A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
NCT ID: NCT00075218
Last Updated: 2009-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2003-12-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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B
Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
A
SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Interventions
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Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Eligibility Criteria
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Inclusion Criteria
* Failed Gleevec treatment or intolerant to Gleevec therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Duarte, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
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Pasadena, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Park Ridge, Illinois, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columubs, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Garran, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Randwick, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Ashford, South Australia, Australia
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Bedford Park, South Australia, Australia
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East Melbourne, Victoria, Australia
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Leuven, , Belgium
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Lyon, , France
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Marseille, , France
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Villejuif, , France
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Aviano, PN, Italy
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Candiolo, Torino, Italy
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Bologna, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Torino, , Italy
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Groningen, Provincie Groningen, Netherlands
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Rotterdam, South Holland, Netherlands
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Barcelona, Barcelona, Spain
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L'Hospitalet Del Llobregat, Barcelona, Spain
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Madrid, Madrid, Spain
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Lausanne, , Switzerland
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Sutton, Surrey, United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181004
Identifier Type: -
Identifier Source: org_study_id
NCT00085618
Identifier Type: -
Identifier Source: nct_alias
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