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

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.

Timeline

Start

2018-10-03

Primary completion

2021-08-13

Completion

2023-08-25

Publications

• Background Anderson CM, Lee CM, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Journal of Clinical Oncology 2022 40:16_suppl, 6005-6005
• Background Saunders D, Lee C, Kelley J, et al. ROMAN: Phase 3 trial of avasopasem to reduce chemoradiotherapy (CRT)-related severe oral mucositis (SOM) in patients with head and neck cancer (HNC). Support Care Cancer 30 (Suppl 1), 1-207 (2022).
• Anderson C, Lee CM, Kelley JR, Walker GV, Dunlap NE, Bar-Ad VC, Miller DA, King VJ, Peddada AV, Ciuba DF, Vincent F, Muzyka BC, Gillespie-Twardy AL, Sonis ST, Holmlund J, Beardsley RA, Kennedy EP, Saunders D. Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN). EClinicalMedicine. 2025 Oct 8;89:103539. doi: 10.1016/j.eclinm.2025.103539. eCollection 2025 Nov.
• Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
• Anderson CM, Lee CM, Saunders DP, Curtis A, Dunlap N, Nangia C, Lee AS, Gordon SM, Kovoor P, Arevalo-Araujo R, Bar-Ad V, Peddada A, Colvett K, Miller D, Jain AK, Wheeler J, Blakaj D, Bonomi M, Agarwala SS, Garg M, Worden F, Holmlund J, Brill JM, Downs M, Sonis ST, Katz S, Buatti JM. Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. J Clin Oncol. 2019 Dec 1;37(34):3256-3265. doi: 10.1200/JCO.19.01507. Epub 2019 Oct 16.

Drugs

Indications