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Early phase clinical trials—are dose expansion cohorts needed?

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From Nature Reviews Clinical Oncology

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Dose-expansion cohorts (DECs) enable investigators to identify potentially effective drugs, for specific patient populations, in a single trial by assessing antitumour activity as early as possible. We discuss how the objectives, design and interpretation of DEC have evolved, and how DECs are changing the landscape of early drug development.

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Acknowledgements

This work was partially supported by the NIH (grant numbers R01 CA142859 and and P30 CA008748) and The Translational and Integrative Medicine Research Fund at Memorial Sloan Kettering Cancer Center, NY, USA.

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Authors and Affiliations

  1. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 485 Lexington Avenue, New York, 10065, NY, USA

    Alexia Iasonos

  2. University Pierre and Marie Curie—Paris 6, 4 Place Jussieu, Paris, 75005, France

    John O'Quigley

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  1. Alexia Iasonos
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  2. John O'Quigley
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Correspondence to Alexia Iasonos.

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The authors declare no competing financial interests.

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Iasonos, A., O'Quigley, J. Early phase clinical trials—are dose expansion cohorts needed?. Nat Rev Clin Oncol 12, 626–628 (2015). https://doi.org/10.1038/nrclinonc.2015.174

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