Table 2.

Dose escalation schedule and dose-limiting toxicities

DoseNo. of patientsNo. of DLTs (in first 28 d)
First phase
    10 mg (for 7, 14, 21, 28 d)1 each0
Second phase
    20 mg10
    40 mg30
    60 mg30
    90 mg30
    130 mg50
    180 mg30
    240 mg40
    320 mg42
Third phase
    240 mg10*1

Abbreviation: DLTs, dose-limiting toxicities.

  • *Two patients reduced to 180 mg at 7 and 12 weeks due to toxicity (grade 3 diarrhea and grade 3 facial flushing, respectively).

  • This patient was in the cohort expansion and therefore is not a true dose-limiting toxicity.