A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2-hour or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)
研究概览
简要总结
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.
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
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of a solid, malignant tumour
- •At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
排除标准
- •Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug
- •Recent major surgery within 4 weeks prior to entry into the study
研究组 & 干预措施
AZD1152
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
干预措施: AZD1152 part A (Drug)
AZD1152
AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
干预措施: AZD1152 part B (Drug)
结局指标
主要结局
The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)
时间窗: Throughout the study. Approximately 9 months for most patients.
Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs).
次要结局
- Assessment of pharmacodynamic biomarker changes(Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).])