A Phase I/II Study of cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in combination with FOLFOX
Study identifier:D8480C00039
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Two Part Study in Japanese Patients with mCRC, Consisting of an Open-label Phase I Part to assess the Safety and Tolerability of cediranib (AZD2171) in combination with FOLFOX followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of cediranib (AZD2171) in combination with FOLFOX
Medical condition
Metastatic Colorectal Cancer
Phase
Phase 1/2
Healthy volunteers
No
Study drug
AZD2171, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), Placebo Cediranib
Sex
All
Actual Enrollment
172
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2007
Primary Completion Date: 01 Oct 2009
Estimated Study Completion Date: 01 Dec 2012
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: FOLFOX + Cediranib 20 mg FOLFOX + Cediranib 20 mg | Drug: AZD2171 oral tablet Other Name: cediranib Other Name: RECENTIN™ Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion Other Name: Eloxatin® Other Name: 5-FU Other Name: Leucovorin |
| Active Comparator: FOLFOX + Cediranib 30 mg FOLFOX + Cediranib 30 mg | Drug: AZD2171 oral tablet Other Name: cediranib Other Name: RECENTIN™ Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion Other Name: Eloxatin® Other Name: 5-FU Other Name: Leucovorin |
| Placebo Comparator: FOLFOX + Placebo Cediranib FOLFOX + Placebo Cediranib | Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion Other Name: Eloxatin® Other Name: 5-FU Other Name: Leucovorin Drug: Placebo Cediranib oral tablet |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
