title: Targeted therapies: redefining the primary objective of phase I oncology trials.
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.
authors.affiliation: Department of Medicine, Comprehensive Cancer Center, and Center for Personalized Therapeutics, The University of Chicago, 5841 South Maryland Avenue, MC2115, Chicago, IL 60637, USA.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Ratain
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017277:Drug Approval; D006801:Humans; D058990:Molecular Targeted Therapy; D012107:Research Design
chemical_list: D000970:Antineoplastic Agents
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