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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00077974
First received: February 13, 2004
Last updated: October 8, 2010
Last verified: October 2010
History of Changes
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: SU011248

  Participant Flow
  Hide Participant Flow

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

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

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)

Participant Flow:   Overall Study
    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  



  Baseline Characteristics
  Hide Baseline Characteristics

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)

Baseline Measures
    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
  Hide All Outcome Measures

1.  Primary:   Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)   [ Time Frame: 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)   [ Time Frame: 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)   [ Time Frame: 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)   [ Time Frame: 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)   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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




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  Other Adverse Events
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00077974     History of Changes
Obsolete Identifiers: NCT00082849
Other Study ID Numbers: A6181006
Study First Received: February 13, 2004
Results First Received: September 25, 2009
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration