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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237325
• Other study ID #: IDR-OM-02
• Status: Completed
• Phase: Phase 3
• Start date: December 4, 2017
• Est. completion date: June 24, 2021

Study information

• Verified date: October 2022
• Source: Soligenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Mucositis
• Oral Mucositis
• Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
• Stomatitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	Centre Hospitalier Jolimont	La Louvière
Belgium	Centre Hospitalier Universitaire de Mons	Mons
France	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
Spain	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
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Edinburgh Cancer Centre	Edinburgh
United Kingdom	Guy's Hospital	London
United Kingdom	Weston Park Hospital	Sheffield
United States	Summa Health Cancer Research	Akron	Ohio
United States	Ashland Bellefonte Cancer Center	Ashland	Kentucky
United States	University Cancer & Blood	Athens	Georgia
United States	Augusta University	Augusta	Georgia
United States	Charleston Cancer Center	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Missouri-Ellis Fischel Cancer Center	Columbia	Missouri
United States	Des Moines Oncology Research Association	Des Moines	Iowa
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	CHI Health St. Francis	Grand Island	Nebraska
United States	Great Falls Clinic	Great Falls	Montana
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Loma Linda University Health	Loma Linda	California
United States	Lakes Research	Miami Lakes	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hackensack Meridian Health	Neptune	New Jersey
United States	Mercy Clinic Oncology and Hematology	Oklahoma City	Oklahoma
United States	Pomona Valley Hospital Medical Center	Pomona	California
United States	University of Rochester	Rochester	New York
United States	Minnesota Oncology	Saint Louis Park	Minnesota
United States	Memorial Health	Savannah	Georgia
United States	Willis Knighton Cancer Center	Shreveport	Louisiana
United States	Spartanburg Regional-Gibbs Cancer Center	Spartanburg	South Carolina
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Oklahoma Cancer Specialists	Tulsa	Oklahoma
United States	Carle Cancer Center	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Countries where clinical trial is conducted

United States,  Belgium,  France,  Spain,  United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Severe Oral Mucositis (SOM)	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.	approx. 13 weeks