Carcinoma, Islet Cell, Carcinoma, Pancreas
Conditions
Brief summary
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug. The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred. Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.
Detailed description
The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.
Interventions
DRUGsunitinib malate
* sunitinib malate oral starting dose 37.5 mg daily (continuous dosing). * Dose may be decreased to 25 mg daily in case of adverse events. * It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment. * Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.
DRUGPlacebo
Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Well-differentiated advanced/metastatic pancreatic islet cell tumor * Tumor has shown progression within the past year.
Exclusion criteria
* Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues * Prior treatment with any tyrosine kinase inhibitors or anti-VEGF\[Vascular endothelial growth factor\] angiogenic inhibitors. * Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DR) | 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 | 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-to-Tumor Response (TTR) | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. |
| Overall Survival (OS) | From start of study treatment up to 22 months | 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. |
| European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Cognitive Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Emotional Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Physical Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Role Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Social Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| Number of Subjects With Objective Response | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | 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. |
| EORTC QLQ-C30 - Constipation Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Diarrhea Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Dyspnea Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Fatigue Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Financial Difficulties Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Insomnia Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Nausea and Vomiting Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Pain Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
| EORTC QLQ-C30 - Appetite Loss Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | 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. |
Countries
Australia, Belgium, Canada, France, Germany, Italy, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule. | 86 |
| Placebo Matching placebo. | 85 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 7 |
| Overall Study | Death | 1 | 3 |
| Overall Study | Global Deterioration of Health Status | 1 | 5 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Objective Progression or Relapse | 19 | 47 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Randomized but not treated | 3 | 3 |
| Overall Study | Study Terminated by Sponsor | 41 | 16 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Sunitinib |
|---|---|---|---|
| Age, Customized >=65 years | 45 participants | 23 participants | 22 participants |
| Age, Customized Between 18 and 44 years | 36 participants | 17 participants | 19 participants |
| Age, Customized Between 45 and 64 | 90 participants | 45 participants | 45 participants |
| Sex: Female, Male Female | 89 Participants | 45 Participants | 44 Participants |
| Sex: Female, Male Male | 82 Participants | 40 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / 83 | 70 / 82 |
| serious Total, serious adverse events | 22 / 83 | 34 / 82 |
Outcome results
Primary
Progression Free Survival (PFS)
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
Population: Intent-to-treat (ITT) population = all subjects who were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Progression Free Survival (PFS) | 11.4 Months |
| Placebo | Progression Free Survival (PFS) | 5.5 Months |
p-value: 0.00011895% CI: [0.263, 0.662]Log Rank
Secondary
Duration of Response (DR)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Duration of Response (DR) | 8.1 Months |
Secondary
EORTC QLQ-C30 - Appetite Loss Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 1 (n=67, 66) | 16.9 scores on a scale | Standard Deviation 25.5 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 2 (n=69, 67) | 25.1 scores on a scale | Standard Deviation 33 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 3 (n=60, 56) | 25.0 scores on a scale | Standard Deviation 34.5 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 4 (n=55, 43) | 33.3 scores on a scale | Standard Deviation 34.5 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 5 (n=48, 41) | 26.4 scores on a scale | Standard Deviation 33.7 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 6 (n=42, 31) | 20.6 scores on a scale | Standard Deviation 30.3 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 7 (n=38, 28) | 24.6 scores on a scale | Standard Deviation 29.7 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 8 (n=34, 21) | 24.5 scores on a scale | Standard Deviation 31 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 9 (n=33, 18) | 23.2 scores on a scale | Standard Deviation 27 |
