drugset
drugset / Trial / NCT04529850

Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

NCT04529850 ↗

Phase 2 Completed 38 enrolled Galera Therapeutics, Inc.
NaSingle-groupOpen-labelPrevention

Summary

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

Timeline

Start
2020-06-30
Primary completion
2021-03-10
Completion
2021-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Avasopasem manganese Other / unclassified 90 mg Intravenous
Background Cisplatin Other / unclassified 40 mg/m2 —
Background Cisplatin Other / unclassified 100 mg/m2 —

Indications

chemotherapy-induced oral mucositis head and neck cancer