A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
NCT ID: NCT00500292
Last Updated: 2018-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2007-03-31
2016-11-30
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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1
FOLFOX + Placebo vandetanib
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
2
FOLFOX + low dose vandetanib
Vandetanib
once daily oral tablet two dose strengths
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
3
FOLFOX + high dose vandetanib
Vandetanib
once daily oral tablet two dose strengths
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
Interventions
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Vandetanib
once daily oral tablet two dose strengths
FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
* Have World Health Organisation (WHO) performance status 0-2 and life expectancy \>12 weeks
Exclusion Criteria
* Previous adjuvant therapy with irinotecan within 12 months of randomisation
* More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
Lille, , France
Research Site
Toulouse, , France
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Szeged, , Hungary
Research Site
Bratislava, , Slovakia
Research Site
Poprad, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Seoul, , South Korea
Research Site
Hospitalet deLlobregat, , Spain
Research Site
Oviedo, , Spain
Research Site
Santander, , Spain
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Countries
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Related Links
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Other Identifiers
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2006-005022-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LPS15025
Identifier Type: OTHER
Identifier Source: secondary_id
D4200C00047
Identifier Type: -
Identifier Source: org_study_id
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