NCT00503204已完成1 期
A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
研究概览
简要总结
This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis & stage
- •Patients received no more than 2 previous systemic chemotherapy regimes
- •Life Expectancy > 12 weeks
- •Patients must be at least 3 months from the completion of cranial radiation therapy
排除标准
- •History of poorly controlled high blood pressure
- •Recent major surgery prior to entry into the study
研究组 & 干预措施
1
Experimental
Lomustine + Cediranib (AZD2171)
干预措施: Cediranib (Drug)
1
Experimental
Lomustine + Cediranib (AZD2171)
干预措施: Lomustine (Drug)
结局指标
主要结局
Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.
时间窗: Assessed at each visit
次要结局
- Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration(assessed 2 & 4 hours post dosing)
研究者
研究点 (1)
Loading locations...
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