A Dose-Escalation Phase Ib International Study to Evaluate the Safety, Pharmacokinetics and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for H&N Cancer
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS(2021)
Abstract
ST-617 administration was safe at all doses tested. The course and severity of patients treated with ST-617 compared favorably with historical controls. A dose-response effect on SOM incidence was noted. Mechanistic correlation between ROS/RNS levels was seen. A randomized, controlled, double blind trial is planned with the recommended dose of 100mg/day.
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Key words
oral mucositis,chemoradiation,pharmacokinetics,cancer,dose-escalation
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