Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Inclusion Criteria

• Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
• Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
• Patients who have had prior surgery may be eligible,
• Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
• Age 18 years or older
• ECOG performance status ≤ 2
• Adequate hematologic function
• Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN

Exclusion Criteria

• Metastatic disease
• Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
• Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
• Planned concurrent chemotherapy other than single agent cisplatin
• Receiving any approved or investigational anti-cancer agent
• Concurrent participation in another interventional clinical study
• Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
• Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
• Malignant tumors other than head and neck cancer (HNC) within the last 5 years
• Active infectious disease excluding oral candidiasis
• Presence of oral mucositis at baseline.
• Known history of human immunodeficiency virus (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, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.