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

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

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.

Study Overview

• Status: Approved for marketing
• Conditions: Gastrointestinal Neoplasm
• Intervention / Treatment: Drug: Sutent

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.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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. Erratum In: Cancer. 2019 Mar 1;125(5):821.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 8, 2004
• First Submitted That Met QC Criteria: October 8, 2004
• First Posted (Estimate): October 11, 2004

Study Record Updates

• Last Update Posted (Estimate): March 9, 2012
• Last Update Submitted That Met QC Criteria: March 8, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms; Digestive System Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181036