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, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Washington, District of Columbia, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Gainsville, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Niles, Illinois, United States
Pfizer Investigational Site
Park Ridge, Illinois, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
New Bedford, Massachusetts, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Farmington Hills, Michigan, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
Creve Coeur, Missouri, United States
Pfizer Investigational Site
St. Louis, Missouri, United States
Pfizer Investigational Site
St. Louis, Missouri, United States
Pfizer Investigational Site
Bronx, New York, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Burnos Aires, Argentina
Pfizer Investigational Site
Camperdown, New South Wales, Australia
Pfizer Investigational Site
Randwick, New South Wales, Australia
Pfizer Investigational Site
Auchenflower, Queensland, Australia
Pfizer Investigational Site
Bedford Park, South Australia, Australia
Pfizer Investigational Site
East Melbourne, Victoria, Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia
Pfizer Investigational Site
Ashford SA, Australia
Pfizer Investigational Site
Auchenflower QLD, Australia
Pfizer Investigational Site
Graz, Austria
Pfizer Investigational Site
Wien, Austria
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Leuven, Belgium
Pfizer Investigational Site
Calgary, Alberta, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Brno, Czech Republic
Pfizer Investigational Site
Praha 5, Czech Republic
Pfizer Investigational Site
Aarhus C, Denmark
Pfizer Investigational Site
Herlev, Denmark
Pfizer Investigational Site
Helsinki, Finland
Pfizer Investigational Site
Bordeaux Cedex, France
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Marseille, France
Pfizer Investigational Site
Berlin, Germany
Pfizer Investigational Site
Duesseldorf, Germany
Pfizer Investigational Site
Koeln, Germany
Pfizer Investigational Site
Muenchen, Germany
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Happy Valley, Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Budapest, Hungary
Pfizer Investigational Site
New Delhi, Delhi, India
Pfizer Investigational Site
Mumbai, Maharashtra, India
Pfizer Investigational Site
Vellore, Tamil Nadu, India
Pfizer Investigational Site
Tel Hashomer, Israel
Pfizer Investigational Site
Tel-Aviv, Israel
Pfizer Investigational Site
Aviano (PN), Italy
Pfizer Investigational Site
Aviano, PN, Italy
Pfizer Investigational Site
Bologna, Italy
Pfizer Investigational Site
Candiolo (TO), Italy
Pfizer Investigational Site
Genova, Italy
Pfizer Investigational Site
Milano, Italy
Pfizer Investigational Site
Milano, Italy
Pfizer Investigational Site
Milano, Italy
Pfizer Investigational Site
Torino, Italy
Pfizer Investigational Site
Seoul, Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of
Pfizer Investigational Site
Mexico, DF, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Groningen, Gr, Netherlands
Pfizer Investigational Site
Leiden, Netherlands
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Warszawa, Poland
Pfizer Investigational Site
Singapore, Singapore
Pfizer Investigational Site
Singapore, Singapore
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Oviedo, Asturias, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Sevilla, Spain
Pfizer Investigational Site
Valencia, Spain
Pfizer Investigational Site
Göteborg, Sweden
Pfizer Investigational Site
Lausanne, Switzerland
Pfizer Investigational Site
Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Ratchatawi, Bangkok, Thailand
Pfizer Investigational Site
Bangkok, Thailand
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Inciralti / IZMIR, Turkey
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Leeds, England, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Manchester, United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, United Kingdom
Pfizer Investigational Site
Newcastle-Upon-Tyne, United Kingdom
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela
Pfizer CT.gov Call Center, Study Director
Pfizer