Effect of Renal Dysfunction on Toxicity in Three Decades of Cancer Therapy Evaluation Program–Sponsored Single-Agent Phase I Studies

Abstract

Patients with mild renal dysfunction by FDA criteria have routinely been enrolled onto phase I studies of antineoplastics without clinically meaningful increase in the risk of toxicity. In future oncology renal dysfunction trials based on the FDA classification, the FDA mild group may only need to be activated when the moderate and normal groups differ substantially in tolerability or pharmacokinetics.