| Sunitinib | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 10 (n=29, 14) | 18.4 scores on a scale | Standard Deviation 29 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 8 (n=34, 21) | 30.2 scores on a scale | Standard Deviation 33.2 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 1 (n=67, 66) | 18.7 scores on a scale | Standard Deviation 27.5 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 6 (n=42, 31) | 23.7 scores on a scale | Standard Deviation 30.1 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 2 (n=69, 67) | 20.4 scores on a scale | Standard Deviation 31.8 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 10 (n=29, 14) | 21.4 scores on a scale | Standard Deviation 33.6 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 3 (n=60, 56) | 23.8 scores on a scale | Standard Deviation 32.9 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 7 (n=38, 28) | 19.0 scores on a scale | Standard Deviation 29.3 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 4 (n=55, 43) | 22.5 scores on a scale | Standard Deviation 27.9 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 9 (n=33, 18) | 22.2 scores on a scale | Standard Deviation 32.3 |
| Placebo | EORTC QLQ-C30 - Appetite Loss Subscale | Cycle 5 (n=48, 41) | 24.0 scores on a scale | Standard Deviation 30.7 |
Comparison: Cycle 2 through Cycle 10p-value: 0.654595% CI: [-6.4, 10.1]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Cognitive Functioning Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 3 (n=60, 56) | 80.1 scores on a scale | Standard Deviation 19.9 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 6 (n=42, 31) | 82.1 scores on a scale | Standard Deviation 22.5 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 2 (n=69, 66) | 82.9 scores on a scale | Standard Deviation 20 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 7 (n=38, 28) | 84.6 scores on a scale | Standard Deviation 21 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 4 (n=55, 43) | 79.7 scores on a scale | Standard Deviation 24.2 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 8 (n=34, 22) | 84.3 scores on a scale | Standard Deviation 18.3 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 1 (n=67, 66) | 87.1 scores on a scale | Standard Deviation 16.6 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 9 (n=33, 18) | 80.3 scores on a scale | Standard Deviation 21.8 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 10 (n=29, 14) | 80.5 scores on a scale | Standard Deviation 24 |
| Sunitinib | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 5 (n=48, 40) | 82.3 scores on a scale | Standard Deviation 20.2 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 10 (n=29, 14) | 85.7 scores on a scale | Standard Deviation 19.5 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 1 (n=67, 66) | 87.1 scores on a scale | Standard Deviation 18.2 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 2 (n=69, 66) | 78.5 scores on a scale | Standard Deviation 24.4 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 3 (n=60, 56) | 80.8 scores on a scale | Standard Deviation 22.7 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 4 (n=55, 43) | 82.6 scores on a scale | Standard Deviation 18.5 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 5 (n=48, 40) | 82.9 scores on a scale | Standard Deviation 21.8 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 6 (n=42, 31) | 82.3 scores on a scale | Standard Deviation 20.6 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 7 (n=38, 28) | 88.1 scores on a scale | Standard Deviation 15.6 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 8 (n=34, 22) | 79.5 scores on a scale | Standard Deviation 23 |
| Placebo | EORTC QLQ-C30 - Cognitive Functioning Subscale | Cycle 9 (n=33, 18) | 83.3 scores on a scale | Standard Deviation 18.1 |
Comparison: Cycle 2 through Cycle 10p-value: 0.605895% CI: [-6.9, 4]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Constipation Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 1 (n=67, 65) | 14.9 scores on a scale | Standard Deviation 24.8 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 2 (n=69, 66) | 8.2 scores on a scale | Standard Deviation 16.6 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 3 (n=59, 56) | 9.0 scores on a scale | Standard Deviation 20.4 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 4 (n=55, 43) | 9.1 scores on a scale | Standard Deviation 17.5 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 5 (n=48, 41) | 7.6 scores on a scale | Standard Deviation 17.2 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 6 (n=42, 31) | 11.1 scores on a scale | Standard Deviation 15.9 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 7 (n=37, 28) | 9.9 scores on a scale | Standard Deviation 19 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 8 (n=34, 22) | 11.8 scores on a scale | Standard Deviation 18.1 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 9 (n=32, 18) | 10.4 scores on a scale | Standard Deviation 15.7 |
