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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02324335
Recruitment Status : Completed
First Posted : December 24, 2014
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Innovation Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 17, 2014
First Posted Date  ICMJE December 24, 2014
Results First Submitted Date  ICMJE October 17, 2018
Results First Posted Date  ICMJE January 16, 2019
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE August 14, 2014
Actual Primary Completion Date October 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
Efficacy Assessed by Sequential WHO Oral Mucositis Score [ Time Frame: 11 weeks ]
Efficacy of the study drug oral rinse will be assessed by trained site personnel twice-weekly. The WHO OM Score will be the primary measure for assessment of presence and severity of OM.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
  • Mouth and Throat Soreness [ Time Frame: 7 weeks ]
    Mouth and throat soreness will be assessed twice weekly using OMDQ Question #2
  • Analgesic Consumption [ Time Frame: 7 weeks ]
    Analgesic consumption for pain due to Oral Mucositis
  • Quality of Life (QOL) [ Time Frame: 7 weeks ]
    Quality of Life
  • Use of Gastrostomy Tube (G-tube) [ Time Frame: 7 weeks ]
    Use of gastrostomy tube (G-tube) for nutritional support due to OM
  • Number of Unplanned Office Visits [ Time Frame: 7 weeks ]
    Number of Unplanned Office visits, emergency department visits, and hospital admissions due to OM
  • Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule [ Time Frame: 7 weeks ]
    Incidence of Unplanned Delays in Chemotherapy and/or RT Schedule due to OM
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Neoplasms
  • Mucositis
Intervention  ICMJE
  • Drug: Brilacidin
    Oral Rinse used 3 times daily for 7 weeks
    Other Name: PMX30063
  • Other: Placebo
    Other Name: Water for Injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo Comparator Oral Rinse
    Water for Injection
    Intervention: Other: Placebo
  • Active Comparator: Active Comparator Oral Rinse
    Brilacidin 3 mg/mL in Water for Injection
    Intervention: Drug: Brilacidin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2014)
Actual Study Completion Date  ICMJE November 22, 2017
Actual Primary Completion Date October 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to read, understand and sign an informed consent form (ICF)
  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:

  1. Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, glottic larynx, subglottic larynx or unknown primary tumor
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02324335
Other Study ID Numbers  ICMJE CTIX-BRI-205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovation Pharmaceuticals, Inc.
Study Sponsor  ICMJE Innovation Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innovation Pharmaceuticals, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP