Trial Outcomes & Findings for A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. (NCT NCT00077974)
NCT ID: NCT00077974
Last Updated: 2010-10-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
Results posted on
2010-10-13
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
104
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lack of Efficacy
|
76
|
|
Overall Study
Decision of Sponsor
|
2
|
Baseline Characteristics
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
Baseline characteristics by cohort
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Age, Customized
< 65 years
|
87 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
19 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafterPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
|
35 participants
|
SECONDARY outcome
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafterPopulation: ITT
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 \[PD\]).
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Time to Tumor Progression (TTP)
|
46.3 weeks
Interval 34.0 to 58.9
|
SECONDARY outcome
Timeframe: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancerPopulation: ITT subgroup of patients with a confirmed objective tumor response
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.
Outcome measures
| Measure |
Sunitinib Malate
n=35 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Duration of Response (DR)
|
60.4 weeks
Interval 48.4 to 70.7
|
SECONDARY outcome
Timeframe: From start of study treatment until deathPopulation: ITT
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).
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Overall Survival (OS)
|
104.1 weeks
Interval 61.0 to 133.1
|
SECONDARY outcome
Timeframe: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or deathPopulation: ITT
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").
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Progression-free Survival (PFS)
|
38.0 weeks
Interval 33.9 to 58.4
|
SECONDARY outcome
Timeframe: From start of study treatment until deathPopulation: ITT
Probability of survival 1 year and 2 years after the first dose of study treatment
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Percent Chance of Patient Survival
1 year
|
67.2 percent chance of survival
|
|
Percent Chance of Patient Survival
2 years
|
50.2 percent chance of survival
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
Observed plasma trough (predose) (Cmin) concentrations of sunitinib
Outcome measures
| Measure |
Sunitinib Malate
n=104 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 10 Day 1 (n = 41)
|
1.69 nanograms per milliliter
Standard Deviation 1.97
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 11 Day 1 (n = 38)
|
2.05 nanograms per milliliter
Standard Deviation 3.00
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 12 Day 1 (n = 34)
|
1.72 nanograms per milliliter
Standard Deviation 1.66
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 13 Day 1 (n = 30)
|
1.74 nanograms per milliliter
Standard Deviation 1.57
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 14 Day 1 (n = 30)
|
1.60 nanograms per milliliter
Standard Deviation 1.45
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 15 Day 1 (n = 24)
|
1.56 nanograms per milliliter
Standard Deviation 2.17
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 1 Day 28 (n = 103)
|
46.82 nanograms per milliliter
Standard Deviation 24.19
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 2 Day 28 (n = 81)
|
50.13 nanograms per milliliter
Standard Deviation 24.66
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 3 Day 28 (n = 73)
|
49.36 nanograms per milliliter
Standard Deviation 25.26
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 4 Day 28 (n = 66)
|
53.18 nanograms per milliliter
Standard Deviation 22.62
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 5 Day 1 (n = 63)
|
1.55 nanograms per milliliter
Standard Deviation 1.48
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 6 Day 1 (n = 59)
|
1.44 nanograms per milliliter
Standard Deviation 1.37
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 7 Day 1 (n = 52)
|
1.51 nanograms per milliliter
Standard Deviation 1.90
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 8 Day 1 (n = 48)
|
1.60 nanograms per milliliter
Standard Deviation 1.38
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 9 Day 1 (n = 46)
|
1.60 nanograms per milliliter
Standard Deviation 1.58
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 16 Day 1 (n = 24)
|
1.46 nanograms per milliliter
Standard Deviation 1.23
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 17 Day 1 (n = 19)
|
1.42 nanograms per milliliter
