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A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors

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ClinicalTrials.gov Identifier: NCT00428597
Recruitment Status : Terminated (Refer to Detailed Description.)
First Posted : January 30, 2007
Results First Posted : October 11, 2010
Last Update Posted : October 11, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Carcinoma, Islet Cell
Carcinoma, Pancreas
Interventions Drug: sunitinib malate
Drug: Placebo
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule. Matching placebo.
Period Title: Overall Study
Started 86 85
Received Treatment 83 82
Completed 0 0
Not Completed 86 85
Reason Not Completed
Randomized but not treated             3             3
Objective Progression or Relapse             19             47
Study Terminated by Sponsor             41             16
Adverse Event             15             7
Global Deterioration of Health Status             1             5
Protocol Violation             2             1
Withdrawal by Subject             2             1
Other             1             1
Lost to Follow-up             0             1
Pregnancy             1             0
Death             1             3
Arm/Group Title Sunitinib Placebo Total
Hide Arm/Group Description Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule. Matching placebo. Total of all reporting groups
Overall Number of Baseline Participants 86 85 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
Between 18 and 44 years 19 17 36
Between 45 and 64 45 45 90
>=65 years 22 23 45
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 85 participants 171 participants
Female
44
  51.2%
45
  52.9%
89
  52.0%
Male
42
  48.8%
40
  47.1%
82
  48.0%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.
Time Frame From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population = all subjects who were randomized.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 86 85
Median (95% Confidence Interval)
Unit of Measure: Months
11.4
(7.4 to 19.8)
5.5
(3.6 to 7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000118
Comments Log-rank test statistic and 2-sided p-value from the unstratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.418
Confidence Interval (2-Sided) 95%
0.263 to 0.662
Estimation Comments Hazard ratio based on the Cox Proportional hazards model
2.Secondary Outcome
Title Number of Subjects With Objective Response
Hide Description Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. No placebo subjects had objective response.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: participants
8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Objective Response Rate (ORR) (percent)
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
4.1 to 17.5
Estimation Comments Confidence interval (CI) using exact method based on binomial distribution.
3.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
Time Frame From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Months
8.1
(1.0 to 15.0)
4.Secondary Outcome
Title Time-to-Tumor Response (TTR)
Hide Description Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.
Time Frame From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Months
3.1
(0.8 to 11.1)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.
Time Frame From start of study treatment up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. The median OS in months could not be calculated for placebo.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Overall Number of Participants Analyzed 86
Median (95% Confidence Interval)
Unit of Measure: months
20.6 [1] 
(20.6 to NA)
[1]
The upper confidence interval was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0204
Comments 2-sided p-value from the unstratified log-rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.409
Confidence Interval (2-Sided) 95%
0.187 to 0.894
Estimation Comments Hazard ratio based on the Cox Proportional hazards model.
