Trial Outcomes & Findings for A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors (NCT NCT00428597)
NCT ID: NCT00428597
Last Updated: 2010-10-11
Results Overview
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.
TERMINATED
PHASE3
171 participants
From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death
2010-10-11
Participant Flow
Participant milestones
| Measure |
Sunitinib
Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
Received Treatment
|
83
|
82
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
86
|
85
|
Reasons for withdrawal
| Measure |
Sunitinib
Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
3
|
3
|
|
Overall Study
Objective Progression or Relapse
|
19
|
47
|
|
Overall Study
Study Terminated by Sponsor
|
41
|
16
|
|
Overall Study
Adverse Event
|
15
|
7
|
|
Overall Study
Global Deterioration of Health Status
|
1
|
5
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
Baseline characteristics by cohort
| Measure |
Sunitinib
n=86 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=85 Participants
Matching placebo.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 44 years
|
19 participants
n=93 Participants
|
17 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Age, Customized
Between 45 and 64
|
45 participants
n=93 Participants
|
45 participants
n=4 Participants
|
90 participants
n=27 Participants
|
|
Age, Customized
>=65 years
|
22 participants
n=93 Participants
|
23 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or deathPopulation: Intent-to-treat (ITT) population = all subjects who were randomized.
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.
Outcome measures
| Measure |
Sunitinib
n=86 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=85 Participants
Matching placebo.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.4 Months
Interval 7.4 to 19.8
|
5.5 Months
Interval 3.6 to 7.4
|
SECONDARY outcome
Timeframe: From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafterPopulation: ITT. No placebo subjects had objective response.
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.
Outcome measures
| Measure |
Sunitinib
n=86 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Number of Subjects With Objective Response
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any causePopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=8 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Duration of Response (DR)
|
8.1 Months
Interval 1.0 to 15.0
|
—
|
SECONDARY outcome
Timeframe: From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafterPopulation: 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.
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.
Outcome measures
| Measure |
Sunitinib
n=8 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Time-to-Tumor Response (TTR)
|
3.1 Months
Interval 0.8 to 11.1
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 22 monthsPopulation: ITT. The median OS in months could not be calculated for placebo.
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.
Outcome measures
| Measure |
Sunitinib
n=86 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
Matching placebo.
|
|---|---|---|
|
Overall Survival (OS)
|
20.6 months
Interval 20.6 to
The upper confidence interval was not reached.
|
—
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 1 (n=66, 66)
|
67.0 scores on a scale
Standard Deviation 20.3 • Interval 58.7 to 66.1
|
64.0 scores on a scale
Standard Deviation 22.7 • Interval 57.2 to 65.3
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 2 (n=68, 66)
|
62.1 scores on a scale
Standard Deviation 19.9
|
62.6 scores on a scale
Standard Deviation 23.6
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 3 (n=60, 56)
|
62.6 scores on a scale
Standard Deviation 20.7
|
63.5 scores on a scale
Standard Deviation 25.1
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 4 (n=55, 43)
|
62.0 scores on a scale
Standard Deviation 21.8
|
61.6 scores on a scale
Standard Deviation 23.3
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 5 (n=48, 40)
|
63.5 scores on a scale
Standard Deviation 21.9
|
61.7 scores on a scale
Standard Deviation 25.4
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 6 (n=42, 31)
|
66.9 scores on a scale
Standard Deviation 22.0
|
56.7 scores on a scale
Standard Deviation 29.8
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 7 (n=37, 28)
|
66.2 scores on a scale
Standard Deviation 23.0
|
64.6 scores on a scale
Standard Deviation 23.4
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 8 (n=33, 22)
|
65.9 scores on a scale
Standard Deviation 23.6
|