Standard Deviation 1.65
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 18 Day 1 (n = 16)
|
2.20 nanograms per milliliter
Standard Deviation 2.17
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 19 Day 1 (n = 14)
|
1.34 nanograms per milliliter
Standard Deviation 1.18
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 20 Day 1 (n = 12)
|
2.96 nanograms per milliliter
Standard Deviation 3.53
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 21 Day 1 (n = 11)
|
2.53 nanograms per milliliter
Standard Deviation 2.07
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 22 Day 1 (n = 11)
|
2.18 nanograms per milliliter
Standard Deviation 2.57
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 23 Day 1 (n = 7)
|
3.14 nanograms per milliliter
Standard Deviation 2.70
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 24 Day 1 (n = 7)
|
2.75 nanograms per milliliter
Standard Deviation 1.86
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 25 Day 1 (n = 6)
|
1.99 nanograms per milliliter
Standard Deviation 1.37
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 26 Day 1 (n = 6)
|
2.46 nanograms per milliliter
Standard Deviation 2.43
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 27 Day 1 (n = 6)
|
1.20 nanograms per milliliter
Standard Deviation 1.21
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 28 Day 1 (n = 4)
|
1.75 nanograms per milliliter
Standard Deviation 1.61
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 29 Day 1 (n = 5)
|
2.93 nanograms per milliliter
Standard Deviation 3.64
|
|
Observed Plasma Trough Concentrations of Sunitinib
Cycle 30 Day 1 (n = 4)
|
1.02 nanograms per milliliter
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 12 Day 1 (n = 34)
|
2.67 nanograms per milliliter
Standard Deviation 2.29
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 13 Day 1 (n = 30)
|
2.77 nanograms per milliliter
Standard Deviation 2.03
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 14 Day 1 (n = 30)
|
2.49 nanograms per milliliter
Standard Deviation 2.05
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 1 Day 28 (n = 103)
|
26.44 nanograms per milliliter
Standard Deviation 15.66
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 2 Day 28 (n = 81)
|
28.21 nanograms per milliliter
Standard Deviation 17.21
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 3 Day 28 (n = 73)
|
28.32 nanograms per milliliter
Standard Deviation 18.38
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 4 Day 28 (n = 66)
|
28.54 nanograms per milliliter
Standard Deviation 16.93
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 5 Day 1 (n = 63)
|
2.50 nanograms per milliliter
Standard Deviation 1.60
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 6 Day 1 (n = 59)
|
2.64 nanograms per milliliter
Standard Deviation 1.67
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 7 Day 1 (n = 52)
|
2.64 nanograms per milliliter
Standard Deviation 1.98
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 8 Day 1 (n = 48)
|
2.66 nanograms per milliliter
Standard Deviation 1.68
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 9 Day 1 (n = 46)
|
2.81 nanograms per milliliter
Standard Deviation 2.32
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 10 Day 1 (n = 41)
|
2.54 nanograms per milliliter
Standard Deviation 1.87
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 11 Day 1 (n = 38)
|
2.78 nanograms per milliliter
Standard Deviation 3.40
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 15 Day 1 (n = 24)
|
2.51 nanograms per milliliter
Standard Deviation 2.98
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 16 Day 1 (n = 24)
|
2.30 nanograms per milliliter
Standard Deviation 1.84
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 17 Day 1 (n = 19)
|
1.83 nanograms per milliliter
Standard Deviation 1.49
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 18 Day 1 (n = 16)
|
2.16 nanograms per milliliter
Standard Deviation 1.07
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 19 Day 1 (n = 14)
|
2.06 nanograms per milliliter
Standard Deviation 1.82
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 20 Day 1 (n = 12)
|
2.92 nanograms per milliliter
Standard Deviation 1.86
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 21 Day 1 (n = 11)
|
3.13 nanograms per milliliter
Standard Deviation 2.19
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 22 Day 1 (n = 11)
|
3.24 nanograms per milliliter
Standard Deviation 3.12
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 23 Day 1 (n = 7)
|
3.10 nanograms per milliliter
Standard Deviation 2.25
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 24 Day 1 (n = 7)
|
2.64 nanograms per milliliter
