The development of a new treatment in cancer generally involves its assessment in Phase I, II and III prospective clinical trials. This article gives an overview of these phases of clinical trials, through which almost every new treatment must pass on the journey from its discovery in the laboratory to its routine use in clinical practice. The aim of the Phase I trial is to establish a dose, that of Phase II to evaluate activity, safety and feasibility, and that of Phase III to compare the new treatment against a suitable comparator.