NCT00500292

A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.

Conditions

• Colorectal
• Cancer

Interventions

Type	Name	Description
DRUG	Vandetanib	once daily oral tablet two dose strengths
DRUG	FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid	intravenous infusion

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2016-11-01
• First posted: 2007-07-12
• Last updated: 2018-01-25
• Results posted: 2011-05-24

Locations

15 sites across 6 countries: France, Hungary, Slovakia, South Korea, Spain, Taiwan