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GC4419

Phase 3

Oral Mucositis | Small molecule | ENT |cbdMD, Inc.|Last Updated: Oct 24, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment455

FDA Designations

No designations recorded

Clinical trial landscape

GC4419 · 1 trial · 1 indication

Phase 3 1
NCT03689712ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer PatientsOral Mucositis
COMPLETED455 Analytics
PHASE3COMPLETED
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Oral Mucositis
NCT03689712455
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Study Endpoints

Primary Endpoints

Cumulative Incidence of Severe Oral Mucositis
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.

Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
GC4419 (avasopasem manganese) 90 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GC4419 90mgDRUG60 minute IV infusion
PlaceboDRUG60 minute IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites97

Inclusion Criteria: * squamous cell carcinoma of the head and neck * 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 * Age 18 years or older * Eastern Cooperat...

Countries:United StatesCanadaPuerto Rico
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Frequently asked questions about GC4419

What is GC4419 used for?

GC4419 is an investigational small molecule being studied for the treatment of oral mucositis, a painful inflammation and ulceration of the mouth that can occur as a side effect of radiation therapy. It is being developed for patients with head and neck cancer who are undergoing radiation treatment.

What does GC4419 target?

GC4419 is a small molecule that targets the enzyme superoxide dismutase, which helps neutralize harmful reactive oxygen species. By mimicking this enzyme, GC4419 is designed to reduce oxidative stress and inflammation in the oral mucosa, potentially preventing or reducing the severity of radiation-induced oral mucositis.

Who makes GC4419?

GC4419 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate the drug's safety and efficacy for oral mucositis in patients with head and neck cancer.

What phase is GC4419 in?

GC4419 is in Phase 3 clinical development. It has completed a Phase 3 trial, but it remains investigational and is not yet approved by regulatory authorities. The drug is still undergoing clinical evaluation to determine its safety and effectiveness for the treatment of oral mucositis.

What clinical trials is GC4419 in?

GC4419 has been studied in one completed Phase 3 clinical trial, identified as NCT03689712. This trial, called ROMAN, investigated the effects of GC4419 on radiation-induced oral mucositis in head and neck cancer patients. The study enrolled 455 participants across the United States, Canada, and Puerto Rico.

Is GC4419 the same as any other drug?

GC4419 is also known by the name avasopasem manganese. This alternative name may be used in scientific literature and clinical trial registries. Researchers and investors should be aware that both names refer to the same investigational drug being developed for oral mucositis.