NCT00973076已完成1 期
A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
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
- 19
- 试验地点
- 1
- 主要终点
- Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
研究概览
简要总结
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
- •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
- •Serious concomitant illness
研究组 & 干预措施
AZD8055
Experimental
AZD8055 will be administered orally
干预措施: AZD8055 (Drug)
结局指标
主要结局
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
时间窗: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
次要结局
- To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)(Every cycle)
- To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours(According to protocol specified schedule, the number of PK samples collected during Cycle 1)
研究者
研究点 (1)
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