A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adherex Technologies, Inc.

Criteria

Inclusion criteria:

• 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)

Exclusion criteria:

• 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