A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Pfizer Investigational Site
Córdoba, Córdoba Province, Argentina
Pfizer Investigational Site
Rosario, Santa Fe Province, Argentina
Pfizer Investigational Site
Number of Subjects With Overall Confirmed Objective Response (OR)
OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% 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 treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Duration of Response (DR)
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7.
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
Time to Tumor Progression (TTP)
Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
Progression-Free Survival (PFS)
Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
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Buenos Aires, Argentina
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
East Bentleigh, Victoria, Australia
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
...and 5 more locations
1-Year Survival
One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Time frame: From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the concentration prior to study drug administration.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Ctrough Correlated With Serious Adverse Events (SAEs)
Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Time frame: Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
Time frame: Baseline
VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
Time frame: Baseline (Cycle 1, Day 1)
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
Time frame: Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Time frame: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Time frame: Baseline to Day 1 of Weeks 3 through 53
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).
Time frame: Baseline to Day 1 of Weeks 3 through 53
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Time frame: Baseline
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Time frame: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).
Time frame: Baseline to Day 1 of Weeks 3 through 53
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 12 weeks\] versus PD).
Time frame: Baseline to Day 1 of Weeks 3 through 53
Patient-Assessed Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.
Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)
Cancer Related Symptoms, Well-Being, and Concerns
FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.
Time frame: Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)