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Trial record 1 of 1 for:    NCT00372567
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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

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ClinicalTrials.gov Identifier: NCT00372567
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 7, 2006
Results First Posted : December 31, 2010
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumor
Interventions Drug: sunitinib malate
Drug: imatinib mesylate
Enrollment 69
Recruitment Details  
Pre-assignment Details 12 participants were enrolled in a lead-in Phase 1 safety sub-study, all of whom received Sunitinib 37.5 milligram (mg) 24 hours after the last dose of imatinib. No efficacy evaluations were planned/conducted for this sub-study.
Arm/Group Title Sunitinib (Phase 3) Imatinib Sunitinib (Phase 1)
Hide Arm/Group Description Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD. Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD. Single 37.5 mg dose administered 24 hours after the last dose of imatinib
Period Title: Phase 1 Sub-study
Started 0 0 12
Completed 0 0 12
Not Completed 0 0 0
Period Title: Phase 3 Study
Started 31 26 12
Received Treatment 31 25 12
Completed 0 0 0
Not Completed 31 26 12
Reason Not Completed
Adverse Event             5             1             1
Death             1             1             0
Protocol Violation             0             0             1
Objective progression or relapse             10             13             4
Global deterioration of health status             0             1             0
Other             2             2             1
study terminated by sponsor             13             8             5
Arm/Group Title Sunitinib (Phase 3) Imatinib Sunitinib (Phase 1) Total
Hide Arm/Group Description Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD. Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD. Single 37.5 mg dose administered 24 hours after the last dose of imatinib Total of all reporting groups
Overall Number of Baseline Participants 31 26 12 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 26 participants 12 participants 69 participants
less than 65 years 19 17 7 43
greater than or equal to 65 years 12 9 5 26
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 26 participants 12 participants 69 participants
Female
11
  35.5%
11
  42.3%
5
  41.7%
27
  39.1%
Male
20
  64.5%
15
  57.7%
7
  58.3%
42
  60.9%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
Time Frame Baseline, Week 5, and every 8 weeks until Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).
Arm/Group Title Sunitinib Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 13 15
Median (95% Confidence Interval)
Unit of Measure: Months
8.6
(5.7 to 9.0)
6.4
(4.5 to 15.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Imatinib
Comments No hypothesis tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.040
Confidence Interval (2-Sided) 95%
0.484 to 2.235
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 31 26
Median (95% Confidence Interval)
Unit of Measure: Months
12.9
(10.7 to 12.9)
NA [1] 
(NA to NA)
[1]
The estimate of median OS in the Imatinib Treatment Arm was not available (NA) because data was not mature.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.818
Confidence Interval (2-Sided) 95%
0.640 to 12.41
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Pain Relief Response (TTPR)
Hide Description Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 31 26
Median (95% Confidence Interval)
Unit of Measure: Days
34.0
(11.0 to 57.0)
22.0
(8.0 to 113.0)
4.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants with treatment failure.
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 16 17
Median (95% Confidence Interval)
Unit of Measure: Months
8.2
(5.5 to 9.0)
6.3
(4.5 to 8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.027
Confidence Interval (2-Sided) 95%
0.505 to 2.088
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Objective Response of Complete Response or Partial Response
Hide Description Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 31 26
Measure Type: Number
Unit of Measure: Participants
5 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.308
Confidence Interval (2-Sided) 95%
0.4 to 13.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to Tumor Response (TTR)
Hide Description Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 31 26
Median (95% Confidence Interval)
Unit of Measure: Weeks
4.1
(3.6 to 20.1)
40.1
(5.4 to 74.7)
7.Secondary Outcome
Title Duration of Response (DR)
Hide Description

Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.

Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 5 2
Median (Full Range)
Unit of Measure: Weeks
18.3
(7.9 to 24.1)
19.8
(6.7 to 32.9)
8.Secondary Outcome
Title Time to Pain Progression (TTPP)
Hide Description TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants with an event.
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 14 10
Median (95% Confidence Interval)
Unit of Measure: Days
22.0
(8.0 to 29.0)
99.0
(8.0 to 134.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cox Proportional Hazards Model
Comments Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.434
Confidence Interval (2-Sided) 95%
1.057 to 11.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Pain Relief Response
Hide Description Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 7 10
Measure Type: Number
Unit of Measure: Participants
2 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.379
Confidence Interval (2-Sided) 95%
0.1 to 2.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Pain Progression
Hide Description Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Time Frame Day 28 of Cycle 1 up to 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.
