Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Anti-Infective Agents

All Drugs and Chemicals

Brilacidin

Brilacidin 3 mg/mL in Water for Injection

Oral Rinse used 3 times daily for 7 weeks

Placebo

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.

This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.

Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer

Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation

Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The higher the score the more severe the mucositis.

Overall duration of severe OM was defined as the number of days from initial WHO Grade ≥3 during radiation therapy to the day prior to the next OM assessment after the last WHO Grade ≥3 during/after radiation therapy.

Incidence of severe oral mucositis (WHO Grade ≥3) for subjects receiving cisplatin every 21 days

Time to onset of severe oral mucositis (WHO Grade ≥3) analyzed using Kaplan-Meier methods.

Innovation Pharmaceuticals, Inc.

Non-Serious AEs Treatment Emergent AEs are presented as those events that were experienced by at least 5 (17%) Subjects in any one Treatment Group and with a Difference in Incidence between Groups of at least 3 (10%) Subjects,

Water for Injection

Placebo: Oral Rinse used 3 times daily for 7 weeks

Placebo Oral Rinse

Brilacidin 3 mg/mL in Water for Injection

Brilacidin: Oral Rinse used 3 times daily for 7 weeks

Active Oral Rinse

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This is the Safety Population. Same as participant flow

Arthur P. Bertolino MD, PhD, MBA

mITT Population included all randomized subjects who received at least one dose of study drug and a cumulative radiation dose of at least 55 Gy (and no more than 72 Gy)

Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy

Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]

Subgroup of subjects receiving cisplatin every 21 days

Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days

Data is presented for all subjects (censored and uncensored) in the mITT population, with a censored outcome reported as "NA".

Spots Global Cancer Trial Database for brilacidin

Every month we try and update this database with for brilacidin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for brilacidin

Every month we try and update this database with for brilacidin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for brilacidin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.