Phase I Evaluation of Crisnatol (BWA770U Mesylate) on a Monthly Extended Infusion Schedule

Patrick W. Cobb, Kathleen A. Havlin, John G. Kuhn, John B. Craig, Glenn S. Harman, J. Scott Luther, Judy N. Turner, Geoffrey R. Weiss, Dennis A. Tweedy, Jim Koeller, Richard L. Tuttle, V. Sol Lucas, William Wargin, John K. Whisnant, Daniel D. Von Hoff

    Research output: Contribution to journalArticlepeer-review

    2 Scopus citations


    Crisnatol is an arylmethylaminopropanediol derivative that has shown promise as an antitumor agent in preclinical testing. In a phase I trial using a monthly six-hour infusion schedule the recommended dose for future phase II trials was found to be 388 mg/m2. Neurologic toxicity was dose-limiting in that trial and correlated with the attainment of a threshold plasma concentration of >4.5 μg/ml. In this study we treated 15 patients with escalating doses of crisnatol from 450 mg/m2 to 900 mg/m2 administered at a rate of 50 mg/m2/hr over 9, 12, 15, and 18 hours. Toxicity was mild to moderate at all dose levels. However, serious central nervous system effects were noted in one patient at 900 mg/m2 over 18 hours whose plasma level was 6.5 μg/ml. This study has demonstrated higher total doses of crisnatol can be given if the drug is administered as a prolonged infusion in an attempt to avoid high plasma levels of the agent.

    Original languageEnglish (US)
    Pages (from-to)85-91
    Number of pages7
    JournalSelective Cancer Therapeutics
    Issue number2
    StatePublished - 1991

    ASJC Scopus subject areas

    • Pharmacology
    • Cancer Research


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