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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 : December 6, 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

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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: December 6, 2018
Last Verified: December 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