Phase I study of 4-demethoxydaunorubicin by oral route in patients with advanced cancer

In a phase I trial 4-demethoxydaunorubicin (4-dm DNR) was administered as oral capsules once a week to 51 adults with advanced mainly gastrointestinal solid tumors. No fatal toxicity was observed at doses up to 25.0 mg/m2. Dose-limiting granulocytopenia and non-hematologic toxicity developed at dosages greater than or equal to 22.5 mg/m2. No response to the therapy was observed. The plasma concentrations of 4-dm DNR were measured in 4 of the patients.