DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Inclusion criteria

• Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
• Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²
• Scheduled to receive a continuous course of fractionated, conventional external beam with a cumulative radiation dose between 55 and 72 Gy at each site

Exclusion criteria

• Current mucositis
• Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial
• Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT
• Prior radiation to the head and neck
• Chemotherapy treatment within the previous 12 months
• Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx
• Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200 cells per μL
• Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
• Women who are pregnant or breast-feeding
• Participation in any study involving administration of an investigational agent within 30 days of randomization into this study