PHASE-I STUDY OF ADOZELESIN (U-73,975) IN PATIENTS WITH SOLID TUMORS

During a phase I clinical and pharmacologic trial, 26 patients with re fractory solid tumors were treated with increasing doses of adozelesin by brief intravenous infusion every 3 weeks. Overall, adozelesin was well tolerated. The dose-limiting toxicity was myelosuppression, mainl y thrombocytopenia and leukopenia. Nonhematologic toxicity was general ly mild, with fatigue (36%), local reaction at the infusion site (24%) , nausea or vomiting (20%) and hypersensitivity reaction (16%) being t he most common adverse effects. There were no objective clinical respo nses. The maximally tolerated dose on this schedule was 188 mug/m2 wit h the recommended phase II starting dose being 150 mug/m2 on an every 3 week schedule. Adozelesin merits broad investigation at the phase II level.