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

October 10, 2022 updated by: Soligenix

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Universitair Ziekenhuis Antwerpen
      • La Louvière, Belgium
        • Centre Hospitalier Jolimont
      • Mons, Belgium
        • Centre Hospitalier Universitaire de Mons
  • France
      • Brest, France
        • CFRO Clinique Pasteur
      • Dunkirk, France
        • Institut Andrée Dutreix
      • Le Mans, France
        • Clinique Victor Hugo
      • Lyon, France
        • Hôpital de La Croix Rousse
      • Osny, France
        • CROM-Osny
      • Saint-Grégoire, France
        • Centre Hospitalier Privé St Grégoire
  • Spain
      • Badalona, Spain
        • Institut Català d'Oncologia Badalona
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Girona, Spain
        • Institut Català D'Oncologia Girona
      • Leganés, Spain
        • Hospital Universitario Severo Ochoa
      • Málaga, Spain
        • Hospital Regional Universitario de Málaga
      • Palma De Mallorca, Spain
        • Hospital Son Llatzer
      • Palma De Mallorca, Spain
        • Hospital Universitari Son Espases
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • Edinburgh, United Kingdom
        • Edinburgh Cancer Centre
      • London, United Kingdom
        • Guy's Hospital
      • Sheffield, United Kingdom
        • Weston Park Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health
      • Pomona, California, United States, 91767
        • Pomona Valley Hospital Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Savannah, Georgia, United States, 31404
        • Memorial Health
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Cancer Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Des Moines Oncology Research Association
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Ashland Bellefonte Cancer Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Willis Knighton Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Minnesota Oncology
    • Missouri
      • Columbia, Missouri, United States, 65203
        • University of Missouri-Ellis Fischel Cancer Center
    • Montana
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health St. Francis
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Hackensack Meridian Health
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health Cancer Research
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Clinic Oncology and Hematology
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional-Gibbs Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGX942
Patients are randomized 1:1 active/placebo.
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.
Other Names:
  • Dusquetide
Placebo Comparator: Placebo
Patients are randomized 1:1 active/placebo.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Severe Oral Mucositis (SOM)
Time Frame: approx. 13 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soligenix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2017

Primary Completion (Actual)

June 24, 2020

Study Completion (Actual)

June 24, 2021

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDR-OM-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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