Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom History of another primary malignancy within 5 years other than curatively treated CIS of the cervix, or basal or squamous cell carcinoma of the skin Known positivity for HIV or hepatitis C Any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent