ABSTRACT

Clinical trials of new anticancer therapies are widespread, critically important tools in the search for more effective cancer treatments. Cancer trials typically proceed through several distinct phases. The major objective in dose-finding (phase I) trials is to identify a working dose for subsequent studies, whereas the major endpoint in phase II and III trials is treatment efficacy. Dose-finding trials represent the first testing of an investigational agent in humans and act as a point of translation of years of laboratory research into the clinic. Whereas dose-finding trials in other areas of medicine enroll healthy participants, oncology dose finding trials typically enroll patients who have cancer and who have exhausted standard treatment options (Roberts et al. 2004).