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

NCT02324335 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CTIX-BRI-205
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 16

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.

Conditions

Head and Neck Neoplasms; Mucositis

Keywords

Oral Mucositis; Brilacidin; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• 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.

  7 weeks

Secondary Outcomes (3)

• Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]

  11 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)

  7 weeks

Study Arms (2)

Placebo Comparator Oral Rinse

PLACEBO COMPARATOR

Water for Injection

Other: Placebo

Active Comparator Oral Rinse

ACTIVE COMPARATOR

Brilacidin 3 mg/mL in Water for Injection

Drug: Brilacidin

Interventions

Brilacidin DRUG

Oral Rinse used 3 times daily for 7 weeks

Also known as: PMX30063

Active Comparator Oral Rinse

Placebo OTHER

Also known as: Water for Injection

Placebo Comparator Oral Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovation Pharmaceuticals, Inc.: lead

Study Sites (16)

Unknown Facility

Gilbert, Arizona, 85234, United States

Location

Unknown Facility

Lakeland, Florida, 33805, United States

Location

Unknown Facility

Columbus, Georgia, 31904, United States

Location

Unknown Facility

Louisville, Kentucky, 40207, United States

Location

Unknown Facility

Shreveport, Louisiana, 71103, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87131, United States

Location

Unknown Facility

Cheektowaga, New York, 14225, United States

Location

Unknown Facility

Poughkeepsie, New York, 11794, United States

Location

Unknown Facility

Rochester, New York, 14642, United States

Location

Unknown Facility

Stony Brook, New York, 11794, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Toledo, Ohio, 43623, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19140, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis; Stomatitis

Interventions

brilacidin; Water; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Arthur P. Bertolino MD, PhD, MBA
• Organization: Innovation Pharmaceuticals Inc.

abertolino@IPharmInc.com

978.921.4125

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 24, 2014
• Study Start: August 14, 2014
• Primary Completion: October 25, 2017
• Study Completion: November 22, 2017
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)