Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials.

Background: The impact of age-, gender-, and race-based differences on safety and efficacy in phase I clinical trials has not been well studied.

Methods: We analyzed data from phase I clinical trials evaluating targeted biologic agents in patients with advanced solid malignancies. Race and gender distribution of enrolled patients was compared to the referral population demographics at the city, metro, and state levels.