NCT04529850

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

An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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).

Conditions

• Head and Neck Cancer
• Oral Mucositis

Interventions

Type	Name	Description
DRUG	Drug: GC4419	GC4419 60 Minute Infusion
RADIATION	Intensity-modulated radiation therapy (IMRT)	2.0 to 2.2 Gy daily over 7 weeks
DRUG	Cisplatin	100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2020-08-28
• Last updated: 2022-08-16
• Results posted: 2022-08-16

Locations

24 sites across 6 countries: Belgium, Czechia, Germany, Poland, Spain, Switzerland

Regulatory

• FDA-regulated drug study