A phase II study of 2 doses of ZD6474 (vandetanib) in combination with FOLFOX vs FOLFOX alone for the treatment of colorectal cancer
Study identifier:D4200C00047
ClinicalTrials.gov identifier:NCT00500292
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
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
Medical condition
colorectal
Phase
Phase 2
Healthy volunteers
No
Study drug
Vandetanib, FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Sex
All
Actual Enrollment
109
Study type
Interventional
Age
18 Years - 120 Years
Date
Study Start Date: 01 Mar 2007
Primary Completion Date: 01 Mar 2008
Estimated Study Completion Date: 01 Jun 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 FOLFOX + Placebo vandetanib | Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid intravenous infusion |
| Experimental: 2 FOLFOX + low dose vandetanib | Drug: Vandetanib once daily oral tablet two dose strengths Other Name: AZ6474 Other Name: ZACTIMA™ Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid intravenous infusion |
| Experimental: 3 FOLFOX + high dose vandetanib | Drug: Vandetanib once daily oral tablet two dose strengths Other Name: AZ6474 Other Name: ZACTIMA™ Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid intravenous infusion |
Contacts
Investigators
Principal Investigator
Gill Pover
AstraZeneca
