The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

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

Further Study Details: 

Expected Total Enrollment:  250

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

Criteria

• Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
• Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
• Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
• Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
• Male or Female, 18 years or older
• Resolution of all acute toxicities of prior therapies
• Adequate organ function
• No symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
• No symptomatic central nervous system metastases
• No serious acute or chronic illness
• No current treatment on another clinical trial
• Not pregnant or breastfeeding.

SU011248 Clinical Trial Information Service:      877-416-6248 
[NEW LOCATIONS ARE UPDATED TO THIS WEBSITE MONTHLY...... FOR MORE CURRENT INFORMATION, PLEASE CALL THE NUMBER LISTED.]    

District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20010,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States; Recruiting
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States; Recruiting
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting
      Pfizer Investigational Site, Farmington Hills,  Michigan,  48334,  United States; Recruiting
Australia, Victoria
      Pfizer Investigational Site, East Melbourne,  Victoria,  3002,  Australia; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
Singapore
      Pfizer Investigational Site, Singapore,  169610,  Singapore; Recruiting

Study ID Numbers:  A6181036
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  October 8, 2004
ClinicalTrials.gov Identifier:  NCT00094029
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08