Comparison of study designs, objectives and results of Phase I trials with cytotoxic versus non-cytotoxic anticancer agents

Cytotoxic anticancer agents are designed to kill tumor cells by interfering with cell division mechanisms. In contrast, non-cytotoxic anticancer agents intend to inhibit cancer growth by targeting specific proteins or signaling pathways or by activating the immune system. We investigated whether these different modes of action are reflected in study designs, objectives and results of Phase I studies.