ABSTRACT
With the growth in knowledge of tumorigenesis, the development of agents to combat cancer has evolved from examining the ability of a compound to destroy more tumor cells than healthy cells without imparting excessive toxicity to developing agents that target aberrant antiproliferation signaling, tumor angiogenesis and invasion, resistance to apoptosis, cell immortalization, and/or capacity to metastasize (1). This evolution in cancer drug development has led to modifications in traditional cancer clinical trial designs. This chapter discusses some of these modifications, both proposed and in current use, to traditional phase I, II, and III cancer clinical trial designs for the identification and evaluation of promising targeted agents.
