A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

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
- 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