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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
Primary Objective:
To assess the effect of GC4419 administered intravenously (IV) on the incidence and severity of severe oral mucositis (SOM) in subjects receiving post-operative or definitive therapy with single-agent cisplatin plus Intensity-Modulated Radiation Therapy (IMRT) for locally advanced, non-metastatic squamous cell carcinoma (SCC) of the oral cavity or oropharynx
Secondary Objectives:
To confirm safety and tolerability of GC4419 administered IV in subjects receiving cisplatin plus IMRT for locally advanced, non-metastatic SCC of the oral cavity or oropharynx
To evaluate potential effects of GC4419 on tumor efficacy outcomes for the study population
Primary Objective:
To assess the effect of GC4419 administered intravenously (IV) on the incidence and severity of severe oral mucositis (SOM) in subjects receiving post-operative or definitive therapy with single-agent cisplatin plus Intensity-Modulated Radiation Therapy (IMRT) for locally advanced, non-metastatic squamous cell carcinoma (SCC) of the oral cavity or oropharynx
Secondary Objectives:
To confirm safety and tolerability of GC4419 administered IV in subjects receiving cisplatin plus IMRT for locally advanced, non-metastatic SCC of the oral cavity or oropharynx
To evaluate potential effects of GC4419 on tumor efficacy outcomes for the study population
Recruitment Status
Past Studies