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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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
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Secondary ID [1]
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A6181004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumor
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Condition category
Condition code
Cancer
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Stomach
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Cancer
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Bowel - Small bowel (duodenum and ileum)
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
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Assessment method [1]
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Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
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Timepoint [1]
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Day 28 of each 6-week cycle : duration of double-blind treatment phase
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Primary outcome [2]
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Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
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Assessment method [2]
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Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
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Timepoint [2]
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Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).
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Timepoint [1]
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Day 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [2]
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Overall Survival Status of Subjects
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Assessment method [2]
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Number of subjects alive at end of study.
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Timepoint [2]
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clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Time from date of randomization to date of death due to any cause.
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Timepoint [3]
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clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
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Secondary outcome [4]
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Overall Survival Based on the Rank Preserving Structural Failure Time Method
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Assessment method [4]
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time from date of randomization to date of death due to any cause (rank preserving structural failure time method).
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Timepoint [4]
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clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
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Secondary outcome [5]
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Best Overall Tumor Response During Double-blind Treatment Phase
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Assessment method [5]
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Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).
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Timepoint [5]
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Day 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [6]
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Confirmed Objective Response (CR or PR) in Subjects
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Assessment method [6]
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Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study = 4 weeks after initial documentation of response.
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Timepoint [6]
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Day 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [7]
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Time to Tumor Response (TTR)
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Assessment method [7]
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Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.
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Timepoint [7]
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Day 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [8]
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Duration of Performance Status Maintenance
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Assessment method [8]
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Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.
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Timepoint [8]
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Day 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [9]
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Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
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Assessment method [9]
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25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)
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Timepoint [9]
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Day 1 & 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [10]
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Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
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Assessment method [10]
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MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.
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Timepoint [10]
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Day 1 & 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [11]
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Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
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Assessment method [11]
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Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
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Timepoint [11]
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Day 1 & 28 of each cycle : duration of double-blind treatment phase
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Secondary outcome [12]
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Change From Baseline in EQ-5D Health State Profile Index
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Assessment method [12]
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Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.
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Timepoint [12]
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Day 1 & 28 of each cycle : duration of double-blind treatment phase
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
investigational agent since the last dose of Gleevec
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2008
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Sample size
Target
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Accrual to date
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Final
361
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Garran
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Recruitment hospital [2]
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Pfizer Investigational Site - Camperdown
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Recruitment hospital [3]
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Pfizer Investigational Site - Randwick
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Recruitment hospital [4]
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Pfizer Investigational Site - Auchenflower
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Recruitment hospital [5]
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Pfizer Investigational Site - Ashford
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Recruitment hospital [6]
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Pfizer Investigational Site - Bedford Park
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Recruitment hospital [7]
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Pfizer Investigational Site - East Melbourne
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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4066 - Auchenflower
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Recruitment postcode(s) [5]
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5035 - Ashford
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Recruitment postcode(s) [6]
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5042 - Bedford Park
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Recruitment postcode(s) [7]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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District of Columbia
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Florida
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Illinois
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Leuven
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Ontario
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Lyon
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France
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Torino
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Milano
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Gr
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Singapore
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Barcelona
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Madrid
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Switzerland
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Lausanne
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Surrey
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Leeds
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London
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United Kingdom
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State/province [37]
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Newcastle-Upon-Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00075218
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00075218
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