Lead Sponsor

Bayer

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Subjects who have a life expectancy of at least 12 weeks
•Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
•Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
•Subjects who have an ECOG PS of 0 or 1
•Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

•Primary ocular or mucosal melanoma
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\]\& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 5 years prior to study entry
•History of cardiac disease
•Known history of human immunodeficiency virus (HIV) infection

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