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

• ClinicalTrials.gov Identifier: NCT03237325
• Recruitment Status: Active, not recruiting
• First Posted: August 2, 2017
• Last Update Posted: July 1, 2020
• Sponsor: Soligenix
• Information provided by (Responsible Party): Soligenix

Tracking Information

• First Submitted Date: July 26, 2017
• First Posted Date: August 2, 2017
• Last Update Posted Date: July 1, 2020
• Actual Study Start Date: December 4, 2017
• Actual Primary Completion Date: June 24, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

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.
  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

• 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 *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 30, 2020): 268
• Original Estimated Enrollment (submitted: July 28, 2017): 190
• Estimated Study Completion Date: March 2021
• Actual Primary Completion Date: June 24, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03237325
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Soligenix
• Study Sponsor: Soligenix
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Soligenix
• Verification Date: June 2020