6.Secondary Outcome
Title European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=66, 66) 67.0  (20.3) 64.0  (22.7)
Cycle 2 (n=68, 66) 62.1  (19.9) 62.6  (23.6)
Cycle 3 (n=60, 56) 62.6  (20.7) 63.5  (25.1)
Cycle 4 (n=55, 43) 62.0  (21.8) 61.6  (23.3)
Cycle 5 (n=48, 40) 63.5  (21.9) 61.7  (25.4)
Cycle 6 (n=42, 31) 66.9  (22.0) 56.7  (29.8)
Cycle 7 (n=37, 28) 66.2  (23.0) 64.6  (23.4)
Cycle 8 (n=33, 22) 65.9  (23.6) 62.1  (23.2)
Cycle 9 (n=33, 18) 67.2  (19.1) 64.4  (22.1)
Cycle 10 (n=29, 14) 71.0  (20.1) 59.5  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6799
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1543
Confidence Interval (2-Sided) 95%
-4.3 to 6.6
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
7.Secondary Outcome
Title EORTC QLQ-C30 - Cognitive Functioning Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 87.1  (16.6) 87.1  (18.2)
Cycle 2 (n=69, 66) 82.9  (20.0) 78.5  (24.4)
Cycle 3 (n=60, 56) 80.1  (19.9) 80.8  (22.7)
Cycle 4 (n=55, 43) 79.7  (24.2) 82.6  (18.5)
Cycle 5 (n=48, 40) 82.3  (20.2) 82.9  (21.8)
Cycle 6 (n=42, 31) 82.1  (22.5) 82.3  (20.6)
Cycle 7 (n=38, 28) 84.6  (21.0) 88.1  (15.6)
Cycle 8 (n=34, 22) 84.3  (18.3) 79.5  (23.0)
Cycle 9 (n=33, 18) 80.3  (21.8) 83.3  (18.1)
Cycle 10 (n=29, 14) 80.5  (24.0) 85.7  (19.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6058
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4404
Confidence Interval (2-Sided) 95%
-6.9 to 4
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
8.Secondary Outcome
Title EORTC QLQ-C30 - Emotional Functioning Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 75.2  (23.0) 73.7  (26.2)
Cycle 2 (n=69, 66) 76.2  (22.1) 73.1  (27.1)
Cycle 3 (n=60, 56) 75.3  (20.2) 70.8  (25.8)
Cycle 4 (n=55, 43) 72.2  (23.2) 76.9  (22.3)
Cycle 5 (n=48, 40) 72.6  (25.2) 75.8  (23.9)
Cycle 6 (n=42, 31) 77.8  (23.8) 72.8  (28.9)
Cycle 7 (n=38, 28) 75.3  (28.6) 80.8  (19.8)
Cycle 8 (n=34, 22) 74.0  (30.9) 76.7  (21.6)
Cycle 9 (n=33, 18) 75.4  (23.4) 75.8  (30.0)
Cycle 10 (n=29, 14) 76.4  (23.4) 76.2  (20.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3008
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5575
Confidence Interval (2-Sided) 95%
-10.3 to 3.2
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
9.Secondary Outcome
Title EORTC QLQ-C30 - Physical Functioning Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 83.1  (20.5) 83.1  (20.6)
Cycle 2 (n=69, 67) 77.7  (20.5) 77.1  (25.9)
Cycle 3 (n=60, 56) 78.2  (21.6) 75.5  (28.5)
Cycle 4 (n=55, 43) 77.5  (21.3) 78.4  (24.5)
Cycle 5 (n=48, 40) 78.3  (20.2) 80.7  (21.9)
Cycle 6 (n=42, 30) 80.9  (16.3) 81.1  (22.3)
Cycle 7 (n=38, 28) 80.3  (18.8) 78.9  (25.4)
Cycle 8 (n=34, 22) 79.4  (20.7) 73.5  (28.1)
Cycle 9 (n=33, 18) 78.8  (17.0) 79.6  (24.8)
Cycle 10 (n=29, 14) 81.4  (18.9) 78.6  (23.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3230
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.7911
Confidence Interval (2-Sided) 95%
