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

Completed · Phase 3 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID

NCT03689712

Run by

Galera Therapeutics, Inc.

People needed

455

Starts

2018-10-03

Expected to finish

2023-08-25

Last updated by the study team

2023-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fowler Family Center for Cancer — Jonesboro, Arkansas, United States
• The Oncology Institute of Hope & Innovation — Corona, 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
• Sharp Clinical Oncology Research — San Diego, California, United States
• The Oncology Institute of Hope & Innovation — Whittier, California, United States
• Dignity Health Research Institute — Woodland, California, United States
• St. Mary's Hospital Regional Medical Center — Grand Junction, Colorado, United States
• Bay Pines VA HealthCare System — Bay Pines, Florida, United States
• Boca Raton Regional Hospital, Lynn Cancer Institute — Boca Raton, Florida, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• BRCR Global — Plantation, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• IACT Health — Columbus, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• SwedishAmerican Regional Cancer Center — Rockford, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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