Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials.

@article{Tourneau2010ChoiceOS,
  title={Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials.},
  author={Christophe Le Tourneau and Anastasios Stathis and Laura Vidal and Malcolm J. Moore and Lillian L. Siu},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2010},
  volume={28 8},
  pages={1401-7}
}
PURPOSE 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. PATIENTS AND METHODS Reports of 81 first-in-human phase I trials evaluating 60 different molecularly targeted agents administered as monotherapy were reviewed. The maximum-tolerated dose (MTD) was… CONTINUE READING

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