NCT00563823已完成2 期
A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Response rate as assessed by RECIST every 8 weeks
研究概览
简要总结
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.
Secondary
- To determine the time to progression in these patients.
- To determine the 6-month and 1-year survival of these patients.
- To determine the overall survival of these patients.
- To determine the safety and toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Response rate as assessed by RECIST every 8 weeks
次要结局
- Time to progression
- Survival at 6 months and 1 year
- Overall survival
- Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks
研究者
研究点 (4)
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