The study is for patients with malignant gastrointestinal stromal tumor who have received treatment with imatinib mesylate and either experienced progression of disease or intolerance. Patients will be randomly assigned to receive either SU011248 or placebo. Patients randomized to receive placebo will be offered crossover to receive SU011248 at the time their disease progresses on study.

Condition	Treatment or Intervention	Phase
Gastrointestinal Neoplasms	Drug: SU011248	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Histopathologically-proven malignant gastrointestinal stromal tumor (GIST)
• Disease that can be measured using radiographic techniques
• Failure during treatment with imatinib mesylate by either progression of disease or significant toxicity precluding further treatment
• Male or female, 18 years of age or older
• ECOG performance status 0 or 1
• Resolution of toxic effects of prior treatments
• Adequate organ and bone marrow function
• No treatment with chemotherapy, chemoembolization, immunotherapy, or investigational anticancer agents after imatinib mesylate
• No diagnosis of other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
• No ongoing severe acute or chronic illness or recent history of significant cardiac abnormality

California
      Pfizer Investigational Site, Duarte,  California,  91010,  United States
      Pfizer Investigational Site, Pasadena,  California,  91105,  United States
      Pfizer Investigational Site, Los Angeles,  California,  90025,  United States
      Pfizer Investigational Site, Santa Monica,  California,  90404,  United States
      Pfizer Investigational Site, Stanford,  California,  94305,  United States
      Pfizer Investigational Site, Los Angeles,  California,  90095,  United States
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20010,  United States
Florida
      Pfizer Investigational Site, Tampa,  Florida,  33612,  United States
      Pfizer Investigational Site, Miami,  Florida,  33136,  United States
      Pfizer Investigational Site, Miami,  Florida,  33136,  United States
Illinois
      Pfizer Investigational Site, Park Ridge,  Illinois,  60068,  United States
      Pfizer Investigational Site, Chicago,  Illinois,  60637,  United States
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States
      Pfizer Investigational Site, Boston,  Massachusetts,  02215,  United States
Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States
Minnesota
      Pfizer Investigational Site, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Pfizer Investigational Site, St. Louis,  Missouri,  63110,  United States
New York
      Pfizer Investigational Site, New York,  New York,  10032,  United States
      Pfizer Investigational Site, New York,  New York,  10021,  United States
      Pfizer Investigational Site, New York,  New York,  10022,  United States
North Carolina
      Pfizer Investigational Site, Durham,  North Carolina,  27710,  United States
Ohio
      Pfizer Investigational Site, Columbus,  Ohio,  43210,  United States
      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States
Oregon
      Pfizer Investigational Site, Portland,  Oregon,  97201,  United States
Pennsylvania
      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19111,  United States
Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  United States
Washington
      Pfizer Investigational Site, Seattle,  Washington,  98109,  United States
      Pfizer Investigational Site, Seattle,  Washington,  98195,  United States
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53792,  United States
Australia, Australian Capital Territory
      Pfizer Investigational Site, Garran,  Australian Capital Territory,  2605,  Australia
Australia, New South Wales
      Pfizer Investigational Site, Randwick,  New South Wales,  2031,  Australia
      Pfizer Investigational Site, Camperdown,  New South Wales,  2050,  Australia
Australia, Queensland
      Pfizer Investigational Site, Auchenflower,  Queensland,  4065,  Australia
Australia, South Australia
      Pfizer Investigational Site, Bedford Park,  South Australia,  5042,  Australia
      Pfizer Investigational Site, Ashford,  South Australia,  5035,  Australia
Australia, Victoria
      Pfizer Investigational Site, East Melbourne,  Victoria,  3002,  Australia
Belgium
      Pfizer Investigational Site, Leuven,  3000,  Belgium
Canada, Alberta
      Pfizer Investigational Site, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, Ontario
      Pfizer Investigational Site, Toronto,  Ontario,  M5G 1X5,  Canada
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H2L 4M1,  Canada
France
      Pfizer Investigational Site, Lyon,  69373,  France
      Pfizer Investigational Site, Marseille,  13385,  France
      Pfizer Investigational Site, Villejuif Cedex,  94805,  France
Italy
      Pfizer Investigational Site, Milano,  20133,  Italy
      Pfizer Investigational Site, Milano,  20141,  Italy
      Pfizer Investigational Site, Bologna,  40138,  Italy
      Pfizer Investigational Site, Genova,  16132,  Italy
      Pfizer Investigational Site, Milano,  20162,  Italy
      Pfizer Investigational Site, Torino,  10153,  Italy
Italy, PN
      Pfizer Investigational Site, Aviano,  PN,  33081,  Italy
Italy, Torino
      Pfizer Investigational Site, Candiolo,  Torino,  10060,  Italy
Netherlands, GR
      Pfizer Investigational Site, Groningen,  GR,  9713 GZ,  Netherlands
Netherlands, ZH
      Pfizer Investigational Site, Rotterdam,  ZH,  3075 EA,  Netherlands
Singapore
      Pfizer Investigational Site, Singapore,  119074,  Singapore
      Pfizer Investigational Site, Singapore,  119074,  Singapore
      Pfizer Investigational Site, Singapore,  169610,  Singapore
Spain
      Pfizer Investigational Site, Barcelona,  08025,  Spain
      Pfizer Investigational Site, Madrid,  28041,  Spain
Spain, Barcelona
      Pfizer Investigational Site, L'Hospitalet del Llobregat,  Barcelona,  08907,  Spain
Switzerland
      Pfizer Investigational Site, Lausanne,  01011,  Switzerland
United Kingdom
      Pfizer Investigational Site, Leeds,  LS9 7TF,  United Kingdom
      Pfizer Investigational Site, London,  W1T 3AA,  United Kingdom
United Kingdom, Surrey
      Pfizer Investigational Site, Sutton,  Surrey,  SM2 5NG,  United Kingdom

Study ID Numbers:  A6181004
Record last reviewed:  February 2005
Last Updated:  February 11, 2005
Record first received:  January 6, 2004
ClinicalTrials.gov Identifier:  NCT00075218
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08