Table 2.
Summary of Dose-Limiting Toxicities
| Stratum | Dose Level | No. Entered | No. Evaluable | No. With DLT | DLT Type (No.) |
|---|---|---|---|---|---|
| Part A | Vorinostat 180 mg/m2 | 10 | 6 | 1 | Thrombosis (1) |
| Vorinostat 230 mg/m2 | 6 | 6 | 1 | Hypokalemia (1) | |
| Hypokalemia (1) | |||||
| Vorinostat 300 mg/m2 | 14 | 12 | 4 | Platelets (2) | |
| Neutropenia (1) | |||||
| Part B | Vorinostat 230 mg/m2 | 6 | 5 | 2 | AST (1) |
| Hyperbilirubinemia (1) | |||||
| GGT (1) | |||||
| Hypokalemia (1) | |||||
| Part C | Vorinostat 180 mg/m2 daily, cis retinoic acid 80 mg/m2/dose bid | 7 | 6 | 2 | Platelets (2) |
| Neutropenia (1) | |||||
| Anorexia (1) | |||||
| Hypertriglyceiremia (1) | |||||
| Hypophosphatemia (1) | |||||
| Vorinostat 180 mg/m2 4 times per week, cis retinoic acid 80 mg/m2/dose bid | 7 | 6 | 0 | ||
| Part D suspension | Vorinostat 230 mg/m2 | 13 | 12 | 4 | ALT (1) |
| Platelets (3) | |||||
| Hyponatremia (1) |