NCT00999882已完成1 期
A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Tor Kinase Inhibitor (AZD8055) in Asian Patients With Advanced Stage Hepatocellular Carcinoma (HCC) and With Mild or Moderate Hepatic Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
研究概览
简要总结
The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology
- •Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma (HCC) which is inoperable and incurable with standard available treatments
- •Relatively good overall health other than cancer (WHO performance status (0-2)
排除标准
- •Patients with severe heart conditions, or those who have had heart surgery such as coronary artery bypass graft within the last 6 months, or patients with uncontrolled high blood pressure despite medical management.
- •Patients must not have received any other anti cancer therapy including TACE within 21 days of entering the trial
- •Patients must not have received a liver transplant.
研究组 & 干预措施
AZD8055
Experimental
Dose escalation
干预措施: AZD8055 (Drug)
结局指标
主要结局
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
时间窗: Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing
时间窗: Blood samples on 6 occasions during the first Cycle of the study (28 days)
次要结局
- Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055(Blood samples x 3 times on Day 1 of the first cycle)
- To collect and store DNA for future exploratory research that may influence response to AZD8055(Blood sample on Day 1 or at any other visit during study)
- To make a preliminary assessment of efficacy(Every 4 weeks)
- To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.(During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle)
研究者
研究点 (1)
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