NCT00731263已完成1 期
A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to 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
- 64
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD8055
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.
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
- •Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
- •Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
- •Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients
排除标准
- •Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
- •Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
- •Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
- •Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
研究组 & 干预措施
1
Experimental
The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.
干预措施: AZD8055 (Drug)
结局指标
主要结局
Safety and tolerability of AZD8055
时间窗: Assessed at all visits
次要结局
- To identify early signals of anti-tumour activity(Visits 1, 5, and 9 and 11)
- To identify early signals of anti-tumor activity(Visits 1, 5, 9 and 13)
研究者
研究点 (1)
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