Table 3.
Treatment-related ≥ grade 2 toxicities on the once-daily vorinostat arm
| DL1 600 mg once daily × 3 |
DL2 800 mg once daily × 3 |
DL3 1,000 mg once daily × 3 |
DL4 1,200 mg once daily × 3 |
DL5 1,400 mg once daily × 3 |
DL6 1,700 mg once daily × 3 |
DL7 2,000 mg once daily × 3 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
n = 3 (G2/G3/G4) |
n = 3 (G2/ G3/G4) |
n = 3 (G2/ G3/G4) |
n = 3 (G2/ G3/G4) |
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 | 1st cycle | Any cycle | 1st cycle | Any cycle | 1st cycle | Any cycle | 1st cycle | Any cycle | |
| Anemia | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 2/1/0 | 0/2/0 | 0/2/0 |
| Neutropenia | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/1/0 | 0/0/0 | 1/0/0 | 1/0/0 | 1/0/0 |
| Thrombocytopenia | 1/0/0 | 1/0/0 | 1/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/1/0 | 0/1/0 |
| Nausea | 1/0/0 | 1/0/0 | 1/0/0 | 2/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 2/0/0 | 4/2/0 | 1/0/0 | 2/0/0 |
| Vomiting | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 2/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 3/3/0 | 0/0/0 | 0/0/0 |
| Diarrhea | 0/0/0 | 0/1/0 | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 | 2/0/0 | 0/1/0 | 3/2/0 | 0/0/0 | 0/0/0 |
| Anorexia | 1/0/0 | 1/0/0 | 1/0/0 | 2/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 1/0/0 | 2/0/0 | 5/0/0 | 1/0/0 | 2/0/0 |
| Fatigue | 1/0/0 | 2/0/0 | 1/0/0 | 2/0/0 | 1/0/0 | 2/0/0 | 2/0/0 | 2/0/0 | 0/0/0 | 2/0/0 | 3/0/0 | 6/0/0 | 0/1*/0 | 0/2/0 |
| Dehydration | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 2/1/0 | 1/0/0 | 1/1/0 |
| Creatinine | 0/0/0 | 1/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 |
| GI bleed | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/1/0 | 0/1/0 |
| Hand and Foot | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/1*/0 | 0/1/0 |
| Mucositis | 0/0/0 | 2/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/1/0 | 0/0/0 | 0/0/0 |
| DVT/PE | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 | 0/0/0 |
| Weight Loss | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 1/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 |
| Infection | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 | 0/2/0 | 0/0/0 | 0/0/0 |
*
Two patients experienced a DLT at DL7.
Abbreviation: DVT/PE, deep vein thrombus/pulmonary event.