Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients with Untreated Metastatic Colorectal Cancer - HORIZON II
Study identifier:D8480C00051
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) when added to 5 fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) with the Efficacy and Safety of Placebo when added to FOLFOX or XELOX in Patients with Previously Untreated Metastatic Colorectal Cancer.
Medical condition
Metastatic Colorectal Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Cediranib, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin), XELOX (Capecitabine and Oxaliplatin), Cediranib Placebo
Sex
All
Actual Enrollment
1254
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 01 Nov 2006
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Aug 2016
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: FOLFOX + placebo Cediranib FOLFOX + placebo Cediranib | Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion Other Name: Other Names: Other Name: 5-FU Other Name: Drug: Leucovorin (in FOLFOX) Other Name: intravenous infusion Other Name: Drug: Oxaliplatin (in FOLFOX) Other Name: intravenous infusion Other Name: Other Names: Other Name: Eloxatin® Drug: Cediranib Placebo oral tablet |
| Placebo Comparator: Xelox + placebo Cediranib Xelox + placebo Cediranib | Drug: XELOX (Capecitabine and Oxaliplatin) intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15) Other Name: Xeloda® + Eloxatin® Drug: Cediranib Placebo oral tablet |
| Experimental: FOLFOX + Cediranib FOLFOX + Cediranib | Drug: Cediranib oral tablet Other Name: AZD2171 Other Name: RECENTIN™ Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion Other Name: Other Names: Other Name: 5-FU Other Name: Drug: Leucovorin (in FOLFOX) Other Name: intravenous infusion Other Name: Drug: Oxaliplatin (in FOLFOX) Other Name: intravenous infusion Other Name: Other Names: Other Name: Eloxatin® |
| Experimental: XELOX + Cediranib XELOX + Cediranib | Drug: Cediranib oral tablet Other Name: AZD2171 Other Name: RECENTIN™ Drug: XELOX (Capecitabine and Oxaliplatin) intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15) Other Name: Xeloda® + Eloxatin® |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
