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A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
This study is currently recruiting participants.
Verified by Pfizer, November 2009
First Received: October 8, 2004   Last Updated: November 6, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00094029
  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 Phase
Gastrointestinal Neoplasm
 Drug: SU011248
 Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib malate Sunitinib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Tumor Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: September 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sunitinib: Experimental
sutent, 25, 37.5, or 50 mg daily
Drug: SU011248
sutent, 25, 37.5, or 50 mg daily

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

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site Completed
Duarte, California, United States, 91010
Pfizer Investigational Site Completed
Pasadena, California, United States, 91105
Pfizer Investigational Site Completed
Santa Monica, California, United States, 90404
Pfizer Investigational Site Active, not recruiting
San Francisco, California, United States, 94115-1705
United States, District of Columbia
Pfizer Investigational Site Completed
Washington, District of Columbia, United States, 20010-2931
United States, Florida
Pfizer Investigational Site Completed
Tampa, Florida, United States, 33612
Pfizer Investigational Site Completed
Miami, Florida, United States, 33136
Pfizer Investigational Site Completed
Gainesville, Florida, United States, 32610
Pfizer Investigational Site Completed
Gainsville, Florida, United States, 32610
United States, Illinois
Pfizer Investigational Site Active, not recruiting
Niles, Illinois, United States, 60714
Pfizer Investigational Site Active, not recruiting
Park Ridge, Illinois, United States, 60068
Pfizer Investigational Site Active, not recruiting
Skokie, Illinois, United States, 60076
United States, Massachusetts
Pfizer Investigational Site Completed
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site Completed
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site Completed
Detroit, Michigan, United States, 48201
Pfizer Investigational Site Completed
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Pfizer Investigational Site Completed
Minneapolis, Minnesota, United States, 55455
Pfizer Investigational Site Completed
Rochester, Minnesota, United States, 55905
United States, Missouri
Pfizer Investigational Site Active, not recruiting
St. Louis, Missouri, United States, 63110-1010
United States, New York
Pfizer Investigational Site Completed
New York, New York, United States, 10032
Pfizer Investigational Site Completed
New York, New York, United States, 10022
Pfizer Investigational Site Completed
Bronx, New York, United States, 10466
Pfizer Investigational Site Completed
Buffalo, New York, United States, 14203-1100
United States, North Carolina
Pfizer Investigational Site Completed
Durham, North Carolina, United States, 27710
United States, Oregon
Pfizer Investigational Site Active, not recruiting
Portland, Oregon, United States, 97201
Pfizer Investigational Site Active, not recruiting
Portland, Oregon, United States, 97239
United States, Texas
Pfizer Investigational Site Completed
Dallas, Texas, United States, 75246
United States, Washington
Pfizer Investigational Site Completed
Seattle, Washington, United States, 98109
Pfizer Investigational Site Completed
Seattle, Washington, United States, 98195
United States, Wisconsin
Pfizer Investigational Site Completed
Madison, Wisconsin, United States, 53792
Argentina
Pfizer Investigational Site Completed
Burnos Aires, Argentina, C1426ANZ
Australia, New South Wales
Pfizer Investigational Site Completed
Randwick, New South Wales, Australia, 2031
Pfizer Investigational Site Completed
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Pfizer Investigational Site Completed
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Pfizer Investigational Site Completed
Bedford Park, South Australia, Australia, 5042
Pfizer Investigational Site Completed
Ashford, South Australia, Australia, 5035
Australia, Victoria
Pfizer Investigational Site Completed
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Pfizer Investigational Site Completed
Nedlands, Western Australia, Australia, 6009
Austria
Pfizer Investigational Site Completed
Graz, Austria, A-8036
Pfizer Investigational Site Completed
Wien, Austria, 1100
Belgium
Pfizer Investigational Site Completed
Brussels, Belgium, 1200
Belgium, 3000
Pfizer Investigational Site Completed
Leuven, 3000, Belgium
Canada, Alberta
Pfizer Investigational Site Completed
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Pfizer Investigational Site Completed
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Pfizer Investigational Site Completed
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
Pfizer Investigational Site Completed
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Pfizer Investigational Site Terminated
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Pfizer Investigational Site Completed
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Pfizer Investigational Site Completed
