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A phase I trial of a new anthracycline derivative, idarubicin, was conducted in 16 patients with various advanced solid tumors. Doses administered were 20, 30 and 40 mg/m2 with single oral doses. Dose-limiting factors were both leukopenia and thrombocytopenia reaching a nadir about 2 weeks after the start of treatment and requiring 7 to 10 days for recovery. Other toxicities were anorexia, nausea and vomiting, but alopecia did not occur. The maximum tolerated dose was judged to be 40 mg/m2 and the recommended dose for phase II trials was determined to be 30-35 mg/m2.
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