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

简要总结

主要结局

次要结局

• 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)
• 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 to Tumor Progression (TTP)(From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter)
• Progression-Free Survival (PFS)(From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death)
• 1-Year Survival(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(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(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)(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)(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)(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)(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)(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)(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)(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(Baseline)
• VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)(Baseline (Cycle 1, Day 1))
• VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)(Baseline (Cycle 1, Day 1))
• VEGF Ratio to Baseline at Each Time Point(Baseline to Day 1 of Weeks 3 through 53)
• VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)(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)(Baseline to Day 1 of Weeks 3 through 53)
• 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))
• sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)(Baseline (Cycle 1, Day 1))
• sVEGFR2 Ratio to Baseline at Each Time Point(Baseline to Day 1 of Weeks 3 through 53)
• sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)(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)(Baseline to Day 1 of Weeks 3 through 53)
• 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))
• 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))