-2.8 to 8.3
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
10.Secondary Outcome
Title EORTC QLQ-C30 - Role Functioning Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 84.3  (23.4) 77.5  (27.7)
Cycle 2 (n=69, 67) 71.6  (28.9) 68.9  (30.6)
Cycle 3 (n=60, 56) 71.0  (26.7) 70.5  (31.0)
Cycle 4 (n=55, 43) 72.1  (28.9) 73.3  (29.6)
Cycle 5 (n=48, 41) 71.5  (27.7) 75.0  (31.4)
Cycle 6 (n=42, 31) 76.6  (26.6) 66.1  (32.6)
Cycle 7 (n=38, 28) 75.7  (28.8) 72.3  (29.7)
Cycle 8 (n=34, 22) 73.0  (29.6) 66.7  (30.9)
Cycle 9 (n=33, 18) 72.2  (24.2) 67.6  (31.6)
Cycle 10 (n=29, 14) 79.9  (22.4) 70.2  (28.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7113
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5113
Confidence Interval (2-Sided) 95%
-6.5 to 9.5
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
11.Secondary Outcome
Title EORTC QLQ-C30 - Social Functioning Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 79.4  (27.2) 77.0  (31.5)
Cycle 2 (n=69, 66) 77.8  (22.1) 75.0  (31.0)
Cycle 3 (n=60, 56) 77.1  (23.1) 77.2  (28.8)
Cycle 4 (n=55, 43) 71.2  (28.4) 79.8  (26.1)
Cycle 5 (n=48, 40) 74.3  (23.8) 77.3  (30.2)
Cycle 6 (n=42, 31) 79.0  (26.3) 74.7  (31.0)
Cycle 7 (n=38, 28) 76.3  (29.2) 83.9  (25.5)
Cycle 8 (n=34, 22) 72.5  (30.4) 74.2  (31.6)
Cycle 9 (n=33, 18) 76.3  (21.7) 74.1  (33.4)
Cycle 10 (n=29, 14) 75.9  (25.8) 81.0  (24.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6487
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.6672
Confidence Interval (2-Sided) 95%
-8.9 to 5.5
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
12.Secondary Outcome
Title EORTC QLQ-C30 - Appetite Loss Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 16.9  (25.5) 18.7  (27.5)
Cycle 2 (n=69, 67) 25.1  (33.0) 20.4  (31.8)
Cycle 3 (n=60, 56) 25.0  (34.5) 23.8  (32.9)
Cycle 4 (n=55, 43) 33.3  (34.5) 22.5  (27.9)
Cycle 5 (n=48, 41) 26.4  (33.7) 24.0  (30.7)
Cycle 6 (n=42, 31) 20.6  (30.3) 23.7  (30.1)
Cycle 7 (n=38, 28) 24.6  (29.7) 19.0  (29.3)
Cycle 8 (n=34, 21) 24.5  (31.0) 30.2  (33.2)
Cycle 9 (n=33, 18) 23.2  (27.0) 22.2  (32.3)
Cycle 10 (n=29, 14) 18.4  (29.0) 21.4  (33.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6545
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.8800
Confidence Interval (2-Sided) 95%
-6.4 to 10.1
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
13.Secondary Outcome
Title EORTC QLQ-C30 - Constipation Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 65) 14.9  (24.8) 14.9  (23.6)
Cycle 2 (n=69, 66) 8.2  (16.6) 13.6  (23.4)
Cycle 3 (n=59, 56) 9.0  (20.4) 18.5  (28.4)
Cycle 4 (n=55, 43) 9.1  (17.5) 14.0  (24.4)
Cycle 5 (n=48, 41) 7.6  (17.2) 15.9  (24.7)
Cycle 6 (n=42, 31) 11.1  (15.9) 14.0  (26.9)
Cycle 7 (n=37, 28) 9.9  (19.0) 10.1  (23.7)
Cycle 8 (n=34, 22) 11.8  (18.1) 18.2  (32.1)
Cycle 9 (n=32, 18) 10.4  (15.7) 18.5  (32.8)
Cycle 10 (n=29, 14) 13.8  (18.9) 16.7  (31.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1936
