jRCT2080220617未知1 期
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
- 主要终点
- safety and tolerability of AZD0530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open Label, Single Group Assignment, Safety Study
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Accepts Healthy Volunteers: No
- •Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists.
- •World Health Organisation (WHO) performance status 0 to
- •Life expectancy of at least 12 weeks.
排除标准
- •Inadequate bone marrow reserve.
- •Inadequate liver function, renal function or low hemoglobin.
- •Unresolved toxicity from anti-cancer therapy.
结局指标
主要结局
safety and tolerability of AZD0530
时间窗: Assessed on an ongoing basis after starting daily dosing with AZD0530
evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of: - AEs - vital signs - ECG - laboratory findings - thoracic imaging - pulmonary function test
次要结局
- Cmin(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- Cmax(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- tmax(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- Cssmax(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- Cssmin(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- AUC0-t(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- AUC0-24(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- AUC(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- AUCss0-24(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- CL/F(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- t1/2(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
- R(1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.)
研究者
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