To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Pfizer Investigational Site
Duarte, California, United States
Pfizer Investigational Site
Pasadena, California, United States
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
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
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
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).
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Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
...and 5 more locations
Time frame: From start of study treatment until death
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
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
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
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
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
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
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
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