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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00094029




Registration number
NCT00094029
Ethics application status
Date submitted
8/10/2004
Date registered
11/10/2004
Date last updated
9/03/2012

Titles & IDs
Public title
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
Scientific 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
Secondary ID [1] 0 0
A6181036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Sutent

Treatment: Drugs: Sutent
Sutent, 25, 37.5, or 50 mg daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Nedlands
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Ashford SA
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Auchenflower QLD
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
5035 - Ashford SA
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower QLD
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Argentina
State/province [15] 0 0
Burnos Aires
Country [16] 0 0
Austria
State/province [16] 0 0
Graz
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Manitoba
Country [23] 0 0
Canada
State/province [23] 0 0
Newfoundland and Labrador
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Chile
State/province [26] 0 0
RM
Country [27] 0 0
Colombia
State/province [27] 0 0
Cundinamarca
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Brno
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Praha 5
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus C
Country [31] 0 0
Denmark
State/province [31] 0 0
Herlev
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Finland
State/province [32] 0 0
Helsinki
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux Cedex
Country [34] 0 0
France
State/province [34] 0 0
Lyon
Country [35] 0 0
France
State/province [35] 0 0
Marseille
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
State/province [38] 0 0
Koeln
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Germany
State/province [39] 0 0
Muenchen
Country [40] 0 0
Greece
State/province [40] 0 0
Thessaloniki
Country [41] 0 0
Hong Kong
State/province [41] 0 0
Happy Valley
Country [42] 0 0
Hong Kong
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Hong Kong
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Hungary
State/province [43] 0 0
Budapest
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India
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Delhi
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India
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Maharashtra
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India
State/province [46] 0 0
Tamil Nadu
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Hashomer
Country [48] 0 0
Israel
State/province [48] 0 0
Tel-Aviv
Country [49] 0 0
Italy
State/province [49] 0 0
Aviano (PN)
Country [50] 0 0
Italy
State/province [50] 0 0
Aviano, PN
Country [51] 0 0
Italy
State/province [51] 0 0
Bologna
Country [52] 0 0
Italy
State/province [52] 0 0
Candiolo (TO)
Country [53] 0 0
Italy
State/province [53] 0 0
Genova
Country [54] 0 0
Italy
State/province [54] 0 0
Milano
Country [55] 0 0
Italy
State/province [55] 0 0
Torino
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Korea, Republic of
State/province [56] 0 0
Seoul
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Mexico
State/province [57] 0 0
DF
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Mexico
State/province [58] 0 0
Jalisco
Country [59] 0 0
Netherlands
State/province [59] 0 0
Gr
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Netherlands
State/province [60] 0 0
Leiden
Country [61] 0 0
Norway
State/province [61] 0 0
Oslo
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Poland
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Warszawa
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Singapore
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Singapore
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Slovakia
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Bratislava
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Spain
State/province [65] 0 0
Asturias
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Spain
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Barcelona
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Spain
State/province [67] 0 0
Madrid
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Spain
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Sevilla
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Sweden
State/province [70] 0 0
Göteborg
Country [71] 0 0
Switzerland
State/province [71] 0 0
Lausanne
Country [72] 0 0
Taiwan
State/province [72] 0 0
Kaohsiung Hsien
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taipei
Country [74] 0 0
Thailand
State/province [74] 0 0
Bangkok
Country [75] 0 0
Turkey
State/province [75] 0 0
Ankara
Country [76] 0 0
Turkey
State/province [76] 0 0
Inciralti / IZMIR
Country [77] 0 0
Turkey
State/province [77] 0 0
Istanbul
Country [78] 0 0
United Kingdom
State/province [78] 0 0
England
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Newcastle upon Tyne
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Newcastle-Upon-Tyne
Country [83] 0 0
Venezuela
State/province [83] 0 0
Distrito Capital

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00094029