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Trial record 1 of 6 for:    Soligenix
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237325
Recruitment Status : Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Soligenix

Tracking Information
First Submitted Date  ICMJE July 26, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE December 4, 2017
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • 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
  • 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
  • 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)
  • Incidence of SOM [ Time Frame: approx. 13 weeks ]
    To assess the impact of SGX942 compared to placebo on the incidence of SOM
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
  • Oral Mucositis
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: SGX942
    Patients are randomized 1:1 active/placebo.
    Intervention: Drug: SGX942
  • Placebo Comparator: Placebo
    Patients are randomized 1:1 active/placebo.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 30, 2020)
268
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2017)
190
Estimated Study Completion Date  ICMJE March 2021
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237325
Other Study ID Numbers  ICMJE IDR-OM-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Soligenix
Study Sponsor  ICMJE Soligenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Soligenix
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP