Trial record 1 of 1 for:    NCT00094029
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A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00094029
First received: October 8, 2004
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Gastrointestinal Neoplasm
Drug: Sutent

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: September 2004
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sutent
    Sutent, 25, 37.5, or 50 mg daily
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094029

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010
Pfizer Investigational Site
Pasadena, California, United States, 91105
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San Francisco, California, United States, 94115-1705
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Santa Monica, California, United States, 90404
United States, District of Columbia
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Washington, District of Columbia, United States, 20010-2931
United States, Florida
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Gainesville, Florida, United States, 32610
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Gainsville, Florida, United States, 32610
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Miami, Florida, United States, 33136
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Tampa, Florida, United States, 33612
United States, Illinois
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Niles, Illinois, United States, 60714
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Park Ridge, Illinois, United States, 60068
United States, Massachusetts
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Boston, Massachusetts, United States, 02115
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New Bedford, Massachusetts, United States, 02741
United States, Michigan
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Detroit, Michigan, United States, 48202
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Detroit, Michigan, United States, 48201
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Farmington Hills, Michigan, United States, 48334
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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Rochester, Minnesota, United States, 55905
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
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St. Louis, Missouri, United States, 63110-1094
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St. Louis, Missouri, United States, 63110-1010
United States, New York
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Bronx, New York, United States, 10466
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Buffalo, New York, United States, 14263
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New York, New York, United States, 10032
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New York, New York, United States, 10022
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Oregon
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Portland, Oregon, United States, 97239
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Portland, Oregon, United States, 97201
United States, Texas
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Dallas, Texas, United States, 75246
United States, Washington
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Seattle, Washington, United States, 98109
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Seattle, Washington, United States, 98195
United States, Wisconsin
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Madison, Wisconsin, United States, 53792
Argentina
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Burnos Aires, Argentina, C1426ANZ
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Randwick, New South Wales, Australia, 2031
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Australia
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Ashford SA, Australia, 5035
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Auchenflower QLD, Australia, 4066
Austria
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Graz, Austria, A-8036
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Wien, Austria, 1100
Belgium
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Brussels, Belgium, 1200
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Leuven, Belgium, 3000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
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Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
Chile
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Santiago, RM, Chile
Colombia
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Bogota, Cundinamarca, Colombia
Czech Republic
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Brno, Czech Republic, 656 53
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Praha 5, Czech Republic, 150 06
Denmark
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Aarhus C, Denmark, 8000
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Herlev, Denmark, 2730
Finland
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Helsinki, Finland, 00029 HUS
France
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Bordeaux Cedex, France, 33076
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Lyon, France, 69373
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Marseille, France, 13385
Germany
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Berlin, Germany, 13125
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Duesseldorf, Germany, 40479
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Koeln, Germany, 50937
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Muenchen, Germany, 81377
Greece
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Thessaloniki, Greece, 54007
Hong Kong
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Happy Valley, Hong Kong, 0
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Hong Kong, Hong Kong
Hungary
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Budapest, Hungary, 1097
India
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New Delhi, Delhi, India, 110 029
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Mumbai, Maharashtra, India, 400 012
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Vellore, Tamil Nadu, India, 632 004
Israel
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Tel Hashomer, Israel, 52621
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Tel-Aviv, Israel, 64239
Italy
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Aviano (PN), Italy, 33081
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Aviano, PN, Italy, 33081
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Bologna, Italy, 40138
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Candiolo (TO), Italy, 10060
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Genova, Italy, 16132
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Milano, Italy, 20141
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Milano, Italy, 20162
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Milano, Italy, 20133
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Torino, Italy, 10153
Korea, Republic of
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
Mexico
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Mexico, DF, Mexico, 14000
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Guadalajara, Jalisco, Mexico, 44240
Netherlands
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Groningen, Gr, Netherlands, 9713 GZ
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Leiden, Netherlands, 2333 ZA
Norway
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Oslo, Norway, 0310
Poland
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Warszawa, Poland, 02-781
Singapore
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Singapore, Singapore, 169610
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Singapore, Singapore, 308433
Slovakia
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Bratislava, Slovakia, 833 10
Spain
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Oviedo, Asturias, Spain, 33006
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
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Barcelona, Spain, 08025
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Madrid, Spain, 28041
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Sevilla, Spain, 41009
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Valencia, Spain, 46009
Sweden
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Göteborg, Sweden, SE-431 45
Switzerland
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Lausanne, Switzerland, CH-1011
Taiwan
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Kaohsiung Hsien, Taiwan, 833
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Taipei, Taiwan, 100
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Taipei, Taiwan, 104
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Taipei, Taiwan, 112
Thailand
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Ratchatawi, Bangkok, Thailand
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Bangkok, Thailand, 10700
Turkey
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Ankara, Turkey, 06100
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Inciralti / IZMIR, Turkey, 35340
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Istanbul, Turkey, 34390
United Kingdom
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Leeds, England, United Kingdom, LS9 7TF
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London, United Kingdom, SW3 6JJ
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London, United Kingdom, W1T 3AA
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Manchester, United Kingdom, M20 4BX
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Newcastle upon Tyne, United Kingdom, NE7 7DN
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Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
Venezuela
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela, 1041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00094029     History of Changes
Other Study ID Numbers: A6181036
Study First Received: October 8, 2004
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014