NCT00252746已完成2 期
A Randomised, Double-blind, Parallel-group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
研究概览
简要总结
To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
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
- Double
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
- •Provision of written informed consent.
- •Life expectancy of 12 weeks or longer.
排除标准
- •Pregnancy, breast feeding or female patients wishing to become pregnant.
- •Treatment with a non-approved or investigational drug within 30 days before enrolment
研究组 & 干预措施
ZD6474 100mg
Experimental
Daily dose
干预措施: ZD6474 (vandetanib) 100mg (Drug)
ZD6474 200mg
Experimental
daily dose
干预措施: ZD6474 (vandetanib) 200mg (Drug)
ZD6474 300mg
Experimental
daily dose
干预措施: ZD6474 (vandetanib) 300mg (Drug)
结局指标
主要结局
To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively
时间窗: Every 4 weeks for the first 24 weeks of treatment and then every 8 weeks until PD is determined or withdrawal due to any reasons other than PD. If PR or CR is observed, tumour assessment will be repeated 4 weeks after for confirmation of the response
次要结局
- To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship(Every 4 weeks till meeting discontinuation criteria)
研究者
研究点 (1)
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