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  • Title: [Phase I and pharmacokinetic study of KRN8602, a new morpholino anthracycline].
    Author: Tabata M, Ogawa M, Horikoshi N, Inoue K, Mukaiyama T, Nagamine D, Shinagawa K, Fukutani H, Hirano A, Mizunuma N.
    Journal: Gan To Kagaku Ryoho; 1989 Jul; 16(7):2361-6. PubMed ID: 2546503.
    Abstract:
    Phase I clinical trial of a new semi-synthetic morpholino anthracycline derivative, KRN8602, was performed. Sixteen patients with advanced malignant neoplasms refractory to standard chemotherapies received 27 courses at doses ranging from 1.5 mg/m2/day to 18 mg/m2/day by bolus injection for three consecutive days. The dose limiting toxicity was leukopenia, and a maximally tolerated dose was 18 mg/m2/day (day 1-3). The recommended dose and schedule for a phase II study is determined to be 12 mg/m2/day for three consecutive days at 3-4 weeks intervals. Among non-hematologic toxicities, nausea and vomiting were severe, but stomatitis and alopecia were rarely observed. Clinical signs of cardiotoxicity were not seen.
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