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Table 2 Clinical studies of romidepsin (depsipeptide)

From: Novel histone deacetylase inhibitors in clinical trials as anti-cancer agents

Phase Other agent Disease (pt. No.) Schedule Recommended dose & response Reference
I   Advanced or refractory colorectal(11), renal (12)and other neoplasms(14) Day1 and 5 of a 21-day cycle 24.9 mg/m2 [94]
I   Colorectal(8), breast(4), sarcoma(3) and other (15) Day1, 8, and 15 of 28-day cycle 13.3 mg/m2 [95]
I   CLL/AML(20) Day1, 8, and 15 of 28-day cycle 13 mg/m2 [98]
I Gemcitabine Solid tumor(33) Days 1, 8, and 15 of a 28 day cycle 12 mg/m2 [101]
I   Solid tumors(26) Days 1,3, and 5 of a 28-day cycle 9 mg/m2 [100]
II   Renal cell carcinoma(42) days 1, 8, and 15 of a 28-day cycle 13 mg/m2.
OR 7%.
[96]
I-II   MDS(3)/AML(9) Day 1 and 5 of a 21-day cycle 18 mg/m2 (CR .6%, SD 46%, POD 30.7%, NA 7.6%). [99]
II   SCLC(3)/NSCLC(16) Day 1 and 7 of a 21 day cycle SD52%, POD 48%. [97]