Phase I study of DABIS maleate given once every 3 weeks

Abstract

DABIS maleate is an alkylating quaternary nitrogen. In a phase I study DABIS maleate was administered as a single intravenous infusion once every 3 weeks. 32 patients with solid tumours were studied, at least 3 per dose level (50–1400 mg/m²). Dose-limiting toxicity was severe paresthaesias in the face, around the mouth and in the tongue. Cerebellar ataxia developed at 750 mg/m² or higher. Haematological toxicity was minimal. Nausea and vomiting were mild to moderate. No other non-haematological side-effects were noted. The recommended dose for phase II studies at once every 3 weeks is 750 mg/m² intravenously as a 15 min infusion.