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

Completed · Phase 3 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT03237325

Run by

Soligenix

People needed

266

Starts

2017-12-04

Expected to finish

2021-06-24

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda University Health — Loma Linda, California, United States
• Pomona Valley Hospital Medical Center — Pomona, California, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, 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
• Karmanos Cancer Institute — Detroit, Michigan, 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
• CHI Health St. Francis — Grand Island, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• Hackensack Meridian Health — Neptune City, New Jersey, United States
• University of Rochester — Rochester, New York, United States
• Summa Health Cancer Research — Akron, Ohio, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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