ABSTRACT
Traditionally, phase II cancer clinical trials have single-arm designs using overall response as the primary endpoint. In a traditional single-arm phase II trial, patients are treated by only an experimental therapy. At the end of such a trial, the efficacy of the experimental therapy is evaluated compared to that of a preselected historical control, which is usually chosen among the current standard therapies for the study population. In this chapter, we review some optimal designs for single-arm phase II clinical trials.
