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)
Inclusion 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