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

Gastrointestinal Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00094029
• Other study ID #: A6181036
• Status: Approved for marketing
• Phase: N/A
• First received: October 8, 2004
• Last updated: March 8, 2012
• Start date: September 2004
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Sutent
Sutent, 25, 37.5, or 50 mg daily

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Burnos Aires
Australia	Pfizer Investigational Site	Ashford SA
Australia	Pfizer Investigational Site	Auchenflower	Queensland
Australia	Pfizer Investigational Site	Auchenflower QLD
Australia	Pfizer Investigational Site	Bedford Park	South Australia
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	East Melbourne	Victoria
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Randwick	New South Wales
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Leuven
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Chile	Pfizer Investigational Site	Santiago	RM
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Praha 5
Denmark	Pfizer Investigational Site	Aarhus C
Denmark	Pfizer Investigational Site	Herlev
Finland	Pfizer Investigational Site	Helsinki
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Marseille
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Duesseldorf
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Muenchen
Greece	Pfizer Investigational Site	Thessaloniki
Hong Kong	Pfizer Investigational Site	Happy Valley
Hong Kong	Pfizer Investigational Site	Hong Kong
Hungary	Pfizer Investigational Site	Budapest
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	New Delhi	Delhi
India	Pfizer Investigational Site	Vellore	Tamil Nadu
Israel	Pfizer Investigational Site	Tel Hashomer
Israel	Pfizer Investigational Site	Tel-Aviv
Italy	Pfizer Investigational Site	Aviano (PN)
Italy	Pfizer Investigational Site	Aviano, PN
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Candiolo (TO)
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Torino
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	DF
Netherlands	Pfizer Investigational Site	Groningen	Gr
Netherlands	Pfizer Investigational Site	Leiden
Norway	Pfizer Investigational Site	Oslo
Poland	Pfizer Investigational Site	Warszawa
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Bratislava
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'Hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Oviedo	Asturias
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Göteborg
Switzerland	Pfizer Investigational Site	Lausanne
Taiwan	Pfizer Investigational Site	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Ratchatawi	Bangkok
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Inciralti / IZMIR
Turkey	Pfizer Investigational Site	Istanbul
United Kingdom	Pfizer Investigational Site	Leeds	England
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United Kingdom	Pfizer Investigational Site	Newcastle upon Tyne
United Kingdom	Pfizer Investigational Site	Newcastle-Upon-Tyne
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Duarte	California
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Gainsville	Florida
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Bedford	Massachusetts
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Niles	Illinois
United States	Pfizer Investigational Site	Park Ridge	Illinois
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Washington	District of Columbia
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

External Links

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