A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With BMX-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
Principal Investigator
,
Co-Principal Investigator(s)
Sue Yom, MD PhD
Status
Open to Accrual
Date Opened To Accrual
December 16 2024
Disease Site
Head and Neck [HN]
Other
Phase
II
Developmental Therapeutics
Yes
Primary Objective
To compare the incidence of severeoral mucositis (SOM) between BMX-001 and placebo, defined as ≥ Grade 3 per WHOcriteria from the start of radiation through 4 weeks after completion of studytreatment, with additional assessments at 6, 8 and 12 weeks after completion ofstudy treatment.
Patient Population
- Patientsmust be planned to receive radiation and concurrent cisplatin chemotherapy asdefinitive therapy. Patients planned to receive concurrent cisplatin andradiation therapy in the adjuvant setting are not eligible.
- Pathologically confirmed (histologically orcytologically) squamous cell carcinoma of the oropharynx, larynx, hypopharynx,nasopharynx, or oral cavity.
Target Accrual
98
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.