Standard Deviation 1.68
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 25 Day 1 (n = 6)
|
1.99 nanograms per milliliter
Standard Deviation 1.07
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 26 Day 1 (n = 6)
|
2.60 nanograms per milliliter
Standard Deviation 2.26
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 27 Day 1 (n = 6)
|
1.36 nanograms per milliliter
Standard Deviation 1.22
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 28 Day 1 (n = 4)
|
1.81 nanograms per milliliter
Standard Deviation 1.20
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 29 Day 1 (n = 5)
|
2.43 nanograms per milliliter
Standard Deviation 2.12
|
|
Observed Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 30 Day 1 (n = 4)
|
1.10 nanograms per milliliter
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 1 Day 28 (n = 103)
|
73.26 nanograms per milliliter
Standard Deviation 36.85
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 2 Day 28 (n = 81)
|
78.34 nanograms per milliliter
Standard Deviation 39.03
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 3 Day 28 (n = 73)
|
77.68 nanograms per milliliter
Standard Deviation 39.84
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 4 Day 28 (n = 66)
|
81.71 nanograms per milliliter
Standard Deviation 36.55
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 5 Day 1 (n = 63)
|
4.04 nanograms per milliliter
Standard Deviation 2.80
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 6 Day 1 (n = 59)
|
4.08 nanograms per milliliter
Standard Deviation 2.72
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 7 Day 1 (n = 52)
|
4.15 nanograms per milliliter
Standard Deviation 3.57
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 8 Day 1 (n = 48)
|
4.26 nanograms per milliliter
Standard Deviation 2.78
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 9 Day 1 (n = 46)
|
4.41 nanograms per milliliter
Standard Deviation 3.65
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 10 Day 1 (n = 41)
|
4.23 nanograms per milliliter
Standard Deviation 3.69
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 11 Day 1 (n = 38)
|
4.83 nanograms per milliliter
Standard Deviation 6.34
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 12 Day 1 (n = 34)
|
4.39 nanograms per milliliter
Standard Deviation 3.69
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 13 Day 1 (n = 30)
|
4.52 nanograms per milliliter
Standard Deviation 3.36
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 14 Day 1 (n = 30)
|
4.09 nanograms per milliliter
Standard Deviation 3.37
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 15 Day 1 (n = 24)
|
4.07 nanograms per milliliter
Standard Deviation 5.00
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 16 Day 1 (n = 24)
|
3.75 nanograms per milliliter
Standard Deviation 2.63
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 17 Day 1 (n = 19)
|
3.25 nanograms per milliliter
Standard Deviation 3.03
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 18 Day 1 (n = 16)
|
4.35 nanograms per milliliter
Standard Deviation 2.90
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 19 Day 1 (n = 14)
|
3.40 nanograms per milliliter
Standard Deviation 2.87
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 20 Day 1 (n = 12)
|
5.88 nanograms per milliliter
Standard Deviation 5.19
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 21 Day 1 (n = 11)
|
5.66 nanograms per milliliter
Standard Deviation 4.09
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 22 Day 1 (n = 11)
|
5.43 nanograms per milliliter
Standard Deviation 5.61
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 23 Day 1 (n = 7)
|
6.24 nanograms per milliliter
Standard Deviation 4.78
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 24 Day 1 (n = 7)
|
5.39 nanograms per milliliter
Standard Deviation 3.31
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 25 Day 1 (n = 6)
|
3.97 nanograms per milliliter
Standard Deviation 2.32
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 26 Day 1 (n = 6)
|
5.06 nanograms per milliliter
Standard Deviation 4.61
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 27 Day 1 (n = 6)
|
2.55 nanograms per milliliter
Standard Deviation 2.41
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 28 Day 1 (n = 4)
|
3.56 nanograms per milliliter
Standard Deviation 2.77
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 29 Day 1 (n = 5)
|
5.36 nanograms per milliliter
Standard Deviation 5.74
|
|
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 30 Day 1 (n = 4)
|
2.13 nanograms per milliliter
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
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.
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 1 Day 28 (n = 33)
|
53.64 nanograms per milliliter
Standard Deviation 22.54
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 2 Day 28 (n = 26)
|
55.94 nanograms per milliliter
Standard Deviation 25.52
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 3 Day 28 (n = 20)
|
69.44 nanograms per milliliter
Standard Deviation 33.21
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 4 Day 28 (n = 25)
|
64.33 nanograms per milliliter
Standard Deviation 41.46
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 5 Day 1 (n = 28)
|
1.94 nanograms per milliliter
Standard Deviation 3.24
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 6 Day 1 (n = 41)
|
2.15 nanograms per milliliter
Standard Deviation 2.94
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 7 Day 1 (n = 35)
|
2.04 nanograms per milliliter
Standard Deviation 4.10
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 8 Day 1 (n = 32)
|
2.32 nanograms per milliliter
Standard Deviation 2.77
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 9 Day 1 (n = 32)
|
2.07 nanograms per milliliter
Standard Deviation 2.62
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 10 Day 1 (n = 32)
|
2.68 nanograms per milliliter
Standard Deviation 4.32
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 11 Day 1 (n = 25)
|
3.42 nanograms per milliliter
Standard Deviation 6.86
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 12 Day 1 (n = 28)
|
1.94 nanograms per milliliter
Standard Deviation 1.63
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 13 Day 1 (n = 23)
|
2.23 nanograms per milliliter
Standard Deviation 2.49
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 14 Day 1 (n = 24)
|
2.41 nanograms per milliliter
Standard Deviation 2.46
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 15 Day 1 (n = 16)
|
1.58 nanograms per milliliter
Standard Deviation 1.09
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 16 Day 1 (n = 18)
|
2.42 nanograms per milliliter
Standard Deviation 2.48
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 17 Day 1 (n = 17)
|
2.23 nanograms per milliliter
Standard Deviation 2.66
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 18 Day 1 (n = 14)
|
3.05 nanograms per milliliter
Standard Deviation 4.57
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 19 Day 1 (n = 11)
|
1.92 nanograms per milliliter
Standard Deviation 1.58
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 20 Day 1 (n = 11)
|
5.09 nanograms per milliliter
Standard Deviation 7.47
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 21 Day 1 (n = 8)
|
3.41 nanograms per milliliter
Standard Deviation 3.24
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 22 Day 1 (n = 9)
|
3.91 nanograms per milliliter
Standard Deviation 5.45
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 23 Day 1 (n = 6)
|
4.53 nanograms per milliliter
Standard Deviation 3.89
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 24 Day 1 (n = 6)
|
3.82 nanograms per milliliter
Standard Deviation 3.68
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 25 Day 1 (n = 5)
|
3.14 nanograms per milliliter
Standard Deviation 3.24
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 26 Day 1 (n = 5)
|
4.09 nanograms per milliliter
Standard Deviation 5.70
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 27 Day 1 (n = 5)
|
2.12 nanograms per milliliter
Standard Deviation 2.58
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 28 Day 1 (n = 4)
|
2.97 nanograms per milliliter
Standard Deviation 3.36
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 29 Day 1 (n = 4)
|
4.02 nanograms per milliliter
Standard Deviation 5.60
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib
Cycle 30 Day 1 (n = 3)
|
1.36 nanograms per milliliter
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
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.
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 2 Day 28 (n = 26)
|
28.15 nanograms per milliliter
Standard Deviation 19.80
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 3 Day 28 (n = 20)
|
40.53 nanograms per milliliter
Standard Deviation 20.38
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 4 Day 28 (n = 25)
|
38.04 nanograms per milliliter
Standard Deviation 24.29
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 12 Day 1 (n = 28)
|
3.24 nanograms per milliliter
Standard Deviation 2.82
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 16 Day 1 (n = 18)
|
3.40 nanograms per milliliter
Standard Deviation 2.27
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 13 Day 1 (n = 23)
|
3.68 nanograms per milliliter
Standard Deviation 2.79
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 14 Day 1 (n = 24)
|
3.54 nanograms per milliliter
Standard Deviation 2.60
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 15 Day 1 (n = 16)
|
2.80 nanograms per milliliter
Standard Deviation 1.82
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 1 Day 28 (n = 33)
|
31.85 nanograms per milliliter
Standard Deviation 18.15
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 5 Day 1 (n = 28)
