A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX
NCT ID: NCT00494221
Last Updated: 2014-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
172 participants
INTERVENTIONAL
2007-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
AZD2171
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
AZD2171
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
FOLFOX + Placebo Cediranib
FOLFOX + Placebo Cediranib
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Placebo Cediranib
oral tablet
Interventions
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AZD2171
oral tablet
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Placebo Cediranib
oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* WHO performance status 0-1
* Life expectancy is 12 weeks or longer
Exclusion Criteria
* Patient with inappropriate laboratory tests values
* Patient with poorly controlled hypertension
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jane Robertson
Role: STUDY_DIRECTOR
AstraZeneca
Hideyuki Mishima, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
National Hospital Organization Osaka National Hospital
Xiaojin Shi, MD
Role: STUDY_CHAIR
AstraZeneca
Locations
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Research Site
Osaka, , Japan
Research Site
Saitama, , Japan
Countries
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Related Links
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Other Identifiers
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D8480C00039
Identifier Type: -
Identifier Source: org_study_id
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