Clinical Trials /

ROMAN: A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

NCT03689712

Description:

The purpose of the phase 3, clinical study is to determine if GC4419 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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: ROMAN: A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GTI-4419-301
  • NCT ID: NCT03689712

Conditions

  • Oral Mucositis

Interventions

DrugSynonymsArms
GC4419GC4419
PlaceboPlacebo

Purpose

The purpose of the phase 3, clinical study is to determine if GC4419 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.

Trial Arms

NameTypeDescriptionInterventions
GC4419Experimental
  • GC4419
PlaceboPlacebo Comparator
  • Placebo

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Cumulative incidence of severe OM
Time Frame:From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks.
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Galera Therapeutics, Inc.

Trial 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

Last Updated

February 26, 2020