A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors
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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.
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)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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