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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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ClinicalTrials.gov Identifier: NCT03237325
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Soligenix

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Oral Mucositis Drug: SGX942 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Severity-weighted duration of SOM by Area-Under-the-Curve (AUC) for the WHO Grade ≥3 by time plot [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 on the severity-weighted duration of SOM

  2. Duration of SOM [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 compared to placebo on duration of SOM; in all randomized patients

  3. Duration of ulcerative OM [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 compared to placebo on the duration of ulcerative OM (UOM; defined as WHO Grade ≥2)

  4. Incidence of SOM [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 compared to placebo on the incidence of SOM

  5. Number of radiation treatment (RT) breaks [ Time Frame: approx. 9 weeks ]
    To assess the impact of SGX942 compared to placebo on the number RT breaks

  6. RECIST categorization of the primary tumor [ Time Frame: approx. 11 weeks ]
    To assess the impact of SGX942 compared to placebo on RECIST (Response Evaluation Criteria In Solid Tumors) categorization of the primary tumor at 4 weeks after completion of RT

  7. Incidence of reported presumed bacterial infections [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 compared to placebo on incidence of reported presumed bacterial infections between Baseline and 6 weeks after completion of RT by total number and by severity of infection, graded using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237325


Contacts
Contact: Christopher Pullion, DO 609-538-8200 ext 23 cpullion@soligenix.com
Contact: Richard Straube, MD 609-538-8200 ext 30 rstraube@soligenix.com

Locations
United States, California
Pomona Valley Hospital Medical Center Recruiting
Pomona, California, United States, 91767
Contact: Dora Vargas       Dora.Vargas@pvhmc.org   
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Linda Borus       Lborus@browardhealth.org   
Pasco Pinellas Cancer Center Recruiting
Holiday, Florida, United States, 34691
Contact: Debbie Kisko       dkisko@tampabay.rr.com   
Lakes Research Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Yamile Sanchez       ysanchez@lakesresearch.com   
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Alyssa Secreto       asecre2@uic.edu   
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sandy Vollstedt    319-353-7143    sandy-vollstedt@uiowa.edu   
Contact: Heather Brown    319-384-7912    heather-brown@uiowa.edu   
United States, Kentucky
Ashland Bellefonte Cancer Center Recruiting
Ashland, Kentucky, United States, 41101
Contact: Asheesh Jain       asheesh@abcc.us   
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Elise Tatje       etatje@tulane.edu   
Willis Knighton Cancer Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Briana Barrow    318-212-8671    bbarrow@wkhs.com   
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Elizabeth Horvat       horvate@karmanos.org   
United States, Missouri
University of Missouri-Ellis Fischel Cancer Center Recruiting
Columbia, Missouri, United States, 65203
Contact: Angela Waller       wallera@health.missouri.edu   
United States, New Jersey
Hackensack Meridian Health Recruiting
Neptune, New Jersey, United States, 07753
Contact: Roxanne Valasa       Roxanne.Valasa@hackensackmeridian.org   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Merrie Lou Nagel       Merrielou_Nagel@urmc.rochester.edu   
United States, Ohio
Summa Health Cancer Research Recruiting
Akron, Ohio, United States, 44304
Contact: Sarah Stanaszek       stanaszeks@summahealth.org   
United States, South Carolina
Charleston Cancer Center Recruiting
Charleston, South Carolina, United States, 29406
Contact: Ashley Moultrie       AshleyA@CharlestonCancer.com   
Spartanburg Regional-Gibbs Cancer Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Luann Lester       LLester@gibbscc.org   
United States, Texas
Baylor Scott and White Research Institute Recruiting
Temple, Texas, United States, 76508
Contact: Gates Anderson    254-724-5889    Gates.Anderson@BSWHealth.org   
Sponsors and Collaborators
Soligenix

Publications:
Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT03237325     History of Changes
Other Study ID Numbers: IDR-OM-02
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Soligenix:
OM
Head and Neck Cancer
SGX942
Dusquetide
Squamous Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases