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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03689712
Other study ID # GTI-4419-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 3, 2018
Est. completion date August 25, 2023

Study information

Verified date October 2023
Source Galera Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 455
Est. completion date August 25, 2023
Est. primary completion date August 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
GC4419 90mg
60 minute IV infusion
Placebo
60 minute IV infusion

Locations

Country Name City State
Canada Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean Chicoutimi
Canada Juravinski Cancer Centre Hamilton
Canada Centre Hospitalier Universitaire de Montreal (CHUM) Montréal
Canada CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont Montréal Quebec
Canada Jewish General Hospital Montréal
Canada McGill University Health Center- Cedars Cancer Center Montréal Quebec
Canada CHU de Quebec - Universite Laval Québec Quebec
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 BC Cancer Center - Vancouver Vancouver British Columbia
Puerto Rico Clinical Research Puerto Rico San Juan
United States Summa Health Akron Ohio
United States New York Oncology Hematology, P.C. Albany New York
United States Anmed Health Cancer Center Anderson South Carolina
United States University of Michigan Ann Arbor Michigan
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Bay Pines VA HealthCare System Bay Pines Florida
United States Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center Beaumont Texas
United States St. Vincent Frontier Cancer Center Billings Montana
United States Boca Raton Regional Hospital, Lynn Cancer Institute Boca Raton Florida
United States Charleston Cancer Center Charleston South Carolina
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States University Hospitals Seidman Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - University of Missouri Columbia Missouri
United States IACT Health Columbus Georgia
United States The Ohio State University Columbus Ohio
United States The Oncology Institute of Hope & Innovation Corona California
United States Chan Soon-Shiong Institute for Medicine Costa Mesa California
United States Texas Oncology- Dallas Presbyterian Hospital Dallas Texas
United States Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Texas Oncology - Denton South Denton Texas
United States NY Cancer and Blood Specialists East Setauket New York
United States St. Luke's Hospital Cancer Center Easton Pennsylvania
United States Texas Oncology - El Paso Cancer Treatment Center El Paso Texas
United States Willamette Valley Cancer Institue and Research Center Eugene Oregon
United States Providence Regional Cancer Partnership Everett Washington
United States Exeter Hospital Exeter New Hampshire
United States Hunterdon Hematology Oncology, LLC Flemington New Jersey
United States Summit Medical Group Florham Park New Jersey
United States New York- Presbyterian Queens/ Weill Cornell Flushing New York
United States Fort Belvoir Community Hospital Fort Belvoir Virginia
United States SAMMC Fort Sam Houston Texas
United States Parkview Research Center Fort Wayne Indiana
United States MetroWest Medical Center Framingham Massachusetts
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Goshen Center for Cancer Care Goshen Indiana
United States CHI Health St. Francis Grand Island Nebraska
United States St. Mary's Hospital Regional Medical Center Grand Junction Colorado
United States Benefis Sletten Cancer institute Great Falls Montana
United States School of Dental Medicine at East Carolina University Greenville North Carolina
United States St. Francis Cancer Center Greenville South Carolina
United States Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi
United States Appalachian Regional Healthcare, INC. Hazard Kentucky
United States The University of Iowa Hospitals & Clinics Iowa City Iowa
United States Henry Ford Allegiance Health Hematology Oncology Jackson Mississippi
United States Cancer Specialists of North Florida Jacksonville Florida
United States Mayo Clinic Florida Jacksonville Florida
United States Mountain States Health Alliance Research Dept Johnson City Tennessee
United States Fowler Family Center for Cancer Jonesboro Arkansas
United States Tennessee Cancer Specialists Knoxville Tennessee
United States University of Tennessee Medical Center Knoxville Tennessee
United States Lakeland Regional Cancer Center Lakeland Florida
United States Long Beach Veteran Affairs Healthcare System Long Beach California
United States Cedars-Sinai Medical Center Los Angeles California
United States USC Norris Cancer Center Los Angeles California
United States Norton Cancer Institute Louisville Kentucky
United States University of Louisville/James Graham Brown Cancer Center Louisville Kentucky
United States Texas Oncology-McAllen McAllen Texas
United States Texas Oncology - McKinney McKinney Texas
United States Minneapolis VA Healthcare System Minneapolis Minnesota
United States Clinical Trials and Research Associates, Inc. Montebello California
United States West Virginia University Morgantown West Virginia
United States Jersey Shore University Medical Center Neptune New Jersey
United States Hoag Memorial Hospital Presbyterian Newport Beach California
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Texas Oncology, Plano West Plano Texas
United States BRCR Global Plantation Florida
United States VA Portland Health Care System Portland Oregon
United States Renown Regional Medical Center Reno Nevada
United States Compassionate Cancer Care Riverside California
United States Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Roanoke Virginia
United States Wilmot Cancer Institute - Univeristy of Rochester Rochester New York
United States SwedishAmerican Regional Cancer Center Rockford Illinois
United States Delbert Day Cancer Institute, Phelps County Regional Medical Center Rolla Missouri
United States Baylor Scott & White- Round Rock Round Rock Texas
United States Mosaic Life Care/Heartland Regional Medical Center Saint Joseph Missouri
United States Sharp Clinical Oncology Research San Diego California
United States Spartanburg Medical Center Spartanburg South Carolina
United States Cancer Care Northwest Spokane Washington
United States Cox Medical Center Springfield Missouri
United States Texas Oncology - Sugar Land Sugar Land Texas
United States Texas Oncology - Waco Waco Texas
United States The Oncology Institute of Hope & Innovation Whittier California
United States Wake Forest Baptist Health Winston-Salem North Carolina
United States Dignity Health Research Institute Woodland California

Sponsors (1)

Lead Sponsor Collaborator
Galera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (2)

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

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).

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative Incidence of Severe Oral Mucositis 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. 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.
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