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

NCT ID: NCT00094029

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Study Start Date

2004-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Neoplasm

Interventions

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Sutent

Sutent, 25, 37.5, or 50 mg daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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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 D.C., 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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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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The Bronx, 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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Vienna, , 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, , Czechia

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Prague, , Czechia

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Aarhus C, , Denmark

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Herlev, , Denmark

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Helsinki, , Finland

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Bordeaux, , France

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Lyon, , France

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Marseille, , France

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Berlin, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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München, , Germany

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Thessaloniki, , Greece

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Happy Valley, Hong Kong, Hong Kong

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Mumbai, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Vellore, Tamil Nadu, India

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Candiolo (TO), Italy, Italy

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Aviano (PN), , Italy

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Aviano, PN, , Italy

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Bologna, , Italy

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Genova, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Torino, , Italy

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Groningen, Provincie Groningen, Netherlands

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Leiden, , Netherlands

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Oslo, , Norway

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Warsaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Bratislava, Bratislava Region, Slovakia

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Madrid, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Gothenburg, , 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 (Türkiye)

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Inciralti / Izmir, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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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 Federal, Venezuela

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Countries

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United States Argentina Australia Austria Belgium Canada Chile Colombia Czechia Denmark Finland France Germany Greece Hong Kong Hungary India Israel Italy Mexico Netherlands Norway Poland Singapore Slovakia South Korea Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom Venezuela

References

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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.

Reference Type DERIVED
PMID: 25641662 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21289369 (View on PubMed)

Related Links

Other Identifiers

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A6181036

Identifier Type: -

Identifier Source: org_study_id

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