Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
NCT ID: NCT02324335
Last Updated: 2019-01-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2014-08-14
2017-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Comparator Oral Rinse
Water for Injection
Placebo
Active Comparator Oral Rinse
Brilacidin 3 mg/mL in Water for Injection
Brilacidin
Oral Rinse used 3 times daily for 7 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brilacidin
Oral Rinse used 3 times daily for 7 weeks
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. 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). \[Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria\]
4. 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)
5. 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).
6. Have adequate hematopoietic, hepatic, and renal function at a screening visit
7. Urine or serum pregnancy test: negative for female patients of childbearing potential
8. 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.
9. Males or females aged ≥18 years on day of consent.
Exclusion Criteria
2. Has metastatic disease (M1) Stage IV C
3. Has had prior radiation to the head and neck
4. Plan to be treated with cetuximab (Erbitux®)
5. Planned use of cisplatin as induction chemotherapy.
6. Has a history of other malignant tumors within the last 5 years, except non melanoma skin cancer or in situ cervical carcinoma curatively excised
7. 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
8. Has incompletely healed sites of dental extractions
9. 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)
10. Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
11. Has active infectious disease undergoing systemic treatment excluding oral candidiasis
12. Has oral mucositis (of any severity) prior to initiation of radiation therapy
13. Has a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression
14. 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)
15. Use of any investigational agent within 30 days of randomization
16. Is pregnant or breastfeeding
17. Has known allergies or intolerance to brilacidin, cisplatin or carboplatin
18. Has inability to give informed consent or comply with study requirements
19. 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.
20. Is unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study period
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovation Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gilbert, Arizona, United States
Lakeland, Florida, United States
Columbus, Georgia, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Cheektowaga, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Stony Brook, New York, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTIX-BRI-205
Identifier Type: -
Identifier Source: org_study_id