Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338884

Enrollment

120

Registered

2006-06-20

Start date

2006-09-30

Completion date

2009-04-30

Last updated

2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Brief summary

A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Interventions

DRUGSunitinib malate

Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Advanced kidney cancer

Exclusion criteria

* Previous treatment for kidney cancer, except surgical removal of kidney tumor

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Overall Confirmed Objective Response (OR)	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter	OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. 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.

Secondary

Measure	Time frame	Description
Time to Tumor Progression (TTP)	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter	Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
Progression-Free Survival (PFS)	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death	Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
1-Year Survival	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year	One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Trough Plasma Concentrations (Ctrough) of Sunitinib	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of SU-012662 (Sunitinib's Metabolite)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of Total Drug (Sunitinib + SU-012662)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough Correlated With Serious Adverse Events (SAEs)	Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53	Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Duration of Response (DR)	From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause	Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7.
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Baseline (Cycle 1, Day 1)	Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Baseline (Cycle 1, Day 1)	Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
VEGF Ratio to Baseline at Each Time Point	Baseline to Day 1 of Weeks 3 through 53	VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Baseline to Day 1 of Weeks 3 through 53	Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Baseline to Day 1 of Weeks 3 through 53	Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline	Baseline	—
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Baseline (Cycle 1, Day 1)	Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Baseline (Cycle 1, Day 1)	Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
sVEGFR2 Ratio to Baseline at Each Time Point	Baseline to Day 1 of Weeks 3 through 53	sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Baseline to Day 1 of Weeks 3 through 53	Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Baseline to Day 1 of Weeks 3 through 53	Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).
Patient-Assessed Fatigue	Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
Cancer Related Symptoms, Well-Being, and Concerns	Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)	FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline	Baseline	—

Countries

Argentina, Australia, Brazil, Mexico, South Korea, Taiwan

Participant flow

Participants by arm

Arm	Count
Sunitinib 37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.	119
Total	119

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	14
Overall Study	Death	8
Overall Study	Global Deterioration of Health Status	3
Overall Study	Lost to Follow-up	1
Overall Study	Objective Disease Progression or Relapse	44
Overall Study	Other	4
Overall Study	Randomized But Did Not Receive Treatment	1
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Sunitinib
Age, Customized 18 to 44 years	14 participants
Age, Customized 45 to 64 years	69 participants
Age, Customized > = 65 years	36 participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	90 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	117 / 119
serious Total, serious adverse events	45 / 119

Outcome results

Primary

Number of Subjects With Overall Confirmed Objective Response (OR)

OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. 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 start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Population: Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.

Arm	Measure	Value (NUMBER)
Sunitinib	Number of Subjects With Overall Confirmed Objective Response (OR)	41 participants

95% CI: [26.7, 44.8]

Secondary

1-Year Survival

One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.

Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year

Population: Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.

Arm	Measure	Value (MEDIAN)
Sunitinib	1-Year Survival	67.8 percent chance of survival

Secondary

Cancer Related Symptoms, Well-Being, and Concerns

FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.

Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Population: Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Baseline (n=109)	44.68 scores on a scale	Standard Deviation 7.78
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 3 (n=104)	43.69 scores on a scale	Standard Deviation 8.38
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 5 (n=101)	42.71 scores on a scale	Standard Deviation 8.64
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 7 (n=97)	43.69 scores on a scale	Standard Deviation 7.99
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 9 (n=88)	44.11 scores on a scale	Standard Deviation 7.55
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 11 (n=84)	43.26 scores on a scale	Standard Deviation 7.88
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 13 (n=81)	43.49 scores on a scale	Standard Deviation 8.01
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 17 (n=72)	44.21 scores on a scale	Standard Deviation 7.34
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 21 (n=63)	45.51 scores on a scale	Standard Deviation 7.5
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 25 (n=55)	45.42 scores on a scale	Standard Deviation 8
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 29 (n=55)	44.64 scores on a scale	Standard Deviation 8.42
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 33 (n=50)	44.06 scores on a scale	Standard Deviation 8.35
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 37 (n=47)	45.23 scores on a scale	Standard Deviation 8.03
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 41 (n=45)	44.71 scores on a scale	Standard Deviation 8.16
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 45 (n=37)	46.73 scores on a scale	Standard Deviation 6.94
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 49 (n=36)	45.92 scores on a scale	Standard Deviation 7.31
Sunitinib	Cancer Related Symptoms, Well-Being, and Concerns	Week 53 (End of Treatment) (n=35)	45.94 scores on a scale	Standard Deviation 7.29

Secondary

Ctrough Correlated With Serious Adverse Events (SAEs)

Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.

