Carcinoma, Renal Cell
Conditions
Brief summary
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Interventions
DRUGSU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytokine refractory metastatic renal cell carcinoma with clear cell component * Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy * Prior nephrectomy
Exclusion criteria
* Prior treatment with any systemic therapy other than 1 cytokine therapy * History of or known brain metastases * Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DR) | Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer | 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. |
| Overall Survival (OS) | From start of study treatment until death | 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). |
| Progression-free Survival (PFS) | From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death | 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). |
| Percent Chance of Patient Survival | From start of study treatment until death | Probability of survival 1 year and 2 years after the first dose of study treatment |
| Observed Plasma Trough Concentrations of Sunitinib | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | Observed plasma trough (predose) (Cmin) concentrations of sunitinib |
| Time to Tumor Progression (TTP) | From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter | 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 \[PD\]). |
| Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662) |
| Dose Corrected Plasma Trough Concentrations of Sunitinib | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 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. |
| Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 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. |
| Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | 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. |
| Observed Plasma Trough Concentrations of Sunitinib Metabolite | Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater | Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Decision of Sponsor | 2 |
| Overall Study | Lack of Efficacy | 76 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Sunitinib Malate |
|---|---|
| Age, Customized < 65 years | 87 participants |
| Age, Customized >= 65 years | 19 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 106 |
| serious Total, serious adverse events | 46 / 106 |
Outcome results
Primary
Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Malate | Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) | 35 participants |
95% CI: [24.2, 42.8]
Secondary
Dose Corrected Plasma Trough Concentrations of Sunitinib
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
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 5 Day 1 (n = 28) | 1.94 nanograms per milliliter | Standard Deviation 3.24 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 6 Day 1 (n = 41) | 2.15 nanograms per milliliter | Standard Deviation 2.94 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 7 Day 1 (n = 35) | 2.04 nanograms per milliliter | Standard Deviation 4.1 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 8 Day 1 (n = 32) | 2.32 nanograms per milliliter | Standard Deviation 2.77 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 9 Day 1 (n = 32) | 2.07 nanograms per milliliter | Standard Deviation 2.62 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 10 Day 1 (n = 32) | 2.68 nanograms per milliliter | Standard Deviation 4.32 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 11 Day 1 (n = 25) | 3.42 nanograms per milliliter | Standard Deviation 6.86 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 12 Day 1 (n = 28) | 1.94 nanograms per milliliter | Standard Deviation 1.63 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 13 Day 1 (n = 23) | 2.23 nanograms per milliliter | Standard Deviation 2.49 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 14 Day 1 (n = 24) | 2.41 nanograms per milliliter | Standard Deviation 2.46 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 15 Day 1 (n = 16) | 1.58 nanograms per milliliter | Standard Deviation 1.09 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 18 Day 1 (n = 14) | 3.05 nanograms per milliliter | Standard Deviation 4.57 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 26 Day 1 (n = 5) | 4.09 nanograms per milliliter | Standard Deviation 5.7 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 30 Day 1 (n = 3) | 1.36 nanograms per milliliter | Standard Deviation 1.5 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 16 Day 1 (n = 18) | 2.42 nanograms per milliliter | Standard Deviation 2.48 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 17 Day 1 (n = 17) | 2.23 nanograms per milliliter | Standard Deviation 2.66 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 19 Day 1 (n = 11) | 1.92 nanograms per milliliter | Standard Deviation 1.58 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 20 Day 1 (n = 11) | 5.09 nanograms per milliliter | Standard Deviation 7.47 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 21 Day 1 (n = 8) | 3.41 nanograms per milliliter | Standard Deviation 3.24 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 22 Day 1 (n = 9) | 3.91 nanograms per milliliter | Standard Deviation 5.45 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 23 Day 1 (n = 6) | 4.53 nanograms per milliliter | Standard Deviation 3.89 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 24 Day 1 (n = 6) | 3.82 nanograms per milliliter | Standard Deviation 3.68 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 25 