NCT00981721已完成1 期
A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies
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
- To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours
研究概览
简要总结
This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.
The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Provision of informed consent
- •Histological and/or cytological confirmed advanced solid malignancies
- •Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist
排除标准
- •For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
- •Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
- •Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.
研究组 & 干预措施
1
Experimental
cediranib 20mg
干预措施: cediranib (RECENTIN TM, AZD2171) (Drug)
2
Experimental
cediranib 30mg
干预措施: cediranib (RECENTIN TM, AZD2171) (Drug)
结局指标
主要结局
To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours
时间窗: Multiple assessments in the first 6 days
次要结局
- To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours(Multiple assessments up to day 29)
- To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.(Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up)
研究者
研究点 (1)
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