Secondary

Ctrough of SU-012662 (Sunitinib's Metabolite)

Ctrough = the concentration prior to study drug administration.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 1 (n=111)	2.62 ng/mL	Standard Deviation 6.88
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 3 (n=108)	20.27 ng/mL	Standard Deviation 8.17
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 5 (n=106)	20.25 ng/mL	Standard Deviation 11.73
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 7 (n=104)	20.41 ng/mL	Standard Deviation 12.45
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 9 (n=97)	21.18 ng/mL	Standard Deviation 13.07
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 13 (n=93)	20.01 ng/mL	Standard Deviation 13.88
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 17 (n=82)	19.76 ng/mL	Standard Deviation 12.84
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 21 (n=73)	17.13 ng/mL	Standard Deviation 11.64
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 25 (n=70)	17.30 ng/mL	Standard Deviation 12.75
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 29 (n=58)	17.38 ng/mL	Standard Deviation 11.76
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 33 (n=58)	16.55 ng/mL	Standard Deviation 12.2
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 37 (n=50)	15.71 ng/mL	Standard Deviation 6.7
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 41 (n=49)	16.50 ng/mL	Standard Deviation 8.95
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 45 (n=44)	15.61 ng/mL	Standard Deviation 7.66
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 49 (n=40)	16.57 ng/mL	Standard Deviation 7.65
Sunitinib	Ctrough of SU-012662 (Sunitinib's Metabolite)	Day 1, Week 53 (n=33)	13.81 ng/mL	Standard Deviation 7.21

Secondary

Ctrough of Total Drug (Sunitinib + SU-012662)

Ctrough = the concentration prior to study drug administration.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 1 (n=111)	9.77 ng/mL	Standard Deviation 25.09
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 3 (n=108)	75.04 ng/mL	Standard Deviation 29.48
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 5 (n=106)	65.89 ng/mL	Standard Deviation 32.37
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 7 (n=104)	66.76 ng/mL	Standard Deviation 32.03
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 9 (n=97)	68.72 ng/mL	Standard Deviation 35.01
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 13 (n=93)	61.31 ng/mL	Standard Deviation 33.31
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 17 (n=82)	61.41 ng/mL	Standard Deviation 30.43
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 21 (n=73)	53.09 ng/mL	Standard Deviation 30.5
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 25 (n=70)	53.69 ng/mL	Standard Deviation 31.52
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 29 (n=58)	55.39 ng/mL	Standard Deviation 31.4
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 33 (n=58)	50.27 ng/mL	Standard Deviation 29.55
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 37 (n=50)	51.74 ng/mL	Standard Deviation 20.54
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 41 (n=49)	49.83 ng/mL	Standard Deviation 23.68
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 45 (n=44)	51.82 ng/mL	Standard Deviation 19.15
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 49 (n=40)	53.07 ng/mL	Standard Deviation 18.25
Sunitinib	Ctrough of Total Drug (Sunitinib + SU-012662)	Day 1, Week 53 (n=33)	46.91 ng/mL	Standard Deviation 21.56

Secondary

Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 3 (CR or PR, n=40)	18.250 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 5 (CR or PR, n=38)	16.650 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 7 (CR or PR, n=40)	17.300 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 9 (CR or PR, n=38)	15.100 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 13 (CR or PR, n=41)	15.900 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 17 (CR or PR, n=38)	14.300 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 21 (CR or PR, n=38)	12.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 25 (CR or PR, n=37)	14.500 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 29 (CR or PR, n=32)	12.850 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 33 (CR or PR, n=33)	12.800 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 37 (CR or PR, n=28)	14.350 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 41 (CR or PR, n=28)	14.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 45 (CR or PR, n=29)	13.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 49 (CR or PR, n=26)	14.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 53 (CR or PR, n=21)	11.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 3 (PD, n=15)	20.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 5 (PD, n=15)	18.800 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 7 (PD, n=13)	14.300 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 9 (PD, n=8)	16.550 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 13 (PD, n=1)	9.710 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 17 (PD, n=1)	12.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 21 (PD, n=1)	23.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 25 (PD, n=1)	29.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 29 (PD, n=1)	13.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 33 (PD, n=1)	4.360 ng/mL

