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

NCT04529850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-08-16

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon Holmlund, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-03-10
Completion
2021-03-10
FDA Drug
Yes

Countries

  • Belgium
  • Czechia
  • Germany
  • Poland
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529850 on ClinicalTrials.gov