title: Eligibility of patients with renal impairment for Phase I trials: Time for a rethink?
abstract: Since the inception of Phase I clinical trials in cancer, patients with renal dysfunction have commonly been excluded from participation because of a poor outlook. Most cancer drugs are approved with limited information on the pharmacokinetics and/or pharmacodynamics of the drugs in patients with renal dysfunction, and no formal renal dysfunction study is ever undertaken. Patients with asymptomatic mild to moderate renal dysfunction pose an increasingly frequent challenge for clinicians. In this paper, we discuss that a subset of patients with asymptomatic mild to moderate renal impairment might be appropriately entered into selected Phase I trials. This will provide physicians timely data of the new agents in this patient population and increase patients' access to experimental treatments.
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. Electronic address: Malikl@uthscsa.edu.
authors.forename: Laeeq
authors.initials: L
authors.lastname: Malik
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Mejia
authors.affiliation: Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Weitman
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D051437:Renal Insufficiency / Q000150:complications* / Q000503:physiopathology
chemical_list: D000970:Antineoplastic Agents
keywords: Phase I; Renal dysfunction