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.0035
Confidence Interval (2-Sided) 95%
-10 to 2
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
14.Secondary Outcome
Title EORTC QLQ-C30 - Diarrhea Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 20.4  (29.6) 19.2  (28.1)
Cycle 2 (n=69, 66) 37.7  (35.2) 18.2  (27.5)
Cycle 3 (n=60, 56) 34.2  (33.7) 16.7  (26.2)
Cycle 4 (n=55, 43) 38.8  (32.6) 18.6  (27.5)
Cycle 5 (n=47, 40) 42.6  (36.6) 15.0  (25.0)
Cycle 6 (n=42, 31) 38.9  (32.9) 18.3  (28.3)
Cycle 7 (n=38, 28) 41.7  (30.0) 16.7  (29.4)
Cycle 8 (n=33, 22) 43.4  (31.7) 15.9  (26.5)
Cycle 9 (n=33, 18) 40.4  (29.8) 14.8  (20.5)
Cycle 10 (n=29, 14) 40.2  (32.6) 9.5  (15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.3801
Confidence Interval (2-Sided) 95%
14.3 to 28.4
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
15.Secondary Outcome
Title EORTC QLQ-C30 - Dyspnea Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 15.9  (21.2) 19.7  (29.2)
Cycle 2 (n=69, 66) 23.2  (26.4) 22.7  (29.3)
Cycle 3 (n=60, 56) 20.6  (24.6) 20.8  (30.2)
Cycle 4 (n=55, 43) 25.5  (26.4) 22.5  (27.9)
Cycle 5 (n=48, 41) 20.8  (27.2) 16.3  (22.5)
Cycle 6 (n=42, 30) 19.0  (23.4) 15.6  (31.2)
Cycle 7 (n=38, 28) 19.3  (24.1) 19.6  (26.1)
Cycle 8 (n=34, 22) 22.5  (28.1) 21.2  (30.1)
Cycle 9 (n=32, 18) 25.0  (25.4) 18.5  (28.5)
Cycle 10 (n=29, 14) 18.4  (26.1) 16.7  (25.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1339
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.2300
Confidence Interval (2-Sided) 95%
-1.6 to 12.1
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
16.Secondary Outcome
Title EORTC QLQ-C30 - Fatigue Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 29.4  (23.7) 34.5  (26.4)
Cycle 2 (n=69, 67) 44.3  (24.2) 40.1  (30.1)
Cycle 3 (n=60, 56) 41.2  (23.6) 42.3  (32.6)
Cycle 4 (n=55, 43) 41.0  (26.0) 37.0  (29.5)
Cycle 5 (n=48, 41) 34.7  (23.4) 36.3  (31.8)
Cycle 6 (n=42, 31) 34.9  (25.9) 42.3  (33.1)
Cycle 7 (n=38, 28) 36.5  (24.9) 34.9  (27.2)
Cycle 8 (n=34, 22) 39.9  (28.4) 43.2  (33.0)
Cycle 9 (n=33, 18) 37.4  (22.5) 37.7  (27.8)
Cycle 10 (n=29, 14) 33.7  (23.7) 43.7  (30.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6138
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.7816
Confidence Interval (2-Sided) 95%
-5.1 to 8.7
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
17.Secondary Outcome
Title EORTC QLQ-C30 - Financial Difficulties Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 19.9  (32.3) 15.7  (27.6)
Cycle 2 (n=68, 65) 14.2  (26.0) 14.4  (26.3)
Cycle 3 (n=59, 56) 15.8  (25.8) 16.7  (28.4)
Cycle 4 (n=55, 43) 18.2  (27.8) 12.4  (27.2)
Cycle 5 (n=48, 40) 18.1  (28.3) 13.3  (24.8)
Cycle 6 (n=42, 30) 19.0  (29.6) 11.1  (23.7)
Cycle 7 (n=38, 28) 20.2  (33.4) 10.7  (22.3)
Cycle 8 (n=34, 22) 18.6  (32.0) 13.6  (19.7)
Cycle 9 (n=33, 18) 20.2  (26.3) 14.8  (28.5)
Cycle 10 (n=29, 14) 17.2  (29.0) 14.3  (31.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9367
