A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Time of maximum observed plasma concentration (Tmax) of Brivanib
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subjects with:
- •Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
- •Not having received prior systemic treatment for advanced HCC
- •Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Subjects with:
- •Brain metastasis or evidence of leptomeningeal disease
- •History of impaired brain function (encephalopathy) or active heart disease
- •Unmanageable fluid in the abdomen (ascites)
- •Bleeding esophageal or gastric varices within 2 months prior to inclusion
研究组 & 干预措施
Arm: Brivanib
干预措施: Brivanib (Drug)
结局指标
主要结局
Time of maximum observed plasma concentration (Tmax) of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Trough observed plasma concentration (Cmin) of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Terminal half-life (T-HALF) of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Maximum observed plasma concentration (Cmax) of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib
时间窗: Days 1, 2, 8, 9 and 15
次要结局
- Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib(Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months))
- Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests(Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months))