62.1 scores on a scale
Standard Deviation 23.2
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 9 (n=33, 18)
|
67.2 scores on a scale
Standard Deviation 19.1
|
64.4 scores on a scale
Standard Deviation 22.1
|
|
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Cycle 10 (n=29, 14)
|
71.0 scores on a scale
Standard Deviation 20.1
|
59.5 scores on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 2 (n=69, 66)
|
82.9 scores on a scale
Standard Deviation 20.0
|
78.5 scores on a scale
Standard Deviation 24.4
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 6 (n=42, 31)
|
82.1 scores on a scale
Standard Deviation 22.5
|
82.3 scores on a scale
Standard Deviation 20.6
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 1 (n=67, 66)
|
87.1 scores on a scale
Standard Deviation 16.6
|
87.1 scores on a scale
Standard Deviation 18.2
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 3 (n=60, 56)
|
80.1 scores on a scale
Standard Deviation 19.9
|
80.8 scores on a scale
Standard Deviation 22.7
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 4 (n=55, 43)
|
79.7 scores on a scale
Standard Deviation 24.2
|
82.6 scores on a scale
Standard Deviation 18.5
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 5 (n=48, 40)
|
82.3 scores on a scale
Standard Deviation 20.2
|
82.9 scores on a scale
Standard Deviation 21.8
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 7 (n=38, 28)
|
84.6 scores on a scale
Standard Deviation 21.0
|
88.1 scores on a scale
Standard Deviation 15.6
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 8 (n=34, 22)
|
84.3 scores on a scale
Standard Deviation 18.3
|
79.5 scores on a scale
Standard Deviation 23.0
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 9 (n=33, 18)
|
80.3 scores on a scale
Standard Deviation 21.8
|
83.3 scores on a scale
Standard Deviation 18.1
|
|
EORTC QLQ-C30 - Cognitive Functioning Subscale
Cycle 10 (n=29, 14)
|
80.5 scores on a scale
Standard Deviation 24.0
|
85.7 scores on a scale
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 9 (n=33, 18)
|
75.4 scores on a scale
Standard Deviation 23.4
|
75.8 scores on a scale
Standard Deviation 30.0
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 10 (n=29, 14)
|
76.4 scores on a scale
Standard Deviation 23.4
|
76.2 scores on a scale
Standard Deviation 20.4
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 1 (n=67, 66)
|
75.2 scores on a scale
Standard Deviation 23.0
|
73.7 scores on a scale
Standard Deviation 26.2
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 2 (n=69, 66)
|
76.2 scores on a scale
Standard Deviation 22.1
|
73.1 scores on a scale
Standard Deviation 27.1
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 3 (n=60, 56)
|
75.3 scores on a scale
Standard Deviation 20.2
|
70.8 scores on a scale
Standard Deviation 25.8
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 4 (n=55, 43)
|
72.2 scores on a scale
Standard Deviation 23.2
|
76.9 scores on a scale
Standard Deviation 22.3
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 5 (n=48, 40)
|
72.6 scores on a scale
Standard Deviation 25.2
|
75.8 scores on a scale
Standard Deviation 23.9
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 6 (n=42, 31)
|
77.8 scores on a scale
Standard Deviation 23.8
|
72.8 scores on a scale
Standard Deviation 28.9
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 7 (n=38, 28)
|
75.3 scores on a scale
Standard Deviation 28.6
|
80.8 scores on a scale
Standard Deviation 19.8
|
|
EORTC QLQ-C30 - Emotional Functioning Subscale
Cycle 8 (n=34, 22)
|
74.0 scores on a scale
Standard Deviation 30.9
|
76.7 scores on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 7 (n=38, 28)
|
80.3 scores on a scale
Standard Deviation 18.8
|
78.9 scores on a scale
Standard Deviation 25.4
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 1 (n=67, 66)
|
83.1 scores on a scale
Standard Deviation 20.5
|
83.1 scores on a scale
Standard Deviation 20.6
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 2 (n=69, 67)
|
77.7 scores on a scale
Standard Deviation 20.5
|
77.1 scores on a scale
Standard Deviation 25.9
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 3 (n=60, 56)
|
78.2 scores on a scale
Standard Deviation 21.6
|
75.5 scores on a scale
Standard Deviation 28.5
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 4 (n=55, 43)
|
77.5 scores on a scale
Standard Deviation 21.3
|
78.4 scores on a scale
Standard Deviation 24.5
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 5 (n=48, 40)
|
78.3 scores on a scale
Standard Deviation 20.2
|
80.7 scores on a scale
Standard Deviation 21.9
