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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00075218




Registration number
NCT00075218
Ethics application status
Date submitted
6/01/2004
Date registered
8/01/2004
Date last updated
28/09/2009

Titles & IDs
Public title
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Secondary ID [1] 0 0
A6181004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumor 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)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - SU011248

Placebo comparator: B -

Active comparator: A -


Treatment: Drugs: Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

Treatment: Drugs: SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
Timepoint [1] 0 0
Day 28 of each 6-week cycle : duration of double-blind treatment phase
Primary outcome [2] 0 0
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
Timepoint [2] 0 0
Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Day 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [2] 0 0
Overall Survival Status of Subjects
Timepoint [2] 0 0
clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Secondary outcome [4] 0 0
Overall Survival Based on the Rank Preserving Structural Failure Time Method
Timepoint [4] 0 0
clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Secondary outcome [5] 0 0
Best Overall Tumor Response During Double-blind Treatment Phase
Timepoint [5] 0 0
Day 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [6] 0 0
Confirmed Objective Response (CR or PR) in Subjects
Timepoint [6] 0 0
Day 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [7] 0 0
Time to Tumor Response (TTR)
Timepoint [7] 0 0
Day 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [8] 0 0
Duration of Performance Status Maintenance
Timepoint [8] 0 0
Day 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [9] 0 0
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Timepoint [9] 0 0
Day 1 & 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [10] 0 0
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Timepoint [10] 0 0
Day 1 & 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [11] 0 0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
Timepoint [11] 0 0
Day 1 & 28 of each cycle : duration of double-blind treatment phase
Secondary outcome [12] 0 0
Change From Baseline in EQ-5D Health State Profile Index
Timepoint [12] 0 0
Day 1 & 28 of each cycle : duration of double-blind treatment phase

Eligibility
Key inclusion criteria
Key

* Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
* Failed Gleevec treatment or intolerant to Gleevec therapy

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
Accrual to date
Final
361
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Garran
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Auchenflower
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Ashford
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [7] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
5035 - Ashford
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
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
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Marseille
Country [22] 0 0
France
State/province [22] 0 0
VILLEJUIF Cedex
Country [23] 0 0
Italy
State/province [23] 0 0
PN
Country [24] 0 0
Italy
State/province [24] 0 0
Torino
Country [25] 0 0
Italy
State/province [25] 0 0
Bologna
Country [26] 0 0
Italy
State/province [26] 0 0
Genova
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Netherlands
State/province [28] 0 0
Gr
Country [29] 0 0
Netherlands
State/province [29] 0 0
ZH
Country [30] 0 0
Singapore
State/province [30] 0 0
Singapore
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Switzerland
State/province [33] 0 0
Lausanne
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Surrey
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Leeds
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Newcastle-Upon-Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.
Trial website
https://clinicaltrials.gov/study/NCT00075218
Trial related presentations / publications
Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
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/NCT00075218