Arm/Group Title Sunitinib (Phase 3) Imatinib
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Participants
14 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib (Phase 3), Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.318
Confidence Interval (2-Sided) 95%
0.5 to 3.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Time Frame Days 1 and 28 of each cycle
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
Arm/Group Title Sunitinib (Phase 3)
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Cycle 1 (n=30) 0.90  (0.159)
Cycle 2 (n=27) 0.84  (0.196)
Cycle 3 (n=21) 0.84  (0.130)
Cycle 4 (n=23) 0.85  (0.186)
Cycle 5 (n=16) 0.89  (0.133)
Cycle 6 (n=16) 0.90  (0.120)
Cycle 7 (n=12) 0.84  (0.182)
Cycle 8 (n=11) 0.83  (0.168)
Cycle 9 (n=6) 0.76  (0.149)
Cycle 10 (n=5) 0.78  (0.128)
Cycle 11 (n=3) 0.83  (0.157)
Cycle 12 (n=2) 0.93  (0.106)
12.Secondary Outcome
Title Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
Hide Description EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Time Frame Days 1 and 28 of each cycle
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
Arm/Group Title Sunitinib (Phase 3)
Hide Arm/Group Description:
Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Cycle 1 (n=30) 78.13  (23.80)
Cycle 2 (n=27) 77.19  (19.98)
Cycle 3 (n=21) 78.52  (14.24)
Cycle 4 (n=23) 80.17  (14.28)
Cycle 5 (n=16) 84.25  (12.30)
Cycle 6 (n=16) 85.81  (13.25)
Cycle 7 (n=12) 78.25  (15.91)
Cycle 8 (n=11) 84.73  (12.71)
Cycle 9 (n=7) 82.57  (14.30)
Cycle 10 (n=6) 81.00  (12.59)
Cycle 11 (n=3) 81.00  (14.93)
Cycle 12 (n=2) 86.50  (16.26)
13.Secondary Outcome
Title Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
Hide Description EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Time Frame Days 1 and 28 of each cycle
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
Arm/Group Title Imatinib
Hide Arm/Group Description:
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Cycle 1 (n=22) 0.80  (0.117)
Cycle 2 (n=23) 0.85  (0.135)
Cycle 3 (n=18) 0.82  (0.162)
Cycle 4 (n=18) 0.86  (0.143)
Cycle 5 (n=17) 0.83  (0.217)
Cycle 6 (n=12) 0.84  (0.157)
Cycle 7 (n=12) 0.81  (0.260)
Cycle 8 ( (n=11) 0.68  (0.292)
Cycle 9 (n=7) 0.86  (0.105)
Cycle 10 (n=7) 0.86  (0.104)
Cycle 11 (n=3) 0.88  (0.106)
14.Secondary Outcome
Title Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
Hide Description EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Time Frame Days 1 and 28 of each cycle
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.
Arm/Group Title Imatinib
Hide Arm/Group Description:
Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Cycle 1 (n=22) 75.41  (16.60)
Cycle 2 (n=22) 73.64  (14.61)
Cycle 3 (n=20) 72.85  (15.24)
Cycle 4 (n=18) 76.14  (15.78)
Cycle 5 (n=15) 68.93  (12.82)
Cycle 6 (n=11) 68.27  (15.10)
Cycle 7 (n=12) 67.08  (18.08)
Cycle 8 (n=10) 63.70  (19.23)
Cycle 9 (n=7) 74.64  (13.26)
Cycle 10 (n=7) 76.86  (8.009)
Cycle 11 (n=3) 75.33  (5.508)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
 
Arm/Group Title All Participants Who Received Sunitinib Imatinib
Hide Arm/Group Description Participants in Phase 1 sub- study and Phase 3 study All participants who received Imatinib
All-Cause Mortality
All Participants Who Received Sunitinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
All Participants Who Received Sunitinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   11/43 (25.58%)   5/25 (20.00%) 
Cardiac disorders     
Myocardial infarction  1  0/43 (0.00%)  1/25 (4.00%) 
Tachycardia  1  0/43 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/43 (0.00%)  1/25 (4.00%) 
Abdominal pain  1  0/43 (0.00%)  1/25 (4.00%) 
Constipation  1  0/43 (0.00%)  1/25 (4.00%) 
Diarrhoea  1  2/43 (4.65%)  0/25 (0.00%) 
Intestinal obstruction  1  1/43 (2.33%)  0/25 (0.00%) 
Nausea  1  1/43 (2.33%)  0/25 (0.00%) 
Peritonitis  1  0/43 (0.00%)  1/25 (4.00%) 
Rectal haemorrhage  1  1/43 (2.33%)  0/25 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/43 (0.00%)  1/25 (4.00%) 
Vomiting  1  2/43 (4.65%)  1/25 (4.00%) 
General disorders     