|
2.99 nanograms per milliliter
Standard Deviation 2.55
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 6 Day 1 (n = 41)
|
3.35 nanograms per milliliter
Standard Deviation 2.52
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 7 Day 1 (n = 35)
|
3.11 nanograms per milliliter
Standard Deviation 3.13
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 8 Day 1 (n = 32)
|
3.37 nanograms per milliliter
Standard Deviation 2.34
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 9 Day 1 (n = 32)
|
3.45 nanograms per milliliter
Standard Deviation 2.80
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 10 Day 1 (n = 32)
|
3.61 nanograms per milliliter
Standard Deviation 3.62
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 11 Day 1 (n = 25)
|
4.37 nanograms per milliliter
Standard Deviation 8.13
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 17 Day 1 (n = 17)
|
2.55 nanograms per milliliter
Standard Deviation 2.23
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 18 Day 1 (n = 14)
|
2.59 nanograms per milliliter
Standard Deviation 1.69
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 19 Day 1 (n = 11)
|
2.93 nanograms per milliliter
Standard Deviation 2.33
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 20 Day 1 (n = 11)
|
4.53 nanograms per milliliter
Standard Deviation 3.82
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 21 Day 1 (n = 8)
|
3.97 nanograms per milliliter
Standard Deviation 2.78
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 22 Day 1 (n = 9)
|
5.31 nanograms per milliliter
Standard Deviation 6.73
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 23 Day 1 (n = 6)
|
4.26 nanograms per milliliter
Standard Deviation 3.16
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 24 Day 1 (n = 6)
|
3.62 nanograms per milliliter
Standard Deviation 2.49
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 25 Day 1 (n = 5)
|
3.00 nanograms per milliliter
Standard Deviation 2.18
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 26 Day 1 (n = 5)
|
4.49 nanograms per milliliter
Standard Deviation 5.29
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 27 Day 1 (n = 5)
|
2.36 nanograms per milliliter
Standard Deviation 2.57
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 28 Day 1 (n = 4)
|
2.94 nanograms per milliliter
Standard Deviation 2.63
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 29 Day 1 (n = 4)
|
3.32 nanograms per milliliter
Standard Deviation 3.28
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
Cycle 30 Day 1 (n = 3)
|
1.18 nanograms per milliliter
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greaterPopulation: Pharmacokinetic analysis population
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.
Outcome measures
| Measure |
Sunitinib Malate
n=106 Participants
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 1 Day 28 (n = 33)
|
85.49 nanograms per milliliter
Standard Deviation 37.49
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 2 Day 28 (n = 26)
|
84.09 nanograms per milliliter
Standard Deviation 42.11
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 3 Day 28 (n = 20)
|
109.97 nanograms per milliliter
Standard Deviation 48.38
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 4 Day 28 (n = 25)
|
102.37 nanograms per milliliter
Standard Deviation 62.69
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 5 Day 1 (n = 28)
|
4.93 nanograms per milliliter
Standard Deviation 5.49
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 6 Day 1 (n = 41)
|
5.50 nanograms per milliliter
Standard Deviation 5.14
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 7 Day 1 (n = 35)
|
5.15 nanograms per milliliter
Standard Deviation 6.97
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 8 Day 1 (n = 32)
|
5.69 nanograms per milliliter
Standard Deviation 4.86
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 9 Day 1 (n = 32)
|
5.52 nanograms per milliliter
Standard Deviation 5.22
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 10 Day 1 (n = 32)
|
6.29 nanograms per milliliter
Standard Deviation 7.80
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 11 Day 1 (n = 25)
|
7.78 nanograms per milliliter
Standard Deviation 14.94
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 12 Day 1 (n = 28)
|
5.19 nanograms per milliliter
Standard Deviation 4.08
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 13 Day 1 (n = 23)
|
5.91 nanograms per milliliter
Standard Deviation 5.03
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 14 Day 1 (n = 24)
|
5.95 nanograms per milliliter
Standard Deviation 4.80
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 15 Day 1 (n = 16)
|
4.39 nanograms per milliliter
Standard Deviation 2.48
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 16 Day 1 (n = 18)
|
5.82 nanograms per milliliter
Standard Deviation 4.21
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 17 Day 1 (n = 17)
|
4.78 nanograms per milliliter
Standard Deviation 4.79
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 18 Day 1 (n = 14)
|
5.64 nanograms per milliliter
Standard Deviation 6.01
