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Phase I trial of 4′-deoxydoxorubicin given weekly

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Summary

Twenty-six patients with various solid tumors entered a Phase I trial with 4′ -Deoxydoxorubicin (Esorubicin, IMI-58), a new doxorubicin analogue. The drug was administered weekly i.v. for 3–4 weeks. Leukopenia proved to be dose limiting. The maximum tolerated dose (MTD) was reached at 20 mg/m2 weekly for 3 weeks. For Phase II trials, a weekly dose of 15 and 17.5 mg/m2 can be proposed for poor and good risk patients respectively. Non-hematologic toxicity was minimal. Phase II trials with this new anthracycline are warranted.

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Sessa, C., Bosia, L., Kaplan, S. et al. Phase I trial of 4′-deoxydoxorubicin given weekly. Invest New Drugs 2, 369–374 (1984). https://doi.org/10.1007/BF00171587

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