About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. squamous cell carcinoma of the head and neck
2. 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
3. Treatment plan to receive standard cisplatin monotherapy
4. Age 18 years or older
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
6. Adequate hematologic, renal and liver function
7. Negative serum pregnancy test
8. Use of effective contraception

Exclusion criteria

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

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.