The Treatment period starts when the patient receives their first dose of the study drug. The maximum time the patient will receive study treatment is 5 months. The intent is for the patient to complete 6 cycles of treatment. Each cycle will be 21 days. The Follow-up period starts when the patient's treatment is completed or discontinued for any reason. The patient will have fewer exams, tests and visits once entering the follow-up period. These visits will be every 6 months for up to 2 years.