NCT01046487已完成1 期
Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- For safety: NCI-CTCAE scale version 3.0
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rare tumor
- •metastatic disease or locally advanced disease, inoperable, with no standard treatment
- •At least 28 days since the prior treatment
- •Measurable disease with at least one measurable lesion
排除标准
- •Medullary insufficiency
- •Cystitis, haemorrhagic cystitis
- •Hepatic porphyria
结局指标
主要结局
For safety: NCI-CTCAE scale version 3.0
时间窗: 42 days
次要结局
- For anti tumoral efficiency : RECIST criteria(70 days)
研究者
研究点 (3)
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