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Manganese-containing Superoxide Dismutase Mimetic

GC4419 (avasopasem manganese) 90 mg for Mouth Sore

Phase 3
Waitlist Available
Research Sponsored by Galera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
Treatment plan to receive standard cisplatin monotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first imrt fraction through the end of the study treatment period (completion of study drug administration, imrt and chemotherapy), which is estimated to be 7 weeks.
Awards & highlights

Study Summary

This trial is testing if a drug can reduce the severity of a side effect from radiation therapy.

Eligible Conditions
  • Mouth Sores

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are scheduled to receive cisplatin alone as part of your treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first imrt fraction through the end of the study treatment period (completion of study drug administration, imrt and chemotherapy), which is estimated to be 7 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first imrt fraction through the end of the study treatment period (completion of study drug administration, imrt and chemotherapy), which is estimated to be 7 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Incidence of Severe Oral Mucositis

Side effects data

From 2023 Phase 3 trial • 455 Patients • NCT03689712
88%
Lymphopenia
86%
Nausea
71%
Fatigue
64%
Constipation
61%
Oropharyngeal Pain
57%
Dysgeusia
56%
Vomiting
54%
Dry Mouth
52%
Radiation Skin Injury
48%
Weight Decreased
15%
Paresthesia
6%
Febrile Neutropenia
3%
Pulmonary Embolism
3%
Dehydration
2%
Pyrexia
2%
Sepsis
1%
Pneumonia
1%
Dysphagia
1%
Decreased Appetite
1%
Device Malfunction
1%
Hypotension
1%
Hypoxia
1%
Malnutrition
1%
Cardiac failure congestive
1%
Hepatitis viral
1%
Pneumonia Aspiration
1%
Failure to Thrive
1%
Deep Vein Thrombosis
1%
Lung Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
GC4419 (Avasopasem Manganese) 90 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GC4419 (avasopasem manganese) 90 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GC4419 90mg
2018
Completed Phase 3
~460

Find a Location

Who is running the clinical trial?

Galera Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
895 Total Patients Enrolled
Jon T. Holmlund, MDStudy ChairChief Medical Officer
1 Previous Clinical Trials
30 Total Patients Enrolled
Gene Kennedy, MDStudy ChairGalera Therapeutics
3 Previous Clinical Trials
139 Total Patients Enrolled

Media Library

GC4419 (Manganese-containing Superoxide Dismutase Mimetic) Clinical Trial Eligibility Overview. Trial Name: NCT03689712 — Phase 3
Mouth Sore Research Study Groups: Placebo, GC4419 (avasopasem manganese) 90 mg
Mouth Sore Clinical Trial 2023: GC4419 Highlights & Side Effects. Trial Name: NCT03689712 — Phase 3
GC4419 (Manganese-containing Superoxide Dismutase Mimetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03689712 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being given this medication as part of the research project?

"This trial is no longer enrolling new patients. The listing for this study, which was last updated on 1/14/2022, indicates that it was originally posted on 10/3/2018. If you are looking for similar studies, 456 trials concerning oral mucositis and 1 study involving GC4419 are still admitting patients."

Answered by AI

Are there any open slots for this research project?

"Right now, this particular clinical trial is not looking for new patients to participate. The study was first posted on October 3rd, 2018 and last updated January 14th, 2022. If you're interested in other trials, 456 are currently recruiting patients with oral mucositis while 1 is actively enrolling GC4419 participants.."

Answered by AI

Does the GC4419 drug have regulatory approval for use in the United States?

"GC4419's safety was rated a 3 by our team. This is due to the fact that it is a Phase 3 trial, thus having both some efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

Is this trial prevalent in Canada?

"With 96 active clinical trial sites, there is likely a location near you. Some of our participating cities include Los Angeles, Jonesboro and Gilbert among many others. By selecting the site nearest to you, you can minimize travel requirements."

Answered by AI

Has a similar clinical trial been done before?

"Galera Therapeutics, Inc. has been sponsoring research into GC4419 since 2018. After an initial study with 455 participants in 2018, GC4419 completed Phase 3 of the drug approval process and is now only being trialed by Galera Therapeutics, Inc.."

Answered by AI

What are the past and present clinical studies for GC4419?

"The initial study for GC4419 took place in at MetroWest Medical Center in 2018. Since that first trial, there have been a total of 18297 completed clinical trials. There is currently 1 live trial and many of these subsequent trials originated from Los Angeles, California."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
~71 spots leftby Mar 2025