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
STUDY SPONSOR: Galera Therapeutics, Inc.
STUDY TYPE: Supportive Care
GTI-4419-301 is a randomized, double-blind, placebo-controlled, multi-center international study
conducted to evaluate GC4419 administered IV to reduce the incidence and severity of radiation induced SOM in subjects receiving chemoradiation for squamous cell carcinoma of the head and neck
(SCCHN), limited to the oral cavity or oropharynx.
Oral mucositis (OM) is a common complication of radiation used to treat head and neck cancer. Symptoms of OM include dry mouth, thickening of saliva, increased amount of mucus, shiny, swollen, or red gums, white patches or pus on the tongue, sores and/or blood in the mouth and pain or a mild burning sensation while eating. The severity of symptoms will vary.
The consequences for those patients who develop severe OM can be serious. Severe OM entails compromise to nutrition and/or hydration, and may require surgical procedure, RT interruption, and/or hospitalization.
OM can impact day-to-day living. Pain control can become an issue requiring narcotics. Weight loss, dehydration, difficulty eating and swallowing and a need for nutritional support can decrease quality of life. Patients may also suffer additional complications of xerostomia (dry mouth), changes in taste, trismus (lockjaw). These complications can be more pronounced with OM.
The treatment of oral mucositis is considered an area of unmet medical need, meaning there has been no substantial change in management over recent years. Current standard of care treatment consists of oral care protocols and palliative approaches to deal with painful symptoms. GC4419 is aimed at reducing the incidence and severity of severe OM.
If you are interested in more information on this study, please contact us. Refer to the Galera GTI-4419-301 study. You can also find information on this study by going to clinicaltrials.gov website and searching for NCT03689712.