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



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:July 25, 2017
End Date:December 2019
Contact:Christopher Pullion, DO
Email:cpullion@soligenix.com
Phone:609-538-8200

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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


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
We found this trial at
35
sites
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Akron, Ohio 44304
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Ashland, Kentucky 41101
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Athens, Georgia 30607
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Augusta, Georgia 30912
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Charleston, South Carolina
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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Denver, Colorado 80224
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300 East Locust Street
Des Moines, Iowa 50309
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Detroit, Michigan 48201
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Gastonia, North Carolina 28054
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2620 West Faidley Avenue
Grand Island, Nebraska 68803
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1400 29th Street South
Great Falls, Montana 59405
406-454-2171
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
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Greenbrae, California 94904
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Holiday, Florida 34691
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-353-7143
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32256
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Loma Linda, California 92354
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Miami Lakes, Florida 33014
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Neptune, New Jersey 07753
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New Orleans, Louisiana 70112
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Oklahoma City, Oklahoma 73120
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Pomona, California 91767
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Saint Louis Park, Minnesota 55416
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Savannah, Georgia 31404
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Shreveport, Louisiana 71103
Phone: 318-212-8671
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Spartanburg, South Carolina 29303
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Temple, Texas 76508
Phone: 254-724-5889
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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