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

October 19, 2023 updated by: Galera Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Chicoutimi, Canada, G7H 5H6
        • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
      • Hamilton, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Montréal, Canada, H3T 1E2
        • Jewish General Hospital
      • Montréal, Canada, H2X OC1
        • Centre Hospitalier Universitaire de Montréal (CHUM)
      • Sudbury, Canada, P3E 5J1
        • Northeast Cancer Centre of Health Sciences North
      • Trois-Rivières, Canada, G8Z3R9
        • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
    • British Columbia
      • Vancouver, British Columbia, Canada, V574E6
        • BC Cancer Center - Vancouver
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Center- Cedars Cancer Center
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Québec - Université Laval
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Fowler Family Center for Cancer
    • California
      • Corona, California, United States, 92882
        • The Oncology Institute of Hope & Innovation
      • Costa Mesa, California, United States, 92627
        • Chan Soon-Shiong Institute for Medicine
      • Long Beach, California, United States, 90822
        • Long Beach Veteran Affairs Healthcare System
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center
      • Montebello, California, United States, 90640
        • Clinical Trials and Research Associates, Inc.
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Riverside, California, United States, 92501
        • Compassionate Cancer Care
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope & Innovation
      • Woodland, California, United States, 95695
        • Dignity Health Research Institute
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Hospital Regional Medical Center
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital, Lynn Cancer Institute
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Plantation, Florida, United States, 33322
        • BRCR Global
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Columbus, Georgia, United States, 31904
        • IACT Health
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Rockford, Illinois, United States, 61114
        • SwedishAmerican Regional Cancer Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa Hospitals & Clinics
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Appalachian Regional Healthcare, Inc.
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40202
        • University of Louisville/James Graham Brown Cancer Center
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • MetroWest Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Healthcare System
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic Hematology/Oncology
      • Jackson, Mississippi, United States, 49201
        • Henry Ford Allegiance Health Hematology Oncology
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Ellis Fischel Cancer Center - University of Missouri
      • Rolla, Missouri, United States, 65401
        • Delbert Day Cancer Institute, Phelps County Regional Medical Center
      • Saint Joseph, Missouri, United States, 64507
        • Mosaic Life Care/Heartland Regional Medical Center
      • Springfield, Missouri, United States, 65807
        • Cox Medical Center
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health St. Francis
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Hematology Oncology, LLC
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
      • East Setauket, New York, United States, 11733
        • NY Cancer and Blood Specialists
      • Flushing, New York, United States, 11355
        • New York- Presbyterian Queens/ Weill Cornell
      • Rochester, New York, United States, 14642
        • Wilmot Cancer Institute - Univeristy of Rochester
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • School of Dental Medicine at East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institue and Research Center
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • St. Luke's Hospital Cancer Center
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Greenville, South Carolina, United States, 29607
        • St. Francis Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Mountain States Health Alliance Research Dept
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists
    • Texas
      • Beaumont, Texas, United States, 77702
        • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology- Dallas Presbyterian Hospital
      • Denton, Texas, United States, 76210
        • Texas Oncology - Denton South
      • El Paso, Texas, United States, 79902
        • Texas Oncology - El Paso Cancer Treatment Center
      • Fort Sam Houston, Texas, United States, 78234
        • SAMMC
      • McAllen, Texas, United States, 78503
        • Texas Oncology-McAllen
      • McKinney, Texas, United States, 75071
        • Texas Oncology - McKinney
      • Plano, Texas, United States, 75093
        • Texas Oncology, Plano West
      • Round Rock, Texas, United States, 78665
        • Baylor Scott & White- Round Rock
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology - Sugar Land
      • Waco, Texas, United States, 76712
        • Texas Oncology - Waco
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Spokane, Washington, United States, 99216
        • Cancer Care Northwest
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
60 minute IV infusion
Experimental: GC4419 (avasopasem manganese) 90 mg
Drug: GC4419 90mg
60 minute IV infusion
Other Names:
  • avasopasem manganese

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Incidence of Severe Oral Mucositis
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galera Therapeutics, Inc.

Investigators

  • Study Chair: Gene Kennedy, MD, Galera Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

August 13, 2021

Study Completion (Actual)

August 25, 2023

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTI-4419-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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