A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD3514 in Japanese Patients With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
研究概览
简要总结
The primary aim of study is to gain an initial assessment of safety and tolerability of AZD3514 in Japanese patients together with assessing Pharmacokinetics (PK) and gaining a preliminary assessment of anti-tumour action. In this study, AZD3514 will be administered to Japanese patients with metastatic castration resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 20 years or older.
- •Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate
- •Documented evidence of metastatic prostate cancer
- •Serum testosterone concentration ≤50 ng/dL
- •World Health Organisation (WHO) performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
排除标准
- •History of hypersensitivity to active or inactive excipients of AZD3514 or drugs with a similar chemical structure or class to AZD3514
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD3514
- •Inadequate bone marrow reserve or organ function
- •Concurrent or recent treatment with certain medications or medical procedures
- •Any medically important factors identified from electrocardiogram (ECG) measurements
研究组 & 干预措施
AZD3514
Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
干预措施: AZD3514 (Drug)
结局指标
主要结局
To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
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
Number of participants with adverse events
次要结局
- To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514(during the single dose period and the first 21 days of multiple dosing (ie, by study day 29))
- To obtain an preliminary assessment of the anti-tumour activity of AZD3514(Every 12 weeks)
- To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses(Multiple timepoints taken, begining at Day 1 and until 48 hrs after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.)
- To obtain an assessment of the activity of AZD3514 on the circulating levels of prostate-specific antigen (PSA)(Day 8, 15, 29 and every 4 weeks)