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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00094029
First received: October 8, 2004
Last updated: March 8, 2012
Last verified: March 2012
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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:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Sutent
Sutent, 25, 37.5, or 50 mg daily
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094029
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| United States, California | |
| Pfizer Investigational Site | |
| 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 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010-2931 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| 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 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Niles, Illinois, United States, 60714 | |
| Pfizer Investigational Site | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | |
| New Bedford, Massachusetts, United States, 02741 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48201 | |
| Pfizer Investigational Site | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| Pfizer Investigational Site | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| 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 | |
| United States, New York | |
| Pfizer Investigational Site | |
| 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 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97201 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98109 | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53792 | |
| Argentina | |
| Pfizer Investigational Site | |
| Burnos Aires, Argentina, C1426ANZ | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Pfizer Investigational Site | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| East Melbourne, Victoria, Australia, 3002 | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Australia | |
| Pfizer Investigational Site | |
| Ashford SA, Australia, 5035 | |
| Pfizer Investigational Site | |
| Auchenflower QLD, Australia, 4066 | |
| Austria | |
| Pfizer Investigational Site | |
| Graz, Austria, A-8036 | |
| Pfizer Investigational Site | |
| Wien, Austria, 1100 | |
| Belgium | |
| Pfizer Investigational Site | |
| Brussels, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Leuven, Belgium, 3000 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile | |
| Colombia | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 656 53 | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic, 150 06 | |
| Denmark | |
| Pfizer Investigational Site | |
| Aarhus C, Denmark, 8000 | |
| Pfizer Investigational Site | |
| Herlev, Denmark, 2730 | |
| Finland | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00029 HUS | |
| France | |
| Pfizer Investigational Site | |
| Bordeaux Cedex, France, 33076 | |
| Pfizer Investigational Site | |
| Lyon, France, 69373 | |
| Pfizer Investigational Site | |
| Marseille, France, 13385 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13125 | |
| Pfizer Investigational Site | |
| Duesseldorf, Germany, 40479 | |
| Pfizer Investigational Site | |
| Koeln, Germany, 50937 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81377 | |
| Greece | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 54007 | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Happy Valley, Hong Kong, 0 | |
| Pfizer Investigational Site | |
| Hong Kong, Hong Kong | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1097 | |
| India | |
| Pfizer Investigational Site | |
| New Delhi, Delhi, India, 110 029 | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400 012 | |
| Pfizer Investigational Site | |
| Vellore, Tamil Nadu, India, 632 004 | |
| Israel | |
| Pfizer Investigational Site | |
| Tel Hashomer, Israel, 52621 | |
| Pfizer Investigational Site | |
| Tel-Aviv, Israel, 64239 | |
| Italy | |
| Pfizer Investigational Site | |
| 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, 20141 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20162 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20133 | |
| Pfizer Investigational Site | |
| Torino, Italy, 10153 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 14000 | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44240 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Groningen, Gr, Netherlands, 9713 GZ | |
| Pfizer Investigational Site | |
| Leiden, Netherlands, 2333 ZA | |
| Norway | |
| Pfizer Investigational Site | |
| Oslo, Norway, 0310 | |
| Poland | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 02-781 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 169610 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 308433 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Pfizer Investigational Site | |
| Oviedo, Asturias, Spain, 33006 | |
| Pfizer Investigational Site | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08025 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28041 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41009 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46009 | |
| Sweden | |
| Pfizer Investigational Site | |
| Göteborg, Sweden, SE-431 45 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Lausanne, Switzerland, CH-1011 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Kaohsiung Hsien, Taiwan, 833 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 100 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 104 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 112 | |
| Thailand | |
| Pfizer Investigational Site | |
| Ratchatawi, Bangkok, Thailand | |
| Pfizer Investigational Site | |
| Bangkok, Thailand, 10700 | |
| Turkey | |
| Pfizer Investigational Site | |
| Ankara, Turkey, 06100 | |
| Pfizer Investigational Site | |
| Inciralti / IZMIR, Turkey, 35340 | |
| Pfizer Investigational Site | |
| Istanbul, Turkey, 34390 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Pfizer Investigational Site | |
| 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 | |
| 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 June 17, 2013