Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion. The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.

Key facts

Study ID

NCT03234465

Run by

Oragenics, Inc.

People needed

200

Starts

2017-07-18

Expected to finish

2020-07-13

Last updated by the study team

2020-11-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to understand and sign the study specific Informed Consent Form
• Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx or hypopharynx or HPV-positive unknown primaries presumed to be of oropharyngeal, nasopharyngeal or hypopharyngeal origin
• Tumor HPV status established
• Planned to receive either primary or post-operative CRT
• Planned IMRT (Intensity-Modulated Radiotherapy)
• Planned administration of cisplatin administered weekly or tri-weekly during RT
• Males or females 21 years or older
• Karnofsky performance score (KPS) ≥ 70%
• Screening laboratory assessments:
• Hemoglobin ≥ 10g/dl
• White blood count ≥ 3500 cells/mm3
• Absolute neutrophil counts ≥ 1500 cells/ mm3
• Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 3 x ULN
• Calculated Creatinine Clearance ≥ 50 ml/min
• Negative pregnancy test (serum or urine) for females of childbearing potential performed 7 days before IMP (Investigational Medicinal Product) administration.
• Subjects of childbearing potential must confirm to use an effective method of birth control during study participation and for 30 days following the last treatment with IMP. Male subjects, when having hetero-sexual intercourse with a female of childbearing potential must use a condom during study participation and 90 days following the last treatment with IMP and their partner should use an effective method of birth control during that period as well.

You may not qualify if…

• Prior radiation to the head and neck
• Increased risk of developing infectious endocarditis
• Prior gene therapy
• Presence of active infectious oral disease
• Presence of any oral lesions that may confound the ability to assess oral mucositis grade
• Current use of antibiotic rinses or troches
• Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study
• Current alcohol abuse syndrome
• Chronic immunosuppression
• Known seropositive for HIV
• Use of investigational agent within 30 days of signing informed consent
• Tooth extraction prior to radiation in which the extraction site is not epithelialized
• Signs and symptoms of active dental disease
• Female subjects who are pregnant or nursing
• Known allergy to excipients of the IMP
• Inability to give informed consent or comply with study requirements
• Unwilling or unable to complete subject diary
• Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States
• Helen F. Graham Cancer Center — Newark, Delaware, United States
• UF Health Cancer Center — Orlando, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• St. Vincent Anderson Regional, Cancer Center — Anderson, Indiana, United States
• Norton Cancer Institute, Multicisciplinary Clinic — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Willis-Knighton Cancer Center — Shreveport, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Comprehensive Cancer Centers of Nevada-Henderson — Henderson, Nevada, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics — Lake Success, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center, Albert Einstein College of Medicine, Department of Radiation Oncology — The Bronx, New York, United States
• Caromont Regional Medical Center — Gastonia, North Carolina, United States
• East Carolina Univ School of Dental Medicine — Greenville, North Carolina, United States
• Mercy Medical Center — Canton, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Temple University Hospital, Radiation Oncology — Philadelphia, Pennsylvania, United States
• UPMC Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• Radiation Oncology Moser — Charlottesville, Virginia, United States
• PeaceHealth St. Joseph Medical Center — Bellingham, Washington, United States

Full record on ClinicalTrials.gov

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