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2778
Confidence Interval (2-Sided) 95%
-6.6 to 7.1
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
18.Secondary Outcome
Title EORTC QLQ-C30 - Insomnia Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 25.4  (29.6) 26.3  (27.7)
Cycle 2 (n=69, 67) 36.7  (35.8) 27.4  (30.7)
Cycle 3 (n=59, 56) 35.6  (30.9) 24.7  (27.2)
Cycle 4 (n=55, 43) 35.2  (33.0) 22.5  (24.9)
Cycle 5 (n=48, 41) 25.0  (26.2) 24.0  (27.4)
Cycle 6 (n=42, 30) 31.0  (32.4) 28.9  (35.8)
Cycle 7 (n=38, 28) 32.9  (35.6) 23.2  (29.2)
Cycle 8 (n=34, 22) 28.4  (34.9) 28.8  (23.7)
Cycle 9 (n=33, 18) 26.3  (32.0) 29.6  (30.0)
Cycle 10 (n=29, 14) 31.0  (34.4) 23.8  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0372
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.7530
Confidence Interval (2-Sided) 95%
0.5 to 15
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
19.Secondary Outcome
Title EORTC QLQ-C30 - Nausea and Vomiting Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 6.7  (12.3) 12.6  (22.1)
Cycle 2 (n=69, 67) 13.0  (19.6) 16.4  (21.8)
Cycle 3 (n=60, 56) 15.8  (22.6) 15.3  (25.4)
Cycle 4 (n=55, 43) 15.8  (21.4) 15.1  (24.1)
Cycle 5 (n=48, 41) 15.6  (25.1) 11.6  (15.9)
Cycle 6 (n=42, 31) 11.5  (16.7) 14.5  (17.6)
Cycle 7 (n=38, 28) 13.8  (19.6) 9.5  (16.0)
Cycle 8 (n=34, 22) 11.8  (22.3) 16.3  (25.0)
Cycle 9 (n=33, 18) 9.6  (16.7) 6.5  (11.6)
Cycle 10 (n=29, 14) 8.6  (14.5) 3.6  (9.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6939
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1463
Confidence Interval (2-Sided) 95%
-4.6 to 6.9
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
20.Secondary Outcome
Title EORTC QLQ-C30 - Pain Subscale
Hide Description EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description:
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
Matching placebo.
Overall Number of Participants Analyzed 73 71
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Cycle 1 (n=67, 66) 22.9  (24.4) 22.5  (28.9)
Cycle 2 (n=69, 67) 29.5  (27.6) 28.6  (34.5)
Cycle 3 (n=60, 56) 28.1  (27.4) 28.7  (32.0)
Cycle 4 (n=55, 43) 25.5  (27.9) 24.0  (28.7)
Cycle 5 (n=48, 41) 26.7  (25.4) 28.0  (32.8)
Cycle 6 (n=42, 31) 25.0  (25.6) 31.2  (34.1)
Cycle 7 (n=38, 28) 23.9  (26.9) 23.5  (25.6)
Cycle 8 (n=34, 22) 23.0  (26.6) 28.0  (33.1)
Cycle 9 (n=33, 18) 25.3  (24.7) 22.2  (32.8)
Cycle 10 (n=29, 14) 17.2  (15.7) 26.2  (26.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Placebo
Comments Cycle 2 through Cycle 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3711
Comments From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.
Method Repeated Measures Mixed-Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5128
Confidence Interval (2-Sided) 95%
-11.2 to 4.2
Estimation Comments Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Placebo
Hide Arm/Group Description Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule. Matching placebo.
