NCT00454116

A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

A Phase II, Double Blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Oxaliplatin and Fluoropyrimidine Containing Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Vandetanib	once daily oral tablet two doses
DRUG	FOLFIRI	Intravenous infusion

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2009-11-01
• First posted: 2007-03-30
• Last updated: 2016-10-07
• Results posted: 2011-05-24

Locations

21 sites across 6 countries: United States, Argentina, Norway, South Korea, Spain, United Kingdom