NCT00497731终止1 期
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
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 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.
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 —（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 measurable or non measurable site of disease as defined by modified RECIST criteria.
排除标准
- •Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
- •Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
- •Recent major surgery within 4 weeks prior to entry to the study
结局指标
主要结局
Safety and Tolerability
时间窗: Assessed at each visit
次要结局
- Pharmacokinetics(Assessed at predetermined timepoints after dose administration)
- Effect on biomarkers(Assessed after treatment)
- Anti-tumor activity(Assessed after treatment)
研究者
研究点 (2)
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