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GC4419 (avasopasem manganese) 90 mg for Mouth Sore
Study Summary
This trial is testing if a drug can reduce the severity of a side effect from radiation therapy.
- Mouth Sores
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 455 Patients • NCT03689712Trial Design
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- You are unable to eat soft solid food at the beginning of the study.A patient who has a cancer diagnosis and an ECOG performance status of ≤ 2 is generally considered to be a good candidate for cancer treatment.You must be at least 18 years old to buy cigarettes.You must use a reliable form of birth control.You have already had radiation therapy in the area where your cancer is located or in nearby body parts.You are taking medication that can cause a sudden drop in blood pressure, such as nitrates.You are currently taking any other cancer medications that are not part of this study.Your cancer is located in specific areas such as lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands.This is a type of cancer that starts in the squamous cells, which are the thin, flat cells that line the surfaces of organs and tissues in the head and neck.You are scheduled to receive cisplatin alone as part of your treatment.
- Group 1: Placebo
- Group 2: GC4419 (avasopasem manganese) 90 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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.."
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."
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."
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.."
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."
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