Sample Size and Power

Number of pts with DLT0/31/30/3 + 0/3(To get here a de-escalation rulemust have been applied at thenext higher dose level)1/3 + 0/31/3 + {1/3* or 2/3 or 3/3}2/3 or 3/3DecisionEscalate one levelEnroll 3 more at current levelSTOP and choose current level as MTDEscalate one level(unless a de-escalation rule was applied atnext higher level, in which case choosecurrent level as MTD)STOP* and choose previous level asMTD(unless previous level has only 3 patients, inwhich case treat 3 more at previous level)STOP and choose previous level as MTD(unless previous level has only 3 patients, inwhich case treat 3 more at previous level)