Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients with Locally Advanced, Non-Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx.

What we are studying

You have been asked to take part in this study because you have been diagnosed with a specific type of cancer called squamous cell carcinoma of the head and neck (SCCHN) and are receiving a standard treatment (radiation therapy and chemotherapy) for your cancer. As a result of your radiation therapy, you may develop soreness, irritation, and ulcers in your mouth and may have a hard time eating, drinking, and/or swallowing. This problem or condition is called “oral mucositis.” This study will involve treatment with an investigational drug called GC4419. Investigational means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) for sale in the United States and will not be approved until tests show that the study drug is safe and effective. GC4419 is an investigational drug that is being tested to prevent or decrease mouth pain and oral mucositis, which can be caused by cancer treatment.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Pathologically confirmed SCCHN
  • Treated with cisplatin plus concurrent radiotherapy
  • Adequate hematologic function
  • ECOG performance status less than or equal to 2
  • Adequate kidney and liver function
  • Documentation of tumor HPV status
  • Non-Pregnant
  • Agreement to use contraceptive while on study
  • Written informed consent.

What is involved

  • Informed consent
  • Inclusion/Exclusion criteria review
  • Medical and head and neck cancer histories
  • Complete physical exam
  • Height
  • Dental exam / IMRT clearance
  • Vital signs
  • ECOG
  • Weight
  • Body surface area
  • Serum pregnancy test (if applicable)
  • Clinical exam of tumor status at screening and at end of IMRT
  • Concomitant medications
  • Adverse events
  • 12-Lead ECG
  • Oral mucositis assessments
  • Trismus assessments
  • Xerostomia assessments
  • Oral mucositis daily questionnaire / analgesic recording
  • Record use and/or placement of gastrostomy tube (if applicable)
  • Review of unscheduled office visits
  • ER visits
  • Or hospitalizations
  • Placement of indwelling venous catheters
  • Blood draws for lab safety
  • PK samples
  • Cytokines
  • And RNA
  • Dosing with GC4419 IP for 35 treatments (if applicable per randomization).


You will be reimbursed $35 per study related visit to assist with parking and travel expenses.

Contact Information

Study Coordinator
Sharon Averill
[email protected]
Principal Investigator
Marcelo Bonomi, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.