A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.

Part 1:

Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.

Part 2:

Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.

Inclusion criteria

• Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
• No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
• If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
• Eastern Cooperative Oncology Group (ECOG) performance status </= 1
• Life expectancy > 12 weeks
• At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
• Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years

Exclusion criteria

• Major surgery within 21 days of the Baseline Visit
• Presence or history of brain metastases
• Primary ocular, choroidal or mucosal melanoma
• Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
• Hypersensitivity to docetaxel or polysorbate 80
• Neuropathy greater than or equal to Grade 2 at Baseline Visit
• The subject has been previously treated with YM155
• Inadequate marrow, hepatic, and/or renal functions