JPRN-jRCT2080221764已完成1 期
A Phase 1, 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
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:
- •-Dignosis of diabetes mellitus type I or II (irrespective of management)
- •-Baseline fasting glucose value of 7mmol/l (126mg/dL) or more
- •-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
研究者
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