Squamous Cell Carcinoma of the Oral Cavity and OropharynxPhase 3NCT03237325
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
A Phase 3 study testing SGX942 in people with Squamous Cell Carcinoma of the Oral Cavity and Oropharynx and Oral Mucositis, run by Soligenix at 53 sites in 5 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
- What is being tested?
- SGX942
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 53 sitesin 5 countries
- Study dates
- 4 Dec 2017to 24 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
United States32 sites
Summa Health Cancer Research
Akron, Ohio, 44304
Ashland Bellefonte Cancer Center
Ashland, Kentucky, 41101
University Cancer & Blood
Athens, Georgia, 30607
Augusta University
Augusta, Georgia, 30912
Charleston Cancer Center
Charleston, South Carolina, 29406
University of Virginia
Charlottesville, Virginia, 22903
University of Illinois Cancer Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
University of Missouri-Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Des Moines Oncology Research Association
Des Moines, Iowa, 50309
Karmanos Cancer Institute
Detroit, Michigan, 48201
Providence Regional Cancer Partnership
Everett, Washington, 98201
CHI Health St. Francis
Grand Island, Nebraska, 68803
Great Falls Clinic
Great Falls, Montana, 59405
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Loma Linda University Health
Loma Linda, California, 92354
Lakes Research
Miami Lakes, Florida, 33014
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hackensack Meridian Health
Neptune City, New Jersey, 07753
Mercy Clinic Oncology and Hematology
Oklahoma City, Oklahoma, 73120
Pomona Valley Hospital Medical Center
Pomona, California, 91767
University of Rochester
Rochester, New York, 14642
Minnesota Oncology
Saint Louis Park, Minnesota, 55416
Memorial Health
Savannah, Georgia, 31404
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
Spartanburg Regional-Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Arizona Clinical Research Center
Tucson, Arizona, 85715
Oklahoma Cancer Specialists
Tulsa, Oklahoma, 74146
Carle Cancer Center
Urbana, Illinois, 61801
Spain8 sites
Institut Català d'Oncologia Badalona
Badalona
Hospital Universitari Vall d'Hebron
Barcelona
Institut Català d'Oncologia Girona
Girona
Hospital Universitario Severo Ochoa
Leganés
Hospital Regional Universitario de Málaga
Málaga
Hospital Son Llàtzer
Palma de Mallorca
Hospital Universitari Son Espases
Palma de Mallorca
Hospital Clínico Universitario Lozano Blesa
Zaragoza
France6 sites
CFRO Clinique Pasteur
Brest
Institut Andrée Dutreix
Dunkirk
Clinique Victor Hugo
Le Mans
Hôpital de la Croix Rousse
Lyon
CROM-Osny
Osny
Centre Hospitalier Privé St Grégoire
Saint-Grégoire
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen
Edinburgh Cancer Centre
Edinburgh
Guy's Hospital
London
Weston Park Hospital
Sheffield
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp
Centre Hospitalier Jolimont
La Louvière
Centre Hospitalier Universitaire de Mons
Mons
About this study
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
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
- Being tested
- SGX942, Placebo
- Keywords
- OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Stomatitis, Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGX942Drug
Also called Dusquetide
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| SGX942 | Experimental | Patients are randomized 1:1 active/placebo. Receives: Drug: SGX942 |
| Placebo | Placebo comparator | Patients are randomized 1:1 active/placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Severe Oral Mucositis (SOM)
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.
Measured: approx. 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start4 Dec 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Oral Cavity and OropharynxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237325
- Sponsor's protocol ID
- IDR-OM-02
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2017
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27015977Kudrimoti 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.
PubMed 27746305Kudrimoti 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.
PubMed 28649557
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03237325
- Acronym / sponsor ID
- IDR-OM-02
- Keywords
- OM, Head and Neck Cancer, SGX942, Dusquetide, Squamous Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Posted 29 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGX942 | Experimental | Drug: SGX942Patients are randomized 1:1 active/placebo. |
| Placebo | Placebo comparator | Drug: PlaceboPatients are randomized 1:1 active/placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGX942Also: Dusquetide1.5 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. | Drug | SGX942 |
| PlaceboPlacebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug. | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27015977North 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.
- Background: PubMed 27746305Kudrimoti 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.
- Background: PubMed 28649557Kudrimoti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SGX942 in people with Squamous Cell Carcinoma of the Oral Cavity and Oropharynx and Oral Mucositis, run by Soligenix at 53 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Spain, France, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Severe Oral Mucositis (SOM) (time frame: approx. 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.