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 19 Day 1 (n = 11)
|
4.85 nanograms per milliliter
Standard Deviation 3.77
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 20 Day 1 (n = 11)
|
9.63 nanograms per milliliter
Standard Deviation 11.00
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 21 Day 1 (n = 8)
|
7.38 nanograms per milliliter
Standard Deviation 5.80
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 22 Day 1 (n = 9)
|
9.23 nanograms per milliliter
Standard Deviation 12.13
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 23 Day 1 (n = 6)
|
8.79 nanograms per milliliter
Standard Deviation 6.77
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 24 Day 1 (n = 6)
|
7.44 nanograms per milliliter
Standard Deviation 5.84
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 25 Day 1 (n = 5)
|
6.13 nanograms per milliliter
Standard Deviation 5.29
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 26 Day 1 (n = 5)
|
8.58 nanograms per milliliter
Standard Deviation 10.94
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 27 Day 1 (n = 5)
|
4.48 nanograms per milliliter
Standard Deviation 5.14
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 28 Day 1 (n = 4)
|
5.90 nanograms per milliliter
Standard Deviation 5.96
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 29 Day 1 (n = 4)
|
7.34 nanograms per milliliter
Standard Deviation 8.85
|
|
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
Cycle 30 Day 1 (n = 3)
|
2.54 nanograms per milliliter
Standard Deviation 2.58
|
Adverse Events
Sunitinib Malate
Serious events: 46 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib Malate
n=106 participants at risk
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/106
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.94%
1/106
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
2/106
|
|
Cardiac disorders
Cardiac failure congestive
|
0.94%
1/106
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
2/106
|
|
Cardiac disorders
Myocardial ischaemia
|
0.94%
1/106
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
1/106
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.94%
1/106
|
|
Gastrointestinal disorders
Nausea
|
0.94%
1/106
|
|
Gastrointestinal disorders
Pancreatitis
|
0.94%
1/106
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.94%
1/106
|
|
Gastrointestinal disorders
Stomatitis
|
0.94%
1/106
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/106
|
|
General disorders
Disease progression
|
6.6%
7/106
|
|
General disorders
Fatigue
|
0.94%
1/106
|
|
General disorders
Impaired healing
|
0.94%
1/106
|
|
General disorders
Non-cardiac chest pain
|
1.9%
2/106
|
|
General disorders
Oedema peripheral
|
0.94%
1/106
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.94%
1/106
|
|
Infections and infestations
Abscess
|
0.94%
1/106
|
|
Infections and infestations
Anorectal infection
|
0.94%
1/106
|
|
Infections and infestations
Clostridium difficile colitis
|
0.94%
1/106
|
|
Infections and infestations
Gastroenteritis viral
|
0.94%
1/106
|
|
Infections and infestations
Infection
|
1.9%
2/106
|
|
Infections and infestations
Pancreatic abscess
|
0.94%
1/106
|
|
Infections and infestations
Perirectal abscess
|
0.94%
1/106
|
|
Infections and infestations
Pneumonia
|
2.8%
3/106
|
|
Infections and infestations
Sepsis
|
0.94%
1/106
|
|
Infections and infestations
Staphylococcal infection
|
0.94%
1/106
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.94%
1/106
|
|
Investigations
Ejection fraction decreased
|
0.94%
1/106
|
|
Investigations
International normalised ratio increased
|
0.94%
1/106
|
|
Investigations
Oxygen saturation decreased
|
0.94%
1/106
|
|
Investigations
Platelet count decreased
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
5/106
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.9%
2/106
|
|
Nervous system disorders
Convulsion
|
0.94%
1/106
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.94%
1/106
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.94%
1/106
|
|
Nervous system disorders
Speech disorder
|
0.94%
1/106
|
|
Nervous system disorders
Spinal cord compression
|
1.9%
2/106
|
|
Nervous system disorders
Syncope
|
0.94%
1/106
|
|
Psychiatric disorders
Depression
|
0.94%
1/106
|
|
Psychiatric disorders
Mental status changes
|
1.9%
2/106
|
|
Renal and urinary disorders
Renal failure
|
2.8%
3/106
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
2/106
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/106
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
2/106
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.94%
1/106
|
|
Surgical and medical procedures
Fracture treatment
|
0.94%
1/106
|
|
Surgical and medical procedures
Tumour excision
|
0.94%
1/106
|
|
Vascular disorders
Aortic stenosis
|
0.94%
1/106
|
Other adverse events
| Measure |
Sunitinib Malate
n=106 participants at risk
50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.9%
19/106
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.4%
11/106
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.4%
11/106
|
|
Endocrine disorders
Hypothyroidism
|
19.8%
21/106
|
|
Eye disorders
Lacrimation increased
|
6.6%
7/106
