NCT01102400已完成1 期
A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having advanced solid malignancy for which no curative or standard therapies exist
- •Karnofsky performance status of ≥60
- •Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)
排除标准
- •Inadequate bone marrow reserve or organ function
- •Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-
- •Patients must have no unhealed wounds or unhealed fractures
- •History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
研究组 & 干预措施
1
Experimental
干预措施: MEDI-575 (Drug)
结局指标
主要结局
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
时间窗: 30 days after the last dose of MEDI-575
次要结局
- Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)(3 months after last dose of study drug)
- Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion(30 days after last dose of study drug)
- To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies(3 months after last dose of study drug)
研究者
研究点 (1)
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