NCT01353781已完成1 期
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies
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
- 39
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.
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
- •Aged at least 20 years
- •Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
- •At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
- •World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- •Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)
排除标准
- •Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- •Diagnosis of diabetes mellitus type I or II (irrespective of management)
- •Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)
- •Glycosylated haemoglobin (HbA1C) >6.5%
- •Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
- •Inadequate bone marrow reserve or organ function
- •Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection
- •With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
研究组 & 干预措施
AZD5363
Experimental
Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD)
干预措施: AZD5363 (Drug)
结局指标
主要结局
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally
时间窗: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies
次要结局
- To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.(once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months))
- To characterise the pharmacokinetics parameters(Cmax)(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
- To characterise the pharmacokinetics parameters AUC(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
- To characterise the pharmacokinetics parameters Vz/F(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
- To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies(Assessed every 3 weeks for initial 2 cycles and every 6 weeks for later cycles for all subjects after start of study treatment until discontinuation of study treatment or withdrawal of consent.)
- To characterise the pharmacokinetics parameters tmax(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
- To characterise the pharmacokinetics parameters CL/F(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
- To characterise the pharmacokinetics parameters Cmin(PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.)
研究者
研究点 (1)
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