NCT01285453已完成1 期
A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
研究概览
简要总结
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
- •WHO Performance Status of 0-1
排除标准
- •Patients having symptomatic CNS tumor/metastasis and requiring treatment
- •Patients who have received prior therapy with ASA404 or other vascular disrupting agents
- •Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg
- •Patients with fluid retention
- •Patients with any one of cardiotoxicities
- •Concomitant use of drugs with a risk of prolonging the QT interval
- •Known allergy or hypersensitivity to taxane or polysorbate 80
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ASA404
Experimental
干预措施: vadimezan (Drug)
研究者
研究点 (1)
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