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)
- 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)
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 30 days before
- 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