Montreal, Quebec, Canada, H2L 4M1
Chile, RM
Pfizer Investigational Site Completed
Santiago, RM, Chile
Colombia, Cundinamarca
Pfizer Investigational Site Completed
Bogota, Cundinamarca, Colombia
Czech Republic
Pfizer Investigational Site Completed
Praha 5, Czech Republic, 150 06
Pfizer Investigational Site Completed
Brno, Czech Republic, 656 53
Denmark
Pfizer Investigational Site Completed
Aarhus C, Denmark, 8000
Pfizer Investigational Site Active, not recruiting
Herlev, Denmark, 2730
Finland
Pfizer Investigational Site Completed
Helsinki, Finland, 00029 HUS
France
Pfizer Investigational Site Active, not recruiting
Lyon, France, 69373
Pfizer Investigational Site Active, not recruiting
Marseille, France, 13385
Pfizer Investigational Site Completed
Bordeaux Cedex, France, 33076
Germany
Pfizer Investigational Site Completed
Berlin, Germany, 13125
Pfizer Investigational Site Active, not recruiting
Duesseldorf, Germany, 40479
Pfizer Investigational Site Completed
Koeln, Germany, 50937
Pfizer Investigational Site Completed
Muenchen, Germany, 81377
Greece
Pfizer Investigational Site Completed
Thessaloniki, Greece, 54007
Hong Kong
Pfizer Investigational Site Active, not recruiting
Hong Kong, Hong Kong
Pfizer Investigational Site Active, not recruiting
Happy Valley, Hong Kong, 0
Hungary
Pfizer Investigational Site Completed
Budapest, Hungary, 1097
India, DELHI
Pfizer Investigational Site Recruiting
New Delhi, DELHI, India, 110 029
India, Maharashtra
Pfizer Investigational Site Recruiting
Mumbai, Maharashtra, India, 400 012
India, Tamil Nadu
Pfizer Investigational Site Active, not recruiting
Vellore, Tamil Nadu, India, 632 004
Israel
Pfizer Investigational Site Active, not recruiting
Tel-Aviv, Israel, 64239
Pfizer Investigational Site Active, not recruiting
Tel Hashomer, Israel, 52621
Italy
Pfizer Investigational Site Completed
Milano, Italy, 20133
Pfizer Investigational Site Completed
Milano, Italy, 20141
Pfizer Investigational Site Active, not recruiting
Bologna, Italy, 40138
Pfizer Investigational Site Active, not recruiting
Aviano, Pn, Italy, 33081
Pfizer Investigational Site Completed
Torino, Italy, 10153
Pfizer Investigational Site Completed
Genova, Italy, 16132
Pfizer Investigational Site Completed
Milano, Italy, 20162
Italy, Torino
Pfizer Investigational Site Completed
Candiolo, Torino, Italy, 10060
Korea, Republic of
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 138-736
Mexico, DF
Pfizer Investigational Site Active, not recruiting
Mexico, DF, Mexico, 14000
Mexico, Jalisco
Pfizer Investigational Site Completed
Guadalajara, Jalisco, Mexico, 44240
Netherlands
Pfizer Investigational Site Active, not recruiting
Leiden, Netherlands, 2333 ZA
Netherlands, Gr
Pfizer Investigational Site Completed
Groningen, Gr, Netherlands, 9713 GZ
Norway
Pfizer Investigational Site Active, not recruiting
Oslo, Norway, 0310
Poland
Pfizer Investigational Site Active, not recruiting
Warszawa, Poland, 02-781
Singapore
Pfizer Investigational Site Completed
Singapore, Singapore, 119074
Pfizer Investigational Site Completed
Singapore, Singapore, 169610
Slovakia
Pfizer Investigational Site Active, not recruiting
Bratislava, Slovakia, 833 10
Spain
Pfizer Investigational Site Completed
Barcelona, Spain, 08025
Pfizer Investigational Site Completed
Madrid, Spain, 28041
Pfizer Investigational Site Active, not recruiting
Sevilla, Spain, 41009
Pfizer Investigational Site Active, not recruiting
Valencia, Spain, 46009
Spain, Asturias
Pfizer Investigational Site Completed
Oviedo, Asturias, Spain, 33006
Spain, Barcelona
Pfizer Investigational Site Completed
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sweden
Pfizer Investigational Site Active, not recruiting
Göteborg, Sweden, SE-431 45
Switzerland
Pfizer Investigational Site Completed
Lausanne, Switzerland, CH-1011
Taiwan
Pfizer Investigational Site Completed
Taipei, Taiwan, 104
Pfizer Investigational Site Active, not recruiting
Taipei, Taiwan, 112
Pfizer Investigational Site Active, not recruiting
Kaohsiung Hsien, Taiwan, 833
Pfizer Investigational Site Completed
Taipei, Taiwan, 100
Thailand
Pfizer Investigational Site Active, not recruiting
Bangkok, Thailand, 10700
Thailand, Bangkok
Pfizer Investigational Site Active, not recruiting
Ratchatawi, Bangkok, Thailand
Turkey
Pfizer Investigational Site Active, not recruiting
Ankara, Turkey, 06100
Pfizer Investigational Site Active, not recruiting
Capa Istanbul, Turkey, 34390
Pfizer Investigational Site Terminated
Inciralti / Izmir, Turkey, 35340
United Kingdom
Pfizer Investigational Site Completed
Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
Pfizer Investigational Site Active, not recruiting
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site Completed
London, United Kingdom, W1T 3AA
Pfizer Investigational Site Active, not recruiting
London, United Kingdom, SW3 6JJ
Venezuela, Distrito Capital
Pfizer Investigational Site Completed
Caracas, Distrito Capital, Venezuela, 1041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A6181036
Study First Received: October 8, 2004
Last Updated: November 6, 2009
ClinicalTrials.gov Identifier: NCT00094029     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2009



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