NCT00077974已完成2 期
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic 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
- 106
- 试验地点
- 1
- 主要终点
- Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
研究概览
简要总结
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytokine refractory metastatic renal cell carcinoma with clear cell component
- •Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- •Prior nephrectomy
排除标准
- •Prior treatment with any systemic therapy other than 1 cytokine therapy
- •History of or known brain metastases
- •Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
研究组 & 干预措施
1
Experimental
干预措施: SU011248 (Drug)
结局指标
主要结局
Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
时间窗: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as \>= 30 percent 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
- Time to Tumor Progression (TTP)(From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter)
- Duration of Response (DR)(Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer)
- Overall Survival (OS)(From start of study treatment until death)
- Progression-free Survival (PFS)(From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death)
- Percent Chance of Patient Survival(From start of study treatment until death)
- Observed Plasma Trough Concentrations of Sunitinib(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
- Observed Plasma Trough Concentrations of Sunitinib Metabolite(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
- Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
- Dose Corrected Plasma Trough Concentrations of Sunitinib(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
- Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
- Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite(Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater)
研究者
研究点 (1)
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