Day 1 (n = 5) | 3.14 nanograms per milliliter | Standard Deviation 3.24 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 27 Day 1 (n = 5) | 2.12 nanograms per milliliter | Standard Deviation 2.58 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 28 Day 1 (n = 4) | 2.97 nanograms per milliliter | Standard Deviation 3.36 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 29 Day 1 (n = 4) | 4.02 nanograms per milliliter | Standard Deviation 5.6 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 1 Day 28 (n = 33) | 53.64 nanograms per milliliter | Standard Deviation 22.54 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 2 Day 28 (n = 26) | 55.94 nanograms per milliliter | Standard Deviation 25.52 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 3 Day 28 (n = 20) | 69.44 nanograms per milliliter | Standard Deviation 33.21 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib | Cycle 4 Day 28 (n = 25) | 64.33 nanograms per milliliter | Standard Deviation 41.46 |
Secondary
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
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
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 1 Day 28 (n = 33) | 31.85 nanograms per milliliter | Standard Deviation 18.15 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 2 Day 28 (n = 26) | 28.15 nanograms per milliliter | Standard Deviation 19.8 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 3 Day 28 (n = 20) | 40.53 nanograms per milliliter | Standard Deviation 20.38 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 4 Day 28 (n = 25) | 38.04 nanograms per milliliter | Standard Deviation 24.29 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 5 Day 1 (n = 28) | 2.99 nanograms per milliliter | Standard Deviation 2.55 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 6 Day 1 (n = 41) | 3.35 nanograms per milliliter | Standard Deviation 2.52 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 10 Day 1 (n = 32) | 3.61 nanograms per milliliter | Standard Deviation 3.62 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 11 Day 1 (n = 25) | 4.37 nanograms per milliliter | Standard Deviation 8.13 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 12 Day 1 (n = 28) | 3.24 nanograms per milliliter | Standard Deviation 2.82 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 16 Day 1 (n = 18) | 3.40 nanograms per milliliter | Standard Deviation 2.27 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 19 Day 1 (n = 11) | 2.93 nanograms per milliliter | Standard Deviation 2.33 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 20 Day 1 (n = 11) | 4.53 nanograms per milliliter | Standard Deviation 3.82 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 22 Day 1 (n = 9) | 5.31 nanograms per milliliter | Standard Deviation 6.73 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 23 Day 1 (n = 6) | 4.26 nanograms per milliliter | Standard Deviation 3.16 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 24 Day 1 (n = 6) | 3.62 nanograms per milliliter | Standard Deviation 2.49 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 25 Day 1 (n = 5) | 3.00 nanograms per milliliter | Standard Deviation 2.18 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 27 Day 1 (n = 5) | 2.36 nanograms per milliliter | Standard Deviation 2.57 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 28 Day 1 (n = 4) | 2.94 nanograms per milliliter | Standard Deviation 2.63 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 29 Day 1 (n = 4) | 3.32 nanograms per milliliter | Standard Deviation 3.28 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 30 Day 1 (n = 3) | 1.18 nanograms per milliliter | Standard Deviation 1.08 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 7 Day 1 (n = 35) | 3.11 nanograms per milliliter | Standard Deviation 3.13 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 8 Day 1 (n = 32) | 3.37 nanograms per milliliter | Standard Deviation 2.34 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 9 Day 1 (n = 32) | 3.45 nanograms per milliliter | Standard Deviation 2.8 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 13 Day 1 (n = 23) | 3.68 nanograms per milliliter | Standard Deviation 2.79 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 14 Day 1 (n = 24) | 3.54 nanograms per milliliter | Standard Deviation 2.6 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 15 Day 1 (n = 16) | 2.80 nanograms per milliliter | Standard Deviation 1.82 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 17 Day 1 (n = 17) | 2.55 nanograms per milliliter | Standard Deviation 2.23 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 18 Day 1 (n = 14) | 2.59 nanograms per milliliter | Standard Deviation 1.69 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 21 Day 1 (n = 8) | 3.97 nanograms per milliliter | Standard Deviation 2.78 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 26 Day 1 (n = 5) | 4.49 nanograms per milliliter | Standard Deviation 5.29 |
Secondary
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
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
