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

Adherex Technologies

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Neoplasms

Treatments

Drug: ADH -1 (Exherin™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225550

Adherex Protocol AHX-01-003

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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