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.
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181036 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.
Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily
Inclusion 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
Exclusion Criteria:
- 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
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
Pfizer Investigational Site
Duarte, California, 91010
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
San Francisco, California, 94115-1705
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Washington, District of Columbia, 20010-2931
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Gainsville, Florida, 32610
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Niles, Illinois, 60714
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
New Bedford, Massachusetts, 02741
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Farmington Hills, Michigan, 48334
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
St. Louis, Missouri, 63110-1010
Pfizer Investigational Site
St. Louis, Missouri, 63110-1094
Pfizer Investigational Site
Bronx, New York, 10466
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Seattle, Washington, 98109
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer CT.gov Call Center
Study Director
Pfizer