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 6 (n=42, 30)
|
80.9 scores on a scale
Standard Deviation 16.3
|
81.1 scores on a scale
Standard Deviation 22.3
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 8 (n=34, 22)
|
79.4 scores on a scale
Standard Deviation 20.7
|
73.5 scores on a scale
Standard Deviation 28.1
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 9 (n=33, 18)
|
78.8 scores on a scale
Standard Deviation 17.0
|
79.6 scores on a scale
Standard Deviation 24.8
|
|
EORTC QLQ-C30 - Physical Functioning Subscale
Cycle 10 (n=29, 14)
|
81.4 scores on a scale
Standard Deviation 18.9
|
78.6 scores on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 1 (n=67, 66)
|
84.3 scores on a scale
Standard Deviation 23.4
|
77.5 scores on a scale
Standard Deviation 27.7
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 2 (n=69, 67)
|
71.6 scores on a scale
Standard Deviation 28.9
|
68.9 scores on a scale
Standard Deviation 30.6
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 3 (n=60, 56)
|
71.0 scores on a scale
Standard Deviation 26.7
|
70.5 scores on a scale
Standard Deviation 31.0
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 4 (n=55, 43)
|
72.1 scores on a scale
Standard Deviation 28.9
|
73.3 scores on a scale
Standard Deviation 29.6
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 5 (n=48, 41)
|
71.5 scores on a scale
Standard Deviation 27.7
|
75.0 scores on a scale
Standard Deviation 31.4
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 6 (n=42, 31)
|
76.6 scores on a scale
Standard Deviation 26.6
|
66.1 scores on a scale
Standard Deviation 32.6
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 7 (n=38, 28)
|
75.7 scores on a scale
Standard Deviation 28.8
|
72.3 scores on a scale
Standard Deviation 29.7
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 8 (n=34, 22)
|
73.0 scores on a scale
Standard Deviation 29.6
|
66.7 scores on a scale
Standard Deviation 30.9
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 9 (n=33, 18)
|
72.2 scores on a scale
Standard Deviation 24.2
|
67.6 scores on a scale
Standard Deviation 31.6
|
|
EORTC QLQ-C30 - Role Functioning Subscale
Cycle 10 (n=29, 14)
|
79.9 scores on a scale
Standard Deviation 22.4
|
70.2 scores on a scale
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 1 (n=67, 66)
|
79.4 scores on a scale
Standard Deviation 27.2
|
77.0 scores on a scale
Standard Deviation 31.5
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 2 (n=69, 66)
|
77.8 scores on a scale
Standard Deviation 22.1
|
75.0 scores on a scale
Standard Deviation 31.0
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 3 (n=60, 56)
|
77.1 scores on a scale
Standard Deviation 23.1
|
77.2 scores on a scale
Standard Deviation 28.8
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 4 (n=55, 43)
|
71.2 scores on a scale
Standard Deviation 28.4
|
79.8 scores on a scale
Standard Deviation 26.1
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 5 (n=48, 40)
|
74.3 scores on a scale
Standard Deviation 23.8
|
77.3 scores on a scale
Standard Deviation 30.2
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 6 (n=42, 31)
|
79.0 scores on a scale
Standard Deviation 26.3
|
74.7 scores on a scale
Standard Deviation 31.0
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 7 (n=38, 28)
|
76.3 scores on a scale
Standard Deviation 29.2
|
83.9 scores on a scale
Standard Deviation 25.5
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 8 (n=34, 22)
|
72.5 scores on a scale
Standard Deviation 30.4
|
74.2 scores on a scale
Standard Deviation 31.6
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 9 (n=33, 18)
|
76.3 scores on a scale
Standard Deviation 21.7
|
74.1 scores on a scale
Standard Deviation 33.4
|
|
EORTC QLQ-C30 - Social Functioning Subscale
Cycle 10 (n=29, 14)
|
75.9 scores on a scale
Standard Deviation 25.8
|
81.0 scores on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 2 (n=69, 67)
|
25.1 scores on a scale
Standard Deviation 33.0
|
20.4 scores on a scale
Standard Deviation 31.8
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 3 (n=60, 56)
|
25.0 scores on a scale
Standard Deviation 34.5
|
23.8 scores on a scale
Standard Deviation 32.9
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 1 (n=67, 66)
|
16.9 scores on a scale
Standard Deviation 25.5
|
18.7 scores on a scale
Standard Deviation 27.5
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 4 (n=55, 43)
|
33.3 scores on a scale
Standard Deviation 34.5
|
22.5 scores on a scale
Standard Deviation 27.9
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 5 (n=48, 41)
|
26.4 scores on a scale
Standard Deviation 33.7