All-Cause Mortality
Sunitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/83 (26.51%)   34/82 (41.46%) 
Blood and lymphatic system disorders     
Anaemia  1  1/83 (1.20%)  0/82 (0.00%) 
Leukopenia  1  1/83 (1.20%)  0/82 (0.00%) 
Neutropenia  1  1/83 (1.20%)  0/82 (0.00%) 
Thrombocytopenia  1  1/83 (1.20%)  0/82 (0.00%) 
Cardiac disorders     
Cardiac failure  1  2/83 (2.41%)  0/82 (0.00%) 
Ventricular arrhythmia  1  1/83 (1.20%)  0/82 (0.00%) 
Eye disorders     
Eye disorder  1  1/83 (1.20%)  0/82 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/83 (2.41%)  4/82 (4.88%) 
Abdominal pain upper  1  2/83 (2.41%)  0/82 (0.00%) 
Ascites  1  1/83 (1.20%)  0/82 (0.00%) 
Diarrhoea  1  1/83 (1.20%)  0/82 (0.00%) 
Duodenal ulcer  1  1/83 (1.20%)  1/82 (1.22%) 
Duodenal ulcer perforation  1  0/83 (0.00%)  1/82 (1.22%) 
Erosive duodenitis  1  0/83 (0.00%)  1/82 (1.22%) 
Haematemesis  1  0/83 (0.00%)  2/82 (2.44%) 
Ileus  1  0/83 (0.00%)  1/82 (1.22%) 
Mallory-Weiss syndrome  1  1/83 (1.20%)  0/82 (0.00%) 
Melaena  1  0/83 (0.00%)  2/82 (2.44%) 
Nausea  1  2/83 (2.41%)  1/82 (1.22%) 
Pancreatitis  1  1/83 (1.20%)  0/82 (0.00%) 
Pancreatitis acute  1  0/83 (0.00%)  1/82 (1.22%) 
Rectal haemorrhage  1  0/83 (0.00%)  1/82 (1.22%) 
Varices oesophageal  1  1/83 (1.20%)  0/82 (0.00%) 
Vomiting  1  2/83 (2.41%)  3/82 (3.66%) 
General disorders     
Asthenia  1  0/83 (0.00%)  1/82 (1.22%) 
Disease progression  1  3/83 (3.61%)  2/82 (2.44%) 
Fatigue  1  1/83 (1.20%)  1/82 (1.22%) 
General physical health deterioration  1  1/83 (1.20%)  2/82 (2.44%) 
Hyperthermia  1  1/83 (1.20%)  0/82 (0.00%) 
Inflammation  1  0/83 (0.00%)  1/82 (1.22%) 
Mucosal inflammation  1  1/83 (1.20%)  0/82 (0.00%) 
Multi-organ failure  1  0/83 (0.00%)  1/82 (1.22%) 
Oedema  1  0/83 (0.00%)  1/82 (1.22%) 
Oedema peripheral  1  0/83 (0.00%)  1/82 (1.22%) 
Pyrexia  1  1/83 (1.20%)  2/82 (2.44%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/83 (1.20%)  0/82 (0.00%) 
Cholangitis  1  0/83 (0.00%)  1/82 (1.22%) 
Hepatic failure  1  0/83 (0.00%)  2/82 (2.44%) 
Hepatic function abnormal  1  1/83 (1.20%)  0/82 (0.00%) 
Hepatic pain  1  1/83 (1.20%)  2/82 (2.44%) 
Infections and infestations     
Anal abscess  1  1/83 (1.20%)  0/82 (0.00%) 
Catheter related infection  1  1/83 (1.20%)  0/82 (0.00%) 
Liver abscess  1  0/83 (0.00%)  1/82 (1.22%) 
Pneumonia  1  0/83 (0.00%)  1/82 (1.22%) 
Varicella  1  1/83 (1.20%)  0/82 (0.00%) 
Injury, poisoning and procedural complications     
Accident  1  0/83 (0.00%)  1/82 (1.22%) 
Facial bones fracture  1  0/83 (0.00%)  1/82 (1.22%) 
Humerus fracture  1  0/83 (0.00%)  1/82 (1.22%) 
Joint sprain  1  0/83 (0.00%)  1/82 (1.22%) 
Road traffic accident  1  0/83 (0.00%)  1/82 (1.22%) 
Spinal compression fracture  1  1/83 (1.20%)  0/82 (0.00%) 