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.6%
7/106
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
19/106
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
10/106
|
|
Gastrointestinal disorders
Constipation
|
37.7%
40/106
|
|
Gastrointestinal disorders
Diarrhoea
|
63.2%
67/106
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
10/106
|
|
Gastrointestinal disorders
Dyspepsia
|
46.2%
49/106
|
|
Gastrointestinal disorders
Dysphagia
|
6.6%
7/106
|
|
Gastrointestinal disorders
Flatulence
|
10.4%
11/106
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.3%
12/106
|
|
Gastrointestinal disorders
Glossodynia
|
10.4%
11/106
|
|
Gastrointestinal disorders
Haematochezia
|
5.7%
6/106
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.5%
9/106
|
|
Gastrointestinal disorders
Nausea
|
62.3%
66/106
|
|
Gastrointestinal disorders
Oral pain
|
11.3%
12/106
|
|
Gastrointestinal disorders
Stomatitis
|
40.6%
43/106
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
51/106
|
|
General disorders
Chest discomfort
|
6.6%
7/106
|
|
General disorders
Chest pain
|
17.0%
18/106
|
|
General disorders
Chills
|
18.9%
20/106
|
|
General disorders
Fatigue
|
79.2%
84/106
|
|
General disorders
Mucosal inflammation
|
26.4%
28/106
|
|
General disorders
Oedema
|
9.4%
10/106
|
|
General disorders
Oedema peripheral
|
20.8%
22/106
|
|
General disorders
Pain
|
12.3%
13/106
|
|
General disorders
Pyrexia
|
17.9%
19/106
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
10/106
|
|
Infections and infestations
Sinusitis
|
8.5%
9/106
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
22/106
|
|
Infections and infestations
Urinary tract infection
|
8.5%
9/106
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
6/106
|
|
Investigations
Blood creatinine increased
|
8.5%
9/106
|
|
Investigations
Ejection fraction decreased
|
17.9%
19/106
|
|
Investigations
Haemoglobin decreased
|
7.5%
8/106
|
|
Investigations
Lipase increased
|
11.3%
12/106
|
|
Investigations
Neutrophil count decreased
|
10.4%
11/106
|
|
Investigations
Platelet count decreased
|
15.1%
16/106
|
|
Investigations
Weight decreased
|
17.0%
18/106
|
|
Investigations
Weight increased
|
6.6%
7/106
|
|
Investigations
White blood cell count decreased
|
11.3%
12/106
|
|
Metabolism and nutrition disorders
Anorexia
|
40.6%
43/106
|
|
Metabolism and nutrition disorders
Dehydration
|
10.4%
11/106
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.6%
24/106
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.5%
27/106
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.3%
13/106
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.5%
9/106
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.4%
10/106
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.5%
8/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.3%
12/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.2%
14/106
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.8%
21/106
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
34.9%
37/106
|
|
Nervous system disorders
Dizziness
|
17.9%
19/106
|
|
Nervous system disorders
Dysgeusia
|
50.9%
54/106
|
|
Nervous system disorders
Headache
|
30.2%
32/106
|
|
Nervous system disorders
Hypoaesthesia
|
6.6%
7/106
|
|
Nervous system disorders
Paraesthesia
|
9.4%
10/106
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.7%
6/106
|
|
Psychiatric disorders
Anxiety
|
9.4%
10/106
|
|
Psychiatric disorders
Depression
|
11.3%
12/106
|
|
Psychiatric disorders
Insomnia
|
13.2%
14/106
|
|
Renal and urinary disorders
Dysuria
|
9.4%
10/106
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
26/106
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.6%
7/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.5%
27/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.3%
12/106
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.6%
25/106
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.5%
9/106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.6%
7/106
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.4%
11/106
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.5%
8/106
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.2%
14/106
|
|
Skin and subcutaneous tissue disorders
Blister
|
9.4%
10/106
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.7%
23/106
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.2%
15/106
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
19.8%
21/106
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
6/106
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
28.3%
30/106
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
11.3%
12/106
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
8/106
|
|
Skin and subcutaneous tissue disorders
Rash
|
35.8%
38/106
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
33.0%
35/106
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
11.3%
12/106
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
9.4%
10/106
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
7.5%
8/106
|
|
Vascular disorders
Hot flush
|
6.6%
7/106
|
|
Vascular disorders
Hypertension
|
35.8%
38/106
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER