A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of adverse events (based on CTCAE version 4.0), LVEF
研究概览
简要总结
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.
详细描述
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients with Advanced Solid Malignancies.
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
- 25 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer
排除标准
- •Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.
研究组 & 干预措施
AZD4547
干预措施: AZD4547 (Drug)
结局指标
主要结局
Assessment of adverse events (based on CTCAE version 4.0), LVEF
时间窗: LVEF on day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), eye examination
时间窗: Eye examination on day 21 in cycle 1.
Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
时间窗: General examination prior to IP administration in treatment cycles
Assessment of adverse events (based on CTCAE version 4.0), laboratory values
时间窗: Laboratory assessment day 21 cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements
时间窗: Vital sign measurements day 21 in cycle 1.
Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF)
时间窗: LVEF prior to study administration
Assessment of adverse events (based on CTCAE version 4.0)general examination
时间窗: General examination day 21 in cycle 1.
次要结局
- Define the maximum tolerated dose (MTD) if possible or biological effective dose.(Up to 3 weeks)
- To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally.(Schedule of PK assessment 1. AZD4547; blood Cycle0-day1 -day21; 27 point 2. AZD4547 metabolite; blood Cycle1-day21; 1 poin 3. AZD4547; urine Cycle1-day21; 1 point)
- To obtain a preliminary assessment of the anti-tumour effect of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1.(Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment)