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

Abstract excerpt

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...

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