Targeted therapies: redefining the primary objective of phase I oncology trials

Nat Rev Clin Oncol. 2014 Sep;11(9):503-4. doi: 10.1038/nrclinonc.2014.135. Epub 2014 Aug 5.

Abstract

Cytotoxic agents are conventionally dosed on the basis of the maximum tolerated dose defined in phase I trials. A study assessing adverse events in over 2,000 patients treated with molecularly targeted agents suggests a need to redefine criteria for dosing of molecularly targeted agents, which should be based on randomized, dose-ranging phase II trials.

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / pharmacokinetics
  • Clinical Trials, Phase I as Topic*
  • Clinical Trials, Phase II as Topic*
  • Drug Approval
  • Humans
  • Molecular Targeted Therapy*
  • Research Design

Substances

  • Antineoplastic Agents