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1:
Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).
The study included an interim analysis of OS. In accordance with the study protocol, an
interim analysis was performed for the purpose of futility and overwhelming efficacy. On the
basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this
study be terminated for futility based on predefined boundary rules.