NCT00507091

Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Conditions

• Metastatic
• Colorectal
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ZD6474 (vandetanib) 100mg	once daily oral tablet
DRUG	Irinotecan	intravenous infusion
DRUG	5-Fluorouracil	intravenous infusion
DRUG	Leucovorin	intravenous infusion
DRUG	ZD6474 (vandetanib) 300mg	once daily oral tablet

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-05-01
• Completion: 2008-06-01
• First posted: 2007-07-25
• Last updated: 2016-08-25

Locations

3 sites across 2 countries: Belgium, United Kingdom