|
24.0 scores on a scale
Standard Deviation 30.7
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 6 (n=42, 31)
|
20.6 scores on a scale
Standard Deviation 30.3
|
23.7 scores on a scale
Standard Deviation 30.1
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 7 (n=38, 28)
|
24.6 scores on a scale
Standard Deviation 29.7
|
19.0 scores on a scale
Standard Deviation 29.3
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 8 (n=34, 21)
|
24.5 scores on a scale
Standard Deviation 31.0
|
30.2 scores on a scale
Standard Deviation 33.2
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 9 (n=33, 18)
|
23.2 scores on a scale
Standard Deviation 27.0
|
22.2 scores on a scale
Standard Deviation 32.3
|
|
EORTC QLQ-C30 - Appetite Loss Subscale
Cycle 10 (n=29, 14)
|
18.4 scores on a scale
Standard Deviation 29.0
|
21.4 scores on a scale
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 1 (n=67, 65)
|
14.9 scores on a scale
Standard Deviation 24.8
|
14.9 scores on a scale
Standard Deviation 23.6
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 2 (n=69, 66)
|
8.2 scores on a scale
Standard Deviation 16.6
|
13.6 scores on a scale
Standard Deviation 23.4
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 3 (n=59, 56)
|
9.0 scores on a scale
Standard Deviation 20.4
|
18.5 scores on a scale
Standard Deviation 28.4
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 4 (n=55, 43)
|
9.1 scores on a scale
Standard Deviation 17.5
|
14.0 scores on a scale
Standard Deviation 24.4
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 5 (n=48, 41)
|
7.6 scores on a scale
Standard Deviation 17.2
|
15.9 scores on a scale
Standard Deviation 24.7
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 6 (n=42, 31)
|
11.1 scores on a scale
Standard Deviation 15.9
|
14.0 scores on a scale
Standard Deviation 26.9
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 7 (n=37, 28)
|
9.9 scores on a scale
Standard Deviation 19.0
|
10.1 scores on a scale
Standard Deviation 23.7
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 8 (n=34, 22)
|
11.8 scores on a scale
Standard Deviation 18.1
|
18.2 scores on a scale
Standard Deviation 32.1
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 9 (n=32, 18)
|
10.4 scores on a scale
Standard Deviation 15.7
|
18.5 scores on a scale
Standard Deviation 32.8
|
|
EORTC QLQ-C30 - Constipation Subscale
Cycle 10 (n=29, 14)
|
13.8 scores on a scale
Standard Deviation 18.9
|
16.7 scores on a scale
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 1 (n=67, 66)
|
20.4 scores on a scale
Standard Deviation 29.6
|
19.2 scores on a scale
Standard Deviation 28.1
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 2 (n=69, 66)
|
37.7 scores on a scale
Standard Deviation 35.2
|
18.2 scores on a scale
Standard Deviation 27.5
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 3 (n=60, 56)
|
34.2 scores on a scale
Standard Deviation 33.7
|
16.7 scores on a scale
Standard Deviation 26.2
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 4 (n=55, 43)
|
38.8 scores on a scale
Standard Deviation 32.6
|
18.6 scores on a scale
Standard Deviation 27.5
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 5 (n=47, 40)
|
42.6 scores on a scale
Standard Deviation 36.6
|
15.0 scores on a scale
Standard Deviation 25.0
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 6 (n=42, 31)
|
38.9 scores on a scale
Standard Deviation 32.9
|
18.3 scores on a scale
Standard Deviation 28.3
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 7 (n=38, 28)
|
41.7 scores on a scale
Standard Deviation 30.0
|
16.7 scores on a scale
Standard Deviation 29.4
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 8 (n=33, 22)
|
43.4 scores on a scale
Standard Deviation 31.7
|
15.9 scores on a scale
Standard Deviation 26.5
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 9 (n=33, 18)
|
40.4 scores on a scale
Standard Deviation 29.8
|
14.8 scores on a scale
Standard Deviation 20.5
|
|
EORTC QLQ-C30 - Diarrhea Subscale
Cycle 10 (n=29, 14)
|
40.2 scores on a scale
Standard Deviation 32.6
|
9.5 scores on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 1 (n=67, 66)
|
15.9 scores on a scale
Standard Deviation 21.2
|
19.7 scores on a scale
Standard Deviation 29.2
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 2 (n=69, 66)
|
23.2 scores on a scale
Standard Deviation 26.4
|
22.7 scores on a scale
Standard Deviation 29.3
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 3 (n=60, 56)
|
20.6 scores on a scale
Standard Deviation 24.6
|
20.8 scores on a scale
Standard Deviation 30.2
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 4 (n=55, 43)