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 1 Day 28 (n = 33) | 85.49 nanograms per milliliter | Standard Deviation 37.49 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 2 Day 28 (n = 26) | 84.09 nanograms per milliliter | Standard Deviation 42.11 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 3 Day 28 (n = 20) | 109.97 nanograms per milliliter | Standard Deviation 48.38 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 4 Day 28 (n = 25) | 102.37 nanograms per milliliter | Standard Deviation 62.69 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 6 Day 1 (n = 41) | 5.50 nanograms per milliliter | Standard Deviation 5.14 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 12 Day 1 (n = 28) | 5.19 nanograms per milliliter | Standard Deviation 4.08 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 14 Day 1 (n = 24) | 5.95 nanograms per milliliter | Standard Deviation 4.8 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 15 Day 1 (n = 16) | 4.39 nanograms per milliliter | Standard Deviation 2.48 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 16 Day 1 (n = 18) | 5.82 nanograms per milliliter | Standard Deviation 4.21 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 17 Day 1 (n = 17) | 4.78 nanograms per milliliter | Standard Deviation 4.79 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 20 Day 1 (n = 11) | 9.63 nanograms per milliliter | Standard Deviation 11 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 21 Day 1 (n = 8) | 7.38 nanograms per milliliter | Standard Deviation 5.8 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 22 Day 1 (n = 9) | 9.23 nanograms per milliliter | Standard Deviation 12.13 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 23 Day 1 (n = 6) | 8.79 nanograms per milliliter | Standard Deviation 6.77 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 24 Day 1 (n = 6) | 7.44 nanograms per milliliter | Standard Deviation 5.84 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 25 Day 1 (n = 5) | 6.13 nanograms per milliliter | Standard Deviation 5.29 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 26 Day 1 (n = 5) | 8.58 nanograms per milliliter | Standard Deviation 10.94 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 5 Day 1 (n = 28) | 4.93 nanograms per milliliter | Standard Deviation 5.49 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 7 Day 1 (n = 35) | 5.15 nanograms per milliliter | Standard Deviation 6.97 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 8 Day 1 (n = 32) | 5.69 nanograms per milliliter | Standard Deviation 4.86 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 9 Day 1 (n = 32) | 5.52 nanograms per milliliter | Standard Deviation 5.22 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 10 Day 1 (n = 32) | 6.29 nanograms per milliliter | Standard Deviation 7.8 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 11 Day 1 (n = 25) | 7.78 nanograms per milliliter | Standard Deviation 14.94 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 13 Day 1 (n = 23) | 5.91 nanograms per milliliter | Standard Deviation 5.03 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 18 Day 1 (n = 14) | 5.64 nanograms per milliliter | Standard Deviation 6.01 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 19 Day 1 (n = 11) | 4.85 nanograms per milliliter | Standard Deviation 3.77 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 27 Day 1 (n = 5) | 4.48 nanograms per milliliter | Standard Deviation 5.14 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 28 Day 1 (n = 4) | 5.90 nanograms per milliliter | Standard Deviation 5.96 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 29 Day 1 (n = 4) | 7.34 nanograms per milliliter | Standard Deviation 8.85 |
| Sunitinib Malate | Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 30 Day 1 (n = 3) | 2.54 nanograms per milliliter | Standard Deviation 2.58 |
Secondary
Duration of Response (DR)
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
Population: ITT subgroup of patients with a confirmed objective tumor response
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Duration of Response (DR) | 60.4 weeks |
Secondary
Observed Plasma Trough Concentrations of Sunitinib
Observed plasma trough (predose) (Cmin) concentrations of sunitinib
Time frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 1 Day 28 (n = 103) | 46.82 nanograms per milliliter | Standard Deviation 24.19 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 2 Day 28 (n = 81) | 50.13 nanograms per milliliter | Standard Deviation 24.66 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 3 Day 28 (n = 73) | 49.36 nanograms per milliliter | Standard Deviation 25.26 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 4 Day 28 (n = 66) | 53.18 nanograms per milliliter | Standard Deviation 22.62 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 5 Day 1 (n = 63) | 1.55 nanograms per milliliter | Standard Deviation 1.48 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 6 Day 1 (n = 59) | 1.44 nanograms per milliliter | Standard Deviation 1.37 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 7 Day 1 (n = 52) | 1.51 nanograms per milliliter | Standard Deviation 1.9 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 8 Day 1 (n = 48) | 1.60 nanograms per milliliter | Standard Deviation 1.38 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 9 Day 1 (n = 46) | 1.60 nanograms per milliliter | Standard Deviation 1.58 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 10 Day 1 (n = 41) | 1.69 nanograms per milliliter | Standard Deviation 1.97 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 11 Day 1 (n = 38) | 2.05 nanograms per milliliter | Standard Deviation 3 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 12 Day 1 (n = 34) | 1.72 nanograms per milliliter | Standard Deviation 1.66 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 13 Day 1 (n = 30) | 1.74 nanograms per milliliter | Standard Deviation 1.57 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 14 Day 1 (n = 30) | 1.60 nanograms per milliliter | Standard Deviation 1.45 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 15 Day 1 (n = 24) | 1.56 nanograms per milliliter | Standard Deviation 2.17 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 16 Day 1 (n = 24) | 1.46 nanograms per milliliter | Standard Deviation 1.23 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 17 Day 1 (n = 19) | 1.42 nanograms per milliliter | Standard Deviation 1.65 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 18 Day 1 (n = 16) | 2.20 nanograms per milliliter | Standard Deviation 2.17 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 19 Day 1 (n = 14) | 1.34 nanograms per milliliter | Standard Deviation 1.18 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 20 Day 1 (n = 12) | 2.96 nanograms per milliliter | Standard Deviation 3.53 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 21 Day 1 (n = 11) | 2.53 nanograms per milliliter | Standard Deviation 2.07 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 22 Day 1 (n = 11) | 2.18 nanograms per milliliter | Standard Deviation 2.57 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 23 Day 1 (n = 7) | 3.14 nanograms per milliliter | Standard Deviation 2.7 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 24 Day 1 (n = 7) | 2.75 nanograms per milliliter | Standard Deviation 1.86 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 25 Day 1 (n = 6) | 1.99 nanograms per milliliter | Standard Deviation 1.37 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 26 Day 1 (n = 6) | 2.46 nanograms per milliliter | Standard Deviation 2.43 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 27 Day 1 (n = 6) | 1.20 nanograms per milliliter | Standard Deviation 1.21 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 28 Day 1 (n = 4) | 1.75 nanograms per milliliter | Standard Deviation 1.61 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 29 Day 1 (n = 5) | 2.93 nanograms per milliliter | Standard Deviation 3.64 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib | Cycle 30 Day 1 (n = 4) | 1.02 nanograms per milliliter | Standard Deviation 0.9 |
Secondary
Observed Plasma Trough Concentrations of Sunitinib Metabolite
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
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 13 Day 1 (n = 30) | 2.77 nanograms per milliliter | Standard Deviation 2.03 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 14 Day 1 (n = 30) | 2.49 nanograms per milliliter | Standard Deviation 2.05 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 15 Day 1 (n = 24) | 2.51 nanograms per milliliter | Standard Deviation 2.98 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 16 Day 1 (n = 24) | 2.30 nanograms per milliliter | Standard Deviation 1.84 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 17 Day 1 (n = 19) | 1.83 nanograms per milliliter | Standard Deviation 1.49 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 18 Day 1 (n = 16) | 2.16 nanograms per milliliter | Standard Deviation 1.07 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 23 Day 1 (n = 7) | 3.10 nanograms per milliliter | Standard Deviation 2.25 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 24 Day 1 (n = 7) | 2.64 nanograms per milliliter | Standard Deviation 1.68 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 25 Day 1 (n = 6) | 1.99 nanograms per milliliter | Standard Deviation 1.07 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 26 Day 1 (n = 6) | 2.60 nanograms per milliliter | Standard Deviation 2.26 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 27 Day 1 (n = 6) | 1.36 nanograms per milliliter | Standard Deviation 1.22 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 28 Day 1 (n = 4) | 1.81 nanograms per milliliter | Standard Deviation 1.2 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 29 Day 1 (n = 5) | 2.43 nanograms per milliliter | Standard Deviation 2.12 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 30 Day 1 (n = 4) | 1.10 nanograms per milliliter | Standard Deviation 0.73 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 1 Day 28 (n = 103) | 26.44 nanograms per milliliter | Standard Deviation 15.66 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 2 Day 28 (n = 81) | 28.21 nanograms per milliliter | Standard Deviation 17.21 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 3 Day 28 (n = 73) | 28.32 nanograms per milliliter | Standard Deviation 18.38 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 4 Day 28 (n = 66) | 28.54 nanograms per milliliter | Standard Deviation 16.93 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 5 Day 1 (n = 63) | 2.50 nanograms per milliliter | Standard Deviation 1.6 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 6 Day 1 (n = 59) | 2.64 nanograms per milliliter | Standard Deviation 1.67 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 7 Day 1 (n = 52) | 2.64 nanograms per milliliter | Standard Deviation 1.98 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 8 Day 1 (n = 48) | 2.66 nanograms per milliliter | Standard Deviation 1.68 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 9 Day 1 (n = 46) | 2.81 nanograms per milliliter | Standard Deviation 2.32 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 10 Day 1 (n = 41) | 2.54 nanograms per milliliter | Standard Deviation 1.87 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 11 Day 1 (n = 38) | 2.78 nanograms per milliliter | Standard Deviation 3.4 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 12 Day 1 (n = 34) | 2.67 nanograms per milliliter | Standard Deviation 2.29 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 19 Day 1 (n = 14) | 2.06 nanograms per milliliter | Standard Deviation 1.82 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 20 Day 1 (n = 12) | 2.92 nanograms per milliliter | Standard Deviation 1.86 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 21 Day 1 (n = 11) | 3.13 nanograms per milliliter | Standard Deviation 2.19 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Metabolite | Cycle 22 Day 1 (n = 11) | 3.24 nanograms per milliliter | Standard Deviation 3.12 |
