Determination of Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
- Conditions
- Oral mucositis (OM) induced by chemoradiation therapy (CRT) used for the treatment of head and neck cancers (HNC)MedDRA version: 20.0Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2016-004161-68-BE
- Lead Sponsor
- Oragenics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
-Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx or unknown primary HPV-positive tumor presumed to be of oropharyngeal 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;
Direct bilirubin = 2x upper limit of normal (ULN);
Serum AST and ALT = 3 x ULN;
Calculated Creatinine Clearance of 50 ml/min;
Pregnancy test (serum or urine): negative for females of childbearing potential: a female is considered to be of child bearing potential unless she has had a tubal ligation or is postmenopausal (without a menstrual period for at least one year)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1.Prior radiation to the head and neck
2.Presence of active infectious oral disease excluding oral candidiasis
3.Presence of any oral lesions that may confound the ability to assess oral mucositis grade
4.Current use of antibiotic rinses or troches
5.Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study.
6.Current alcohol abuse syndrome
7.Chronic immunosuppression
8.Known seropositive for HIV
9.Use of investigational agent within 30 days of signing informed consent
10.Tooth extraction prior to radiation
11.Signs and symptoms of active dental disease
12.Female subjects who are pregnant or nursing
13.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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method