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Phase I and pharmacokinetic study of SM-5887, a new anthracycline derivative

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Summary

SM-5887, a new totally synthetic anthracycline derivative was studied in a phase I setting. Twenty-nine evaluable courses of treatment were conducted in groups at doses increasing from 10 to 130 mg/m2. Myelosuppression was the dose-limiting toxicity and a MTD was 130 mg/m2. At 130 mg/m2 the median lowest white blood cell count was 0.7 × 103/cmm (range: 0.3–1.8) and the median lowest granulocyte count was 0.1 × 103/cmm (range: 0–0.7) and the median lowest platelet count was 57 × l03/cmm (range: 4–176). Nonhematologic side effects were mild gastrointestinal symptoms and hair loss. The recommended dose and schedule for phase II setting is 100 mg/m2 every 3 weeks.

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Inoue, K., Ogawa, M., Horikoshi, N. et al. Phase I and pharmacokinetic study of SM-5887, a new anthracycline derivative. Invest New Drugs 7, 213–218 (1989). https://doi.org/10.1007/BF00170860

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