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

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