NCT00450138已完成1 期
An Open Label Phase 1 Study to Assess the Maximum Tolerated Dose of ZACTIMA™ Given Concomitantly With Weekly Cisplatin Chemotherapy and Radiation Therapy in Patients With Previously Untreated, Unresected Stage III-IV Head and Neck Squamous Cell Carcinoma
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
- Sanofi
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.
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
- •Stage III-IV squamous cell carcinoma of the head and neck
排除标准
- •No previous treatment for head and neck cancer, adequate cardiac function
研究组 & 干预措施
1
Experimental
Radiation + vandetanib
干预措施: ZD6474 (vandetanib) (Drug)
1
Experimental
Radiation + vandetanib
干预措施: Radiation (Radiation)
2
Experimental
Radiation + cisplatin + vandetanib
干预措施: ZD6474 (vandetanib) (Drug)
2
Experimental
Radiation + cisplatin + vandetanib
干预措施: Cisplatin (Drug)
2
Experimental
Radiation + cisplatin + vandetanib
干预措施: Radiation (Radiation)
结局指标
主要结局
To determine the maximum tolerated dose of vandetanib given in combination with radiation or radiation and chemotherapy in patients with late stage head and neck cancer
时间窗: assessed at each visit
次要结局
未报告次要终点
研究者
研究点 (1)
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