Clinical trial NCT03237325: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Official title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
Oral Mucositis
Keywords: OM
Head and Neck Cancer
SGX942
Dusquetide
Squamous Cell Carcinoma
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Duration of Severe Oral Mucositis (SOM)
timeFrame: approx. 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Pomona
country: United States
facility: Pomona Valley Hospital Medical Center
state: California
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Savannah
country: United States
facility: Memorial Health
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Ashland
country: United States
facility: Ashland Bellefonte Cancer Center
state: Kentucky
city: Shreveport
country: United States
facility: Willis Knighton Cancer Center
state: Louisiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis Park
country: United States
facility: Minnesota Oncology
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri-Ellis Fischel Cancer Center
state: Missouri
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Grand Island
country: United States
facility: CHI Health St. Francis
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Neptune
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Akron
country: United States
facility: Summa Health Cancer Research
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology and Hematology
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists
state: Oklahoma
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional-Gibbs Cancer Center
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: La Louvière
country: Belgium
facility: Centre Hospitalier Jolimont
city: Mons
country: Belgium
facility: Centre Hospitalier Universitaire de Mons
city: Brest
country: France
facility: CFRO Clinique Pasteur
city: Dunkirk
country: France
facility: Institut Andrée Dutreix
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Osny
country: France
facility: CROM-Osny
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé St Grégoire
city: Badalona
country: Spain
facility: Institut Català d'Oncologia Badalona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Institut Català d'Oncologia Girona
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre
city: London
country: United Kingdom
facility: Guy's Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.