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

Study Overview
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Brief Summary
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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

Official Title
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A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

Conditions
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Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis

Intervention / Treatment
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* Drug: SGX942
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGX942<br>Patients are randomized 1:1 active/placebo. | Drug: SGX942<br>* 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.<br>* Other names: Dusquetide;|
| Placebo Comparator: Placebo<br>Patients are randomized 1:1 active/placebo. | Drug: Placebo<br>* Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Severe Oral Mucositis (SOM) | To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization [WHO] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3. | approx. 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma