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Head and Neck, Non-Metastatic, Reduce Severe Oral Mucositis (GTI-4419-301)

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

Overview

Overview

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Key Inclusion Criteria

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • 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
Key Exclusion Criteria

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.

  • 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
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Phase III

Principal Investigator(s)

Amarinthia Curtis, MD

Contact Us

Contact Us

To participate in this study, please contact Luann Lester at
864-560-1045
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