Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of TAC-101
研究概览
简要总结
RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer).
详细描述
OBJECTIVES:
Phase I
-
Primary
-
Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma.
-
Determine the safety of 2 consecutive courses of this drug in these patients.
-
Determine the pharmacokinetics of this drug in these patients.
-
Determine the toxic and adverse effects profile of this drug in these patients.
Phase II
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 80 Years（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
TAC-101
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
干预措施: TAC-101 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of TAC-101
时间窗: 60 Days
次要结局
未报告次要终点