Primary brain cancers or active CNS metastases should be excluded from this clinical trial Subjects with primary brain cancers or active CNS metastases should be excluded from this clinical trial Subjects with brain metastases should be excluded from this clinical trial unless all the metastasis are treated surgically or radio-surgically Subjects with brain metastases are excluded from this clinical trial unless all the metastases are adequately treated with surgery or radiation\r\n* Follow-up imaging showing treatment adequacy is not required Subjects with previously treated progressing brain metastases are excluded from the study Subjects with galactosemia will be excluded. Subjects will be screened and excluded per standard clinical protocol