PHASE-1 INVESTIGATION OF AMETANTRONE

  • 1 January 1983
    • journal article
    • research article
    • Vol. 67  (11) , 987-991
Abstract
Ametantrone is the third of a family of anthracene derivatives to undergo a phase I trial. Sixteen patients received 33 courses of drug as a single i.v. dose given every 3 wk. Escalations proceeded from 120 to 180 mg/m2. Predictable and reversible leukopenia was the dose-limiting toxic effect. Four patients developed thrombocytopenia. Nonhematologic toxic effects included a marked cumulative blue discoloration of the skin seen in all patients receiving more than 3 courses of the drug. This cumulative cosmetic effect may also be dose-limiting. Other nonhematologic, toxic effects included: blue urine (all patients), nausea (2), vomiting (1), a blue stool (1) and reversible elevations of either SGOT (serum glutamic oxalacetic transaminase) or alkaline phosphatase (2). No objective responses were seen in this study. A dose of 140-160 mg/m2 is recommended as the starting dose for phase II trials in patients who have received prior chemotherapy or radiotherapy.

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