Comparison: Day 1, Week 1 (CR or PR Versus PD)p-value: 0.5784Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR Versus PD)p-value: 0.6251Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR Versus PD)p-value: 0.1639Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR Versus PD)p-value: 0.2782Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR Versus PD)p-value: 0.8627Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR Versus PD)p-value: 0.462Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR Versus PD)p-value: 0.7575Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR Versus PD)p-value: 0.3566Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR Versus PD)p-value: 0.2809Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR Versus PD)p-value: 0.8758Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR Versus PD)p-value: 0.2702Wilcoxon Rank Sum Test

Secondary

Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 3 (CR or PR, n=40)	76.950 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 5 (CR or PR, n=38)	65.900 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 7 (CR or PR, n=40)	66.100 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 9 (CR or PR, n=38)	65.150 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 13 (CR or PR, n=41)	57.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 17 (CR or PR, n=38)	55.660 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 21 (CR or PR, n=38)	47.370 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 25 (CR or PR, n=37)	50.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 29 (CR or PR, n=32)	50.650 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 33 (CR or PR, n=33)	46.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 37 (CR or PR, n=28)	49.750 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 41 (CR or PR, n=28)	43.365 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 45 (CR or PR, n=29)	45.200 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 49 (CR or PR, n=26)	49.975 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 53 (CR or PR, n=21)	41.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 3 (PD, n=15)	69.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 5 (PD, n=15)	64.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 7 (PD, n=13)	50.200 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 9 (PD, n=8)	55.850 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 13 (PD, n=1)	34.810 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 17 (PD, n=1)	40.800 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 21 (PD, n=1)	71.100 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 25 (PD, n=1)	52.100 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 29 (PD, n=1)	37.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)	Day 1, Week 33 (PD, n=1)	13.880 ng/mL

Comparison: Day 1, Week 1 (CR or PR Versus PD)p-value: 0.5784Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR Versus PD)p-value: 0.9625Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR Versus PD)p-value: 0.8519Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR Versus PD)p-value: 0.0513Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR Versus PD)p-value: 0.4051Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR Versus PD)p-value: 0.2548Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR Versus PD)p-value: 0.5091Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR Versus PD)p-value: 0.3133Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR Versus PD)p-value: 0.9278Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR Versus PD)p-value: 0.407Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR Versus PD)p-value: 0.2703Wilcoxon Rank Sum Test

Secondary

Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib

Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 1 (CR or PR, n=39)	0.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 3 (CR or PR, n=40)	57.900 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 5 (CR or PR, n=38)	45.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 7 (CR or PR, n=40)	45.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 9 (CR or PR, n=38)	46.250 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 13 (CR or PR, n=41)	40.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 17 (CR or PR, n=38)	41.350 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 21 (CR or PR, n=38)	34.400 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 25 (CR or PR, n=37)	34.200 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 29 (CR or PR, n=32)	34.450 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 33 (CR or PR, n=33)	33.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 37 (CR or PR, n=28)	35.350 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 41 (CR or PR, n=28)	30.900 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 45 (CR or PR, n=29)	34.000 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 49 (CR or PR, n=26)	36.250 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 53 (CR or PR, n=21)	28.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 3 (PD, n=15)	50.200 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 5 (PD, n=15)	45.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 7 (PD, n=13)	35.600 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 9 (PD, n=8)	39.050 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 13 (PD, n=1)	25.100 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 17 (PD, n=1)	28.200 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 21 (PD, n=1)	47.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 25 (PD, n=1)	22.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 29 (PD, n=1)	23.700 ng/mL
Sunitinib	Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib	Day 1, Week 33 (PD, n=1)	9.520 ng/mL

Comparison: Day 1, Week 29 (CR or PR Versus PD)p-value: 0.3259Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR Versus PD)p-value: 0.2702Wilcoxon Rank Sum Test

Comparison: Day 1, Week 1 (CR or PR Versus PD)p-value: 0.5581Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR Versus PD)p-value: 0.7635Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR Versus PD)p-value: 0.8366Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR Versus PD)p-value: 0.0278Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR Versus PD)p-value: 0.1988Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR Versus PD)p-value: 0.2898Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR Versus PD)p-value: 0.3567Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR Versus PD)p-value: 0.4547Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR Versus PD)p-value: 0.2809Wilcoxon Rank Sum Test

