A Study of Volociximab in Metastatic Melanoma

Exclusion Criteria

• •1. Subjects with any other active malignancy in addition to metastatic melanoma.
• •2. CNS metastases, unless stable for at least 2 months following definitive local therapy (surgery, stereotactic radiation). Subjects may not require treatment with steroids or anticonvulsants.
• •3. History of any other significant medical condition, including cardiovascular, pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or fungal); or a psychiatric condition within 6 months of Day 1
• •4. History of hepatitis B or C.
• •5. Known history of HIV infection or AIDS.
• •6. History of thromboembolic or cerebrovascular events, such as stroke, transient ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior to Day 1.
• •7. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1.
• •8. Previous exposure to volociximab.
• •9. Aspirin, high dose warfarin, or heparin use. (Note: Aspirin \<=81 mg/day, low-dose warfarin 1 mg/day or low-dose heparin for IV catheter patency is allowed.)
• •10. Major surgery within 4 weeks prior to Day 1.
• •11. Requirement for immunosuppression, and/or systemic steroid therapy.
• •12. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer).
• •13. Known hypersensitivity to murine or chimeric antibodies.
• •14. Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
• •15. Female subjects who are pregnant or currently breastfeeding.