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

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ClinicalTrials.gov Identifier: NCT00075218
Recruitment Status : Completed
First Posted : January 8, 2004
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumor
Interventions: Drug: Placebo
Drug: SU011248

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began (medical clinic) in December 2003. Study was unblinded on 27 January 2005 (end of Double-blind treatment). Subjects experiencing disease progression could crossover to Open-label treatment. Open-label data collection ended May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

361 subjects randomized to double-blind treatment in 2:1 ratio (sunitinib vs. Placebo).

255 subjects continued on or crossed over to Open-label treatment.

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.
Sunitinib Open-Label Treatment Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.

Participant Flow for 2 periods

 Period 1:   Double-Blind Treatment
    Sunitinib Double-Blind Treatment   Placebo Double-Blind Treatment   Sunitinib Open-Label Treatment
STARTED   243 [1]   118 [1]   0 
Received Double-Blind Treatment   228 [2]   114 [2]   0 
Crossed Over to Open-Label Treatment   152   103   0 
COMPLETED   152 [3]   103 [3]   0 
NOT COMPLETED   91   15   0 
Adverse Event                23                4                0 
Withdrawal by Subject                7                4                0 
Lost to Follow-up                1                0                0 
Lack of Efficacy                58                6                0 
Decision of Sponsor                0                1                0 
No study medication taken                2                0                0 
[1] Intent To Treat Population (ITT)
[2] As Treated Population (AT)
[3] Defined:subjects completed double-blind treatment phase and/or entered open-label treatment phase.

Period 2:   Open-Label Treatment
    Sunitinib Double-Blind Treatment   Placebo Double-Blind Treatment   Sunitinib Open-Label Treatment
STARTED   0   0   255 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   255 
Lack of Efficacy                0                0                174 
Adverse Event                0                0                51 
Withdrawal by Subject                0                0                12 
Decision of Sponsor                0                0                8 
Protocol Violation                0                0                1 
enrolled in a separate continuation                0                0                9 



  Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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

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

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

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

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 ]
  Hide Outcome Measure 11

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

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.
Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.

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.

Measured Values
   Sunitinib Double-Blind Treatment   Placebo Double-Blind Treatment 
Participants Analyzed 
[Units: Participants]
 		 37   0 
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) 
[Units: Weeks (25th Quartile)]
Median (95% Confidence Interval) 		 12.1 
 (6.1 to 27.1)  		  


Statistical Analysis 1 for Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.9322
Hazard Ratio (HR) [5] 0.972
95% Confidence Interval 0.508 to 1.860
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  2-sided, unstratified log-rank test
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information