ABSTRACT

Cancer clinical trials investigate the efficacy and toxicity of experimental cancer therapies. Through a phase I trial, we determine an appropriate dose level for treating humans based on the information collected from preclinical animal studies. In a phase I trial, the most popular primary clinical outcome is toxicity. Usually, for an anticancer chemotherapy, both the efficacy and toxicity increase as the dose level increases. We choose a dose with a tolerable toxicity level for further investigation of the therapy.