NCT00254540已完成2 期
Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
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
- 51
- 试验地点
- 1
- 主要终点
- Number of Subjects With Objective Response
研究概览
简要总结
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven renal cell carcinoma with metastases with a component of clear cell histology
排除标准
- •Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.
研究组 & 干预措施
SU-011248 capsule
Experimental
干预措施: SU011248 capsule (Drug)
结局指标
主要结局
Number of Subjects With Objective Response
时间窗: Day 28 of Cycles 1-4
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = 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
- Progression-Free Survival (PFS)(Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.)
- Time To Tumor Progression (TTP)(Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.)
- Duration of Response (DR)(Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.)
- Time to Tumor Response (TTR)(Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.)
- Overall Survival Time(once year. Up to 3 years after the completion of subject registration.)
- Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score(Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4)
- Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)(Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4)
- Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population(Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)(Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
- Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)(Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3)
研究者
研究点 (1)
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