A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

NCT00094029 | Unknown

• 1 other identifier: A6181036
• Study Type: expanded_access
• Target: N/A
• Locations: 33 countries
• Sites: 110

Brief Summary

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.

Conditions

Gastrointestinal Neoplasm

Interventions

Sutent DRUG

Sutent, 25, 37.5, or 50 mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (118)

Pfizer Investigational Site

Duarte, California, 91010, United States

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Pasadena, California, 91105, United States

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San Francisco, California, 94115-1705, United States

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Santa Monica, California, 90404, United States

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Washington D.C., District of Columbia, 20010-2931, United States

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Gainesville, Florida, 32610, United States

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Gainsville, Florida, 32610, United States

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Miami, Florida, 33136, United States

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Tampa, Florida, 33612, United States

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Niles, Illinois, 60714, United States

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Park Ridge, Illinois, 60068, United States

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Boston, Massachusetts, 02115, United States

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New Bedford, Massachusetts, 02741, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202, United States

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Farmington Hills, Michigan, 48334, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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Creve Coeur, Missouri, 63141, United States

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St Louis, Missouri, 63110-1010, United States

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St Louis, Missouri, 63110-1094, United States

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Buffalo, New York, 14263, United States

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New York, New York, 10022, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10466, United States

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Durham, North Carolina, 27710, United States

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Portland, Oregon, 97201, United States

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Portland, Oregon, 97239, United States

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Dallas, Texas, 75246, United States

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Seattle, Washington, 98109, United States

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Seattle, Washington, 98195, United States

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Madison, Wisconsin, 53792, United States

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Burnos Aires, C1426ANZ, Argentina

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Camperdown, New South Wales, 2050, Australia

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Randwick, New South Wales, 2031, Australia

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Auchenflower, Queensland, 4066, Australia

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Bedford Park, South Australia, 5042, Australia

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East Melbourne, Victoria, 3002, Australia

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Nedlands, Western Australia, 6009, Australia

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Ashford SA, 5035, Australia

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Auchenflower QLD, 4066, Australia

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Graz, A-8036, Austria

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Vienna, 1100, Austria

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Brussels, 1200, Belgium

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Leuven, 3000, Belgium

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Calgary, Alberta, T2N 4N2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Santiago, RM, Chile

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Bogota, Cundinamarca, Colombia

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Brno, 656 53, Czechia

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Prague, 150 06, Czechia

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Aarhus C, 8000, Denmark

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Herlev, 2730, Denmark

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Helsinki, 00029 HUS, Finland

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Bordeaux, 33076, France

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Lyon, 69373, France

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Marseille, 13385, France

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Berlin, 13125, Germany

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Cologne, 50937, Germany

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Düsseldorf, 40479, Germany

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München, 81377, Germany

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Thessaloniki, 54007, Greece

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Happy Valley, Hong Kong, 0, Hong Kong

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Hong Kong, Hong Kong

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Budapest, 1097, Hungary

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Mumbai, Maharashtra, 400 012, India

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New Delhi, National Capital Territory of Delhi, 110 029, India

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Vellore, Tamil Nadu, 632 004, India

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Candiolo (TO), Italy, 10060, Italy

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Aviano (PN), 33081, Italy

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Aviano, PN, 33081, Italy

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Bologna, 40138, Italy

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Genova, 16132, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Milan, 20162, Italy

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Torino, 10153, Italy

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Guadalajara, Jalisco, 44240, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Groningen, Provincie Groningen, 9713 GZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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Oslo, 0310, Norway

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Warsaw, 02-781, Poland

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Singapore, 169610, Singapore

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Singapore, 308433, Singapore

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Bratislava, Bratislava Region, 833 10, Slovakia

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Seoul, 110-744, South Korea

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Seoul, 138-736, South Korea

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Barcelona, Barcelona, 08025, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Madrid, Madrid, 28041, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41009, Spain

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Valencia, Valencia, 46009, Spain

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Gothenburg, SE-431 45, Sweden

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Lausanne, CH-1011, Switzerland

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Kaohsiung Hsien, 833, Taiwan

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Taipei, 100, Taiwan

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Taipei, 104, Taiwan

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Taipei, 112, Taiwan

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Ratchatawi, Bangkok, Thailand

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Bangkok, 10700, Thailand

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Ankara, 06100, Turkey (Türkiye)

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Inciralti / Izmir, 35340, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Leeds, England, LS9 7TF, United Kingdom

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London, SW3 6JJ, United Kingdom

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London, W1T 3AA, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE4 6BE, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Caracas, Distrito Federal, 1041, Venezuela

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Related Publications (2)

• Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13.

  PMID: 25641662 DERIVED

• Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.

  PMID: 21289369 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2004
• First Posted: October 11, 2004
• Study Start: September 1, 2004
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

KR (2); IT (9); TU (3); DK (2); FI (1); AR (1); CA (6); NL (2); US (32); SG (2); FR (3); NO (1); TW (4); IN (3); TH (2); SE (1); CL (1); HK (2); HU (1); AU (2); BE (2); ME (2); CH (1); SL (1); CO (1); CZ (2); PL (1); DE (4); GB (6); VE (1); GR (1); IL (2); ES (6)