Table 2.
Dose-limiting toxicities attributable to MLN8237
| Part and schedule | Dose level (mg/m2/dose) | Number entered | Number eligible | Number evaluable | Number with DLT | Type of DLT (n) |
|---|---|---|---|---|---|---|
| A1 (daily) | 45 | 7 | 7 | 6 | 1 | Mucositis/stomatitis (1) |
| 60 | 6 | 6 | 5 | 0 | ||
| 80 | 6 | 6 | 6 | 1 | Mood alteration/depression (1) | |
| 100 | 5 | 4 | 4 | 3 | Neutropenia > 7 days (2) | |
| Platelets (3)a | ||||||
| A2 (twice daily) | 30 | 6 | 5 | 5 | 1 | Alkaline phosphatase (1) |
| 40 | 7 | 7 | 6 | 2 | ANC (2) | |
| Mucositis/stomatitis (1) |
Abbreviation: ANC, absolute neutrophil count.
a
Two patients requiring transfusions on 2 separate days within a 7-day period, and 1 did not recover to baseline within 14 days.