ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
- Conditions
- Oral Mucositis
- Interventions
- Drug: GC4419 90mgDrug: Placebo
- Registration Number
- NCT03689712
- Lead Sponsor
- Galera Therapeutics, Inc.
- Brief Summary
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 455
- 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
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical
- Prior induction chemotherapy
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline
- Malignant tumors other than HNC within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline
- Known history of HIV or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GC4419 (avasopasem manganese) 90 mg GC4419 90mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Cumulative Incidence of Severe Oral Mucositis From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks. Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
USC Norris Cancer Center
🇺🇸Los Angeles, California, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology- Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University Hospitals Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
Minneapolis VA Healthcare System
🇺🇸Minneapolis, Minnesota, United States
St. Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
IACT Health
🇺🇸Columbus, Georgia, United States
Exeter Hospital
🇺🇸Exeter, New Hampshire, United States
Hunterdon Hematology Oncology, LLC
🇺🇸Flemington, New Jersey, United States
St. Luke's Hospital Cancer Center
🇺🇸Easton, Pennsylvania, United States
Texas Oncology - Sugar Land
🇺🇸Sugar Land, Texas, United States
Texas Oncology-McAllen
🇺🇸McAllen, Texas, United States
Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
CHI Health St. Francis
🇺🇸Grand Island, Nebraska, United States
School of Dental Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
Summa Health
🇺🇸Akron, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Texas Oncology - Denton South
🇺🇸Denton, Texas, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
NY Cancer and Blood Specialists
🇺🇸East Setauket, New York, United States
Mountain States Health Alliance Research Dept
🇺🇸Johnson City, Tennessee, United States
Texas Oncology - McKinney
🇺🇸McKinney, Texas, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Mosaic Life Care/Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Delbert Day Cancer Institute, Phelps County Regional Medical Center
🇺🇸Rolla, Missouri, United States
Benefis Sletten Cancer institute
🇺🇸Great Falls, Montana, United States
Wilmot Cancer Institute - Univeristy of Rochester
🇺🇸Rochester, New York, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
New York- Presbyterian Queens/ Weill Cornell
🇺🇸Flushing, New York, United States
Texas Oncology - El Paso Cancer Treatment Center
🇺🇸El Paso, Texas, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Baylor Scott & White- Round Rock
🇺🇸Round Rock, Texas, United States
McGill University Health Center- Cedars Cancer Center
🇨🇦Montréal, Quebec, Canada
Texas Oncology - Waco
🇺🇸Waco, Texas, United States
SAMMC
🇺🇸Fort Sam Houston, Texas, United States
CHU de Quebec - Universite Laval
🇨🇦Québec, Quebec, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Canada
VA Portland Health Care System
🇺🇸Portland, Oregon, United States
Cox Medical Center
🇺🇸Springfield, Missouri, United States
Willamette Valley Cancer Institue and Research Center
🇺🇸Eugene, Oregon, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
The Oncology Institute of Hope & Innovation
🇺🇸Whittier, California, United States
Long Beach Veteran Affairs Healthcare System
🇺🇸Long Beach, California, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Dignity Health Research Institute
🇺🇸Woodland, California, United States
St. Mary's Hospital Regional Medical Center
🇺🇸Grand Junction, Colorado, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
BRCR Global
🇺🇸Plantation, Florida, United States
SwedishAmerican Regional Cancer Center
🇺🇸Rockford, Illinois, United States
Fowler Family Center for Cancer
🇺🇸Jonesboro, Arkansas, United States
Boca Raton Regional Hospital, Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
Bay Pines VA HealthCare System
🇺🇸Bay Pines, Florida, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
The University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Hattiesburg Clinic Hematology/Oncology
🇺🇸Hattiesburg, Mississippi, United States
Ellis Fischel Cancer Center - University of Missouri
🇺🇸Columbia, Missouri, United States
Henry Ford Allegiance Health Hematology Oncology
🇺🇸Jackson, Mississippi, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Oncology, Plano West
🇺🇸Plano, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Fort Belvoir Community Hospital
🇺🇸Fort Belvoir, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
BC Cancer Center - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Canada
CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital
🇨🇦Montréal, Canada
Centre Hospitalier Universitaire de Montreal (CHUM)
🇨🇦Montréal, Canada
Northeast Cancer Centre of Health Sciences North
🇨🇦Sudbury, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
🇨🇦Trois-Rivières, Canada
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Chan Soon-Shiong Institute for Medicine
🇺🇸Costa Mesa, California, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Appalachian Regional Healthcare, INC.
🇺🇸Hazard, Kentucky, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Louisville/James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Compassionate Cancer Care
🇺🇸Riverside, California, United States
Anmed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
MetroWest Medical Center
🇺🇸Framingham, Massachusetts, United States