| Sunitinib | EORTC QLQ-C30 - Constipation Subscale | Cycle 10 (n=29, 14) | 13.8 scores on a scale | Standard Deviation 18.9 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 8 (n=34, 22) | 18.2 scores on a scale | Standard Deviation 32.1 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 1 (n=67, 65) | 14.9 scores on a scale | Standard Deviation 23.6 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 6 (n=42, 31) | 14.0 scores on a scale | Standard Deviation 26.9 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 2 (n=69, 66) | 13.6 scores on a scale | Standard Deviation 23.4 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 10 (n=29, 14) | 16.7 scores on a scale | Standard Deviation 31.4 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 3 (n=59, 56) | 18.5 scores on a scale | Standard Deviation 28.4 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 7 (n=37, 28) | 10.1 scores on a scale | Standard Deviation 23.7 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 4 (n=55, 43) | 14.0 scores on a scale | Standard Deviation 24.4 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 9 (n=32, 18) | 18.5 scores on a scale | Standard Deviation 32.8 |
| Placebo | EORTC QLQ-C30 - Constipation Subscale | Cycle 5 (n=48, 41) | 15.9 scores on a scale | Standard Deviation 24.7 |
Comparison: Cycle 2 through Cycle 10p-value: 0.193695% CI: [-10, 2]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Diarrhea Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 9 (n=33, 18) | 40.4 scores on a scale | Standard Deviation 29.8 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 2 (n=69, 66) | 37.7 scores on a scale | Standard Deviation 35.2 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 8 (n=33, 22) | 43.4 scores on a scale | Standard Deviation 31.7 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 3 (n=60, 56) | 34.2 scores on a scale | Standard Deviation 33.7 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 10 (n=29, 14) | 40.2 scores on a scale | Standard Deviation 32.6 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 4 (n=55, 43) | 38.8 scores on a scale | Standard Deviation 32.6 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 7 (n=38, 28) | 41.7 scores on a scale | Standard Deviation 30 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 5 (n=47, 40) | 42.6 scores on a scale | Standard Deviation 36.6 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 1 (n=67, 66) | 20.4 scores on a scale | Standard Deviation 29.6 |
| Sunitinib | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 6 (n=42, 31) | 38.9 scores on a scale | Standard Deviation 32.9 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 1 (n=67, 66) | 19.2 scores on a scale | Standard Deviation 28.1 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 7 (n=38, 28) | 16.7 scores on a scale | Standard Deviation 29.4 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 8 (n=33, 22) | 15.9 scores on a scale | Standard Deviation 26.5 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 9 (n=33, 18) | 14.8 scores on a scale | Standard Deviation 20.5 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 10 (n=29, 14) | 9.5 scores on a scale | Standard Deviation 15.6 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 6 (n=42, 31) | 18.3 scores on a scale | Standard Deviation 28.3 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 2 (n=69, 66) | 18.2 scores on a scale | Standard Deviation 27.5 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 3 (n=60, 56) | 16.7 scores on a scale | Standard Deviation 26.2 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 4 (n=55, 43) | 18.6 scores on a scale | Standard Deviation 27.5 |
| Placebo | EORTC QLQ-C30 - Diarrhea Subscale | Cycle 5 (n=47, 40) | 15.0 scores on a scale | Standard Deviation 25 |
Comparison: Cycle 2 through Cycle 10p-value: <0.000195% CI: [14.3, 28.4]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Dyspnea Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 1 (n=67, 66) | 15.9 scores on a scale | Standard Deviation 21.2 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 2 (n=69, 66) | 23.2 scores on a scale | Standard Deviation 26.4 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 3 (n=60, 56) | 20.6 scores on a scale | Standard Deviation 24.6 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 4 (n=55, 43) | 25.5 scores on a scale | Standard Deviation 26.4 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 5 (n=48, 41) | 20.8 scores on a scale | Standard Deviation 27.2 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 6 (n=42, 30) | 19.0 scores on a scale | Standard Deviation 23.4 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 7 (n=38, 28) | 19.3 scores on a scale | Standard Deviation 24.1 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 8 (n=34, 22) | 22.5 scores on a scale | Standard Deviation 28.1 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 9 (n=32, 18) | 25.0 scores on a scale | Standard Deviation 25.4 |
