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JNCI Journal of the National Cancer Institute 2004 96(13):975; doi:10.1093/jnci/96.13.975-b
© 2004 by Oxford University Press
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© 2004 Oxford University Press

IN THIS ISSUE

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

Phase I Trial Design for Targeted, Non-Cytotoxic Agents

New targeted, non-cytotoxic anticancer agents, such as small-molecule kinase inhibitors, pose challenges to the current phase I paradigm of dose selection based on toxicity. Parulekar and Eisenhauer (p. 990) reviewed strategies used in 60 completed phase I studies of 31 targeted drugs. The authors found that toxicity was the major endpoint used in the selection of the recommended phase II dose. Nontraditional endpoints, such as measures of molecular drug effects in tumor or surrogate tissue or functional imaging studies, were not routinely incorporated into the study design and rarely formed the primary . . . [Full Text of this Article]

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