ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer
Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma that plan to undergo cisplatin monotherapy
What treatments are being studied? GC4419
Status: Active, not recruiting
Location: See all (97) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• squamous cell carcinoma of the head and neck
• treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
• Treatment plan to receive standard cisplatin monotherapy
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate hematologic, renal and liver function
• Negative serum pregnancy test
• Use of effective contraception
Locations
United States
Arkansas
Fowler Family Center for Cancer
Jonesboro
Arizona
Banner MD Anderson Cancer Center
Gilbert
California
The Oncology Institute of Hope & Innovation
Corona
Chan Soon-Shiong Institute for Medicine
Costa Mesa
Long Beach Veteran Affairs Healthcare System
Long Beach
Cedars-Sinai Medical Center
Los Angeles
USC Norris Cancer Center
Los Angeles
Clinical Trials and Research Associates, Inc.
Montebello
Hoag Memorial Hospital Presbyterian
Newport Beach
Compassionate Cancer Care
Riverside
Sharp Clinical Oncology Research
San Diego
The Oncology Institute of Hope & Innovation
Whittier
Dignity Health Research Institute
Woodland
Colorado
St. Mary's Hospital Regional Medical Center
Grand Junction
Florida
Bay Pines VA HealthCare System
Bay Pines
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton
Cancer Specialists of North Florida
Jacksonville
Mayo Clinic Florida
Jacksonville
Lakeland Regional Cancer Center
Lakeland
BRCR Global
Plantation
Georgia
Winship Cancer Institute of Emory University
Atlanta
IACT Health
Columbus
Iowa
The University of Iowa Hospitals & Clinics
Iowa City
Illinois
Northwestern University Feinberg School of Medicine
Chicago
SwedishAmerican Regional Cancer Center
Rockford
Indiana
Parkview Research Center
Fort Wayne
Goshen Center for Cancer Care
Goshen
Kentucky
Appalachian Regional Healthcare, INC.
Hazard
Norton Cancer Institute
Louisville
University of Louisville/James Graham Brown Cancer Center
Louisville
Massachusetts
MetroWest Medical Center
Framingham
Michigan
University of Michigan
Ann Arbor
Minnesota
Minneapolis VA Healthcare System
Minneapolis
Missouri
Ellis Fischel Cancer Center - University of Missouri
Columbia
Delbert Day Cancer Institute, Phelps County Regional Medical Center
Rolla
Mosaic Life Care/Heartland Regional Medical Center
Saint Joseph
Cox Medical Center
Springfield
Mississippi
Hattiesburg Clinic Hematology/Oncology
Hattiesburg
Henry Ford Allegiance Health Hematology Oncology
Jackson
Montana
St. Vincent Frontier Cancer Center
Billings
Benefis Sletten Cancer institute
Great Falls
North Carolina
School of Dental Medicine at East Carolina University
Greenville
Wake Forest Baptist Health
Winston-salem
Nebraska
CHI Health St. Francis
Grand Island
New Hampshire
Exeter Hospital
Exeter
New Jersey
Hunterdon Hematology Oncology, LLC
Flemington
Summit Medical Group
Florham Park
Jersey Shore University Medical Center
Neptune
Nevada
Renown Regional Medical Center
Reno
New York
New York Oncology Hematology, P.C.
