Original Publication Date: 1 June, 2014
Publication / Source: Clinical Investigation
Authors: Aaron R Hansen, Albiruni RA Razak
The primary objective of a Phase I study is to determine the recommended Phase II dose (RP2D) of a new drug or combination of agents. Increasingly, these studies are enrolling additional patients once the RP2D has been determined to further characterize the toxicity and efficacy profile, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) properties of the studied agent/combination. Typically referred to as an expansion cohort, this design is often employed in specific patient populations with either a particular histology or molecular aberration.