|
25.5 scores on a scale
Standard Deviation 26.4
|
22.5 scores on a scale
Standard Deviation 27.9
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 5 (n=48, 41)
|
20.8 scores on a scale
Standard Deviation 27.2
|
16.3 scores on a scale
Standard Deviation 22.5
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 6 (n=42, 30)
|
19.0 scores on a scale
Standard Deviation 23.4
|
15.6 scores on a scale
Standard Deviation 31.2
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 7 (n=38, 28)
|
19.3 scores on a scale
Standard Deviation 24.1
|
19.6 scores on a scale
Standard Deviation 26.1
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 8 (n=34, 22)
|
22.5 scores on a scale
Standard Deviation 28.1
|
21.2 scores on a scale
Standard Deviation 30.1
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 9 (n=32, 18)
|
25.0 scores on a scale
Standard Deviation 25.4
|
18.5 scores on a scale
Standard Deviation 28.5
|
|
EORTC QLQ-C30 - Dyspnea Subscale
Cycle 10 (n=29, 14)
|
18.4 scores on a scale
Standard Deviation 26.1
|
16.7 scores on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 9 (n=33, 18)
|
37.4 scores on a scale
Standard Deviation 22.5
|
37.7 scores on a scale
Standard Deviation 27.8
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 1 (n=67, 66)
|
29.4 scores on a scale
Standard Deviation 23.7
|
34.5 scores on a scale
Standard Deviation 26.4
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 2 (n=69, 67)
|
44.3 scores on a scale
Standard Deviation 24.2
|
40.1 scores on a scale
Standard Deviation 30.1
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 3 (n=60, 56)
|
41.2 scores on a scale
Standard Deviation 23.6
|
42.3 scores on a scale
Standard Deviation 32.6
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 4 (n=55, 43)
|
41.0 scores on a scale
Standard Deviation 26.0
|
37.0 scores on a scale
Standard Deviation 29.5
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 5 (n=48, 41)
|
34.7 scores on a scale
Standard Deviation 23.4
|
36.3 scores on a scale
Standard Deviation 31.8
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 6 (n=42, 31)
|
34.9 scores on a scale
Standard Deviation 25.9
|
42.3 scores on a scale
Standard Deviation 33.1
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 7 (n=38, 28)
|
36.5 scores on a scale
Standard Deviation 24.9
|
34.9 scores on a scale
Standard Deviation 27.2
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 8 (n=34, 22)
|
39.9 scores on a scale
Standard Deviation 28.4
|
43.2 scores on a scale
Standard Deviation 33.0
|
|
EORTC QLQ-C30 - Fatigue Subscale
Cycle 10 (n=29, 14)
|
33.7 scores on a scale
Standard Deviation 23.7
|
43.7 scores on a scale
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 1 (n=67, 66)
|
19.9 scores on a scale
Standard Deviation 32.3
|
15.7 scores on a scale
Standard Deviation 27.6
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 2 (n=68, 65)
|
14.2 scores on a scale
Standard Deviation 26.0
|
14.4 scores on a scale
Standard Deviation 26.3
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 3 (n=59, 56)
|
15.8 scores on a scale
Standard Deviation 25.8
|
16.7 scores on a scale
Standard Deviation 28.4
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 4 (n=55, 43)
|
18.2 scores on a scale
Standard Deviation 27.8
|
12.4 scores on a scale
Standard Deviation 27.2
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 5 (n=48, 40)
|
18.1 scores on a scale
Standard Deviation 28.3
|
13.3 scores on a scale
Standard Deviation 24.8
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 6 (n=42, 30)
|
19.0 scores on a scale
Standard Deviation 29.6
|
11.1 scores on a scale
Standard Deviation 23.7
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 7 (n=38, 28)
|
20.2 scores on a scale
Standard Deviation 33.4
|
10.7 scores on a scale
Standard Deviation 22.3
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 8 (n=34, 22)
|
18.6 scores on a scale
Standard Deviation 32.0
|
13.6 scores on a scale
Standard Deviation 19.7
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 9 (n=33, 18)
|
20.2 scores on a scale
Standard Deviation 26.3
|
14.8 scores on a scale
Standard Deviation 28.5
|
|
EORTC QLQ-C30 - Financial Difficulties Subscale
Cycle 10 (n=29, 14)
|
17.2 scores on a scale
Standard Deviation 29.0
|
14.3 scores on a scale
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 1 (n=67, 66)
|
25.4 scores on a scale
Standard Deviation 29.6
|
26.3 scores on a scale
Standard Deviation 27.7
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 2 (n=69, 67)
|
36.7 scores on a scale
Standard Deviation 35.8
|
