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

> **NCT03689712** · PHASE3 · COMPLETED · sponsor: **Galera Therapeutics, Inc.** · enrollment: 455 (actual)

## Conditions studied

- Oral Mucositis

## Interventions

- **DRUG:** GC4419 90mg
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03689712
- **Lead sponsor:** Galera Therapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-10-03
- **Primary completion:** 2021-08-13
- **Final completion:** 2023-08-25
- **Target enrollment:** 455 (ACTUAL)
- **Last updated:** 2023-10-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03689712

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03689712, "ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03689712. Licensed CC0.

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