- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02324335
Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (Brilacidin)
January 15, 2019 updated by: Innovation Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Gilbert, Arizona, United States, 85234
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-
Florida
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Lakeland, Florida, United States, 33805
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Georgia
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Columbus, Georgia, United States, 31904
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-
Kentucky
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Louisville, Kentucky, United States, 40207
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Louisiana
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Shreveport, Louisiana, United States, 71103
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Missouri
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Saint Louis, Missouri, United States, 63110
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New Mexico
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Albuquerque, New Mexico, United States, 87131
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New York
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Cheektowaga, New York, United States, 14225
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Poughkeepsie, New York, United States, 11794
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Rochester, New York, United States, 14642
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Stony Brook, New York, United States, 11794
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Ohio
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Cleveland, Ohio, United States, 44106
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Toledo, Ohio, United States, 43623
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
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South Carolina
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Charleston, South Carolina, United States, 29425
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing and able to read, understand and sign an informed consent form (ICF)
- Have recently diagnosed (within previous 6 months) pathologically confirmed, non-metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx that will be treated with CRT therapy as first line non-surgical treatment. Scans (CT, PET, and/or MRI) obtained within 120 days prior to consent for screening can be used to determine the subject's eligibility.
- Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose ≥55 Gy and ≤72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate). [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]
- Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. However, potential subjects with an ECOG of 3 may be enrolled provided their condition does not preclude performing the actions required by study participation (e.g., opening medication bottles, swishing the oral rinse and spitting out, completing or participating in completion of daily diaries and FACT-H&N forms).
- Have adequate hematopoietic, hepatic, and renal function at a screening visit
- Urine or serum pregnancy test: negative for female patients of childbearing potential
- Agree to utilize medically accepted methods of birth control during study participation and for 90 days following the last treatment with study drug if a female subject is of childbearing potential or if a male subject has an opposite sex partner of child bearing potential.
- Males or females aged ≥18 years on day of consent.
Exclusion Criteria:
- Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
- Has metastatic disease (M1) Stage IV C
- Has had prior radiation to the head and neck
- Plan to be treated with cetuximab (Erbitux®)
- Planned use of cisplatin as induction chemotherapy.
- Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
- Has had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for major surgical procedure during the course of the study
- Has incompletely healed sites of dental extractions
- Has an 12-lead ECG obtained at screening visit which shows medically significant abnormality(ies) (e.g. left bundle branch block, frequent premature ventricular contractions, QTc interval prolongation > 450 msec for males and > 470 msec for females)
- Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
- Has active infectious disease undergoing systemic treatment excluding oral candidiasis
- Has oral mucositis (of any severity) prior to initiation of radiation therapy
- Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
- Has known seropositivity for HIV or hepatitis C antibody, or known to be hepatitis B surface antigen positive (testing for these serologic markers is not required for enrollment in this protocol)
- Use of any investigational agent within 30 days of randomization
- Is pregnant or breastfeeding
- Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
- Has inability to give informed consent or comply with study requirements
- Has any other condition or prior therapy that in the opinion of the Investigator would make the patient unsuitable for the study and/or unable to comply with requirements for follow-up visits.
- Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Comparator Oral Rinse
Water for Injection
|
Other Names:
|
Active Comparator: Active Comparator Oral Rinse
Brilacidin 3 mg/mL in Water for Injection
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Oral Rinse used 3 times daily for 7 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy
Time Frame: 7 weeks
|
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.
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]
Time Frame: 11 weeks
|
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.
|
11 weeks
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Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days
Time Frame: 7 weeks
|
Incidence of severe oral mucositis (WHO Grade ≥3) for subjects receiving cisplatin every 21 days
|
7 weeks
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Time to Onset of Severe Oral Mucositis (WHO Grade ≥3)
Time Frame: 7 weeks
|
Time to onset of severe oral mucositis (WHO Grade ≥3) analyzed using Kaplan-Meier methods.
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7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2014
Primary Completion (Actual)
October 25, 2017
Study Completion (Actual)
November 22, 2017
Study Registration Dates
First Submitted
December 17, 2014
First Submitted That Met QC Criteria
December 19, 2014
First Posted (Estimate)
December 24, 2014
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 15, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTIX-BRI-205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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