| Sunitinib | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 10 (n=29, 14) | 18.4 scores on a scale | Standard Deviation 26.1 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 8 (n=34, 22) | 21.2 scores on a scale | Standard Deviation 30.1 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 1 (n=67, 66) | 19.7 scores on a scale | Standard Deviation 29.2 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 6 (n=42, 30) | 15.6 scores on a scale | Standard Deviation 31.2 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 2 (n=69, 66) | 22.7 scores on a scale | Standard Deviation 29.3 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 10 (n=29, 14) | 16.7 scores on a scale | Standard Deviation 25.3 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 3 (n=60, 56) | 20.8 scores on a scale | Standard Deviation 30.2 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 7 (n=38, 28) | 19.6 scores on a scale | Standard Deviation 26.1 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 4 (n=55, 43) | 22.5 scores on a scale | Standard Deviation 27.9 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 9 (n=32, 18) | 18.5 scores on a scale | Standard Deviation 28.5 |
| Placebo | EORTC QLQ-C30 - Dyspnea Subscale | Cycle 5 (n=48, 41) | 16.3 scores on a scale | Standard Deviation 22.5 |
Comparison: Cycle 2 through Cycle 10p-value: 0.133995% CI: [-1.6, 12.1]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Emotional Functioning Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 1 (n=67, 66) | 75.2 scores on a scale | Standard Deviation 23 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 2 (n=69, 66) | 76.2 scores on a scale | Standard Deviation 22.1 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 3 (n=60, 56) | 75.3 scores on a scale | Standard Deviation 20.2 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 4 (n=55, 43) | 72.2 scores on a scale | Standard Deviation 23.2 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 5 (n=48, 40) | 72.6 scores on a scale | Standard Deviation 25.2 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 6 (n=42, 31) | 77.8 scores on a scale | Standard Deviation 23.8 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 7 (n=38, 28) | 75.3 scores on a scale | Standard Deviation 28.6 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 8 (n=34, 22) | 74.0 scores on a scale | Standard Deviation 30.9 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 9 (n=33, 18) | 75.4 scores on a scale | Standard Deviation 23.4 |
| Sunitinib | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 10 (n=29, 14) | 76.4 scores on a scale | Standard Deviation 23.4 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 8 (n=34, 22) | 76.7 scores on a scale | Standard Deviation 21.6 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 1 (n=67, 66) | 73.7 scores on a scale | Standard Deviation 26.2 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 6 (n=42, 31) | 72.8 scores on a scale | Standard Deviation 28.9 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 2 (n=69, 66) | 73.1 scores on a scale | Standard Deviation 27.1 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 10 (n=29, 14) | 76.2 scores on a scale | Standard Deviation 20.4 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 3 (n=60, 56) | 70.8 scores on a scale | Standard Deviation 25.8 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 7 (n=38, 28) | 80.8 scores on a scale | Standard Deviation 19.8 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 4 (n=55, 43) | 76.9 scores on a scale | Standard Deviation 22.3 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 9 (n=33, 18) | 75.8 scores on a scale | Standard Deviation 30 |
| Placebo | EORTC QLQ-C30 - Emotional Functioning Subscale | Cycle 5 (n=48, 40) | 75.8 scores on a scale | Standard Deviation 23.9 |
Comparison: Cycle 2 through Cycle 10p-value: 0.300895% CI: [-10.3, 3.2]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Fatigue Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 1 (n=67, 66) | 29.4 scores on a scale | Standard Deviation 23.7 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 2 (n=69, 67) | 44.3 scores on a scale | Standard Deviation 24.2 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 3 (n=60, 56) | 41.2 scores on a scale | Standard Deviation 23.6 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 4 (n=55, 43) | 41.0 scores on a scale | Standard Deviation 26 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 5 (n=48, 41) | 34.7 scores on a scale | Standard Deviation 23.4 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 6 (n=42, 31) | 34.9 scores on a scale | Standard Deviation 25.9 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 7 (n=38, 28) | 36.5 scores on a scale | Standard Deviation 24.9 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 8 (n=34, 22) | 39.9 scores on a scale | Standard Deviation 28.4 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 9 (n=33, 18) | 37.4 scores on a scale | Standard Deviation 22.5 |
| Sunitinib | EORTC QLQ-C30 - Fatigue Subscale | Cycle 10 (n=29, 14) | 33.7 scores on a scale | Standard Deviation 23.7 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 8 (n=34, 22) | 43.2 scores on a scale | Standard Deviation 33 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 1 (n=67, 66) | 34.5 scores on a scale | Standard Deviation 26.4 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 6 (n=42, 31) | 42.3 scores on a scale | Standard Deviation 33.1 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 2 (n=69, 67) | 40.1 scores on a scale | Standard Deviation 30.1 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 10 (n=29, 14) | 43.7 scores on a scale | Standard Deviation 30.3 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 3 (n=60, 56) | 42.3 scores on a scale | Standard Deviation 32.6 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 7 (n=38, 28) | 34.9 scores on a scale | Standard Deviation 27.2 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 4 (n=55, 43) | 37.0 scores on a scale | Standard Deviation 29.5 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 9 (n=33, 18) | 37.7 scores on a scale | Standard Deviation 27.8 |
| Placebo | EORTC QLQ-C30 - Fatigue Subscale | Cycle 5 (n=48, 41) | 36.3 scores on a scale | Standard Deviation 31.8 |
Comparison: Cycle 2 through Cycle 10p-value: 0.613895% CI: [-5.1, 8.7]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Financial Difficulties Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 1 (n=67, 66) | 19.9 scores on a scale | Standard Deviation 32.3 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 2 (n=68, 65) | 14.2 scores on a scale | Standard Deviation 26 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 3 (n=59, 56) | 15.8 scores on a scale | Standard Deviation 25.8 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 4 (n=55, 43) | 18.2 scores on a scale | Standard Deviation 27.8 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 5 (n=48, 40) | 18.1 scores on a scale | Standard Deviation 28.3 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 6 (n=42, 30) | 19.0 scores on a scale | Standard Deviation 29.6 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 7 (n=38, 28) | 20.2 scores on a scale | Standard Deviation 33.4 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 8 (n=34, 22) | 18.6 scores on a scale | Standard Deviation 32 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 9 (n=33, 18) | 20.2 scores on a scale | Standard Deviation 26.3 |
| Sunitinib | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 10 (n=29, 14) | 17.2 scores on a scale | Standard Deviation 29 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 8 (n=34, 22) | 13.6 scores on a scale | Standard Deviation 19.7 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 1 (n=67, 66) | 15.7 scores on a scale | Standard Deviation 27.6 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 6 (n=42, 30) | 11.1 scores on a scale | Standard Deviation 23.7 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 2 (n=68, 65) | 14.4 scores on a scale | Standard Deviation 26.3 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 10 (n=29, 14) | 14.3 scores on a scale | Standard Deviation 31.3 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 3 (n=59, 56) | 16.7 scores on a scale | Standard Deviation 28.4 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 7 (n=38, 28) | 10.7 scores on a scale | Standard Deviation 22.3 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 4 (n=55, 43) | 12.4 scores on a scale | Standard Deviation 27.2 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 9 (n=33, 18) | 14.8 scores on a scale | Standard Deviation 28.5 |
| Placebo | EORTC QLQ-C30 - Financial Difficulties Subscale | Cycle 5 (n=48, 40) | 13.3 scores on a scale | Standard Deviation 24.8 |
Comparison: Cycle 2 through Cycle 10p-value: 0.936795% CI: [-6.6, 7.1]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Insomnia Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 1 (n=67, 66) | 25.4 scores on a scale | Standard Deviation 29.6 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 2 (n=69, 67) | 36.7 scores on a scale | Standard Deviation 35.8 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 3 (n=59, 56) | 35.6 scores on a scale | Standard Deviation 30.9 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 4 (n=55, 43) | 35.2 scores on a scale | Standard Deviation 33 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 5 (n=48, 41) | 25.0 scores on a scale | Standard Deviation 26.2 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 6 (n=42, 30) | 31.0 scores on a scale | Standard Deviation 32.4 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 7 (n=38, 28) | 32.9 scores on a scale | Standard Deviation 35.6 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 8 (n=34, 22) | 28.4 scores on a scale | Standard Deviation 34.9 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 9 (n=33, 18) | 26.3 scores on a scale | Standard Deviation 32 |
