DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
NCT ID: NCT03237325
Last Updated: 2022-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2017-12-04
2021-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SGX942
Patients are randomized 1:1 active/placebo.
SGX942
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.
Placebo
Patients are randomized 1:1 active/placebo.
Placebo
Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Interventions
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SGX942
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.
Placebo
Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, 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
18 Years
ALL
No
Sponsors
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Soligenix
INDUSTRY
Responsible Party
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Locations
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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
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
Mercy Clinic Oncology and Hematology
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists
Tulsa, Oklahoma, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Spartanburg Regional-Gibbs Cancer Center
Spartanburg, South Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
Centre Hospitalier Jolimont
La Louvière, , Belgium
Centre Hospitalier Universitaire de Mons
Mons, , Belgium
CFRO Clinique Pasteur
Brest, , France
Institut Andrée Dutreix
Dunkirk, , France
Clinique Victor Hugo
Le Mans, , France
Hôpital de la Croix Rousse
Lyon, , France
CROM-Osny
Osny, , France
Centre Hospitalier Privé St Grégoire
Saint-Grégoire, , France
Institut Català d'Oncologia Badalona
Badalona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Institut Català d'Oncologia Girona
Girona, , Spain
Hospital Universitario Severo Ochoa
Leganés, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Son Llàtzer
Palma de Mallorca, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Edinburgh Cancer Centre
Edinburgh, , United Kingdom
Guy's Hospital
London, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Countries
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References
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North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.
Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.
Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IDR-OM-02
Identifier Type: -
Identifier Source: org_study_id
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