NCT00569114已完成1 期
A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
研究概览
简要总结
This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Other
干预措施: TG01 (Drug)
结局指标
主要结局
Saftey, maximum tolerated dose, optimal biological dose and pharmacokinetics.
时间窗: Baseline, 8, 15 and 28 days
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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