Back to resultsDOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SGX942
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Oral Cavity and Oropharynx focused on measuring OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma
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
Sites / Locations
- Arizona Clinical Research Center
- Loma Linda University Health
- Pomona Valley Hospital Medical Center
- Cancer Specialists of North Florida
- Lakes Research
- University Cancer & Blood
- Augusta University
- Memorial Health
- University of Illinois Cancer Center
- Carle Cancer Center
- Des Moines Oncology Research Association
- University of Iowa Hospitals and Clinics
- Ashland Bellefonte Cancer Center
- Willis Knighton Cancer Center
- Karmanos Cancer Institute
- Minnesota Oncology
- University of Missouri-Ellis Fischel Cancer Center
- Great Falls Clinic
- CHI Health St. Francis
- Comprehensive Cancer Centers of Nevada
- Nevada Cancer Research Foundation
- Hackensack Meridian Health
- University of Rochester
- Summa Health Cancer Research
- The Christ Hospital
- Mercy Clinic Oncology and Hematology
- Oklahoma Cancer Specialists
- Charleston Cancer Center
- Spartanburg Regional-Gibbs Cancer Center
- University of Virginia
- Providence Regional Cancer Partnership
- Medical College of Wisconsin
- Universitair Ziekenhuis Antwerpen
- Centre Hospitalier Jolimont
- Centre Hospitalier Universitaire de Mons
- CFRO Clinique Pasteur
- Institut Andrée Dutreix
- Clinique Victor Hugo
- Hôpital de la Croix Rousse
- CROM-Osny
- Centre Hospitalier Privé St Grégoire
- Institut Català d'Oncologia Badalona
- Hospital Universitari Vall d'Hebron
- Institut Català d'Oncologia Girona
- Hospital Universitario Severo Ochoa
- Hospital Regional Universitario de Málaga
- Hospital Son Llàtzer
- Hospital Universitari Son Espases
- Hospital Clínico Universitario Lozano Blesa
- Aberdeen Royal Infirmary
- Edinburgh Cancer Centre
- Guy's Hospital
- Weston Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SGX942
Placebo
Arm Description
Patients are randomized 1:1 active/placebo.
Patients are randomized 1:1 active/placebo.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03237325
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
Keywords
OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGX942
Arm Type
Experimental
Arm Description
Patients are randomized 1:1 active/placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients are randomized 1:1 active/placebo.
Intervention Type
Drug
Intervention Name(s)
SGX942
Other Intervention Name(s)
Dusquetide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Primary Outcome Measure Information:
Title
Duration of Severe Oral Mucositis (SOM)
Description
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.
Time Frame
approx. 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
University Cancer & Blood
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial Health
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Des Moines Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ashland Bellefonte Cancer Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Willis Knighton Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minnesota Oncology
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Missouri-Ellis Fischel Cancer Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
CHI Health St. Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Hackensack Meridian Health
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Summa Health Cancer Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Mercy Clinic Oncology and Hematology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Cancer Specialists
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Spartanburg Regional-Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
Country
Belgium
Facility Name
Centre Hospitalier Jolimont
City
La Louvière
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Mons
City
Mons
Country
Belgium
Facility Name
CFRO Clinique Pasteur
City
Brest
Country
France
Facility Name
Institut Andrée Dutreix
City
Dunkirk
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
CROM-Osny
City
Osny
Country
France
Facility Name
Centre Hospitalier Privé St Grégoire
City
Saint-Grégoire
Country
France
Facility Name
Institut Català d'Oncologia Badalona
City
Badalona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Institut Català d'Oncologia Girona
City
Girona
Country
Spain
Facility Name
Hospital Universitario Severo Ochoa
City
Leganés
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre
City
Edinburgh
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27015977
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.
Results Reference
background
PubMed Identifier
27746305
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.
Results Reference
background
PubMed Identifier
28649557
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.
Results Reference
background
Learn more about this trial
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
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