Statistical considerations
Each cohort is monitored using a Simon-like two-stage ‘admissible’ monitoring plan. Admissible designs lie between MiniMax and Optimal designs and have good characteristics of both (i.e., small maximum sample size, and low expected sample size under the null hypothesis of low activity). A true response rate (defined as CR/PR or SD at 16 weeks) of less than 10% will be considered of no clinical interest. A response rate of 30%, although not comprehensively reflecting efficacy [