ROMAN: A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the phase 3, clinical study is to determine if GC4419 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galera Therapeutics, Inc.
• Treatments: Avasopasem manganese

Criteria

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