MedTrace Logo

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

NCT03234465 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-11-23

Study results available
· View outcomes & findings →

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 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.

Conditions

  • Oral Mucositis

Interventions

BIOLOGICAL

AG013

AG013 is made up of genetically modified (GM) bacteria called Lactococcus lactis (L. lactis). Wild type L. lactis are commonly used to produce dairy products including cheeses and milk. To make AG013, the DNA of L. lactis has been changed in the laboratory to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted in saliva and intestines. Trefoil factors have been shown to be important in protecting and healing mucosal tissues, such as the tissue in the mouth, when these tissues are damaged by cancer therapies such as chemotherapy and radiation therapy.

OTHER

Placebo

Subjects assigned to the placebo group will receive appearance- and taste-matched placebo powder.

Sponsors & Collaborators

  • Oragenics, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan Joslyn, Ph.D. · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2020-03-31
Completion
2020-07-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234465 on ClinicalTrials.gov