Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
- Registration Number
- NCT00338884
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Advanced kidney cancer
- Previous treatment for kidney cancer, except surgical removal of kidney tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SUNITINIB MALATE. Sunitinib malate Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
- Primary Outcome Measures
Name Time Method Number of Subjects With Overall Confirmed Objective Response (OR) From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter 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.
- Secondary Outcome Measures
Name Time Method sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Baseline (Cycle 1, Day 1) Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.
Duration of Response (DR) From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause 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.
sVEGFR2 Ratio to Baseline at Each Time Point Baseline to Day 1 of Weeks 3 through 53 sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Time to Tumor Progression (TTP) From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter 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.
Progression-Free Survival (PFS) From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death 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.
1-Year Survival From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.
Trough Plasma Concentrations (Ctrough) of Sunitinib Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of SU-012662 (Sunitinib's Metabolite) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough of Total Drug (Sunitinib + SU-012662) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Ctrough = the concentration prior to study drug administration.
Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.
Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.
Ctrough Correlated With Serious Adverse Events (SAEs) Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 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.
Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline Baseline VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD) Baseline (Cycle 1, Day 1) Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.
VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Baseline (Cycle 1, Day 1) Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.
VEGF Ratio to Baseline at Each Time Point Baseline to Day 1 of Weeks 3 through 53 VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Baseline to Day 1 of Weeks 3 through 53 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).
VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Baseline to Day 1 of Weeks 3 through 53 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).
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline Baseline sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD) Baseline (Cycle 1, Day 1) Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD) Baseline to Day 1 of Weeks 3 through 53 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).
sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) Baseline to Day 1 of Weeks 3 through 53 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).
Patient-Assessed Fatigue 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) 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.
Cancer Related Symptoms, Well-Being, and Concerns 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) 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan