Trials / Completed
CompletedNCT03689712
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 455 (actual)
- Sponsor
- Galera Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GC4419 90mg | 60 minute IV infusion |
| DRUG | Placebo | 60 minute IV infusion |
Timeline
- Start date
- 2018-10-03
- Primary completion
- 2021-08-13
- Completion
- 2023-08-25
- First posted
- 2018-09-28
- Last updated
- 2023-10-24
- Results posted
- 2023-04-13
Locations
97 sites across 3 countries: United States, Canada, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03689712. Inclusion in this directory is not an endorsement.