Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Stomatitis

Mucositis

Oral Ulcer

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Cisplatin

Manganese

Superoxide Dismutase

Avasopasem manganese

Trace Elements

Antioxidants

Protective Agents

GC4419 90mg

Placebo

Gene Kennedy, MD

The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the 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.

ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer

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.

Galera Therapeutics, Inc.

GC4419 (Avasopasem Manganese) 90 mg

GC4419 (avasopasem manganese): 60 minute IV infusion

GC4419 (Avasopasem Manganese)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Intent-to-Treat (ITT) population includes all randomized subjects who received at least one dose of GC4419/Placebo, with the exception of the 28 subjects whose treatment course was discontinued during the Sponsor's voluntary suspension of dosing.

Megan Holm

GC4419 (Avasopasem Manganese) 90mg

The Intent to treat population consisted of all randomized subjects who received at least 1 dose of avasopasem manganese or placebo (with the exception of subjects whose treatment course was discontinued due to the sponsor's voluntary suspension of dosing)

Cumulative Incidence of Severe Oral Mucositis

Overall Study

Spots Global Cancer Trial Database for avasopasem mangenese