Table 2

Study design

Accelerated phaseEmbedded Image SwitchEmbedded Image Standard design stage
Cohorts of 1 new subject per dose levelSecond instance of grade 2 toxicity or first instance of DLT at any courseCohorts of 3–6 subjects per dose level
Dose increments of 100%Dose increments of 30–40%
Intrapatient dose escalationNo intrapatient dose escalation
Two cycles per treatment