Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [32] 0 0
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
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Duesseldorf
Country [38] 0 0
Germany
State/province [38] 0 0
Koeln
Country [39] 0 0
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
State/province [42] 0 0
Hong Kong
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
India
State/province [44] 0 0
Delhi
Country [45] 0 0
India
State/province [45] 0 0
Maharashtra
Country [46] 0 0
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
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Mexico
State/province [57] 0 0
DF
Country [58] 0 0
Mexico
State/province [58] 0 0
Jalisco
Country [59] 0 0
Netherlands
State/province [59] 0 0
Gr
Country [60] 0 0
Netherlands
State/province [60] 0 0
Leiden
Country [61] 0 0
Norway
State/province [61] 0 0
Oslo
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Singapore
State/province [63] 0 0
Singapore
Country [64] 0 0
Slovakia
State/province [64] 0 0
Bratislava
Country [65] 0 0
Spain
State/province [65] 0 0
Asturias
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00094029
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00094029