Status:
COMPLETED
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Lead Sponsor:
Soligenix
Conditions:
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT03237325
Start Date
December 4 2017
End Date
June 24 2021
Last Update
November 8 2022
Active Locations (53)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
2
Loma Linda University Health
Loma Linda, California, United States, 92354
3
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
4
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256