An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations.

@article{Mandrekar2007AnAP,
  title={An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations.},
  author={Sumithra J. Mandrekar and Yue Cui and Daniel J. Sargent},
  journal={Statistics in medicine},
  year={2007},
  volume={26 11},
  pages={2317-30}
}
Historically, designs for dose seeking trials using chemotherapeutic drug combinations have been geared towards finding the maximum tolerated dose, with safety as the primary outcome. With target based agents whose dose-efficacy curves are unknown and dose-toxicity relationships may be minimal, alternative designs are needed. In this paper, we propose an extension to an adaptive single agent dose-finding design previously reported. A generalization of the continuation ratio model allowing… CONTINUE READING

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