Eligibility of patients with renal impairment for Phase i trials: Time for a rethink?

Laeeq Malik, Alex Mejia, Steven Weitman

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2893-2896
Number of pages4
JournalEuropean Journal of Cancer
Volume50
Issue number17
DOIs
StatePublished - Nov 2014

Keywords

  • Keywords Renal dysfunction
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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