Human Absorption, Metabolism, and Excretion (hAME) Mass Balance Studies in Patients With Cancer

Radiolabeled mass balance human studies are a critical component of clinical pharmacology programs supporting the development of new investigational drugs. These studies provide information about absorption, metabolism, and excretion (AME) of the parent drug and metabolite(s) in the human body and are normally conducted in healthy volunteers (HVs). However, in some instances, based on the characteristics and toxicity of the molecule, conducting the study in HVs may not be a viable option and therefore cancer patients (CPs) need to be enrolled. Successful navigation of aspects such as pharmacologic characteristics, dose administration, patient clinical status and comorbidities, confinement period, study extension, team training, and requirements of the hospitals/units are essential to successfully deliver radiolabeled mass balance studies in CPs. This article provides an overview of the main aspects that must be taken into consideration to conduct AME studies in CPs.