NCT00574275

Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study included: * A screening visit of up to 21 days prior to randomization * Randomization at baseline * A Treatment period (initiated within 3 days of randomization), which included 28-day treatment cycles in both arms until predefined treatment discontinuation criteria were met * A follow-up visit 30 days after discontinuation of treatment, * A post study treatment follow-up period until death or the study cutoff date. The criteria for treatment discontinuation were: * Participant (or legal representative) chose to withdraw from treatment * The investigator thought that continuation of the study would be detrimental to the participants well-being, such as: * Disease progression * Unacceptable AEs not manageable by symptomatic therapy, dose delay, or dose modification * Intercurrent illness that prevented further administration of study treatment * Noncompliance with the study protocol * Participant was lost to follow-up * Unblinding of the participant's investigational treatment

Conditions

• Pancreatic Neoplasm

Interventions

Type	Name	Description
DRUG	Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)	4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
DRUG	Placebo	4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle
DRUG	Gemcitabine	1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-10-01
• Completion: 2010-11-01
• First posted: 2007-12-17
• Last updated: 2016-06-07
• Results posted: 2012-09-25

Locations

24 sites across 24 countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Cyprus, Czechia, France, Germany, Greece, Hungary, India, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, Spain, Switzerland