Head and Neck NeoplasmsPhase 2BrilacidinNCT02324335
Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
A Phase 2 study testing Brilacidin in people with Head and Neck Neoplasms and Mucositis, run by Innovation Pharmaceuticals, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Mucositis
- What is being tested?
- Brilacidin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 16 sitesUnited States
- Study dates
- 14 Aug 2014to 22 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Charleston, South Carolina, 29425
Study site
Cheektowaga, New York, 14225
Study site
Cleveland, Ohio, 44106
Study site
Columbus, Georgia, 31904
Study site
Gilbert, Arizona, 85234
Study site
Lakeland, Florida, 33805
Study site
Louisville, Kentucky, 40207
Study site
Milwaukee, Wisconsin, 53211
Study site
Philadelphia, Pennsylvania, 19140
Study site
Poughkeepsie, New York, 11794
Study site
Rochester, New York, 14642
Study site
Shreveport, Louisiana, 71103
Study site
St Louis, Missouri, 63110
Study site
Stony Brook, New York, 11794
Study site
Toledo, Ohio, 43623
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Mucositis
- Being tested
- Brilacidin, Placebo
- Keywords
- Oral Mucositis, Brilacidin, Chemoradiation
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrilacidinDrug
Also called PMX30063
Oral Rinse used 3 times daily for 7 weeks
PlaceboOther
Also called Water for Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator Oral Rinse | Placebo comparator | Water for Injection Receives: Other: Placebo |
| Active Comparator Oral Rinse | Active comparator | Brilacidin 3 mg/mL in Water for Injection Receives: Drug: Brilacidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy
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.
Measured: 7 weeks
Secondary outcomes (3)
Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]
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.
Measured: 11 weeks
Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days
Incidence of severe oral mucositis (WHO Grade ≥3) for subjects receiving cisplatin every 21 days
Measured: 7 weeks
Time to Onset of Severe Oral Mucositis (WHO Grade ≥3)
Time to onset of severe oral mucositis (WHO Grade ≥3) analyzed using Kaplan-Meier methods.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start14 Aug 2014
- Primary completion25 Oct 2017
- Study completion22 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324335
- Sponsor's protocol ID
- CTIX-BRI-205
- Acronym
- Brilacidin
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2014
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02324335
- Acronym / sponsor ID
- Brilacidin / CTIX-BRI-205
- Conditions
- Head and Neck Neoplasms, Mucositis
- Keywords
- Oral Mucositis, Brilacidin, Chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Innovation Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator Oral Rinse | Placebo comparator | Other: PlaceboWater for Injection |
| Active Comparator Oral Rinse | Active comparator | Drug: BrilacidinBrilacidin 3 mg/mL in Water for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrilacidinAlso: PMX30063Oral Rinse used 3 times daily for 7 weeks | Drug | Active Comparator Oral Rinse |
| PlaceboAlso: Water for Injection | Other | Placebo Comparator Oral Rinse |
Primary outcome
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.
3 secondary outcomes
Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]
Time frame: 11 weeks
Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days
Time frame: 7 weeks
Time to Onset of Severe Oral Mucositis (WHO Grade ≥3)
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brilacidin in people with Head and Neck Neoplasms and Mucositis, run by Innovation Pharmaceuticals, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.