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Compressing drug development timelines in oncology using phase '0' trials

  1. Author:
    Kummar, S.
    Kinders, R.
    Rubinstein, L.
    Parchment, R. E.
    Murgo, A. J.
    Collins, J.
    Pickeral, O.
    Low, J.
    Steinberg, S. M.
    Gutierrez, M.
    Yang, S.
    Helman, L.
    Wiltrout, R.
    Tomaszewski, J. E.
    Doroshow, J. H.

  2. Author Address

    NCI, Ctr Canc Res, SAIC Frederick, Frederick, MD 21701 USA. NCI, Div Canc Treatment & Diagnosis, Bethesda, MD 20892 USA.;Doroshow, JH, NCI, Ctr Canc Res, SAIC Frederick, Frederick, MD 21701 USA.;doroshoj@mail.nih.gov
    1. Year: 2007
    2. Date: Feb
  2. Journal: Nature Reviews Cancer
    1. 7
    2. 2
    3. Pages: 131-139
  4. Type of Article: Article
  5. ISSN: 1474-175X
  1. Abstract:

    The optimal evaluation of molecularly targeted anticancer agents requires the integration of pharmacodynamic assays into early clinical investigations. Phase '0' trials conducted under the new Exploratory Investigational New Drug Guidance from the US Food and Drug Administration can provide a platform to establish the feasibility of assays for target modulation in human samples, evaluate biomarkers for drug effects and provide pharmacokinetic data. Phase 0 trials could facilitate rational drug selection, identify therapeutic failures early, and might compress timelines for anticancer drug development. We expect that such trials will become a routine part of early-phase oncological drug development in the future.

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External Sources

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  2. DOI: 10.1038/nrc2066
  3. View record in Web of Science®
  4. WOS: 000243790200015

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