Official Title
A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
Brief Summary

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.

Detailed Description

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.

Approved for marketing
Gastrointestinal Neoplasm

Drug: Sutent

Sutent, 25, 37.5, or 50 mg daily

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Australia
Austria
Belgium
Canada
Chile
Colombia
Czech Republic
Denmark
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Israel
Italy
Korea, Republic of
Mexico
Netherlands
Norway
Poland
Singapore
Slovakia
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States
Venezuela
Locations

Pfizer Investigational Site
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

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
MeSH Terms
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Sunitinib