Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With

Status Completed

Clinical Trial 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)

Clinical Trial Description

Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice). All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04529850
Study type	Interventional
Source	Galera Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	June 30, 2020
Completion date	March 10, 2021

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms