A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

"DOSING REGIMEN(S):~Table 1: Dose Escalation Schedule Dose Level Dose and Schedule a, c 5-Azacitidine (PO) Romidepsin (IV)~Level -1b 100mg daily days 1-14 8mg/m2 days 8 and 15~Level 1 200mg daily days 1-14 8mg/m2 days 8 and 15~Level 2 300mg daily days 1-14 8mg/m2 days 8 and 15~Level 3 300mg daily days 1-21 8mg/m2 days 8 and 15~Level 4d MTD 8mg/m2 days 8, 15, and 22~1. Each cycle will last 28 days.~2. Subjects will be enrolled in Level -1 if the MTD is reached in the subjects enrolled in Level 1.~3. On days when both agents are administered, oral 5-azacitidine should be administered at the start of the romidepsin infusion.~4. Level 4 is optional and decisions whether to initiate this level will be based on discussions between the study investigator and Celgene."