Use of a failure probability constraint to suggest an initial dose in a phase…

The primary objective of a Phase I cancer clinical trial is to determine the maximum tolerated dose of a drug. The “failure probability” was proposed and used as a constraint to help identify a suitable initial dose range. The maximum tolerated dose was then determined based on a 3 þ 3 cohort-based escalation scheme. Multiple simulations were conducted,and the method was evaluated accordin…