A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.

Outcome Time Frame:

From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10262

NCT ID:

NCT00561470

Start Date:

November 2007

Completion Date:

June 2012

Related Keywords:

• Colorectal Neoplasms
• Neoplasm Metastasis
• colorectal cancer
• metastatic
• anti-angiogenic
• irinotecan
• 5-FU
• FOLFIRI
• Neoplasms
• Colorectal Neoplasms
• Neoplasm Metastasis