NCT01181245已完成1 期
A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
研究概览
简要总结
Objectives
- Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
- Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FG-3019
Experimental
All subjects are treated with FG-3019
干预措施: FG-3019 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
时间窗: Through the end of the study
次要结局
- Maximal tumor response as determined by RECIST criteria(Through the end of the study)
- FG-3019 PK parameters(Through the end of the study)
- Time to Progression (TTP)(Through the end of the study)
- 6-month, 12-month and overall median survival rates(Through the end of the study)
研究者
研究点 (7)
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