Disease progression  1  1/43 (2.33%)  0/25 (0.00%) 
Pyrexia  1  1/43 (2.33%)  0/25 (0.00%) 
Infections and infestations     
Lower respiratory tract infection  1  1/43 (2.33%)  0/25 (0.00%) 
Lung infection  1  0/43 (0.00%)  1/25 (4.00%) 
Pyelonephritis  1  1/43 (2.33%)  0/25 (0.00%) 
Investigations     
Haemoglobin decreased  1  0/43 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Muscle haemorrhage  1  1/43 (2.33%)  0/25 (0.00%) 
Nervous system disorders     
Sciatica  1  1/43 (2.33%)  0/25 (0.00%) 
Renal and urinary disorders     
Renal impairment  1  0/43 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/43 (2.33%)  1/25 (4.00%) 
Pulmonary embolism  1  3/43 (6.98%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants Who Received Sunitinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   43/43 (100.00%)   23/25 (92.00%) 
Blood and lymphatic system disorders     
Anaemia  1  5/43 (11.63%)  2/25 (8.00%) 
Neutropenia  1  9/43 (20.93%)  2/25 (8.00%) 
Thrombocytopenia  1  8/43 (18.60%)  0/25 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  3/43 (6.98%)  1/25 (4.00%) 
Eye disorders     
Eyelid oedema  1  0/43 (0.00%)  2/25 (8.00%) 
Lacrimation increased  1  1/43 (2.33%)  2/25 (8.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/43 (4.65%)  3/25 (12.00%) 
Abdominal distension  1  3/43 (6.98%)  4/25 (16.00%) 
Abdominal pain  1  6/43 (13.95%)  3/25 (12.00%) 
Abdominal pain upper  1  4/43 (9.30%)  3/25 (12.00%) 
Constipation  1  5/43 (11.63%)  4/25 (16.00%) 
Diarrhoea  1  19/43 (44.19%)  8/25 (32.00%) 
Dyspepsia  1  6/43 (13.95%)  1/25 (4.00%) 
Flatulence  1  3/43 (6.98%)  0/25 (0.00%) 
Glossodynia  1  5/43 (11.63%)  0/25 (0.00%) 
Nausea  1  12/43 (27.91%)  9/25 (36.00%) 
Oral pain  1  3/43 (6.98%)  0/25 (0.00%) 
Stomatitis  1  5/43 (11.63%)  1/25 (4.00%) 
Vomiting  1  6/43 (13.95%)  6/25 (24.00%) 
General disorders     
Asthenia  1  5/43 (11.63%)  2/25 (8.00%) 
Face oedema  1  1/43 (2.33%)  2/25 (8.00%) 
Fatigue  1  13/43 (30.23%)  8/25 (32.00%) 
Feeling cold  1  0/43 (0.00%)  2/25 (8.00%) 
Mucosal inflammation  1  15/43 (34.88%)  0/25 (0.00%) 
Oedema  1  0/43 (0.00%)  5/25 (20.00%) 
Oedema peripheral  1  4/43 (9.30%)  5/25 (20.00%) 
Pyrexia  1  5/43 (11.63%)  2/25 (8.00%) 
Infections and infestations     
Upper respiratory tract infection  1  0/43 (0.00%)  2/25 (8.00%) 
Investigations     
Electrocardiogram QT prolonged  1  0/43 (0.00%)  2/25 (8.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  7/43 (16.28%)  3/25 (12.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/43 (6.98%)  0/25 (0.00%) 
Myalgia  1  5/43 (11.63%)  0/25 (0.00%) 
Pain in extremity  1  3/43 (6.98%)  2/25 (8.00%) 
Nervous system disorders     
Dysgeusia  1  9/43 (20.93%)  0/25 (0.00%) 
Headache  1  6/43 (13.95%)  2/25 (8.00%) 
Lethargy  1  3/43 (6.98%)  1/25 (4.00%) 
Psychiatric disorders     
Insomnia  1  3/43 (6.98%)  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/43 (6.98%)  2/25 (8.00%) 
Oropharyngeal pain  1  3/43 (6.98%)  0/25 (0.00%) 
Pleural effusion  1  0/43 (0.00%)  3/25 (12.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/43 (6.98%)  1/25 (4.00%) 
Blister  1  4/43 (9.30%)  0/25 (0.00%) 
Dry skin  1  1/43 (2.33%)  3/25 (12.00%) 
Hair colour changes  1  3/43 (6.98%)  0/25 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  16/43 (37.21%)  0/25 (0.00%) 
Periorbital oedema  1  0/43 (0.00%)  4/25 (16.00%) 
Pruritus  1  1/43 (2.33%)  4/25 (16.00%) 
Rash  1  8/43 (18.60%)  4/25 (16.00%) 
Yellow skin  1  3/43 (6.98%)  0/25 (0.00%) 
Vascular disorders     
Flushing  1  3/43 (6.98%)  1/25 (4.00%) 
Hypertension  1  16/43 (37.21%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
On 18 June 2009, the study was prematurely stopped for operational reasons (poor recruitment, lack of interest, and change of clinical practice) and not related to safety concerns
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00372567    
Other Study ID Numbers: A6181112
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: October 27, 2010
Results First Posted: December 31, 2010
Last Update Posted: March 17, 2011