A Phase I Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Capivasertib Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- terminal half-life (t1/2) of Capivasertib
研究概览
简要总结
This is an open-label, 2-part Phase I study to assess the PK, safety and tolerability of capivasertib as monotherapy and in combination with paclitaxel in Chinese participants with advanced solid tumours
详细描述
A Phase I study is designed to assess the PK, safety and tolerability of single-dose and multiple-dose capivasertib as monotherapy (Part A) and in combination with paclitaxel (Part B) in approximately 16 Chinese participants with advanced solid tumours and to detect any differences in the PK profile between Chinese and Caucasian participants due to ethnicity. Descriptive summary will be conducted on the PK analysis set and safety analysis set.The evaluation of capivasertib PK data will be based on the PK analysis set.The assessment on safety and tolerability will be based on the safety analysis set.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
capivasertib
single-dose and multiple-dose capivasertib as monotherapy (Part A) and then in combination with paclitaxel (Part B)
干预措施: Capivasertib (Drug)
capivasertib
single-dose and multiple-dose capivasertib as monotherapy (Part A) and then in combination with paclitaxel (Part B)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
terminal half-life (t1/2) of Capivasertib
时间窗: first dose up to approximately 6 months
t1/2 is defined as terminal half-life
Area under the plasma concentration-time curve from time zero to 12 hours post-dose (AUC 0-12) of Capivasertib
时间窗: first dose up to approximately 6 months
AUC0-12 is defined as area under the curve from 0 to 12 hours.
Maximum plasma concentration (Cmax) of Capivasertib
时间窗: first dose up to approximately 6 months
Cmax is defined as maximum plasma concentration
Accumulation ratio (Rac) of Capivasertib
时间窗: first dose up to approximately 6 months
Rac is defined as accumulation ratio
次要结局
- Safety and tolerability of drugs by assessment of AEs/SAEs(From time of signature of the ICF, through study completion, up to 17 months, and including the 30-day follow-up period after discontinuation of study drug)