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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Oral Mucositis

Intervention / Treatment
-----------------
* Drug: GC4419 90mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Cooperative Oncology Group (ECOG) performance status ≤ 2 Adequate hematologic, renal and liver function Negative serum pregnancy test Use of effective contraception Exclusion Criteria: Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands Metastatic disease Prior radiotherapy to the region of the study cancer or adjacent anatomical Prior induction chemotherapy Receiving any approved or investigational anti-cancer agent other than those provided for in this study Concurrent participation in another interventional clinical study Inability to eat soft solid food at baseline Malignant tumors other than HNC within the last 5 years Active infectious disease excluding oral candidiasis Presence of oral mucositis at baseline Known history of HIV or active hepatitis B/C Female patients who are pregnant or breastfeeding Known allergies or intolerance to cisplatin and similar platinum-containing compounds Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC4419 (avasopasem manganese) 90 mg<br> | Drug: GC4419 90mg<br>* 60 minute IV infusion<br>* Other names: avasopasem manganese;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 60 minute IV infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Severe Oral Mucositis | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OM, Oral Mucositis, Superoxide Dismutase Mimetic, Cisplatin, Intensity-Modulated Radiation Therapy, Chemoradiation, IMRT, Head and Neck Cancer, Squamous Cell Carcinoma, SCC, Oral Cavity, Oropharnyx, Mouth Sores, avasopasem mangenese