A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00075218
First received: January 6, 2004
Last updated: August 31, 2009
Last verified: August 2009
Results First Received: May 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Interventions: Drug: Placebo
Drug: SU011248

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sunitinib Double-Blind Treatment Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Total Total of all reporting groups

Baseline Measures
    Sunitinib Double-Blind Treatment     Placebo Double-Blind Treatment     Total  
Number of Participants  
[units: participants]
  243     118     361  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     170     81     251  
>=65 years     73     37     110  
Gender  
[units: participants]
     
Female     91     71     162  
Male     152     47     199  



  Outcome Measures
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1.  Primary:   Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase   [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase ]

2.  Primary:   Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study   [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]

4.  Secondary:   Overall Survival Status of Subjects   [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

5.  Secondary:   Overall Survival   [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

6.  Secondary:   Overall Survival Based on the Rank Preserving Structural Failure Time Method   [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]

7.  Secondary:   Best Overall Tumor Response During Double-blind Treatment Phase   [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]

8.  Secondary:   Confirmed Objective Response (CR or PR) in Subjects   [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]

9.  Secondary:   Time to Tumor Response (TTR)   [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]

10.  Secondary:   Duration of Performance Status Maintenance   [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]

11.  Secondary:   Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)   [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

12.  Secondary:   Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)   [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

13.  Secondary:   Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)   [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]

14.  Secondary:   Change From Baseline in EQ-5D Health State Profile Index   [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Duration of Tumor Response could not be reliably estimated at the time of analysis.


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