Table 3

Summary of toxicities greater than grade 1 in the 21-day determinative period

Dose level (mg/m2)No. of patientsNo. of patients with DLTaElevated AST/ALTElevated alkaline phosphataseElevated total bilirubinElevated amylase/lipaseAnemiaFatigueNauseaDiarrhea
Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3Grade 2Grade 3
401
601
803
9641
1152317511112311
1387313b221b
  • a DLT, dose-limiting toxicity; AST, aspartate aminotransferase; ALT, alanine aminotransferase.

  • b This event constituted a DLT.