Albany
NY Cancer and Blood Specialists
East Setauket
New York- Presbyterian Queens/ Weill Cornell
Flushing
Wilmot Cancer Institute - Univeristy of Rochester
Rochester
Ohio
Summa Health
Akron
University Hospitals Seidman Cancer Center
Cleveland
The Ohio State University
Columbus
Oregon
Willamette Valley Cancer Institue and Research Center
Eugene
VA Portland Health Care System
Portland
Pennsylvania
St. Luke's Hospital Cancer Center
Easton
Gettysburg Cancer Center
Gettysburg
Fox Chase Cancer Center
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
South Carolina
Anmed Health Cancer Center
Anderson
Charleston Cancer Center
Charleston
St. Francis Cancer Center
Greenville
Spartanburg Medical Center
Spartanburg
Tennessee
Mountain States Health Alliance Research Dept
Johnson City
Tennessee Cancer Specialists
Knoxville
University of Tennessee Medical Center
Knoxville
Texas
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont
Texas Oncology- Dallas Presbyterian Hospital
Dallas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas
Texas Oncology - Denton South
Denton
Texas Oncology - El Paso Cancer Treatment Center
El Paso
SAMMC
Fort Sam Houston
Texas Oncology-McAllen
Mcallen
Texas Oncology - McKinney
Mckinney
Texas Oncology, Plano West
Plano
Baylor Scott & White- Round Rock
Round Rock
Texas Oncology - Sugar Land
Sugar Land
Texas Oncology - Waco
Waco
Virginia
Fort Belvoir Community Hospital
Fort Belvoir
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke
Washington
Providence Regional Cancer Partnership
Everett
Cancer Care Northwest
Spokane
West Virginia
West Virginia University
Morgantown
Other Locations
Canada
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi
Juravinski Cancer Centre
Hamilton
Centre Hospitalier Universitaire de Montreal (CHUM)
Montréal
CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
Montréal
Jewish General Hospital
Montréal
McGill University Health Center- Cedars Cancer Center
Montréal
CHU de Quebec - Universite Laval
Québec
Northeast Cancer Centre of Health Sciences North
Sudbury
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
Trois-rivières
BC Cancer Center - Vancouver
Vancouver
Puerto Rico
Clinical Research Puerto Rico
San Juan
Time Frame
Start Date: October 3, 2018
Estimated Completion Date: December 2023
Participants
Target number of participants: 455
Treatments
Experimental: GC4419
Placebo Comparator: Placebo
Authors
Christal Murray, Douglas Ciuba, Anand Desai, Pramvir Verma, Kyle Colvett, Gopichand Pendurti, Brian Muzyka, Michael Kasper, Richy Agajanian, John Thropay, Mohammed Almubarak, Min Yao, Ines Sanchez-Rivera, Chaitali Nangia, Ganesh Kudva, Daniel Huang, Neal Dunlap, Andy Chen, Mark Klein, Tracy Dobbs, Panagiotis Fidias, Carryn Anderson, Zulfiqar Malik, Bing Xia, Anand Shivnani, Mercedes Porosnicu, Zachary Zumsteg, Yanis Boumber, Abhinand Peddada, David Crockett, Ronald Maggiore, Ibrahim Abdalla, Brian Chang, Philip Kovoor, Tina Khair, Brian Kim, Yaser Homsi, Vernon King, Thomas Galloway, Gary Walker, Steven DiBiase, Dong Moon Shin, Justin Juliano, Charles Holladay, Robert Siegel, Carlos Encarnacion, Patrick Cobb, Leander Cannick, Emily Dunn, Richard Zuniga, Jaspreet Grewal, Joseph Kelley, Sonia Reichert, Richard Cassidy, Steven Kossman, Francis Worden, Robert Fairbanks, Mark Agulnik, Eddie Thara, Steve Lee, Jeffery Morton, James Wheeler, Kamal Haider, William Wisbeck, Byron May, Douglas Miller, Neil Faulkner, William Schulz, Nurul Wahid, Grant Harrer, Vivek Kavadi, Jason Tache, Ryan Burri, Brian Choi, Christopher Spencer, Sarada Gurubhagavatula, Mayra Rivera-Figueroa, Amarintha Curtis, Kala Seetharaman, Mathieu LeClerc, Francois Vincent, Felix Nguyen, Kristi Mclntyre, Wagas Rehman, Wilfred DeLaCruz, Jaffar Hilli, Marc-Andre Brassard, Nader Khaouam, John Hrom, Sarah Hamilton, Samuel Bailey, Brandon Meyers, Eric Nadler, Mauricio Gamez, George Shenouda, Daniel Clayburgh, Amanda Gillespie-Twardy, Kevin Collins, Deborah Saunders, Gary Lu, Voichita Bar-Ad, Khalil Sultanem
Related Therapeutic Areas
Sponsors
Leads: Galera Therapeutics, Inc.