Table 2.
Dose-limiting toxicities among patientsa in the dose-escalation phase
| Schedule, Patient, n | Eribulin-LF dose | Patient, n | DLT |
|---|---|---|---|
| 1 (18) | 1.5 mg/m2 | 1 | Grade 4 hypophosphatemia |
| 1 | Grade 4 increased ALT/AST | ||
| 2 (12) | 1.5 mg/m2 | 1 | Grade 4 febrile neutropenia |
| Grade 3 stomatitis | |||
| 2.0 mg/m2 | 1 | Grade 3 increased ALT | |
| 1 | Grade 4 neutropenia | ||
aDetermination of the MTD was based on the dose-finding analysis set, which included all patients in the dose-escalation part who completed cycle 1 treatment and were evaluated for DLTs, and those who discontinued cycle 1 during the DLT. Of the 35 patients treated in the dose-escalation phase, 30 were evaluable for DLTs (n = 18 in Schedule 1 and n = 12 in Schedule 2)
ALT alanine aminotransferase, DLT dose-limiting toxicity, LF liposomal formulation, MTD maximum tolerated dose