Pharmacologically based phase I trials in cancer chemotherapy.
Recent developments in Phase I trial methodology are reviewed. Preclinical pharmacological studies can be used in Phase I trials to improve patient selection, starting dose identification, and dose escalation. Establishing pharmacokinetic-pharmacodynamic relationships is also an important new aspect of Phase I trial methodology; these relationships can be exploited in subsequent efficacy studies. Finally, the inclusion of molecular pharmacodynamic studies in Phase I trials is increasing with a view to identifying the mechanism of action of a new agent in patients.
Cancer Research Unit, University of Newcastle upon Tyne, England, United Kingdom.
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Newell
D000818:Animals; D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D004305:Dose-Response Relationship, Drug; D006801:Humans
D000970:Antineoplastic Agents