NCT03970616终止1 期
A Phase 1b/2, Open-Label, Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
Tivozanib in Combination with Durvalumab
Experimental
Tivozanib in Combination with Durvalumab
干预措施: Tivozanib (Drug)
Tivozanib in Combination with Durvalumab
Experimental
Tivozanib in Combination with Durvalumab
干预措施: Durvalumab (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Approximately 24 months; Through study completion
To establish the safety of tivozanib in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) previously treated with both bevacizumab and atezolizumab or both bevacizumab and atezolizumab in combination with a second immune checkpoint inhibitor in a prior line of therapy.
次要结局
- Response Rate (Objective Response Rate)(Approximately 24 months)
- Overall Survival (OS)(Approximately 24 months; Through study completion)
- Progression Free Survival (PFS)(Approximately 24 months; Through study completion)
研究者
研究点 (10)
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