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. Author manuscript; available in PMC: 2020 Aug 15.
Published in final edited form as: Cancer. 2019 Apr 23;125(16):2837–2845. doi: 10.1002/cncr.32138

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.