NCT00740441Unknown2 期
A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
Antisoma Research7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- To determine the Overall Response Rate to AS1411
研究概览
简要总结
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
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
- •Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
- •Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)
排除标准
- •Collecting duct histology
- •A history of bleeding disorders or currently taking oral vitamin K antagonise medication
- •Unstable brain metastases
- •History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)
研究组 & 干预措施
A
Experimental
AS1411 treatment
干预措施: AS1411 (Drug)
结局指标
主要结局
To determine the Overall Response Rate to AS1411
次要结局
- To measure progression free survival with AS1411
- To measure time to disease progression with AS1411
- To measure the duration of overall response and stable disease with AS1411
- To determine the safety and tolerability of two cycles of AS1411
- To assess the pharmacokinetic profile of AS1411
- To assess pharmacodynamic markers of AS1411
研究者
研究点 (7)
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