ABSTRACT
The primary objective of phase I drug combination trials is to identify the maximum tolerated dose (MTD) combination(s). A number of novel model-based and model-assisted adaptive designs have been proposed to find the MTD for early phase drug combination trials. In this chapter, we review some of these novel designs with a particular focus on the model-assisted drug combination designs because of their transparency, simplicity, and excellent operating characteristics. For each of the model-assisted designs, we introduce its methodology and freely available software for implementation. We illustrate the application of the designs using trial examples with step-by-step instructions.
