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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
    • Florida
      • Lakeland, Florida, United States, 33805
    • Georgia
      • Columbus, Georgia, United States, 31904
    • Kentucky
      • Louisville, Kentucky, United States, 40207
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Cheektowaga, New York, United States, 14225
      • Poughkeepsie, New York, United States, 11794
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Toledo, Ohio, United States, 43623
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Comparator Oral Rinse
Water for Injection
Other: Placebo
Other Names:
  • Water for Injection
Active Comparator: Active Comparator Oral Rinse
Brilacidin 3 mg/mL in Water for Injection
Drug: Brilacidin
Oral Rinse used 3 times daily for 7 weeks
Other Names:
  • PMX30063

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovation Pharmaceuticals, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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