Secondary

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 3 (CR or PR or SD, n=83)	18.800 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 5 (CR or PR or SD, n=83)	17.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 7 (CR or PR or SD, n=86)	17.900 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 9 (CR or PR or SD, n=85)	18.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 13 (CR or PR or SD, n=88)	16.350 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 17 (CR or PR or SD, n=79)	14.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 21 (CR or PR or SD, n=71)	14.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 25 (CR or PR or SD, n=68)	14.950 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 29 (CR or PR or SD, n=56)	14.900 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 33 (CR or PR or SD, n=56)	14.050 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 37 (CR or PR or SD, n=49)	15.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 41 (CR or PR or SD, n=49)	15.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 45 (CR or PR or SD, n=44)	13.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 49 (CR or PR or SD, n=40)	14.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 53 (CR or PR or SD, n=32)	11.450 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 3 (PD, n=15)	20.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 5 (PD, n=15)	18.800 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 7 (PD, n=13)	14.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 9 (PD, n=8)	16.550 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 13 (PD, n=1)	9.710 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 17 (PD, n=1)	12.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 21 (PD, n=1)	23.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 25 (PD, n=1)	29.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 29 (PD, n=1)	13.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)	Day 1, Week 33 (PD, n=1)	4.360 ng/mL

Comparison: Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.7267Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.8555Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2259Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2074Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4779Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3628Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.546Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3637Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2229Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.9759Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2179Wilcoxon Rank Sum Test

Secondary

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 3 (CR or PR or SD, n=83)	75.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 5 (CR or PR or SD, n=83)	63.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 7 (CR or PR or SD, n=86)	66.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 9 (CR or PR or SD, n=85)	70.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 13 (CR or PR or SD, n=88)	57.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 17 (CR or PR or SD, n=79)	58.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 21 (CR or PR or SD, n=71)	49.860 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 25 (CR or PR or SD, n=68)	51.150 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 29 (CR or PR or SD, n=56)	53.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 33 (CR or PR or SD, n=56)	50.050 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 37 (CR or PR or SD, n=49)	50.800 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 41 (CR or PR or SD, n=49)	48.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 45 (CR or PR or SD, n=44)	50.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 49 (CR or PR or SD, n=40)	54.885 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 53 (CR or PR or SD, n=32)	42.160 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 3 (PD, n=15)	69.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 5 (PD, n=15)	64.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 7 (PD, n=13)	50.200 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 9 (PD, n=8)	55.850 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 13 (PD, n=1)	34.810 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 17 (PD, n=1)	40.800 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 21 (PD, n=1)	71.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 25 (PD, n=1)	52.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 29 (PD, n=1)	37.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)	Day 1, Week 33 (PD, n=1)	13.880 ng/mL

Comparison: Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.7267Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.8286Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6867Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.045Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.174Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2703Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3659Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3391Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.98Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.335Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2179Wilcoxon Rank Sum Test

Secondary

Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib

Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 1 (CR or PR or SD, n=83)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 3 (CR or PR or SD, n=83)	55.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 5 (CR or PR or SD, n=83)	44.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 7 (CR or PR or SD, n=86)	46.750 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 9 (CR or PR or SD, n=85)	49.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 13 (CR or PR or SD, n=88)	39.550 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 17 (CR or PR or SD, n=79)	42.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 21 (CR or PR or SD, n=71)	36.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 25 (CR or PR or SD, n=68)	35.500 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 29 (CR or PR or SD, n=56)	37.250 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 33 (CR or PR or SD, n=56)	34.400 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 37 (CR or PR or SD, n=49)	35.300 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 41 (CR or PR or SD, n=49)	33.200 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 45 (CR or PR or SD, n=44)	35.950 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 49 (CR or PR or SD, n=40)	37.250 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 53 (CR or PR or SD, n=32)	31.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 1 (PD, n=16)	0.000 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 3 (PD, n=15)	50.200 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 5 (PD, n=15)	45.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 7 (PD, n=13)	35.600 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 9 (PD, n=8)	39.050 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 13 (PD, n=1)	25.100 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 17 (PD, n=1)	28.200 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 21 (PD, n=1)	47.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 25 (PD, n=1)	22.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 29 (PD, n=1)	23.700 ng/mL
Sunitinib	Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib	Day 1, Week 33 (PD, n=1)	9.520 ng/mL

Comparison: Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.7154Wilcoxon Rank Sum Test

Comparison: Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6263Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.9608Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.03Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.0927Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2873Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3018Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4161Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3069Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.292Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2409Wilcoxon Rank Sum Test

Secondary

Duration of Response (DR)

Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7.

Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause

Population: Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.

Arm	Measure	Value (MEAN)
Sunitinib	Duration of Response (DR)	7.14 months

Secondary

Patient-Assessed Fatigue

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.

Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)

Population: Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	Patient-Assessed Fatigue	Baseline (n=118)	39.29 scores on a scale	Standard Deviation 9.55
Sunitinib	Patient-Assessed Fatigue	Week 3 (n=113)	36.98 scores on a scale	Standard Deviation 11.38
Sunitinib	Patient-Assessed Fatigue	Week 5 (n=110)	35.44 scores on a scale	Standard Deviation 10.87
Sunitinib	Patient-Assessed Fatigue	Week 7 (n=106)	36.54 scores on a scale	Standard Deviation 10.86
Sunitinib	Patient-Assessed Fatigue	Week 9 (n=97)	36.82 scores on a scale	Standard Deviation 9.43
Sunitinib	Patient-Assessed Fatigue	Week 11 (n=93)	35.94 scores on a scale	Standard Deviation 9.75
Sunitinib	Patient-Assessed Fatigue	Week 13 (n=90)	36.58 scores on a scale	Standard Deviation 10.32
Sunitinib	Patient-Assessed Fatigue	Week 17 (n=80)	37.44 scores on a scale	Standard Deviation 9.83
Sunitinib	Patient-Assessed Fatigue	Week 21 (n=71)	38.42 scores on a scale	Standard Deviation 10.08
Sunitinib	Patient-Assessed Fatigue	Week 25 (n=62)	38.05 scores on a scale	Standard Deviation 9.69
Sunitinib	Patient-Assessed Fatigue	Week 29 (n=60)	36.77 scores on a scale	Standard Deviation 10.89
Sunitinib	Patient-Assessed Fatigue	Week 33 (n=55)	36.00 scores on a scale	Standard Deviation 11.22
Sunitinib	Patient-Assessed Fatigue	Week 37 (n=52)	37.88 scores on a scale	Standard Deviation 9.77
Sunitinib	Patient-Assessed Fatigue	Week 41 (n=50)	36.96 scores on a scale	Standard Deviation 10.74
Sunitinib	Patient-Assessed Fatigue	Week 45 (n=42)	38.71 scores on a scale	Standard Deviation 8.66
Sunitinib	Patient-Assessed Fatigue	Week 49 (n=41)	39.32 scores on a scale	Standard Deviation 8.98
Sunitinib	Patient-Assessed Fatigue	Week 53 (End of Treatment) (n=40)	39.05 scores on a scale	Standard Deviation 8.62

Secondary

Progression-Free Survival (PFS)

Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.

Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death

Population: Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.

Arm	Measure	Value (MEDIAN)
Sunitinib	Progression-Free Survival (PFS)	9.0 months

Secondary

Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline

Time frame: Baseline

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.

Arm	Measure	Value (MEAN)	Dispersion
Sunitinib	Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline	9163.4 pg/mL	Standard Deviation 2215.8

Secondary

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.

Time frame: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Cycle 1, Day 1 (CR or PR or SD, n=85)	9772.500 pg/mL
Sunitinib	sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Cycle 1, Day 1 (PD, n=16)	8342.750 pg/mL

Comparison: CR or PR or (SD \> = 12 Weeks) Versus PDp-value: 0.1087Wilcoxon Rank Sum Test

Secondary

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)

Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.

Time frame: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Cycle 1, Day 1 (CR or PR, n=40)	9968.000 pg/mL
Sunitinib	sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Cycle 1, Day 1 (PD, n=16)	8342.750 pg/mL

Comparison: CR or PR Versus PDp-value: 0.0292Wilcoxon Rank Sum Test

Secondary

sVEGFR2 Ratio to Baseline at Each Time Point

sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 3 (n=106)	0.7 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 5 (n=104)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 7 (n=101)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 9 (n=95)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 13 (n=91)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 17 (n=79)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 21 (n=69)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 25 (n=68)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 29 (n=55)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 33 (n=55)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 37 (n=50)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 41 (n=48)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 45 (n=42)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 49 (n=38)	0.6 ratio	Standard Deviation 0.2
Sunitinib	sVEGFR2 Ratio to Baseline at Each Time Point	Day 1, Week 53 (n=31)	0.7 ratio	Standard Deviation 0.2

Secondary

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 3 (CR or PR or SD, n=81)	0.691 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 3 (PD, n=15)	0.653 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 5 (CR or PR or SD, n=81)	0.625 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 5 (PD, n=15)	0.531 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 7 (CR or PR or SD, n=84)	0.599 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 7 (PD, n=13)	0.574 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 9 (CR or PR or SD, n=83)	0.563 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 9 (PD, n=8)	0.603 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 13 (CR or PR or SD, n=85)	0.534 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 13 (PD, n=2)	0.529 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 17 (CR or PR or SD, n=77)	0.524 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 17 (PD, n=1)	0.687 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 21 (CR or PR or SD, n=67)	0.548 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 21 (PD, n=1)	0.540 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 25 (CR or PR or SD, n=66)	0.570 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 25 (PD, n=1)	0.509 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 29 (CR or PR or SD, n=53)	0.556 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 29 (PD, n=1)	0.671 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 33 (CR or PR or SD, n=54)	0.569 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 33 (PD, n=1)	0.610 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 37 (CR or PR or SD, n=49)	0.559 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 41 (CR or PR or SD, n=48)	0.572 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 45 (CR or PR or SD, n=42)	0.538 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 49 (CR or PR or SD, n=38)	0.569 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 53 (CR or PR or SD, n=30)	0.638 ratio

Comparison: Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4632Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.1701Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.8204Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.5162Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.9437Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4013Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.9595Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6249Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3731Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.8263Wilcoxon Rank Sum Test

Secondary

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)

Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 3 (CR or PR, n=39)	0.704 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 3 (PD, n=15)	0.653 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 5 (CR or PR, n=38)	0.638 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 5 (PD, n=15)	0.531 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 7 (CR or PR, n=40)	0.596 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 7 (PD, n=13)	0.574 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 9 (CR or PR, n=38)	0.562 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 9 (PD, n=8)	0.603 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 13 (CR or PR, n=40)	0.555 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 13 (PD, n=2)	0.529 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 17 (CR or PR, n=37)	0.545 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 17 (PD, n=1)	0.687 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 21 (CR or PR, n=36)	0.566 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 21 (PD, n=1)	0.540 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 25 (CR or PR, n=36)	0.564 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 25 (PD, n=1)	0.509 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 29 (CR or PR, n=30)	0.564 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 29 (PD, n=1)	0.671 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 33 (CR or PR, n=32)	0.547 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 33 (PD, n=1)	0.610 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 37 (CR or PR, n=29)	0.554 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 41 (CR or PR, n=29)	0.561 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 45 (CR or PR, n=28)	0.535 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 49 (CR or PR, n=25)	0.555 ratio
Sunitinib	sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 53 (CR or PR, n=20)	0.630 ratio

Comparison: Day 1, Week 3 (CR or PR Versus PD)p-value: 0.3386Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR Versus PD)p-value: 0.1949Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR Versus PD)p-value: 0.7037Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR Versus PD)p-value: 0.5748Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR Versus PD)p-value: 0.747Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR Versus PD)p-value: 0.4703Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR Versus PD)p-value: 0.8162Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR Versus PD)p-value: 0.5465Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR Versus PD)p-value: 0.3495Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR Versus PD)p-value: 0.6397Wilcoxon Rank Sum Test

Secondary

Time to Tumor Progression (TTP)

Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.

Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter

Population: Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.

Arm	Measure	Value (MEDIAN)
Sunitinib	Time to Tumor Progression (TTP)	10.0 months

Secondary

Trough Plasma Concentrations (Ctrough) of Sunitinib

Ctrough = the concentration prior to study drug administration.

Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53

Population: Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 1 (n=111)	7.15 nanograms (ng)/milliliter (mL)	Standard Deviation 18.8
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 3 (n=108)	54.78 nanograms (ng)/milliliter (mL)	Standard Deviation 23.67
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 5 (n=106)	45.64 nanograms (ng)/milliliter (mL)	Standard Deviation 22.83
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 7 (n=104)	46.35 nanograms (ng)/milliliter (mL)	Standard Deviation 21.98
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 9 (n=97)	47.54 nanograms (ng)/milliliter (mL)	Standard Deviation 24.96
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 13 (n=93)	41.29 nanograms (ng)/milliliter (mL)	Standard Deviation 22.41
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 17 (n=82)	41.65 nanograms (ng)/milliliter (mL)	Standard Deviation 20.25
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 21 (n=73)	35.95 nanograms (ng)/milliliter (mL)	Standard Deviation 20.38
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 25 (n=70)	36.39 nanograms (ng)/milliliter (mL)	Standard Deviation 20.72
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 29 (n=58)	38.01 nanograms (ng)/milliliter (mL)	Standard Deviation 21.24
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 33 (n=58)	33.72 nanograms (ng)/milliliter (mL)	Standard Deviation 18.94
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 37 (n=50)	36.04 nanograms (ng)/milliliter (mL)	Standard Deviation 16.48
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 41 (n=49)	33.33 nanograms (ng)/milliliter (mL)	Standard Deviation 15.8
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 45 (n=44)	36.20 nanograms (ng)/milliliter (mL)	Standard Deviation 13.79
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 49 (n=40)	36.49 nanograms (ng)/milliliter (mL)	Standard Deviation 13.1
Sunitinib	Trough Plasma Concentrations (Ctrough) of Sunitinib	Day 1, Week 53 (n=33)	33.10 nanograms (ng)/milliliter (mL)	Standard Deviation 16.18

Secondary

Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline

Time frame: Baseline

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.

Arm	Measure	Value (MEAN)	Dispersion
Sunitinib	Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline	154.8 picograms (pg)/mL	Standard Deviation 186.6

Secondary

VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.

Time frame: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Cycle 1, Day 1 (CR or PR or SD, n=85)	86.400 pg/mL
Sunitinib	VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Cycle 1, Day 1 (PD, n=16)	109.300 pg/mL

Comparison: CR or PR or (SD \> = 12 Weeks) Versus PDp-value: 0.1159Wilcoxon Rank Sum Test

Secondary

VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)

Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.

Time frame: Baseline (Cycle 1, Day 1)

Population: Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Cycle 1, Day 1 (CR or PR, n=39)	73.600 pg/mL
Sunitinib	VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)	Cycle 1, Day 1 (PD, n=16)	109.300 pg/mL

Comparison: CR or PR Versus PDp-value: 0.068Wilcoxon Rank Sum Test

Secondary

VEGF Ratio to Baseline at Each Time Point

VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Population: Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 3 (n=108)	2.9 ratio	Standard Deviation 2.8
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 5 (n=104)	2.6 ratio	Standard Deviation 2.9
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 7 (n=101)	2.6 ratio	Standard Deviation 2
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 9 (n=95)	3.4 ratio	Standard Deviation 3.3
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 13 (n=91)	3.2 ratio	Standard Deviation 3.4
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 17 (n=78)	2.8 ratio	Standard Deviation 2.4
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 21 (n=70)	2.6 ratio	Standard Deviation 2.1
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 25 (n=67)	3 ratio	Standard Deviation 3.2
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 29 (n=55)	2.5 ratio	Standard Deviation 1.8
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 33 (n=54)	2.3 ratio	Standard Deviation 1.4
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 37 (n=49)	2.7 ratio	Standard Deviation 2.1
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 41 (n=48)	5.5 ratio	Standard Deviation 20.5
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 45 (n=41)	2.9 ratio	Standard Deviation 2.1
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 49 (n=37)	2.8 ratio	Standard Deviation 1.8
Sunitinib	VEGF Ratio to Baseline at Each Time Point	Day 1, Week 53 (n=30)	3.2 ratio	Standard Deviation 3

