A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine

A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)

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 the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.

Inclusion criteria:

• Signed written informed consent
• Male and female patients > or = 18 years of age with a solid tumor(s) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate
• Measurable disease
• Immunohistochemical evidence of N-cadherin expression in tumor tissue
• Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG

Exclusion criteria:

• Receipt of ADH-1 prior to this clinical study
• Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
• History of spinal cord compression, or history of primary brain tumor(s) 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 tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
• Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
• Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states