Secondary
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
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
Population: Pharmacokinetic analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 1 Day 28 (n = 103) | 73.26 nanograms per milliliter | Standard Deviation 36.85 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 2 Day 28 (n = 81) | 78.34 nanograms per milliliter | Standard Deviation 39.03 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 3 Day 28 (n = 73) | 77.68 nanograms per milliliter | Standard Deviation 39.84 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 6 Day 1 (n = 59) | 4.08 nanograms per milliliter | Standard Deviation 2.72 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 7 Day 1 (n = 52) | 4.15 nanograms per milliliter | Standard Deviation 3.57 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 13 Day 1 (n = 30) | 4.52 nanograms per milliliter | Standard Deviation 3.36 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 14 Day 1 (n = 30) | 4.09 nanograms per milliliter | Standard Deviation 3.37 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 15 Day 1 (n = 24) | 4.07 nanograms per milliliter | Standard Deviation 5 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 18 Day 1 (n = 16) | 4.35 nanograms per milliliter | Standard Deviation 2.9 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 19 Day 1 (n = 14) | 3.40 nanograms per milliliter | Standard Deviation 2.87 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 20 Day 1 (n = 12) | 5.88 nanograms per milliliter | Standard Deviation 5.19 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 21 Day 1 (n = 11) | 5.66 nanograms per milliliter | Standard Deviation 4.09 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 22 Day 1 (n = 11) | 5.43 nanograms per milliliter | Standard Deviation 5.61 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 23 Day 1 (n = 7) | 6.24 nanograms per milliliter | Standard Deviation 4.78 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 24 Day 1 (n = 7) | 5.39 nanograms per milliliter | Standard Deviation 3.31 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 25 Day 1 (n = 6) | 3.97 nanograms per milliliter | Standard Deviation 2.32 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 26 Day 1 (n = 6) | 5.06 nanograms per milliliter | Standard Deviation 4.61 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 27 Day 1 (n = 6) | 2.55 nanograms per milliliter | Standard Deviation 2.41 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 28 Day 1 (n = 4) | 3.56 nanograms per milliliter | Standard Deviation 2.77 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 30 Day 1 (n = 4) | 2.13 nanograms per milliliter | Standard Deviation 1.57 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 4 Day 28 (n = 66) | 81.71 nanograms per milliliter | Standard Deviation 36.55 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 5 Day 1 (n = 63) | 4.04 nanograms per milliliter | Standard Deviation 2.8 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 8 Day 1 (n = 48) | 4.26 nanograms per milliliter | Standard Deviation 2.78 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 9 Day 1 (n = 46) | 4.41 nanograms per milliliter | Standard Deviation 3.65 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 10 Day 1 (n = 41) | 4.23 nanograms per milliliter | Standard Deviation 3.69 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 11 Day 1 (n = 38) | 4.83 nanograms per milliliter | Standard Deviation 6.34 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 12 Day 1 (n = 34) | 4.39 nanograms per milliliter | Standard Deviation 3.69 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 16 Day 1 (n = 24) | 3.75 nanograms per milliliter | Standard Deviation 2.63 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 17 Day 1 (n = 19) | 3.25 nanograms per milliliter | Standard Deviation 3.03 |
| Sunitinib Malate | Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite | Cycle 29 Day 1 (n = 5) | 5.36 nanograms per milliliter | Standard Deviation 5.74 |
Secondary
Overall Survival (OS)
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
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Overall Survival (OS) | 104.1 weeks |
Secondary
Percent Chance of Patient Survival
Probability of survival 1 year and 2 years after the first dose of study treatment
Time frame: From start of study treatment until death
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib Malate | Percent Chance of Patient Survival | 1 year | 67.2 percent chance of survival |
| Sunitinib Malate | Percent Chance of Patient Survival | 2 years | 50.2 percent chance of survival |
Secondary
Progression-free Survival (PFS)
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
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Progression-free Survival (PFS) | 38.0 weeks |
Secondary
Time to Tumor Progression (TTP)
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
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Malate | Time to Tumor Progression (TTP) | 46.3 weeks |