Secondary

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 3 (CR or PR or SD, n=83)	2.127 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 3 (PD, n=15)	1.948 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 5 (CR or PR or SD, n=81)	1.574 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 5 (PD, n=15)	2.471 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 7 (CR or PR or SD, n=84)	1.798 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 7 (PD, n=13)	1.405 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 9 (CR or PR or SD, n=83)	2.481 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 9 (PD, n=8)	1.176 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 13 (CR or PR or SD, n=85)	1.890 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 13 (PD, n=2)	3.921 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 17 (CR or PR or SD, n=76)	2.070 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 17 (PD, n=1)	0.988 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 21 (CR or PR or SD, n=68)	1.972 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 21 (PD, n=1)	1.510 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 25 (CR or PR or SD, n=65)	1.906 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 25 (PD, n=1)	1.433 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 29 (CR or PR or SD, n=53)	1.831 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 29 (PD, n=1)	1.929 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 33 (CR or PR or SD, n=53)	2.200 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 33 (PD, n=1)	1.063 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 37 (CR or PR or SD, n=48)	2.201 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 41 (CR or PR or SD, n=48)	1.859 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 45 (CR or PR or SD, n=41)	2.484 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 49 (CR or PR or SD, n=37)	2.329 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)	Day 1, Week 53 (CR or PR or SD, n=29)	2.431 ratio

Comparison: Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6939Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.5871Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4572Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.112Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.4896Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.2369Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6709Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.6382Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.8481Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)p-value: 0.3731Wilcoxon Rank Sum Test

Secondary

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)

Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).

Time frame: Baseline to Day 1 of Weeks 3 through 53

Arm	Measure	Group	Value (MEDIAN)
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 3 (CR or PR, n=38)	1.999 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 3 (PD, n=15)	1.948 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 5 (CR or PR, n=37)	1.383 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 5 (PD, n=15)	2.471 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 7 (CR or PR, n=39)	1.761 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 7 (PD, n=13)	1.405 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 9 (CR or PR, n=37)	2.215 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 9 (PD, n=8)	1.176 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 13 (CR or PR, n=39)	1.753 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 13 (PD, n=2)	3.921 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 17 (CR or PR, n=36)	2.012 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 17 (PD, n=1)	0.988 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 21 (CR or PR, n=36)	1.523 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 21 (PD, n=1)	1.510 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 25 (CR or PR, n=35)	1.809 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 25 (PD, n=1)	1.433 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 29 (CR or PR, n=30)	1.805 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 29 (PD, n=1)	1.929 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 33 (CR or PR, n=31)	2.248 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 33 (PD, n=1)	1.063 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 37 (CR or PR, n=28)	2.179 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 41 (CR or PR, n=28)	1.864 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 45 (CR or PR, n=27)	2.240 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 49 (CR or PR, n=24)	2.707 ratio
Sunitinib	VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)	Day 1, Week 53 (CR or PR, n=19)	2.863 ratio

Comparison: Day 1, Week 3 (CR or PR Versus PD)p-value: 0.8519Wilcoxon Rank Sum Test

Comparison: Day 1, Week 5 (CR or PR Versus PD)p-value: 0.5879Wilcoxon Rank Sum Test

Comparison: Day 1, Week 7 (CR or PR Versus PD)p-value: 0.4757Wilcoxon Rank Sum Test

Comparison: Day 1, Week 9 (CR or PR Versus PD)p-value: 0.1933Wilcoxon Rank Sum Test

Comparison: Day 1, Week 13 (CR or PR Versus PD)p-value: 0.4187Wilcoxon Rank Sum Test

Comparison: Day 1, Week 17 (CR or PR Versus PD)p-value: 0.3795Wilcoxon Rank Sum Test

Comparison: Day 1, Week 21 (CR or PR Versus PD)p-value: 1Wilcoxon Rank Sum Test

Comparison: Day 1, Week 25 (CR or PR Versus PD)p-value: 0.6333Wilcoxon Rank Sum Test

Comparison: Day 1, Week 29 (CR or PR Versus PD)p-value: 0.8679Wilcoxon Rank Sum Test

Comparison: Day 1, Week 33 (CR or PR Versus PD)p-value: 0.592Wilcoxon Rank Sum Test

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026

Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects With Overall Confirmed Objective Response (OR)

1-Year Survival

Cancer Related Symptoms, Well-Being, and Concerns

Ctrough Correlated With Serious Adverse Events (SAEs)

Ctrough of SU-012662 (Sunitinib's Metabolite)

Ctrough of Total Drug (Sunitinib + SU-012662)

Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)

Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)

Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)

Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)

Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib

Duration of Response (DR)

Patient-Assessed Fatigue

Progression-Free Survival (PFS)

Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)

sVEGFR2 Ratio to Baseline at Each Time Point

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)

Time to Tumor Progression (TTP)

Trough Plasma Concentrations (Ctrough) of Sunitinib

Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline

VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)

VEGF Ratio to Baseline at Each Time Point

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)

VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)