| Sunitinib | EORTC QLQ-C30 - Insomnia Subscale | Cycle 10 (n=29, 14) | 31.0 scores on a scale | Standard Deviation 34.4 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 8 (n=34, 22) | 28.8 scores on a scale | Standard Deviation 23.7 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 1 (n=67, 66) | 26.3 scores on a scale | Standard Deviation 27.7 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 6 (n=42, 30) | 28.9 scores on a scale | Standard Deviation 35.8 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 2 (n=69, 67) | 27.4 scores on a scale | Standard Deviation 30.7 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 10 (n=29, 14) | 23.8 scores on a scale | Standard Deviation 24.2 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 3 (n=59, 56) | 24.7 scores on a scale | Standard Deviation 27.2 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 7 (n=38, 28) | 23.2 scores on a scale | Standard Deviation 29.2 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 4 (n=55, 43) | 22.5 scores on a scale | Standard Deviation 24.9 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 9 (n=33, 18) | 29.6 scores on a scale | Standard Deviation 30 |
| Placebo | EORTC QLQ-C30 - Insomnia Subscale | Cycle 5 (n=48, 41) | 24.0 scores on a scale | Standard Deviation 27.4 |
Comparison: Cycle 2 through Cycle 10p-value: 0.037295% CI: [0.5, 15]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Nausea and Vomiting Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 1 (n=67, 66) | 6.7 scores on a scale | Standard Deviation 12.3 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 2 (n=69, 67) | 13.0 scores on a scale | Standard Deviation 19.6 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 3 (n=60, 56) | 15.8 scores on a scale | Standard Deviation 22.6 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 4 (n=55, 43) | 15.8 scores on a scale | Standard Deviation 21.4 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 5 (n=48, 41) | 15.6 scores on a scale | Standard Deviation 25.1 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 6 (n=42, 31) | 11.5 scores on a scale | Standard Deviation 16.7 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 7 (n=38, 28) | 13.8 scores on a scale | Standard Deviation 19.6 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 8 (n=34, 22) | 11.8 scores on a scale | Standard Deviation 22.3 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 9 (n=33, 18) | 9.6 scores on a scale | Standard Deviation 16.7 |
| Sunitinib | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 10 (n=29, 14) | 8.6 scores on a scale | Standard Deviation 14.5 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 8 (n=34, 22) | 16.3 scores on a scale | Standard Deviation 25 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 1 (n=67, 66) | 12.6 scores on a scale | Standard Deviation 22.1 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 6 (n=42, 31) | 14.5 scores on a scale | Standard Deviation 17.6 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 2 (n=69, 67) | 16.4 scores on a scale | Standard Deviation 21.8 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 10 (n=29, 14) | 3.6 scores on a scale | Standard Deviation 9.6 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 3 (n=60, 56) | 15.3 scores on a scale | Standard Deviation 25.4 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 7 (n=38, 28) | 9.5 scores on a scale | Standard Deviation 16 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 4 (n=55, 43) | 15.1 scores on a scale | Standard Deviation 24.1 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 9 (n=33, 18) | 6.5 scores on a scale | Standard Deviation 11.6 |
| Placebo | EORTC QLQ-C30 - Nausea and Vomiting Subscale | Cycle 5 (n=48, 41) | 11.6 scores on a scale | Standard Deviation 15.9 |
Comparison: Cycle 2 through Cycle 10p-value: 0.693995% CI: [-4.6, 6.9]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Pain Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 1 (n=67, 66) | 22.9 scores on a scale | Standard Deviation 24.4 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 2 (n=69, 67) | 29.5 scores on a scale | Standard Deviation 27.6 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 3 (n=60, 56) | 28.1 scores on a scale | Standard Deviation 27.4 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 4 (n=55, 43) | 25.5 scores on a scale | Standard Deviation 27.9 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 5 (n=48, 41) | 26.7 scores on a scale | Standard Deviation 25.4 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 6 (n=42, 31) | 25.0 scores on a scale | Standard Deviation 25.6 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 7 (n=38, 28) | 23.9 scores on a scale | Standard Deviation 26.9 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 8 (n=34, 22) | 23.0 scores on a scale | Standard Deviation 26.6 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 9 (n=33, 18) | 25.3 scores on a scale | Standard Deviation 24.7 |
| Sunitinib | EORTC QLQ-C30 - Pain Subscale | Cycle 10 (n=29, 14) | 17.2 scores on a scale | Standard Deviation 15.7 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 8 (n=34, 22) | 28.0 scores on a scale | Standard Deviation 33.1 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 1 (n=67, 66) | 22.5 scores on a scale | Standard Deviation 28.9 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 6 (n=42, 31) | 31.2 scores on a scale | Standard Deviation 34.1 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 2 (n=69, 67) | 28.6 scores on a scale | Standard Deviation 34.5 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 10 (n=29, 14) | 26.2 scores on a scale | Standard Deviation 26.7 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 3 (n=60, 56) | 28.7 scores on a scale | Standard Deviation 32 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 7 (n=38, 28) | 23.5 scores on a scale | Standard Deviation 25.6 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 4 (n=55, 43) | 24.0 scores on a scale | Standard Deviation 28.7 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 9 (n=33, 18) | 22.2 scores on a scale | Standard Deviation 32.8 |
