Skip NavigationSkip to Content
Return Return to Search Results

Phase 0 clinical trials: Conceptions and misconceptions

  1. Author:
    Kummar, S.
    Rubinstein, L.
    Kinders, R.
    Parchment, R. E.
    Gutierrez, M. E.
    Murgo, A. J.
    Ji, J.
    Mroczkowski, B.
    Pickeral, O. K.
    Simpson, M.
    Hollingshead, M.
    Yang, S. X.
    Helman, L.
    Wiltrout, R.
    Collins, J.
    Tomaszewski, J. E.
    Doroshow, J. H.

  2. Author Address

    Doroshow, James H.] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA. [Kummar, Shivaani, Gutierrez, Martin E.; Helman, Lee, Wiltrout, Robert, Doroshow, James H.] NCI, Ctr Canc Res, Bethesda, MD 20892 USA. [Kinders, Robert, Parchment, Ralph E.; Ji, Jay, Simpson, Mel] NCI, SAIC Frederick, Lab Human Toxicol & Pharmacol, Frederick, MD 21702 USA.
    1. Year: 2008
  2. Journal: Cancer Journal
    1. 14
    2. 3
    3. Pages: 133-137
  4. Type of Article: Article
  1. Abstract:

    Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA)'s recent exploratory Investigational New Drug (IND) guidance, are intended to expedite the clinical evaluation of new molecular entities. The exploratory IND supports the performance of first-in-human testing of new investigational agents at subtherapeutic doses based on reduced manufacturing and toxicologic requirements, allowing the demonstration of drug-target effects and assessment of pharmacokinetic-pharmacodynamic relationships in humans earlier in clinical development. The objectives of a phase 0 cancer clinical trial are to establish at the very earliest opportunity-before large numbers of patients have been accrued and exposed to potential drug-associated toxicity-whether an agent is modulating its target in a tumor, and consequently whether further clinical development is warranted. We review here the fundamental requirements of clinical studies conducted under an exploratory IND and address some common misconceptions regarding oncologic phase 0 trials.

    See More

  1. Keywords:

External Sources

  1. PMID: 18536551

Library Notes

  1. No notes added.
NCI at Frederick

You are leaving a government website.

This external link provides additional information that is consistent with the intended purpose of this site. The government cannot attest to the accuracy of a non-federal site.

Linking to a non-federal site does not constitute an endorsement by this institution or any of its employees of the sponsors or the information and products presented on the site. You will be subject to the destination site's privacy policy when you follow the link.

ContinueCancel