NCT00621725已完成1 期
A Phase I, Open Label Study of the Pharmacokinetics and Safety of Cediranib (RECENTINTM, AZD2171) Following Single and Multiple Oral Doses in Patients With Advanced Solid Tumours With Various Degrees of Hepatic Dysfunction
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
- 36
- 试验地点
- 1
- 主要终点
- To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).
研究概览
简要总结
To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Written informed consent
- •Advanced solid tumour (not prostate cancer) for which no standard therapy exists
- •WHO performance status 0-2
- •Bilirubin levels within the target range
排除标准
- •Unstable brain/meningeal metastases
- •Inadequate bone marrow reserve
- •Biochemistry/haematology results outside of required ranges
- •History of significant GI impairment
研究组 & 干预措施
1
Experimental
干预措施: AZD2171 (Drug)
结局指标
主要结局
To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).
时间窗: Single dose PK assessed on Day 1 of dosing
次要结局
- Safety/tolerability of Cediranib (single and multiple dose PK)(assessed from randomisation to data cut-off (15th July 2010))
研究者
研究点 (1)
Loading locations...
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