An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib
研究概览
简要总结
The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 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
Group I
patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score
干预措施: Nintedanib medium dose (Drug)
Group I
patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score
干预措施: Nintedanib high dose (Drug)
Group II
patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
干预措施: Nintedanib low dose (Drug)
Group II
patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
干预措施: Nintedanib medium dose (Drug)
Group II
patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score
干预措施: Nintedanib high dose (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib
时间窗: up to 28 days
The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase \[ALP\] elevation \>5x ULN, or total bilirubin \>3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP \> baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.
次要结局
- Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0(up to 28 months)
- Progression Free Survival (PFS)(up to 28 months)
- Time to Progression (TTP)(up to 28 months)
- Number of Participants With Response by Alpha Fetoprotein (AFP)(up to 28 months)