Phase I Study of Combination of Sorafenib and LBH589 in Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Assessment of Safety and Tolerability
研究概览
简要总结
RATIONALE: Panobinostat and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with sorafenib in treating patients with liver cancer that is metastatic and/or cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Assess the safety and tolerability of panobinostat when combined with standard doses of sorafenib tosylate in patients with metastatic and/or unresectable hepatocellular carcinoma.
- Determine the maximum tolerated dose of panobinostat when combined with standard doses of sorafenib tosylate in these patients.
Secondary
- Determine the response rate.
- Determine the progression-free survival.
- Determine the overall survival rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
LBH589
This study utilizes a sequential dose-escalation design to define the MTD of LBH589 when combined with standard doses of sorafenib.
干预措施: panobinostat (Drug)
LBH589
This study utilizes a sequential dose-escalation design to define the MTD of LBH589 when combined with standard doses of sorafenib.
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Assessment of Safety and Tolerability
时间窗: 6months to 1 year
•Primary objective of the phase I trial will be to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) of LBH 589 when combined with standard doses of sorafenib in the treatment of hepatocellular carcinoma.
次要结局
- Progression-free survival(6mo 1 year)
- Overall survival(until death)
- Response as assessed by RECIST(every 42 days)
- Adverse events and abnormal laboratory value severity as assessed by NCI CTCAE version 3.0(weekly during treatment to 30 days after treatment)