NCT00225550终止1 期
Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)
Adherex Technologies, Inc.2 个研究点 分布在 1 个国家开始时间: 2005年9月26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
- 试验地点
- 2
研究概览
简要总结
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.
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
- •Signed written informed consent
- •Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
- •Clinically or radiologically documented measurable disease.
- •Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
- •Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
排除标准
- •Receipt of ADH-1 prior to this clinical study
- •Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
- •History of primary brain tumors or brain metastases
- •History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.
- •Stroke, major surgery, or other major tissue injury within 30 days before study entry
- •History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
研究者
研究点 (2)
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