A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
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