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

PHASE3CompletedINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

June 24, 2020

Study Completion Date

June 24, 2021

Conditions
Squamous Cell Carcinoma of the Oral Cavity and OropharynxOral Mucositis
Interventions
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.

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.

Trial Locations (53)

14642

University of Rochester, Rochester

22903

University of Virginia, Charlottesville

29303

Spartanburg Regional-Gibbs Cancer Center, Spartanburg

29406

Charleston Cancer Center, Charleston

30607

University Cancer & Blood, Athens

30912

Augusta University, Augusta

31404

Memorial Health, Savannah

32256

Cancer Specialists of North Florida, Jacksonville

33014

Lakes Research, Miami Lakes

41101

Ashland Bellefonte Cancer Center, Ashland

44304

Summa Health Cancer Research, Akron

45219

The Christ Hospital, Cincinnati

48201

Karmanos Cancer Institute, Detroit

50309

Des Moines Oncology Research Association, Des Moines

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Medical College of Wisconsin, Milwaukee

55416

Minnesota Oncology, Saint Louis Park

59405

Great Falls Clinic, Great Falls

60612

University of Illinois Cancer Center, Chicago

61801

Carle Cancer Center, Urbana

65203

University of Missouri-Ellis Fischel Cancer Center, Columbia

68803

CHI Health St. Francis, Grand Island

71103

Willis Knighton Cancer Center, Shreveport

73120

Mercy Clinic Oncology and Hematology, Oklahoma City

74146

Oklahoma Cancer Specialists, Tulsa

85715

Arizona Clinical Research Center, Tucson

89052

Comprehensive Cancer Centers of Nevada, Henderson

89106

Nevada Cancer Research Foundation, Las Vegas

91767

Pomona Valley Hospital Medical Center, Pomona

92354

Loma Linda University Health, Loma Linda

98201

Providence Regional Cancer Partnership, Everett

07753

Hackensack Meridian Health, Neptune City

Unknown

Universitair Ziekenhuis Antwerpen, Antwerp

Centre Hospitalier Jolimont, La Louvière

Centre Hospitalier Universitaire de Mons, Mons

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

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

Aberdeen Royal Infirmary, Aberdeen

Edinburgh Cancer Centre, Edinburgh

Guy's Hospital, London

Weston Park Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Soligenix

INDUSTRY