Trial record 1 of 2 for:
SGX942
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 |
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Recruitment Status :
Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : July 1, 2020
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Sponsor:
Soligenix
Information provided by (Responsible Party):
Soligenix
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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) |
| Actual Enrollment : | 268 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 : | December 4, 2017 |
| Actual Primary Completion Date : | June 24, 2020 |
| Estimated Study Completion Date : | March 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Head and neck squamous cell carcinoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: SGX942
Patients are randomized 1:1 active/placebo.
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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 |
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Placebo Comparator: Placebo
Patients are randomized 1:1 active/placebo.
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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 :
- 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 :
- 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)
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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
Locations
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Sponsors and Collaborators
Soligenix
Publications:
| Responsible Party: | Soligenix |
| ClinicalTrials.gov Identifier: | NCT03237325 |
| Other Study ID Numbers: |
IDR-OM-02 |
| First Posted: | August 2, 2017 Key Record Dates |
| Last Update Posted: | July 1, 2020 |
| Last Verified: | June 2020 |
| 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:
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OM Head and Neck Cancer SGX942 Dusquetide Squamous Cell Carcinoma |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Mucositis Stomatitis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases |