A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well talabostat works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic renal cell carcinoma treated with talabostat mesylate.
- Determine the progression-free survival of patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Correlate changes in specific cytokine levels and peripheral blood flow cytometry with progression-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
干预措施: laboratory biomarker analysis (Diagnostic Test)
Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
干预措施: talabostat mesylate (Drug)
Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
干预措施: enzyme inhibitor therapy (Biological)
Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
干预措施: flow cytometry (Diagnostic Test)
Talabostat
Talabostat 600 mcg orally, daily x 14 days (21 day cycle); 2 cycles
干预措施: non-specific immune-modulator therapy (Biological)
结局指标
主要结局
Objective response rate
时间窗: After 9 and 12 evaluable patients (126 to 168 days of total treatment). Each course is 14 days and repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Evaluable patients are those that have completed 4 cycles of treatment.
次要结局
- Dose-limiting toxicity(From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.)
- Adverse events(From day 1 through 14 of each course. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.)