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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
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United States of America
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Illinois
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United States of America
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Massachusetts
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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New York
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North Carolina
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Oregon
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Argentina
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Burnos Aires
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Austria
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Graz
Country [17] 0 0
Austria
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Wien
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Chile
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RM
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Colombia
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Cundinamarca
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Czech Republic
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Brno
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Czech Republic
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Praha 5
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Denmark
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Aarhus C
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Denmark
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Herlev
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Finland
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Helsinki
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France
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Bordeaux Cedex
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France
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Lyon
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France
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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
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Koeln
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Germany
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Muenchen
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Greece
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Thessaloniki
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Hong Kong
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Happy Valley
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Hong Kong
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Hong Kong
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Hungary
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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
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Tamil Nadu
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Italy
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Aviano (PN)
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Italy
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Aviano, PN
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Italy
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Bologna
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Italy
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Candiolo (TO)
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Italy
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Genova
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Italy
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Milano
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Italy
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Torino
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Korea, Republic of
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Seoul
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Mexico
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DF
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Mexico
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Jalisco
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Netherlands
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Gr
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Netherlands
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Leiden
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Norway
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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
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Switzerland
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Lausanne
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Taipei
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Thailand
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Bangkok
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Turkey
State/province [75] 0 0
Ankara
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Turkey
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Inciralti / IZMIR
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Turkey
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Istanbul
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United Kingdom
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England
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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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/study/NCT00094029
Trial related presentations / 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. doi: 10.1002/cncr.31929.
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.
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/study/NCT00094029