Phase I clinical trial of a new anthracycline: 4′-o-tetrahydropyranyl adriamycin

Abstract

The phase I study of a new anthracycline, 4′-o-tetrahydropyranyl adriamycin, was performed. A dose limiting factor was leukopenia while thrombocytopenia was less frequent and a maximum tolerated dose was determined as 54 mg/m². Mild gastrointestinal toxicities including anorexia, nausea and vomiting occurred in about half of the patients, while very minimal alopecia was seen in only one patient. A recommended dose for phase II study was established: 40 mg/m² at 3-week intervals.