Table 3.

DLTs encountered

Dose levelNo. patientsNo. DLTsType DLT
Stratum A*
    171Mucositis
    27,§3Thrombocytopenia, rash; mucositis
Stratum B
    150
    261Hypertriglyceridemia
    382Diarrhea; mucositis
  • * Stratum A: patients not on EIAEDs (phenytoin, phenobarbitol, carbamazepine, oxcarbazepine, and primidone).

  • One additional patient was treated at the MTD (dose level 1) for stratum A for additional safety and pk data.

  • One patient treated at dose level 2 of stratum A was not eligible for MTD determination due to fulminant progressive disease.

  • § One patient treated at dose level 2 of stratum A and two patients treated at dose level 3 of stratum B interrupted dosing during cycle 1 and were replaced for MTD determination.

  • Stratum B: patients on EIAEDs (phenytoin, phenobarbitol, carbamazepine, oxcarbazepine, and primidone).