ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

October 3, 2018

Primary Completion Date

August 13, 2021

Study Completion Date

August 25, 2023

Conditions
Oral Mucositis
Interventions
DRUG

GC4419 90mg

60 minute IV infusion

DRUG

Placebo

60 minute IV infusion

Trial Locations (97)

11355

New York- Presbyterian Queens/ Weill Cornell, Flushing

11733

NY Cancer and Blood Specialists, East Setauket

12206

New York Oncology Hematology, P.C., Albany

14642

Wilmot Cancer Institute - Univeristy of Rochester, Rochester

17325

Gettysburg Cancer Center, Gettysburg

18045

St. Luke's Hospital Cancer Center, Easton

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

22060

Fort Belvoir Community Hospital, Fort Belvoir

24014

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Roanoke

26506

West Virginia University, Morgantown

27157

Wake Forest Baptist Health, Winston-Salem

27834

School of Dental Medicine at East Carolina University, Greenville

29303

Spartanburg Medical Center, Spartanburg

29406

Charleston Cancer Center, Charleston

29607

St. Francis Cancer Center, Greenville

29621

Anmed Health Cancer Center, Anderson

30322

Winship Cancer Institute of Emory University, Atlanta

31904

IACT Health, Columbus

32224

Mayo Clinic Florida, Jacksonville

32256

Cancer Specialists of North Florida, Jacksonville

33322

BRCR Global, Plantation

33486

Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton

33744

Bay Pines VA HealthCare System, Bay Pines

33805

Lakeland Regional Cancer Center, Lakeland

37604

Mountain States Health Alliance Research Dept, Johnson City

37909

Tennessee Cancer Specialists, Knoxville

37920

University of Tennessee Medical Center, Knoxville

39401

Hattiesburg Clinic Hematology/Oncology, Hattiesburg

40202

University of Louisville/James Graham Brown Cancer Center, Louisville

40241

Norton Cancer Institute, Louisville

41701

Appalachian Regional Healthcare, INC., Hazard

43210

The Ohio State University, Columbus

44106

University Hospitals Seidman Cancer Center, Cleveland

44304

Summa Health, Akron

46526

Goshen Center for Cancer Care, Goshen

46845

Parkview Research Center, Fort Wayne

48109

University of Michigan, Ann Arbor

49201

Henry Ford Allegiance Health Hematology Oncology, Jackson

52242

The University of Iowa Hospitals & Clinics, Iowa City

55417

Minneapolis VA Healthcare System, Minneapolis

59102

St. Vincent Frontier Cancer Center, Billings

59405

Benefis Sletten Cancer institute, Great Falls

60611

Northwestern University Feinberg School of Medicine, Chicago

61114

SwedishAmerican Regional Cancer Center, Rockford

64507

Mosaic Life Care/Heartland Regional Medical Center, Saint Joseph

65212

Ellis Fischel Cancer Center - University of Missouri, Columbia

65401

Delbert Day Cancer Institute, Phelps County Regional Medical Center, Rolla

65807

Cox Medical Center, Springfield

68803

CHI Health St. Francis, Grand Island

72401

Fowler Family Center for Cancer, Jonesboro

75071

Texas Oncology - McKinney, McKinney

75093

Texas Oncology, Plano West, Plano

75231

Texas Oncology- Dallas Presbyterian Hospital, Dallas

75246

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

76210

Texas Oncology - Denton South, Denton

76712

Texas Oncology - Waco, Waco

77479

Texas Oncology - Sugar Land, Sugar Land

77702

Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center, Beaumont

78234

SAMMC, Fort Sam Houston

78503

Texas Oncology-McAllen, McAllen

78665

Baylor Scott & White- Round Rock, Round Rock

79902

Texas Oncology - El Paso Cancer Treatment Center, El Paso

81501

St. Mary's Hospital Regional Medical Center, Grand Junction

85234

Banner MD Anderson Cancer Center, Gilbert

89502

Renown Regional Medical Center, Reno

90033

USC Norris Cancer Center, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90603

The Oncology Institute of Hope & Innovation, Whittier

90640

Clinical Trials and Research Associates, Inc., Montebello

90822

Long Beach Veteran Affairs Healthcare System, Long Beach

92123

Sharp Clinical Oncology Research, San Diego

92501

Compassionate Cancer Care, Riverside

92627

Chan Soon-Shiong Institute for Medicine, Costa Mesa

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

92882

The Oncology Institute of Hope & Innovation, Corona

95695

Dignity Health Research Institute, Woodland

97239

VA Portland Health Care System, Portland

97401

Willamette Valley Cancer Institue and Research Center, Eugene

98201

Providence Regional Cancer Partnership, Everett

99216

Cancer Care Northwest, Spokane

01702

MetroWest Medical Center, Framingham

03833

Exeter Hospital, Exeter

08822

Hunterdon Hematology Oncology, LLC, Flemington

07932

Summit Medical Group, Florham Park

07753

Jersey Shore University Medical Center, Neptune City

V574E6

BC Cancer Center - Vancouver, Vancouver

H1T 2M4

CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont, Montreal

H4A 3J1

McGill University Health Center- Cedars Cancer Center, Montreal

G1R 2J6

CHU de Quebec - Universite Laval, Québec

G7H 5H6

Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi

P3E 5J1

Northeast Cancer Centre of Health Sciences North, Greater Sudbury

L8V 5C2

Juravinski Cancer Centre, Hamilton

H2X OC1

Centre Hospitalier Universitaire de Montreal (CHUM), Montreal

H3T 1E2

Jewish General Hospital, Montreal

G8Z3R9

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec, Trois-Rivières

00909

Clinical Research Puerto Rico, San Juan

Sponsors
All Listed Sponsors
lead

Galera Therapeutics, Inc.

INDUSTRY

NCT03689712 - ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients | Biotech Hunter | Biotech Hunter