| Placebo | EORTC QLQ-C30 - Pain Subscale | Cycle 5 (n=48, 41) | 28.0 scores on a scale | Standard Deviation 32.8 |
Comparison: Cycle 2 through Cycle 10p-value: 0.371195% CI: [-11.2, 4.2]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Physical Functioning Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 1 (n=67, 66) | 83.1 scores on a scale | Standard Deviation 20.5 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 2 (n=69, 67) | 77.7 scores on a scale | Standard Deviation 20.5 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 3 (n=60, 56) | 78.2 scores on a scale | Standard Deviation 21.6 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 4 (n=55, 43) | 77.5 scores on a scale | Standard Deviation 21.3 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 5 (n=48, 40) | 78.3 scores on a scale | Standard Deviation 20.2 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 6 (n=42, 30) | 80.9 scores on a scale | Standard Deviation 16.3 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 7 (n=38, 28) | 80.3 scores on a scale | Standard Deviation 18.8 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 8 (n=34, 22) | 79.4 scores on a scale | Standard Deviation 20.7 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 9 (n=33, 18) | 78.8 scores on a scale | Standard Deviation 17 |
| Sunitinib | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 10 (n=29, 14) | 81.4 scores on a scale | Standard Deviation 18.9 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 8 (n=34, 22) | 73.5 scores on a scale | Standard Deviation 28.1 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 1 (n=67, 66) | 83.1 scores on a scale | Standard Deviation 20.6 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 6 (n=42, 30) | 81.1 scores on a scale | Standard Deviation 22.3 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 2 (n=69, 67) | 77.1 scores on a scale | Standard Deviation 25.9 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 10 (n=29, 14) | 78.6 scores on a scale | Standard Deviation 23.3 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 3 (n=60, 56) | 75.5 scores on a scale | Standard Deviation 28.5 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 7 (n=38, 28) | 78.9 scores on a scale | Standard Deviation 25.4 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 4 (n=55, 43) | 78.4 scores on a scale | Standard Deviation 24.5 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 9 (n=33, 18) | 79.6 scores on a scale | Standard Deviation 24.8 |
| Placebo | EORTC QLQ-C30 - Physical Functioning Subscale | Cycle 5 (n=48, 40) | 80.7 scores on a scale | Standard Deviation 21.9 |
Comparison: Cycle 2 through Cycle 10p-value: 0.32395% CI: [-2.8, 8.3]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Role Functioning Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 1 (n=67, 66) | 84.3 scores on a scale | Standard Deviation 23.4 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 2 (n=69, 67) | 71.6 scores on a scale | Standard Deviation 28.9 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 3 (n=60, 56) | 71.0 scores on a scale | Standard Deviation 26.7 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 4 (n=55, 43) | 72.1 scores on a scale | Standard Deviation 28.9 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 5 (n=48, 41) | 71.5 scores on a scale | Standard Deviation 27.7 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 6 (n=42, 31) | 76.6 scores on a scale | Standard Deviation 26.6 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 7 (n=38, 28) | 75.7 scores on a scale | Standard Deviation 28.8 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 8 (n=34, 22) | 73.0 scores on a scale | Standard Deviation 29.6 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 9 (n=33, 18) | 72.2 scores on a scale | Standard Deviation 24.2 |
| Sunitinib | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 10 (n=29, 14) | 79.9 scores on a scale | Standard Deviation 22.4 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 8 (n=34, 22) | 66.7 scores on a scale | Standard Deviation 30.9 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 1 (n=67, 66) | 77.5 scores on a scale | Standard Deviation 27.7 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 6 (n=42, 31) | 66.1 scores on a scale | Standard Deviation 32.6 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 2 (n=69, 67) | 68.9 scores on a scale | Standard Deviation 30.6 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 10 (n=29, 14) | 70.2 scores on a scale | Standard Deviation 28.6 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 3 (n=60, 56) | 70.5 scores on a scale | Standard Deviation 31 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 7 (n=38, 28) | 72.3 scores on a scale | Standard Deviation 29.7 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 4 (n=55, 43) | 73.3 scores on a scale | Standard Deviation 29.6 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 9 (n=33, 18) | 67.6 scores on a scale | Standard Deviation 31.6 |
| Placebo | EORTC QLQ-C30 - Role Functioning Subscale | Cycle 5 (n=48, 41) | 75.0 scores on a scale | Standard Deviation 31.4 |
Comparison: Cycle 2 through Cycle 10p-value: 0.711395% CI: [-6.5, 9.5]Repeated Measures Mixed-Effects Model
Secondary
EORTC QLQ-C30 - Social Functioning Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 1 (n=67, 66) | 79.4 scores on a scale | Standard Deviation 27.2 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 2 (n=69, 66) | 77.8 scores on a scale | Standard Deviation 22.1 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 3 (n=60, 56) | 77.1 scores on a scale | Standard Deviation 23.1 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 4 (n=55, 43) | 71.2 scores on a scale | Standard Deviation 28.4 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 5 (n=48, 40) | 74.3 scores on a scale | Standard Deviation 23.8 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 6 (n=42, 31) | 79.0 scores on a scale | Standard Deviation 26.3 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 7 (n=38, 28) | 76.3 scores on a scale | Standard Deviation 29.2 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 8 (n=34, 22) | 72.5 scores on a scale | Standard Deviation 30.4 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 9 (n=33, 18) | 76.3 scores on a scale | Standard Deviation 21.7 |
| Sunitinib | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 10 (n=29, 14) | 75.9 scores on a scale | Standard Deviation 25.8 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 8 (n=34, 22) | 74.2 scores on a scale | Standard Deviation 31.6 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 1 (n=67, 66) | 77.0 scores on a scale | Standard Deviation 31.5 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 6 (n=42, 31) | 74.7 scores on a scale | Standard Deviation 31 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 2 (n=69, 66) | 75.0 scores on a scale | Standard Deviation 31 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 10 (n=29, 14) | 81.0 scores on a scale | Standard Deviation 24.3 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 3 (n=60, 56) | 77.2 scores on a scale | Standard Deviation 28.8 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 7 (n=38, 28) | 83.9 scores on a scale | Standard Deviation 25.5 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 4 (n=55, 43) | 79.8 scores on a scale | Standard Deviation 26.1 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 9 (n=33, 18) | 74.1 scores on a scale | Standard Deviation 33.4 |
| Placebo | EORTC QLQ-C30 - Social Functioning Subscale | Cycle 5 (n=48, 40) | 77.3 scores on a scale | Standard Deviation 30.2 |
Comparison: Cycle 2 through Cycle 10p-value: 0.648795% CI: [-8.9, 5.5]Repeated Measures Mixed-Effects Model
Secondary
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Sunitinib | 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 |
| Placebo | 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) | 62.1 scores on a scale | Standard Deviation 23.2 |
| 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) | 64.0 scores on a scale | Standard Deviation 22.7 |
| Placebo | 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) | 56.7 scores on a scale | Standard Deviation 29.8 |
| Placebo | 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) | 62.6 scores on a scale | Standard Deviation 23.6 |
| Placebo | 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) | 59.5 scores on a scale | Standard Deviation 24 |
| Placebo | 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) | 63.5 scores on a scale | Standard Deviation 25.1 |
| Placebo | 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) | 64.6 scores on a scale | Standard Deviation 23.4 |
| Placebo | 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) | 61.6 scores on a scale | Standard Deviation 23.3 |
| Placebo | 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) | 64.4 scores on a scale | Standard Deviation 22.1 |
| Placebo | 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) | 61.7 scores on a scale | Standard Deviation 25.4 |
Comparison: Cycle 2 through Cycle 10p-value: 0.679995% CI: [-4.3, 6.6]Repeated Measures Mixed-Effects Model
Secondary
Number of Subjects With 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.
Time frame: From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
Population: ITT. No placebo subjects had objective response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Subjects With Objective Response | 8 participants |
95% CI: [4.1, 17.5]
Secondary
Overall Survival (OS)
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
Population: ITT. The median OS in months could not be calculated for placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Overall Survival (OS) | 20.6 months |
p-value: 0.020495% CI: [0.187, 0.894]Log Rank
Secondary
Time-to-Tumor Response (TTR)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Time-to-Tumor Response (TTR) | 3.1 Months |