DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity and OropharynxOral Mucositis
- Interventions
- Drug: SGX942Drug: Placebo
- Registration Number
- NCT03237325
- Lead Sponsor
- Soligenix
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SGX942 SGX942 Patients are randomized 1:1 active/placebo. Placebo Placebo Patients are randomized 1:1 active/placebo.
- Primary Outcome Measures
Name Time Method Duration of Severe Oral Mucositis (SOM) approx. 13 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
CROM-Osny
🇫🇷Osny, France
Hackensack Meridian Health
🇺🇸Neptune, New Jersey, United States
Clinique Victor Hugo
🇫🇷Le Mans, France
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Institut Català d'Oncologia Girona
🇪🇸Girona, Spain
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Centre Hospitalier Privé St Grégoire
🇫🇷Saint-Grégoire, France
Oklahoma Cancer Specialists
🇺🇸Tulsa, Oklahoma, United States
Summa Health Cancer Research
🇺🇸Akron, Ohio, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Loma Linda University Health
🇺🇸Loma Linda, California, United States
Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
Lakes Research
🇺🇸Miami Lakes, Florida, United States
University Cancer & Blood
🇺🇸Athens, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Memorial Health
🇺🇸Savannah, Georgia, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Des Moines Oncology Research Association
🇺🇸Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Ashland Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Willis Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Minnesota Oncology
🇺🇸Saint Louis Park, Minnesota, United States
University of Missouri-Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Centre Hospitalier Universitaire de Mons
🇧🇪Mons, Belgium
CFRO Clinique Pasteur
🇫🇷Brest, France
Institut Andrée Dutreix
🇫🇷Dunkirk, France
Institut Català d'Oncologia Badalona
🇪🇸Badalona, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Edinburgh Cancer Centre
🇬🇧Edinburgh, United Kingdom
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Spain
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Centre Hospitalier Jolimont
🇧🇪La Louvière, Belgium
CHI Health St. Francis
🇺🇸Grand Island, Nebraska, United States
Spartanburg Regional-Gibbs Cancer Center
🇺🇸Spartanburg, South Carolina, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerp, Belgium
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mercy Clinic Oncology and Hematology
🇺🇸Oklahoma City, Oklahoma, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
University of Rochester
🇺🇸Rochester, New York, United States
Guy's Hospital
🇬🇧London, United Kingdom