Table 2.

Dose escalation and DLTs

Dose cohort, mgNo. of patients in dose cohort (n)No. of patients with DLTa (n)DLT
Arm 1
 0.530
 130
 230
 330
 4.540
 660
 840
 1040
 12b160
 1652One patient with grade III diarrhea and 1 patient with grade III AST elevation and grade II diarrhea
Arm 2
 8b170
 1032Two patients with grade III diarrhea

Abbreviations: Arm 1, intermittent dosing; arm 2, continuous dosing.

  • aIn patients during the first treatment cycle.

  • bIncludes MTD expansion cohort.