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Dose levels and dose-limiting toxicities
| Dose Level | Bortezomib (mg/m2) D1,4,8,11 IV Push | Belinostat (mg/m2) D1-5, 8-12 IV | Number of Patients Treated/Number of Patients DLT Evaluable | DLT Event | Median Number of Cycles (Range) |
|---|---|---|---|---|---|
| 1 | 1.0 | 500 | 6/3 | 1.5 (1-4) | |
| 2 | 1.3 | 500 | 6/4 | 1.5 (1-4) | |
| 3 | 1.3 | 650 | 4/3 | 2 (1-2) | |
| 4 | 1.3 | 850 | 3/3 | 6 (2-10) | |
| 5* | 1.3 | 1000 | 9/6 | 3 (1-14) | |
| 6 | 1.3 | 1200 | 7/6 | Gr3 QTc prolongation (2 patients) | 2 (1-32) |
| 7 | 1.3 | 1400 | 3/2 | Gr3 QTc prolongation (2 patients) | 2 (1-8) |
Maximum tolerated dose (MTD).
