NCT00503711已完成1 期
An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年9月最近更新:
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
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) (0-24) (ng.h/mL) after single dose
研究概览
简要总结
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
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
- •histological and/or cytological confirmation of a malignant solid tumor
- •refractory to standard therapies or for which no appropriate therapies exist
- •WHO performance status 0-2
排除标准
- •patients with brain tumors or symptomatic cerebral metastases
- •systemic anticancer therapy within the last 4 weeks
研究组 & 干预措施
100 mg Vandetanib eod
Experimental
100 mg Vandetanib every other day dosing
干预措施: Vandetanib (Drug)
100 mg Vandetanib od
Experimental
100 mg Vandetanib once daily dosing
干预措施: Vandetanib (Drug)
300 mg Vandetanib od
Experimental
300 mg Vandetanib once daily dosing
干预措施: Vandetanib 300 mg (Drug)
结局指标
主要结局
Area under the curve (AUC) (0-24) (ng.h/mL) after single dose
时间窗: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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