NCT00575562已完成1 期
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
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
- •Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
- •Are not candidates for a surgically curative procedure.
- •Have progressed despite, are intolerant of, or are not appropriate for current therapies.
排除标准
- •Have an active, uncontrolled infection.
- •Have known or suspected cerebral metastasis.
- •Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
- •Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
- •Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
结局指标
主要结局
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.
时间窗: For up to12 weeks
次要结局
- The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD).(For up to12 weeks)
研究者
研究点 (4)
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