27.4 scores on a scale
Standard Deviation 30.7
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 3 (n=59, 56)
|
35.6 scores on a scale
Standard Deviation 30.9
|
24.7 scores on a scale
Standard Deviation 27.2
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 4 (n=55, 43)
|
35.2 scores on a scale
Standard Deviation 33.0
|
22.5 scores on a scale
Standard Deviation 24.9
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 5 (n=48, 41)
|
25.0 scores on a scale
Standard Deviation 26.2
|
24.0 scores on a scale
Standard Deviation 27.4
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 6 (n=42, 30)
|
31.0 scores on a scale
Standard Deviation 32.4
|
28.9 scores on a scale
Standard Deviation 35.8
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 7 (n=38, 28)
|
32.9 scores on a scale
Standard Deviation 35.6
|
23.2 scores on a scale
Standard Deviation 29.2
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 8 (n=34, 22)
|
28.4 scores on a scale
Standard Deviation 34.9
|
28.8 scores on a scale
Standard Deviation 23.7
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 9 (n=33, 18)
|
26.3 scores on a scale
Standard Deviation 32.0
|
29.6 scores on a scale
Standard Deviation 30.0
|
|
EORTC QLQ-C30 - Insomnia Subscale
Cycle 10 (n=29, 14)
|
31.0 scores on a scale
Standard Deviation 34.4
|
23.8 scores on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 6 (n=42, 31)
|
11.5 scores on a scale
Standard Deviation 16.7
|
14.5 scores on a scale
Standard Deviation 17.6
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 7 (n=38, 28)
|
13.8 scores on a scale
Standard Deviation 19.6
|
9.5 scores on a scale
Standard Deviation 16.0
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 8 (n=34, 22)
|
11.8 scores on a scale
Standard Deviation 22.3
|
16.3 scores on a scale
Standard Deviation 25.0
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 9 (n=33, 18)
|
9.6 scores on a scale
Standard Deviation 16.7
|
6.5 scores on a scale
Standard Deviation 11.6
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 10 (n=29, 14)
|
8.6 scores on a scale
Standard Deviation 14.5
|
3.6 scores on a scale
Standard Deviation 9.6
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 2 (n=69, 67)
|
13.0 scores on a scale
Standard Deviation 19.6
|
16.4 scores on a scale
Standard Deviation 21.8
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 3 (n=60, 56)
|
15.8 scores on a scale
Standard Deviation 22.6
|
15.3 scores on a scale
Standard Deviation 25.4
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 4 (n=55, 43)
|
15.8 scores on a scale
Standard Deviation 21.4
|
15.1 scores on a scale
Standard Deviation 24.1
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 5 (n=48, 41)
|
15.6 scores on a scale
Standard Deviation 25.1
|
11.6 scores on a scale
Standard Deviation 15.9
|
|
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Cycle 1 (n=67, 66)
|
6.7 scores on a scale
Standard Deviation 12.3
|
12.6 scores on a scale
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawalPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib
n=73 Participants
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=71 Participants
Matching placebo.
|
|---|---|---|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 1 (n=67, 66)
|
22.9 scores on a scale
Standard Deviation 24.4
|
22.5 scores on a scale
Standard Deviation 28.9
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 2 (n=69, 67)
|
29.5 scores on a scale
Standard Deviation 27.6
|
28.6 scores on a scale
Standard Deviation 34.5
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 3 (n=60, 56)
|
28.1 scores on a scale
Standard Deviation 27.4
|
28.7 scores on a scale
Standard Deviation 32.0
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 4 (n=55, 43)
|
25.5 scores on a scale
Standard Deviation 27.9
|
24.0 scores on a scale
Standard Deviation 28.7
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 5 (n=48, 41)
|
26.7 scores on a scale
Standard Deviation 25.4
|
28.0 scores on a scale
Standard Deviation 32.8
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 6 (n=42, 31)
|
25.0 scores on a scale
Standard Deviation 25.6
|
31.2 scores on a scale
Standard Deviation 34.1
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 7 (n=38, 28)
|
23.9 scores on a scale
Standard Deviation 26.9
|
23.5 scores on a scale
Standard Deviation 25.6
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 8 (n=34, 22)
|
23.0 scores on a scale
Standard Deviation 26.6
|
28.0 scores on a scale
Standard Deviation 33.1
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 9 (n=33, 18)
|
25.3 scores on a scale
Standard Deviation 24.7
