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

Soligenix

Status and phase: Completed; Phase 3

Conditions: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis

Treatments: Drug: Placebo; Drug: SGX942

Study type: Interventional

Funder types: Industry

Identifiers

NCT03237325

IDR-OM-02

Details and patient eligibility

About

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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266 participants in 2 patient groups, including a placebo group

SGX942

Experimental group

Description:

Patients are randomized 1:1 active/placebo.

Treatment:

Drug: SGX942

Placebo

Placebo Comparator group

Description:

Patients are randomized 1:1 active/placebo.

Treatment:

Drug: Placebo