Status:
TERMINATED
Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
Lead Sponsor:
Oragenics, Inc.
Conditions:
Oral Mucositis
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a Phase 2, double-blind, placebo-controlled, 2-arm, multi-center trial in which subjects will be randomized in a 1:1 ratio to receive either placebo or AG013. AG013 is a mouth rinse formulatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03234465
Start Date
July 18 2017
End Date
July 13 2020
Last Update
November 23 2020
Active Locations (50)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
2
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
3
UF Health Cancer Center
Orlando, Florida, United States, 32806
4
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904