NCT01839604已完成1 期
A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients With Advanced/Metastatic Hepatocellular Carcinoma
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
- 58
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities During Cycle 1
研究概览
简要总结
This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.
详细描述
A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with Advanced/Metastatic Hepatocellular Carcinoma.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years. Patient from Japan and Taiwan aged at least 20 years
- •Histologically or cytologically confirmed HCC (with the exception of fibrolamellar carcinoma or mixed variants of HCC with fibrolamellar histology OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis)
- •Relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity)
- •Metastatic or locally advanced meeting ANY of the criteria below:
- •HCC not suitable to receive local therapy
- •Disease recurred or was refractory to last therapy (local or systemic)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks
排除标准
- •More than 2 prior systemic treatments for HCC
- •Prior grade 3 hematologic toxicity related to treatment with a JAK or STAT3 inhibitor
- •Presence of hepatic encephalopathy within 4 weeks of 1st dose
- •Uncontrolled massive ascites
- •High likelihood of bleeding
研究组 & 干预措施
AZD9150
Experimental
There are two parts, dose escalation phase (Part A) and dose expansion phase (Part B).
干预措施: AZD9150 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities During Cycle 1
时间窗: DLT assessment window - Cycle 1 (22 days)
Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.
次要结局
- Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.(8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.)
- Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.(Every 6 weeks, assessed up to 12 months.)
- Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.(8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.)
研究者
研究点 (1)
Loading locations...
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