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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00338884
Registration number
NCT00338884
Ethics application status
Date submitted
16/06/2006
Date registered
20/06/2006
Date last updated
31/08/2012
Titles & IDs
Public title
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
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Scientific title
A Phase II Efficacy And Safety Study Of Sunitinib Malate (SU011248) Administered In A Continuous Daily Regimen In Patients With Advanced (First-Line) Renal Cell Cancer
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Secondary ID [1]
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A6181110
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate
Experimental: SUNITINIB MALATE. - Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Treatment: Drugs: Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Overall Confirmed Objective Response (OR)
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Assessment method [1]
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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.
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Timepoint [1]
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From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
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Secondary outcome [1]
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Duration of Response (DR)
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Assessment method [1]
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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.
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Timepoint [1]
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From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause
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Secondary outcome [2]
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Time to Tumor Progression (TTP)
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Assessment method [2]
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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.
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Timepoint [2]
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From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter
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Secondary outcome [3]
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Progression-Free Survival (PFS)
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Assessment method [3]
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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.
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Timepoint [3]
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From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death
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Secondary outcome [4]
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1-Year Survival
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Assessment method [4]
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One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
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Timepoint [4]
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From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year
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Secondary outcome [5]
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Trough Plasma Concentrations (Ctrough) of Sunitinib
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Assessment method [5]
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Ctrough = the concentration prior to study drug administration.
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Timepoint [5]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [6]
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Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib
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Assessment method [6]
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Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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Timepoint [6]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [7]
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Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib
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Assessment method [7]
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Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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Timepoint [7]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [8]
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Ctrough of SU-012662 (Sunitinib's Metabolite)
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Assessment method [8]
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Ctrough = the concentration prior to study drug administration.
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Timepoint [8]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [9]
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Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)
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Assessment method [9]
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Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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Timepoint [9]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [10]
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Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)
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Assessment method [10]
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Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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Timepoint [10]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [11]
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Ctrough of Total Drug (Sunitinib + SU-012662)
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Assessment method [11]
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Ctrough = the concentration prior to study drug administration.
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Timepoint [11]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [12]
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Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)
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Assessment method [12]
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Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
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Timepoint [12]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [13]
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Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)
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Assessment method [13]
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Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
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Timepoint [13]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [14]
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Ctrough Correlated With Serious Adverse Events (SAEs)
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Assessment method [14]
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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.
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Timepoint [14]
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Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53
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Secondary outcome [15]
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Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline
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Assessment method [15]
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)
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Assessment method [16]
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Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
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Timepoint [16]
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Baseline (Cycle 1, Day 1)
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Secondary outcome [17]
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VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
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Assessment method [17]
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Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
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Timepoint [17]
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Baseline (Cycle 1, Day 1)
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Secondary outcome [18]
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VEGF Ratio to Baseline at Each Time Point
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Assessment method [18]
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VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
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Timepoint [18]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [19]
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VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
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Assessment method [19]
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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).
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Timepoint [19]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [20]
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VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
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Assessment method [20]
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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).
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Timepoint [20]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [21]
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Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
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Assessment method [21]
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Timepoint [21]
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Baseline
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Secondary outcome [22]
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sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)
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Assessment method [22]
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Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
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Timepoint [22]
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Baseline (Cycle 1, Day 1)
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Secondary outcome [23]
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sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
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Assessment method [23]
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Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
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Timepoint [23]
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Baseline (Cycle 1, Day 1)
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Secondary outcome [24]
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sVEGFR2 Ratio to Baseline at Each Time Point
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Assessment method [24]
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sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
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Timepoint [24]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [25]
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sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)
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Assessment method [25]
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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).
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Timepoint [25]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [26]
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sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)
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Assessment method [26]
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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).
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Timepoint [26]
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Baseline to Day 1 of Weeks 3 through 53
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Secondary outcome [27]
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Patient-Assessed Fatigue
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Assessment method [27]
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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.
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Timepoint [27]
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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)
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Secondary outcome [28]
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Cancer Related Symptoms, Well-Being, and Concerns
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Assessment method [28]
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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.
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Timepoint [28]
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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)
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Eligibility
Key inclusion criteria
* Advanced kidney cancer
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Previous treatment for kidney cancer, except surgical removal of kidney tumor
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Adelaide
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Recruitment hospital [2]
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Pfizer Investigational Site - Clayton
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Recruitment hospital [3]
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Pfizer Investigational Site - East Bentleigh
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3165 - East Bentleigh
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Santa Fé
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Country [2]
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Argentina
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State/province [2]
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Buenos Aires
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Country [3]
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Argentina
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State/province [3]
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Cordoba
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Country [4]
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Brazil
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State/province [4]
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RS
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Country [5]
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Brazil
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State/province [5]
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SP
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Country [6]
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Korea, Republic of
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State/province [6]
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Seoul
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Country [7]
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Mexico
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State/province [7]
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Jalisco
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Country [8]
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Mexico
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State/province [8]
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Nuevo Leon
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Country [9]
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Taiwan
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State/province [9]
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Taichung
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Country [10]
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Taiwan
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State/province [10]
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Tainan
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Country [11]
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Taiwan
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State/province [11]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00338884
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Trial related presentations / publications
de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21. Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26. Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7. Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00338884
Download to PDF