Table 4.
Treatment-related ≥grade 2 toxicities on the twice-daily vorinostat arm
| DL1 500 mg twice daily × 3 |
DL2 600 mg twice daily × 3 |
DL3 800 mg twice daily × 3 |
||||
|---|---|---|---|---|---|---|
|
n = 3 (G2/G3/G4) |
n = 6 (G2/G3/G4) |
n = 3 (G2/G3/G4) |
||||
| 1st cycle | Any cycle | 1st cycle | Any cycle | 1st cycle | Any cycle | |
| Anemia | 0/0/0 | 0/0/0 | 1/0/0 | 1/1/0 | 0/0/0 | 0/2/0 |
| Neutropenia | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 2/0/0 |
| Thrombocytopenia | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/1 | 3/0/0 | 2/1/0 |
| Nausea | 1/0/0 | 2/0/0 | 3/0/0 | 3/0/0 | 0/0/0 | 0/0/0 |
| Vomiting | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 0/0/0 | 0/0/0 |
| Diarrhea | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 0/1/0 |
| Anorexia | 0/0/0 | 2/0/0 | 2/0/0 | 2/0/0 | 1/0/0 | 2/0/0 |
| Fatigue | 2/0/0 | 3/0/0 | 3/0/0 | 3/1/0 | 2/1*/0 | 1/2/0 |
| Mucositis | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 1/1*/0* | 2/1/1 |
| Chelitis | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 2/0/0 |
| Esophagitis | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 1/0/0 |
| Dehydration | 0/0/0 | 0/0/0 | 0/0/0 | 2/0/0 | 2/0/0 | 2/0/0 |
| Fever | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/1 | 0/0/0 | 0/0/0 |
| Headache | 0/0/0 | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 | 0/0/0 |
| VTE | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/1 |
| ATE | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/1 |
Two patients experienced a DLT at DL3.