At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 455 enrolled
Drug / intervention
GC4419 90mg +1 moredrug
Likely dose
GC4419 90mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GC4419 90mg and Placebo for Oral Mucositis. Completed, enrolled 455 participants across 97 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionAug 2021
Study CompletionAug 2023
TodayJul 2026
First PostedSep 28, 2018
Enrollment StartOct 3, 2018
Primary CompletionAug 13, 2021
Study CompletionAug 25, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.8 years ago
Interventions
GC4419 90mgdrug
60 minute IV infusion
Placebodrug
60 minute IV infusion