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.

The statistical operating characteristics of this approach are as follows (Table 2). If at least 2 of 3 patients treated at a particular dose show DLT, we can conclude with 90% confidence that the true probability of DLT at that dose is greater than 20%. (In other words, as we see in Table 2, unless the true probability of DLT at that dose is at

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  Phases, Design, Clinical, Statistical, Trail, Probability, Phase i clinical trial design

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