Phase 1b/2a Trial of The Superoxide Dismutase Mimetic GC4419 to Reduce Chemoradiotherapy-induced Oral Mucositis in Patients with Oral Cavity or Oropharyngeal Carcinoma

Severe oral mucositis is a critical problem in patients receiving chemoradiation for oral cavity and oropharynx cancer. This Phase I/II dose and duration escalation study tested safety of a daily 60-minute pre-RT infusion of GC4419, a superoxide dismutation mimetic. A maximum tolerated dose was not reached, safety was acceptable (nausea/vomiting and facial paresthesia during infusion appeared GC4419 dose-related) and doses of 30 and 90 mg/day for the duration of radiation were selected for further study.

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