NCT00251550已完成1 期
Phase I/II Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate
研究概览
简要总结
To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inapplicable for radical operation
- •Not received prior systemic chemotherapy
- •Performance status: 0-1
排除标准
- •Having a history of sensitivity to platinum agent, folic acid or vitamin B12
结局指标
主要结局
To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate
次要结局
- QOL
- Duration of response
- Progression free survival
- Median survival time
- 1 year survival rate
- Pulmonary function
- Safety
- Plasma concentration
研究者
研究点 (7)
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