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

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.

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Key information

Conditions

Oral Mucositis Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oral Ulcer Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BC Cancer Center - Vancouver, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GC4419 90mg

Drug

60 minute IV infusion

Other names: avasopasem manganese

Placebo

Drug

60 minute IV infusion

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Galera Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2023
First posted: Sep 28, 2018
Registry last updated: Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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