The purpose of this study is to permit access to SU011248 for treatment use by patientswith GIST given the following conditions: a) patients undergo screening, but are noteligible for participation in ongoing clinical studies such as A6181004; AND b) patientshave GIST which standard treatments have not been able to control with acceptabletoxicity AND c) patients have the potential to derive clinical benefit from treatmentwith 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.
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Duarte, California, United States
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Pasadena, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Washington, District of Columbia, United States
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Gainesville, Florida, United States
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Gainsville, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Niles, Illinois, United States
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Park Ridge, Illinois, United States
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Boston, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Creve Coeur, Missouri, United States
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St. Louis, Missouri, United States
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St. Louis, Missouri, United States
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Bronx, New York, United States
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Buffalo, 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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Portland, Oregon, United States
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Portland, Oregon, United States
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Dallas, Texas, 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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Burnos Aires, Argentina
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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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Bedford Park, South Australia, Australia
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East Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Ashford SA, Australia
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Auchenflower QLD, Australia
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Graz, Austria
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Wien, Austria
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Brussels, Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Santiago, RM, Chile
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Bogota, Cundinamarca, Colombia
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Brno, Czech Republic
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Praha 5, Czech Republic
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Aarhus C, Denmark
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Herlev, Denmark
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Helsinki, Finland
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Bordeaux Cedex, France
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Lyon, France
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Marseille, France
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Berlin, Germany
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Duesseldorf, Germany
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Koeln, Germany
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Muenchen, Germany
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Thessaloniki, Greece
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Happy Valley, Hong Kong
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Hong Kong, Hong Kong
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Budapest, Hungary
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New Delhi, Delhi, India
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Mumbai, Maharashtra, India
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Vellore, Tamil Nadu, India
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Tel Hashomer, Israel
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Tel-Aviv, Israel
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Aviano (PN), Italy
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Aviano, PN, Italy
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Bologna, Italy
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Candiolo (TO), Italy
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Genova, Italy
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Milano, Italy
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Milano, Italy
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Milano, Italy
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Torino, Italy
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Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Mexico, DF, Mexico
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Guadalajara, Jalisco, Mexico
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Groningen, Gr, Netherlands
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Leiden, Netherlands
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Oslo, Norway
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Warszawa, Poland
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Singapore, Singapore
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Singapore, Singapore
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Bratislava, Slovakia
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Oviedo, Asturias, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Sevilla, Spain
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Valencia, Spain
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Göteborg, Sweden
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Lausanne, Switzerland
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Kaohsiung Hsien, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Ratchatawi, Bangkok, Thailand
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Bangkok, Thailand
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Ankara, Turkey
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Inciralti / IZMIR, Turkey
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Istanbul, Turkey
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Leeds, England, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Newcastle-Upon-Tyne, United Kingdom
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Caracas, Distrito Capital, Venezuela
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