Transcription of Phase I Clinical Trial Design
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Phase I Clinical Trial Design
Phase I Clinical Trial Design Lawrence V Rubinstein, PhD* Richard M Simon, DSc* Biometric Research Branch, National Cancer Institute 6130 Executive Blvd, Suite 8130, MSC 7434 Bethesda, MD 20892-7434 Phone: 301-496-4836 FAX: 301-402-0560 ( To Appear in Handbook of Anticancer Drug Development) * Authors contributed equally and are listed alphabetically Introduction The objective of a Phase I Trial is to determine the appropriate dosage of an agent or combination to be taken into further study and to provide initial pharmacologic and pharmacokinetic studies. It is generally assumed, at this stage of testing, that increased dose is associated with increased chance of Clinical efficacy. Therefore, the Phase I Trial is designed as a dose-escalation study to determine the maximum tolerable dosage (MTD), that is, the maximum dose associated with an acceptable level of dose-limiting toxicity (DLT--usually defined to be grade 3 or above toxicity, excepting grade 3 neutropenia unaccompanied by either fever or infection 35).
trial. If the agent is new to clinical testing, this must be based on animal studies. It has been determined that the dose (defined in mg per meters squared of body surface area) associated with 10% lethality in mice (MELD10) can be predicted to be roughly equivalent to the human MTD 18. This approach is derived from the concept of
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