A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma

This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense

Inclusion Criteria:

• Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
• ECOG Performance Status of 0, 1, or 2
• Life expectancy of at least 12 weeks
• Adequate venous access
• Agreement to practice effective method of birth control

Exclusion Criteria:

• Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
• Significant medical disease
• Known hypersensitivity to phosphorothioate-containing oligonucleotides
• Known hypersensitivity to DTIC
• Pregnancy/Lactation