NCT00288925已完成1 期
Phase Ib/IIa, to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects With Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment
Zeria Pharmaceutical2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety, Pharmacokinetics
研究概览
简要总结
To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study
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
- •Subjects with unresectable locally advanced or metastatic pancreatic cancer
- •KPS > 70%
- •Life expectancy of at least 3 months
排除标准
- •received previous chemotherapy for the current indication
- •received previous radiotherapy for the current indication
- •Currently receiving chemotherapy
结局指标
主要结局
Safety, Pharmacokinetics
次要结局
- Tumour shrinkage, Tumour objective response rate
研究者
研究点 (2)
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