NCT00265057已完成1 期
Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Weekly in 3 Week Cycles by Intravenous Infusion in Patients With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX-01-004)
Adherex Technologies, Inc.6 个研究点 分布在 2 个国家开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 6
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. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.
- •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 (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months. History of spinal cord compression. History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks 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 (6)
Loading locations...
相似试验
终止
1 期
A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid TumorsNeoplasmsNCT00225550Adherex Technologies, Inc.
已完成
1 期
A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or CapecitabineNeoplasmsNCT00390676Adherex Technologies, Inc.
已完成
2 期
A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single AgentNeoplasmsNCT00264433Adherex Technologies, Inc.
已完成
1 期
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of MelphalanNeoplasmsNCT00421811Adherex Technologies, Inc.56
已完成
1 期
A Study Of PF-03732010 In Patients With Advanced Solid TumorsNeoplasmsNCT00557505Pfizer43