Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Review Meta Analysis
Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials.
One tenth of the lethal dose to 10% of mice is one of the conventional parameters used to derive a safe starting dose in phase I trials of cytotoxic agents. There is no consensus on which preclinical models and parameters should define the starting dose for molecularly targeted agents. ⋯ The derivation of starting dose for first-in-human phase I trials of molecularly targeted agents in patients with cancer is safe but is based on diverse practices using a variety of preclinical toxicologic parameters.