Clinical trial NCT03689712: ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Mucositis
Keywords: Oral Mucositis
Superoxide Dismutase Mimetic
Cisplatin
Intensity-Modulated Radiation Therapy
Chemoradiation
OM
IMRT
Head and Neck Cancer
Squamous Cell Carcinoma
SCC
Oral Cavity
Oropharnyx
Mouth Sores
avasopasem mangenese
Lead sponsor: Galera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cumulative Incidence of Severe Oral Mucositis
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Jonesboro
country: United States
facility: Fowler Family Center for Cancer
state: Arkansas
city: Corona
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Costa Mesa
country: United States
facility: Chan Soon-Shiong Institute for Medicine
state: California
city: Long Beach
country: United States
facility: Long Beach Veteran Affairs Healthcare System
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Woodland
country: United States
facility: Dignity Health Research Institute
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Medical Center
state: Colorado
city: Bay Pines
country: United States
facility: Bay Pines VA HealthCare System
state: Florida
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital, Lynn Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Plantation
country: United States
facility: BRCR Global
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Rockford
country: United States
facility: SwedishAmerican Regional Cancer Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics
state: Iowa
city: Hazard
country: United States
facility: Appalachian Regional Healthcare, INC.
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville/James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Healthcare System
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology
state: Mississippi
city: Jackson
country: United States
facility: Henry Ford Allegiance Health Hematology Oncology
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - University of Missouri
state: Missouri
city: Rolla
country: United States
facility: Delbert Day Cancer Institute, Phelps County Regional Medical Center
state: Missouri
city: Saint Joseph
country: United States
facility: Mosaic Life Care/Heartland Regional Medical Center
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Great Falls
country: United States
facility: Benefis Sletten Cancer institute
state: Montana
city: Grand Island
country: United States
facility: CHI Health St. Francis
state: Nebraska
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Exeter
country: United States
facility: Exeter Hospital
state: New Hampshire
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology, LLC
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: East Setauket
country: United States
facility: NY Cancer and Blood Specialists
state: New York
city: Flushing
country: United States
facility: New York- Presbyterian Queens/ Weill Cornell
state: New York
city: Rochester
country: United States
facility: Wilmot Cancer Institute - Univeristy of Rochester
state: New York
city: Greenville
country: United States
facility: School of Dental Medicine at East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institue and Research Center
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Easton
country: United States
facility: St. Luke's Hospital Cancer Center
state: Pennsylvania
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Anderson
country: United States
facility: Anmed Health Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Johnson City
country: United States
facility: Mountain States Health Alliance Research Dept
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton South
state: Texas
city: El Paso
country: United States
facility: Texas Oncology - El Paso Cancer Treatment Center
state: Texas
city: Fort Sam Houston
country: United States
facility: SAMMC
state: Texas
city: McAllen
country: United States
facility: Texas Oncology-McAllen
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Plano
country: United States
facility: Texas Oncology, Plano West
state: Texas
city: Round Rock
country: United States
facility: Baylor Scott & White- Round Rock
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology - Sugar Land
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Vancouver
country: Canada
facility: BC Cancer Center - Vancouver
state: British Columbia
city: Montréal
country: Canada
facility: CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center- Cedars Cancer Center
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec - Universite Laval
state: Quebec
city: Chicoutimi
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montreal (CHUM)
city: Montréal
country: Canada
facility: Jewish General Hospital
city: Sudbury
country: Canada
facility: Northeast Cancer Centre of Health Sciences North
city: Trois-Rivières
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
affiliation: Galera Therapeutics
name: Gene Kennedy, MD
role: STUDY_CHAIR
References:
citation: Anderson CM, Lee CM, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Journal of Clinical Oncology 2022 40:16_suppl, 6005-6005
citation: Saunders D, Lee C, Kelley J, et al. ROMAN: Phase 3 trial of avasopasem to reduce chemoradiotherapy (CRT)-related severe oral mucositis (SOM) in patients with head and neck cancer (HNC). Support Care Cancer 30 (Suppl 1), 1-207 (2022).
citation: Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
citation: Anderson CM, Lee CM, Saunders DP, Curtis A, Dunlap N, Nangia C, Lee AS, Gordon SM, Kovoor P, Arevalo-Araujo R, Bar-Ad V, Peddada A, Colvett K, Miller D, Jain AK, Wheeler J, Blakaj D, Bonomi M, Agarwala SS, Garg M, Worden F, Holmlund J, Brill JM, Downs M, Sonis ST, Katz S, Buatti JM. Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. J Clin Oncol. 2019 Dec 1;37(34):3256-3265. doi: 10.1200/JCO.19.01507. Epub 2019 Oct 16.