Stent occlusion  1  0/83 (0.00%)  1/82 (1.22%) 
Therapeutic agent toxicity  1  0/83 (0.00%)  1/82 (1.22%) 
Traumatic brain injury  1  0/83 (0.00%)  1/82 (1.22%) 
Investigations     
Haemoglobin decreased  1  0/83 (0.00%)  1/82 (1.22%) 
Lipase increased  1  1/83 (1.20%)  0/82 (0.00%) 
Metabolism and nutrition disorders     
Acidosis  1  0/83 (0.00%)  1/82 (1.22%) 
Dehydration  1  0/83 (0.00%)  1/82 (1.22%) 
Hypercalcaemia  1  0/83 (0.00%)  1/82 (1.22%) 
Hyperkalaemia  1  1/83 (1.20%)  0/82 (0.00%) 
Hypoglycaemia  1  0/83 (0.00%)  2/82 (2.44%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/83 (0.00%)  2/82 (2.44%) 
Bone pain  1  1/83 (1.20%)  0/82 (0.00%) 
Neck pain  1  0/83 (0.00%)  1/82 (1.22%) 
Pain in extremity  1  0/83 (0.00%)  1/82 (1.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion  1  0/83 (0.00%)  1/82 (1.22%) 
Nervous system disorders     
Cerebral haematoma  1  1/83 (1.20%)  0/82 (0.00%) 
Cerebrovascular accident  1  0/83 (0.00%)  1/82 (1.22%) 
Convulsion  1  0/83 (0.00%)  1/82 (1.22%) 
Headache  1  1/83 (1.20%)  0/82 (0.00%) 
Hepatic encephalopathy  1  1/83 (1.20%)  1/82 (1.22%) 
Leukoencephalopathy  1  1/83 (1.20%)  0/82 (0.00%) 
Somnolence  1  0/83 (0.00%)  1/82 (1.22%) 
Renal and urinary disorders     
Renal failure  1  2/83 (2.41%)  0/82 (0.00%) 
Renal failure acute  1  0/83 (0.00%)  1/82 (1.22%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/83 (1.20%)  0/82 (0.00%) 
Haemoptysis  1  1/83 (1.20%)  0/82 (0.00%) 
Pleurisy  1  0/83 (0.00%)  1/82 (1.22%) 
Pulmonary embolism  1  0/83 (0.00%)  2/82 (2.44%) 
Vascular disorders     
Deep vein thrombosis  1  0/83 (0.00%)  1/82 (1.22%) 
Hypertension  1  1/83 (1.20%)  0/82 (0.00%) 
Hypotension  1  0/83 (0.00%)  2/82 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   80/83 (96.39%)   70/82 (85.37%) 
Blood and lymphatic system disorders     
Anaemia  1  4/83 (4.82%)  8/82 (9.76%) 
Leukopenia  1  8/83 (9.64%)  1/82 (1.22%) 
Neutropenia  1  23/83 (27.71%)  3/82 (3.66%) 
Thrombocytopenia  1  13/83 (15.66%)  4/82 (4.88%) 
Endocrine disorders     
Hypothyroidism  1  6/83 (7.23%)  1/82 (1.22%) 
Eye disorders     
Eyelid oedema  1  6/83 (7.23%)  0/82 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  23/83 (27.71%)  23/82 (28.05%) 
Abdominal pain upper  1  10/83 (12.05%)  6/82 (7.32%) 
Aphthous stomatitis  1  5/83 (6.02%)  2/82 (2.44%) 
Constipation  1  12/83 (14.46%)  16/82 (19.51%) 
Diarrhoea  1  48/83 (57.83%)  32/82 (39.02%) 
Dry mouth  1  7/83 (8.43%)  5/82 (6.10%) 
Dyspepsia  1  12/83 (14.46%)  5/82 (6.10%) 
Flatulence  1  5/83 (6.02%)  2/82 (2.44%) 
Gingival bleeding  1  7/83 (8.43%)  0/82 (0.00%) 
Haemorrhoids  1  5/83 (6.02%)  0/82 (0.00%) 
Nausea  1  36/83 (43.37%)  24/82 (29.27%) 
Oral pain  1  5/83 (6.02%)  0/82 (0.00%) 
Stomatitis  1  18/83 (21.69%)  2/82 (2.44%) 
