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

Innovation Pharmaceuticals, Inc.0 sites61 target enrollmentAugust 14, 2014

ConditionsHead and Neck Neoplasms Mucositis

InterventionsPlacebo Brilacidin

DrugsBrilacidin

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Head and Neck Neoplasms
Sponsor: Innovation Pharmaceuticals, Inc.
Enrollment: 61
Primary Endpoint: Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 14, 2014

End Date

November 22, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Innovation Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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.

Arms & Interventions

Placebo Comparator Oral Rinse

Water for Injection

Intervention: Placebo

Active Comparator Oral Rinse

Brilacidin 3 mg/mL in Water for Injection

Intervention: Brilacidin

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)