Table 1:
Planned Dose Levels
| Dose and Schedule (28 day cycles) | Number of subjects enrolled | |||
|---|---|---|---|---|
| Dose Level | 5-Azacitidine | Romidepsin | Phase I | Expansion |
| Level −1† | 100mg daily days 1–14 | 8mg/m2 days 8 and 15 | - | - |
| Level 1 | 200mg daily days 1–14 | 8mg/m2 days 8 and 15 | 3 | - |
| Level 2 | 300mg daily days 1–14 | 8mg/m2 days 8 and 15 | 8 | 4 |
| Level 3 | 300mg daily days 1–21 | 8mg/m2 days 8 and 15 | 3 | - |
| Level 4‡ | MTD daily days 1–21 | 8mg/m2 days 8, 15, and 22 | - | - |
Subjects would only be enrolled in Level −1 if >2 DLTs in Level 1
Level 4 was optional and based on discussions between the study investigator and Celgene was not opened to enrollment.