|
22.2 scores on a scale
Standard Deviation 32.8
|
|
EORTC QLQ-C30 - Pain Subscale
Cycle 10 (n=29, 14)
|
17.2 scores on a scale
Standard Deviation 15.7
|
26.2 scores on a scale
Standard Deviation 26.7
|
Adverse Events
Sunitinib
Placebo
Serious adverse events
| Measure |
Sunitinib
n=83 participants at risk
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=82 participants at risk
Matching placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/83
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/83
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
1/83
|
0.00%
0/82
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/83
|
0.00%
0/82
|
|
Cardiac disorders
Cardiac failure
|
2.4%
2/83
|
0.00%
0/82
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/83
|
0.00%
0/82
|
|
Eye disorders
Eye disorder
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/83
|
4.9%
4/82
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
2/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.2%
1/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/83
|
2.4%
2/82
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/83
|
2.4%
2/82
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/83
|
1.2%
1/82
|
|
Gastrointestinal disorders
Varices oesophageal
|
1.2%
1/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/83
|
3.7%
3/82
|
|
General disorders
Asthenia
|
0.00%
0/83
|
1.2%
1/82
|
|
General disorders
Disease progression
|
3.6%
3/83
|
2.4%
2/82
|
|
General disorders
Fatigue
|
1.2%
1/83
|
1.2%
1/82
|
|
General disorders
General physical health deterioration
|
1.2%
1/83
|
2.4%
2/82
|
|
General disorders
Hyperthermia
|
1.2%
1/83
|
0.00%
0/82
|
|
General disorders
Inflammation
|
0.00%
0/83
|
1.2%
1/82
|
|
General disorders
Mucosal inflammation
|
1.2%
1/83
|
0.00%
0/82
|
|
General disorders
Multi-organ failure
|
0.00%
0/83
|
1.2%
1/82
|
|
General disorders
Oedema
|
0.00%
0/83
|
1.2%
1/82
|
|
General disorders
Oedema peripheral
|
0.00%
0/83
|
1.2%
1/82
|
|
General disorders
Pyrexia
|
1.2%
1/83
|
2.4%
2/82
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.2%
1/83
|
0.00%
0/82
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/83
|
1.2%
1/82
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/83
|
2.4%
2/82
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.2%
1/83
|
0.00%
0/82
|
|
Hepatobiliary disorders
Hepatic pain
|
1.2%
1/83
|
2.4%
2/82
|
|
Infections and infestations
Anal abscess
|
1.2%
1/83
|
0.00%
0/82
|
|
Infections and infestations
Catheter related infection
|
1.2%
1/83
|
0.00%
0/82
|
|
Infections and infestations
Liver abscess
|
0.00%
0/83
|
1.2%
1/82
|
|
Infections and infestations
Pneumonia
|
0.00%
0/83
|
1.2%
1/82
|
|
Infections and infestations
Varicella
|
1.2%
1/83
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.2%
1/83
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/83
|
1.2%
1/82
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/83
|
1.2%
1/82
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/83
|
1.2%
1/82
|
|
Investigations
Lipase increased
|
1.2%
1/83
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/83
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/83
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/83
|
1.2%
1/82
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
1/83
|
0.00%
0/82
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/83
|
2.4%
2/82
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/83
|
2.4%
2/82
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/83
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/83
|
1.2%
1/82
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/83
|
1.2%
1/82
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/83
|
1.2%
1/82
|
|
Nervous system disorders
Cerebral haematoma
|
1.2%
1/83
|
0.00%
0/82
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/83
|
1.2%
1/82
|
|
Nervous system disorders
Convulsion
|
0.00%
0/83
|
1.2%
1/82
|
|
Nervous system disorders
Headache
|
1.2%
1/83
|
0.00%
0/82
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.2%
1/83
|
1.2%
1/82
|
|
Nervous system disorders
Leukoencephalopathy
|
1.2%
1/83
|
0.00%
0/82
|
|
Nervous system disorders
Somnolence
|
0.00%
0/83
|
1.2%
1/82
|
|
Renal and urinary disorders
Renal failure
|
2.4%
2/83
|
0.00%
0/82
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/83
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/83
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/83
|
0.00%
0/82
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/83
|
1.2%
1/82
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/83
|
2.4%
2/82
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/83
