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

D Osei Fofie,G Landers, J A Wetter, P A Kraus,S Sukumaran,V Bray, C Connell, P Habana,S Dalvie, L A Jones, P Y Song, A Lategan, J Gelfand, B Framroze, M Dimitriu,S Sonis

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS（2021）

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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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