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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00574275
Phase
PHASE3
Status
Terminated

Conditions

  • Pancreatic Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) — DRUG
    4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.
  • Placebo — DRUG
    4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle
  • Gemcitabine — DRUG
    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.

Study Details

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 Dates

Start date
Dec 31, 2007
Status verified
May 2016
Primary completion
Oct 31, 2009
Completion
Nov 30, 2010

Study Design

Enrollment
546 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo and Gemcitabine
    Participants with metastatic pancreatic cancer administered Placebo and 1000 mg/m\^2 Gemcitabine.
  • Experimental: Aflibercept and Gemcitabine
    Participants with metastatic pancreatic cancer administered 4 mg/kg Aflibercept and 1000 mg/m\^2 Gemcitabine.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the first randomization until the end of study data cutoff date (approximately 2 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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