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NCT03689712 · ClinicalTrials.gov registry record · Phase 3
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
A Phase 3 study, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT03689712: Completed Phase 3 study, sponsored by Galera Therapeutics.
NCT03689712 is a Phase 3 study that has completed, run by Galera Therapeutics. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689712, a Phase 3 study, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG GC4419 90mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 3 |
What the finished NCT03689712 record still lists
NCT03689712 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03689712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03689712 about?
NCT03689712 is a clinical study titled "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 c...
What is the current status of trial NCT03689712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2018-10-03. Estimated completion is 2023-08-25.
What interventions are being tested in trial NCT03689712?
The interventions under investigation include: Placebo (DRUG), GC4419 90mg (DRUG).
Who is sponsoring clinical trial NCT03689712?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03689712's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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