A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Carcinoma, Renal Cell
Intervention:	Drug: SU011248

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	Sunitinib Malate
STARTED	106
COMPLETED	2
NOT COMPLETED	104
Adverse Event	22
Protocol Violation	1
Withdrawal by Subject	3
Lack of Efficacy	76
Decision of Sponsor	2

	Sunitinib Malate
Number of Participants [units: participants]	106
Age, Customized [units: participants]
< 65 years	87
>= 65 years	19
Gender [units: participants]
Female	39
Male	67

Outcome Measures

1. Primary:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

Measure Type	Primary
Measure Title	Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
Measure Description	Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent 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 study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [units: participants]	35

Statistical Analysis 1 for Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Groups ^[1]	Sunitinib Malate
Percent ^[2]	33
95% Confidence Interval	( 24.2 to 42.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Using exact method based on binomial distribution. Percent equals n divided by N times 100.

2. Secondary:

Time to Tumor Progression (TTP) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

Measure Type	Secondary
Measure Title	Time to Tumor Progression (TTP)
Measure Description	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Time Frame	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Time to Tumor Progression (TTP) [units: weeks] Median ( 95% Confidence Interval )	46.3 ( 34.0 to 58.9 )

No statistical analysis provided for Time to Tumor Progression (TTP)

3. Secondary:

Duration of Response (DR) [ Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer ]

Measure Type	Secondary
Measure Title	Duration of Response (DR)
Measure Description	Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response.
Time Frame	Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT subgroup of patients with a confirmed objective tumor response

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	35
Duration of Response (DR) [units: weeks] Median ( 95% Confidence Interval )	60.4 ( 48.4 to 70.7 )

No statistical analysis provided for Duration of Response (DR)

4. Secondary:

Overall Survival (OS) [ From start of study treatment until death ]

Measure Type	Secondary
Measure Title	Overall Survival (OS)
Measure Description	Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).
Time Frame	From start of study treatment until death
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Overall Survival (OS) [units: weeks] Median ( 95% Confidence Interval )	104.1 ( 61.0 to 133.1 )

No statistical analysis provided for Overall Survival (OS)

5. Secondary:

Progression-free Survival (PFS) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death ]

Measure Type	Secondary
Measure Title	Progression-free Survival (PFS)
Measure Description	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was “Death”).
Time Frame	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Progression-free Survival (PFS) [units: weeks] Median ( 95% Confidence Interval )	38.0 ( 33.9 to 58.4 )

No statistical analysis provided for Progression-free Survival (PFS)

6. Secondary:

Percent Chance of Patient Survival [ From start of study treatment until death ]

Measure Type	Secondary
Measure Title	Percent Chance of Patient Survival
Measure Description	Probability of survival 1 year and 2 years after the first dose of study treatment
Time Frame	From start of study treatment until death
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Percent Chance of Patient Survival [units: percent chance of survival]
1 year	67.2
2 years	50.2

No statistical analysis provided for Percent Chance of Patient Survival

7. Secondary:

Observed Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Observed Plasma Trough Concentrations of Sunitinib
Measure Description	Observed plasma trough (predose) (Cmin) concentrations of sunitinib
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	104
Observed Plasma Trough Concentrations of Sunitinib [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 103)	46.82 ± 24.19
Cycle 2 Day 28 (n = 81)	50.13 ± 24.66
Cycle 3 Day 28 (n = 73)	49.36 ± 25.26
Cycle 4 Day 28 (n = 66)	53.18 ± 22.62
Cycle 5 Day 1 (n = 63)	1.55 ± 1.48
Cycle 6 Day 1 (n = 59)	1.44 ± 1.37
Cycle 7 Day 1 (n = 52)	1.51 ± 1.90
Cycle 8 Day 1 (n = 48)	1.60 ± 1.38
Cycle 9 Day 1 (n = 46)	1.60 ± 1.58
Cycle 10 Day 1 (n = 41)	1.69 ± 1.97
Cycle 11 Day 1 (n = 38)	2.05 ± 3.00
Cycle 12 Day 1 (n = 34)	1.72 ± 1.66
Cycle 13 Day 1 (n = 30)	1.74 ± 1.57
Cycle 14 Day 1 (n = 30)	1.60 ± 1.45
Cycle 15 Day 1 (n = 24)	1.56 ± 2.17
Cycle 16 Day 1 (n = 24)	1.46 ± 1.23
Cycle 17 Day 1 (n = 19)	1.42 ± 1.65
Cycle 18 Day 1 (n = 16)	2.20 ± 2.17
Cycle 19 Day 1 (n = 14)	1.34 ± 1.18
Cycle 20 Day 1 (n = 12)	2.96 ± 3.53
Cycle 21 Day 1 (n = 11)	2.53 ± 2.07
Cycle 22 Day 1 (n = 11)	2.18 ± 2.57
Cycle 23 Day 1 (n = 7)	3.14 ± 2.70
Cycle 24 Day 1 (n = 7)	2.75 ± 1.86
Cycle 25 Day 1 (n = 6)	1.99 ± 1.37
Cycle 26 Day 1 (n = 6)	2.46 ± 2.43
Cycle 27 Day 1 (n = 6)	1.20 ± 1.21
Cycle 28 Day 1 (n = 4)	1.75 ± 1.61
Cycle 29 Day 1 (n = 5)	2.93 ± 3.64
Cycle 30 Day 1 (n = 4)	1.02 ± 0.90

