CLINICAL TRIALS PROFILE FOR GC4419

Clinical Trials for GC4419

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01921426 ↗	A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck	Completed	Galera Therapeutics, Inc.	Phase 1	The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following: - Effect on the incidence and severity of radiation induced oral mucositis; - Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy; - Total concentrations of GC4419 that can be achieved in the blood; - Changes in proteins and genetics associated with oral mucositis; - Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth); - Observe changes in genetic and molecular markers of oral mucositis; - Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients; - Assess the overall quality of life in study patients with oral mucositis.
NCT02508389 ↗	A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer	Completed	Clinical Assistance Programs, LLC	Phase 2	The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
NCT02508389 ↗	A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer	Completed	Novella Clinical	Phase 2	The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
NCT02508389 ↗	A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer	Completed	Galera Therapeutics, Inc.	Phase 2	The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
NCT03099824 ↗	A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers	Completed	INC Research Australia Pty Ltd	Phase 1	The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
NCT03099824 ↗	A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers	Completed	Nucleus Network Ltd	Phase 1	The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.

Clinical Trial Conditions for GC4419

Condition Name

Condition Name
Intervention	Trials
Healthy	5
Healthy Volunteers	4
Oral Mucositis	2
Pancreatic Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Head and Neck Neoplasms	3
Stomatitis	3
Mucositis	3
Neoplasms, Squamous Cell	1

Clinical Trial Locations for GC4419

Trials by Country

Trials by Country
Location	Trials
United States	92
Canada	5
Australia	4
Puerto Rico	2
Spain	1

Trials by US State

Trials by US State
Location	Trials
Florida	7
Missouri	5
Iowa	5
Washington	4
Ohio	4

Clinical Trial Progress for GC4419

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	3
Recruiting	1

Clinical Trial Sponsors for GC4419

Sponsor Name

Sponsor Name
Sponsor	Trials
Galera Therapeutics, Inc.	13
INC Research	2
Syneos Health	2

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	14
Other	11