NCT00338884已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Subjects With Overall Confirmed Objective Response (OR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced kidney cancer
排除标准
- •Previous treatment for kidney cancer, except surgical removal of kidney tumor
研究组 & 干预措施
SUNITINIB MALATE.
Experimental
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
干预措施: Sunitinib malate (Drug)
结局指标
主要结局
Number of Subjects With Overall Confirmed Objective Response (OR)
时间窗: 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.
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))
研究者
研究点 (1)
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