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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689712
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Results First Posted : April 13, 2023
Last Update Posted : April 13, 2023
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: GC4419 90mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 3, 2018
Actual Primary Completion Date : August 13, 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Manganese

Arms and Interventions
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Arm Intervention/treatment
Experimental: GC4419 (avasopasem manganese) 90 mg Drug: GC4419 90mg
60 minute IV infusion
Other Name: avasopasem manganese
Placebo Comparator: Placebo Drug: Placebo
60 minute IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689712


Locations
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Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Gene Kennedy, MD Galera Therapeutics
  Study Documents (Full-Text)

Documents provided by Galera Therapeutics, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 13, 2020

More Information
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Publications:
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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03689712    
Other Study ID Numbers: GTI-4419-301
First Posted: September 28, 2018    Key Record Dates
Results First Posted: April 13, 2023
Last Update Posted: April 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galera Therapeutics, Inc.:
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
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
 Manganese
Avasopasem manganese
Trace Elements
Micronutrients
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents