NCT00257881终止1 期
Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors
Wyeth is now a wholly owned subsidiary of Pfizer2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity, Adverse Event
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193.
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 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant solid tumor progressed, or no standard treatment available
- •Tumor expression of Lewis Y antigen
排除标准
- •Cancer therapy within 28 days before enrollment
- •Pregnant or breastfeeding women
- •Unstable or serious concurrent medical conditions
结局指标
主要结局
Dose Limiting Toxicity, Adverse Event
次要结局
- Pharmacokinetics parameters, Tumor assessment
研究者
研究点 (2)
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