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

Phase 3

Completed

• Conditions: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis
• Interventions: Drug: Placebo; Drug: SGX942

• 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

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Start: 2017-12-04
• Primary Completion: 2020-06-24
• Study Completion: 2021-06-24
• Results First Submitted: 2022-08-03
• Results First Submitted QC: 2022-08-03
• Results First Posted: 2022-08-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients are randomized 1:1 active/placebo.
SGX942	SGX942	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.

Trial Locations

Locations (53)

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

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

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