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JNCI Journal of the National Cancer Institute 2004 96(13):977-978; doi:10.1093/jnci/djh208
© 2004 by Oxford University Press
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© 2004 Oxford University Press

EDITORIAL

Nontoxicity Endpoints in Phase I Trial Designs for Targeted, Non-Cytotoxic Agents

Edward L. Korn

Correspondence to: Edward L. Korn, PhD, Biometric Research Branch, EPN-8129, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 (e-mail: korne@ctep.nci.nih.gov)

The first 10% of the full text of this article appears below.

Phase I trial designs for cytotoxic agents are based on the assumptions that (a) the clinical benefit of the agent increases with increasing dose, (b) the toxicity of the agent increases with increasing dose, and (c) there is a dose with acceptable toxicity that offers clinical benefit. For a targeted, non-cytotoxic agent, researchers and clinicians still obviously use the third assumption, but the first and second assumptions require additional consideration. When the first or second assumptions are not reasonable for an agent, one might want to consider using a dose escalation design that is not based on occurrences of toxicity, as in a standard phase I . . . [Full Text of this Article]


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