|
1.2%
1/82
|
|
Vascular disorders
Hypertension
|
1.2%
1/83
|
0.00%
0/82
|
|
Vascular disorders
Hypotension
|
0.00%
0/83
|
2.4%
2/82
|
Other adverse events
| Measure |
Sunitinib
n=83 participants at risk
Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
|
Placebo
n=82 participants at risk
Matching placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
4/83
|
9.8%
8/82
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.6%
8/83
|
1.2%
1/82
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.7%
23/83
|
3.7%
3/82
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.7%
13/83
|
4.9%
4/82
|
|
Endocrine disorders
Hypothyroidism
|
7.2%
6/83
|
1.2%
1/82
|
|
Eye disorders
Eyelid oedema
|
7.2%
6/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Abdominal pain
|
27.7%
23/83
|
28.0%
23/82
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.0%
10/83
|
7.3%
6/82
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
6.0%
5/83
|
2.4%
2/82
|
|
Gastrointestinal disorders
Constipation
|
14.5%
12/83
|
19.5%
16/82
|
|
Gastrointestinal disorders
Diarrhoea
|
57.8%
48/83
|
39.0%
32/82
|
|
Gastrointestinal disorders
Dry mouth
|
8.4%
7/83
|
6.1%
5/82
|
|
Gastrointestinal disorders
Dyspepsia
|
14.5%
12/83
|
6.1%
5/82
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
5/83
|
2.4%
2/82
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.4%
7/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.0%
5/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Nausea
|
43.4%
36/83
|
29.3%
24/82
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
5/83
|
0.00%
0/82
|
|
Gastrointestinal disorders
Stomatitis
|
21.7%
18/83
|
2.4%
2/82
|
|
Gastrointestinal disorders
Vomiting
|
33.7%
28/83
|
29.3%
24/82
|
|
General disorders
Asthenia
|
33.7%
28/83
|
26.8%
22/82
|
|
General disorders
Chest pain
|
6.0%
5/83
|
6.1%
5/82
|
|
General disorders
Chills
|
9.6%
8/83
|
2.4%
2/82
|
|
General disorders
Fatigue
|
32.5%
27/83
|
25.6%
21/82
|
|
General disorders
Mucosal inflammation
|
15.7%
13/83
|
7.3%
6/82
|
|
General disorders
Oedema
|
6.0%
5/83
|
2.4%
2/82
|
|
General disorders
Oedema peripheral
|
12.0%
10/83
|
13.4%
11/82
|
|
General disorders
Pyrexia
|
10.8%
9/83
|
8.5%
7/82
|
|
Infections and infestations
Urinary tract infection
|
7.2%
6/83
|
3.7%
3/82
|
|
Investigations
Blood alkaline phosphatase increased
|
3.6%
3/83
|
7.3%
6/82
|
|
Investigations
Weight decreased
|
15.7%
13/83
|
11.0%
9/82
|
|
Metabolism and nutrition disorders
Anorexia
|
21.7%
18/83
|
20.7%
17/82
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
5/83
|
4.9%
4/82
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.4%
2/83
|
8.5%
7/82
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.6%
8/83
|
2.4%
2/82
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
5/83
|
2.4%
2/82
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
12/83
|
6.1%
5/82
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
10/83
|
17.1%
14/82
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
5/83
|
4.9%
4/82
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.2%
6/83
|
9.8%
8/82
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
8/83
|
6.1%
5/82
|
|
Nervous system disorders
Dizziness
|
6.0%
5/83
|
6.1%
5/82
|
|
Nervous system disorders
Dysgeusia
|
20.5%
17/83
|
4.9%
4/82
|
|
Nervous system disorders
Headache
|
18.1%
15/83
|
13.4%
11/82
|
|
Psychiatric disorders
Depression
|
2.4%
2/83
|
6.1%
5/82
|
|
Psychiatric disorders
Insomnia
|
18.1%
15/83
|
12.2%
10/82
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
7/83
|
8.5%
7/82
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
10/83
|
14.6%
12/82
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.5%
17/83
|
4.9%
4/82
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.2%
6/83
|
2.4%
2/82
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
5/83
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.5%
12/83
|
11.0%
9/82
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.6%
8/83
|
4.9%
4/82
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
28.9%
24/83
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.6%
3/83
|
7.3%
6/82
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
9.6%
8/83
|
1.2%
1/82
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
22.9%
19/83
|
2.4%
2/82
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
4/83
|
11.0%
9/82
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.1%
15/83
|
4.9%
4/82
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
7.2%
6/83
|
0.00%
0/82
|
|
Vascular disorders
Hypertension
|
26.5%
22/83
|
4.9%
4/82
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER