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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

squamous cell carcinoma of the head and neck
treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
Treatment plan to receive standard cisplatin monotherapy
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate hematologic, renal and liver function
Negative serum pregnancy test
Use of effective contraception

Exclusion Criteria

Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
Metastatic disease
Prior radiotherapy to the region of the study cancer or adjacent anatomical
Prior induction chemotherapy
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
Concurrent participation in another interventional clinical study
Inability to eat soft solid food at baseline
Malignant tumors other than HNC within the last 5 years
Active infectious disease excluding oral candidiasis
Presence of oral mucositis at baseline
Known history of HIV or active hepatitis B/C
Female patients who are pregnant or breastfeeding
Known allergies or intolerance to cisplatin and similar platinum-containing compounds
Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure

Arm && Interventions

Group	Intervention	Description
GC4419 (avasopasem manganese) 90 mg	GC4419 90mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Severe Oral Mucositis	From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (96): Banner MD Anderson Cancer Center
🇺🇸
Gilbert, Arizona, United States
Fowler Family Center for Cancer
🇺🇸
Jonesboro, Arkansas, United States
The Oncology Institute of Hope & Innovation
🇺🇸
Whittier, California, United States
Chan Soon-Shiong Institute for Medicine
🇺🇸
Costa Mesa, California, United States
Long Beach Veteran Affairs Healthcare System
🇺🇸
Long Beach, California, United States
USC Norris Cancer Center
🇺🇸
Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
🇺🇸
Montebello, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸
Newport Beach, California, United States
Compassionate Cancer Care
🇺🇸
Riverside, California, United States
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Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States