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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pancreatic Neoplasm

In brief

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.

Key facts

Study ID

NCT00574275

Run by

Sanofi

People needed

546

Starts

2007-12-01

Expected to finish

2010-11-01

Last updated by the study team

2016-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas
• Metastatic disease
• No prior chemotherapy for pancreatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Adequate renal, liver and bone marrow functions

You may not qualify if…

• Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of randomization
• Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
• Uncontrolled hypertension
• Pregnancy or breastfeeding
• Participant with reproductive potential (M/F) without effective method of contraception
• The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Bogotá, Colombia
• Sanofi-Aventis Administrative Office — Nicosia, Cyprus
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — San Juan, Puerto Rico
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Brastislava, Slovakia
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Geneva, Switzerland

Full record on ClinicalTrials.gov

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