Vomiting  1  28/83 (33.73%)  24/82 (29.27%) 
General disorders     
Asthenia  1  28/83 (33.73%)  22/82 (26.83%) 
Chest pain  1  5/83 (6.02%)  5/82 (6.10%) 
Chills  1  8/83 (9.64%)  2/82 (2.44%) 
Fatigue  1  27/83 (32.53%)  21/82 (25.61%) 
Mucosal inflammation  1  13/83 (15.66%)  6/82 (7.32%) 
Oedema  1  5/83 (6.02%)  2/82 (2.44%) 
Oedema peripheral  1  10/83 (12.05%)  11/82 (13.41%) 
Pyrexia  1  9/83 (10.84%)  7/82 (8.54%) 
Infections and infestations     
Urinary tract infection  1  6/83 (7.23%)  3/82 (3.66%) 
Investigations     
Blood alkaline phosphatase increased  1  3/83 (3.61%)  6/82 (7.32%) 
Weight decreased  1  13/83 (15.66%)  9/82 (10.98%) 
Metabolism and nutrition disorders     
Anorexia  1  18/83 (21.69%)  17/82 (20.73%) 
Decreased appetite  1  5/83 (6.02%)  4/82 (4.88%) 
Hypoalbuminaemia  1  2/83 (2.41%)  7/82 (8.54%) 
Hypoglycaemia  1  8/83 (9.64%)  2/82 (2.44%) 
Hypokalaemia  1  5/83 (6.02%)  2/82 (2.44%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/83 (14.46%)  5/82 (6.10%) 
Back pain  1  10/83 (12.05%)  14/82 (17.07%) 
Muscle spasms  1  5/83 (6.02%)  4/82 (4.88%) 
Musculoskeletal pain  1  6/83 (7.23%)  8/82 (9.76%) 
Pain in extremity  1  8/83 (9.64%)  5/82 (6.10%) 
Nervous system disorders     
Dizziness  1  5/83 (6.02%)  5/82 (6.10%) 
Dysgeusia  1  17/83 (20.48%)  4/82 (4.88%) 
Headache  1  15/83 (18.07%)  11/82 (13.41%) 
Psychiatric disorders     
Depression  1  2/83 (2.41%)  5/82 (6.10%) 
Insomnia  1  15/83 (18.07%)  10/82 (12.20%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/83 (8.43%)  7/82 (8.54%) 
Dyspnoea  1  10/83 (12.05%)  12/82 (14.63%) 
Epistaxis  1  17/83 (20.48%)  4/82 (4.88%) 
Oropharyngeal pain  1  6/83 (7.23%)  2/82 (2.44%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  5/83 (6.02%)  1/82 (1.22%) 
Dry skin  1  12/83 (14.46%)  9/82 (10.98%) 
Erythema  1  8/83 (9.64%)  4/82 (4.88%) 
Hair colour changes  1  24/83 (28.92%)  1/82 (1.22%) 
Hyperhidrosis  1  3/83 (3.61%)  6/82 (7.32%) 
Nail disorder  1  8/83 (9.64%)  1/82 (1.22%) 
Palmar-plantar erythrodysaesthesia syndrome  1  19/83 (22.89%)  2/82 (2.44%) 
Pruritus  1  4/83 (4.82%)  9/82 (10.98%) 
Rash  1  15/83 (18.07%)  4/82 (4.88%) 
Yellow skin  1  6/83 (7.23%)  0/82 (0.00%) 
Vascular disorders     
Hypertension  1  22/83 (26.51%)  4/82 (4.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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 < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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.govCallCenter@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00428597     History of Changes
Other Study ID Numbers: A6181111
First Submitted: January 29, 2007
First Posted: January 30, 2007
Results First Submitted: April 15, 2010
Results First Posted: October 11, 2010
Last Update Posted: October 11, 2010