No statistical analysis provided for Observed Plasma Trough Concentrations of Sunitinib

8. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Observed Plasma Trough Concentrations of Sunitinib Metabolite
Measure Description	Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Observed Plasma Trough Concentrations of Sunitinib Metabolite [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 103)	26.44 ± 15.66
Cycle 2 Day 28 (n = 81)	28.21 ± 17.21
Cycle 3 Day 28 (n = 73)	28.32 ± 18.38
Cycle 4 Day 28 (n = 66)	28.54 ± 16.93
Cycle 5 Day 1 (n = 63)	2.50 ± 1.60
Cycle 6 Day 1 (n = 59)	2.64 ± 1.67
Cycle 7 Day 1 (n = 52)	2.64 ± 1.98
Cycle 8 Day 1 (n = 48)	2.66 ± 1.68
Cycle 9 Day 1 (n = 46)	2.81 ± 2.32
Cycle 10 Day 1 (n = 41)	2.54 ± 1.87
Cycle 11 Day 1 (n = 38)	2.78 ± 3.40
Cycle 12 Day 1 (n = 34)	2.67 ± 2.29
Cycle 13 Day 1 (n = 30)	2.77 ± 2.03
Cycle 14 Day 1 (n = 30)	2.49 ± 2.05
Cycle 15 Day 1 (n = 24)	2.51 ± 2.98
Cycle 16 Day 1 (n = 24)	2.30 ± 1.84
Cycle 17 Day 1 (n = 19)	1.83 ± 1.49
Cycle 18 Day 1 (n = 16)	2.16 ± 1.07
Cycle 19 Day 1 (n = 14)	2.06 ± 1.82
Cycle 20 Day 1 (n = 12)	2.92 ± 1.86
Cycle 21 Day 1 (n = 11)	3.13 ± 2.19
Cycle 22 Day 1 (n = 11)	3.24 ± 3.12
Cycle 23 Day 1 (n = 7)	3.10 ± 2.25
Cycle 24 Day 1 (n = 7)	2.64 ± 1.68
Cycle 25 Day 1 (n = 6)	1.99 ± 1.07
Cycle 26 Day 1 (n = 6)	2.60 ± 2.26
Cycle 27 Day 1 (n = 6)	1.36 ± 1.22
Cycle 28 Day 1 (n = 4)	1.81 ± 1.20
Cycle 29 Day 1 (n = 5)	2.43 ± 2.12
Cycle 30 Day 1 (n = 4)	1.10 ± 0.73

No statistical analysis provided for Observed Plasma Trough Concentrations of Sunitinib Metabolite

9. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Measure Description	Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 103)	73.26 ± 36.85
Cycle 2 Day 28 (n = 81)	78.34 ± 39.03
Cycle 3 Day 28 (n = 73)	77.68 ± 39.84
Cycle 4 Day 28 (n = 66)	81.71 ± 36.55
Cycle 5 Day 1 (n = 63)	4.04 ± 2.80
Cycle 6 Day 1 (n = 59)	4.08 ± 2.72
Cycle 7 Day 1 (n = 52)	4.15 ± 3.57
Cycle 8 Day 1 (n = 48)	4.26 ± 2.78
Cycle 9 Day 1 (n = 46)	4.41 ± 3.65
Cycle 10 Day 1 (n = 41)	4.23 ± 3.69
Cycle 11 Day 1 (n = 38)	4.83 ± 6.34
Cycle 12 Day 1 (n = 34)	4.39 ± 3.69
Cycle 13 Day 1 (n = 30)	4.52 ± 3.36
Cycle 14 Day 1 (n = 30)	4.09 ± 3.37
Cycle 15 Day 1 (n = 24)	4.07 ± 5.00
Cycle 16 Day 1 (n = 24)	3.75 ± 2.63
Cycle 17 Day 1 (n = 19)	3.25 ± 3.03
Cycle 18 Day 1 (n = 16)	4.35 ± 2.90
Cycle 19 Day 1 (n = 14)	3.40 ± 2.87
Cycle 20 Day 1 (n = 12)	5.88 ± 5.19
Cycle 21 Day 1 (n = 11)	5.66 ± 4.09
Cycle 22 Day 1 (n = 11)	5.43 ± 5.61
Cycle 23 Day 1 (n = 7)	6.24 ± 4.78
Cycle 24 Day 1 (n = 7)	5.39 ± 3.31
Cycle 25 Day 1 (n = 6)	3.97 ± 2.32
Cycle 26 Day 1 (n = 6)	5.06 ± 4.61
Cycle 27 Day 1 (n = 6)	2.55 ± 2.41
Cycle 28 Day 1 (n = 4)	3.56 ± 2.77
Cycle 29 Day 1 (n = 5)	5.36 ± 5.74
Cycle 30 Day 1 (n = 4)	2.13 ± 1.57

No statistical analysis provided for Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

10. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Dose Corrected Plasma Trough Concentrations of Sunitinib
Measure Description	Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Dose Corrected Plasma Trough Concentrations of Sunitinib [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 33)	53.64 ± 22.54
Cycle 2 Day 28 (n = 26)	55.94 ± 25.52
Cycle 3 Day 28 (n = 20)	69.44 ± 33.21
Cycle 4 Day 28 (n = 25)	64.33 ± 41.46
Cycle 5 Day 1 (n = 28)	1.94 ± 3.24
Cycle 6 Day 1 (n = 41)	2.15 ± 2.94
Cycle 7 Day 1 (n = 35)	2.04 ± 4.10
Cycle 8 Day 1 (n = 32)	2.32 ± 2.77
Cycle 9 Day 1 (n = 32)	2.07 ± 2.62
Cycle 10 Day 1 (n = 32)	2.68 ± 4.32
Cycle 11 Day 1 (n = 25)	3.42 ± 6.86
Cycle 12 Day 1 (n = 28)	1.94 ± 1.63
Cycle 13 Day 1 (n = 23)	2.23 ± 2.49
Cycle 14 Day 1 (n = 24)	2.41 ± 2.46
Cycle 15 Day 1 (n = 16)	1.58 ± 1.09
Cycle 16 Day 1 (n = 18)	2.42 ± 2.48
Cycle 17 Day 1 (n = 17)	2.23 ± 2.66
Cycle 18 Day 1 (n = 14)	3.05 ± 4.57
Cycle 19 Day 1 (n = 11)	1.92 ± 1.58
Cycle 20 Day 1 (n = 11)	5.09 ± 7.47
Cycle 21 Day 1 (n = 8)	3.41 ± 3.24
Cycle 22 Day 1 (n = 9)	3.91 ± 5.45
Cycle 23 Day 1 (n = 6)	4.53 ± 3.89
Cycle 24 Day 1 (n = 6)	3.82 ± 3.68
Cycle 25 Day 1 (n = 5)	3.14 ± 3.24
Cycle 26 Day 1 (n = 5)	4.09 ± 5.70
Cycle 27 Day 1 (n = 5)	2.12 ± 2.58
Cycle 28 Day 1 (n = 4)	2.97 ± 3.36
Cycle 29 Day 1 (n = 4)	4.02 ± 5.60
Cycle 30 Day 1 (n = 3)	1.36 ± 1.50

No statistical analysis provided for Dose Corrected Plasma Trough Concentrations of Sunitinib

11. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Measure Description	Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 33)	31.85 ± 18.15
Cycle 2 Day 28 (n = 26)	28.15 ± 19.80
Cycle 3 Day 28 (n = 20)	40.53 ± 20.38
Cycle 4 Day 28 (n = 25)	38.04 ± 24.29
Cycle 5 Day 1 (n = 28)	2.99 ± 2.55
Cycle 6 Day 1 (n = 41)	3.35 ± 2.52
Cycle 7 Day 1 (n = 35)	3.11 ± 3.13
Cycle 8 Day 1 (n = 32)	3.37 ± 2.34
Cycle 9 Day 1 (n = 32)	3.45 ± 2.80
Cycle 10 Day 1 (n = 32)	3.61 ± 3.62
Cycle 11 Day 1 (n = 25)	4.37 ± 8.13
Cycle 12 Day 1 (n = 28)	3.24 ± 2.82
Cycle 13 Day 1 (n = 23)	3.68 ± 2.79
Cycle 14 Day 1 (n = 24)	3.54 ± 2.60
Cycle 15 Day 1 (n = 16)	2.80 ± 1.82
Cycle 16 Day 1 (n = 18)	3.40 ± 2.27
Cycle 17 Day 1 (n = 17)	2.55 ± 2.23
Cycle 18 Day 1 (n = 14)	2.59 ± 1.69
Cycle 19 Day 1 (n = 11)	2.93 ± 2.33
Cycle 20 Day 1 (n = 11)	4.53 ± 3.82
Cycle 21 Day 1 (n = 8)	3.97 ± 2.78
Cycle 22 Day 1 (n = 9)	5.31 ± 6.73
Cycle 23 Day 1 (n = 6)	4.26 ± 3.16
Cycle 24 Day 1 (n = 6)	3.62 ± 2.49
Cycle 25 Day 1 (n = 5)	3.00 ± 2.18
Cycle 26 Day 1 (n = 5)	4.49 ± 5.29
Cycle 27 Day 1 (n = 5)	2.36 ± 2.57
Cycle 28 Day 1 (n = 4)	2.94 ± 2.63
Cycle 29 Day 1 (n = 4)	3.32 ± 3.28
Cycle 30 Day 1 (n = 3)	1.18 ± 1.08

No statistical analysis provided for Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite

12. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

Measure Type	Secondary
Measure Title	Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Measure Description	Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
Time Frame	Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic analysis population

Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Measured Values

	Sunitinib Malate
Number of Participants Analyzed [units: participants]	106
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [units: nanograms per milliliter] Mean ± Standard Deviation
Cycle 1 Day 28 (n = 33)	85.49 ± 37.49
Cycle 2 Day 28 (n = 26)	84.09 ± 42.11
Cycle 3 Day 28 (n = 20)	109.97 ± 48.38
Cycle 4 Day 28 (n = 25)	102.37 ± 62.69
Cycle 5 Day 1 (n = 28)	4.93 ± 5.49
Cycle 6 Day 1 (n = 41)	5.50 ± 5.14
Cycle 7 Day 1 (n = 35)	5.15 ± 6.97
Cycle 8 Day 1 (n = 32)	5.69 ± 4.86
Cycle 9 Day 1 (n = 32)	5.52 ± 5.22
Cycle 10 Day 1 (n = 32)	6.29 ± 7.80
Cycle 11 Day 1 (n = 25)	7.78 ± 14.94
Cycle 12 Day 1 (n = 28)	5.19 ± 4.08
Cycle 13 Day 1 (n = 23)	5.91 ± 5.03
Cycle 14 Day 1 (n = 24)	5.95 ± 4.80
Cycle 15 Day 1 (n = 16)	4.39 ± 2.48
Cycle 16 Day 1 (n = 18)	5.82 ± 4.21
Cycle 17 Day 1 (n = 17)	4.78 ± 4.79
Cycle 18 Day 1 (n = 14)	5.64 ± 6.01
Cycle 19 Day 1 (n = 11)	4.85 ± 3.77
Cycle 20 Day 1 (n = 11)	9.63 ± 11.00
Cycle 21 Day 1 (n = 8)	7.38 ± 5.80
Cycle 22 Day 1 (n = 9)	9.23 ± 12.13
Cycle 23 Day 1 (n = 6)	8.79 ± 6.77
Cycle 24 Day 1 (n = 6)	7.44 ± 5.84
Cycle 25 Day 1 (n = 5)	6.13 ± 5.29
Cycle 26 Day 1 (n = 5)	8.58 ± 10.94
Cycle 27 Day 1 (n = 5)	4.48 ± 5.14
Cycle 28 Day 1 (n = 4)	5.90 ± 5.96
Cycle 29 Day 1 (n = 4)	7.34 ± 8.85
Cycle 30 Day 1 (n = 3)	2.54 ± 2.58

No statistical analysis provided for Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181006
Study First Received:	February 13, 2004
Results First Received:	September 25, 2009
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00077974 History of Changes
Health Authority:	United States: Food and Drug Administration