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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.

The primary criticisms of the standard phase I design 17, 30, 35, 39 are: 1) It does not target a particular probability of DLT to be associated with the MTD, and, in practice, the DLT rate associated with the defined MTD will be somewhat dependent on the …

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