200
Participants
Start Date
July 18, 2017
Primary Completion Date
March 31, 2020
Study Completion Date
July 13, 2020
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.
Placebo
Subjects assigned to the placebo group will receive appearance- and taste-matched placebo powder.
Jules Bordet Institute, Brussels
University Hospital Brussels, Brussels
University Hospital Antwerp, Edegem
St. Maarten General Hospital, Mechelen
University Hospitals Leuven, Leuven
Montefiore Medical Center, Albert Einstein College of Medicine, Department of Radiation Oncology, The Bronx
Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics, Lake Success
University of Rochester Medical Center, Rochester
UPMC Shadyside Hospital, Pittsburgh
Temple University Hospital, Radiation Oncology, Philadelphia
Helen F. Graham Cancer Center, Newark
Radiation Oncology Moser, Charlottesville
University Hospital Schleswig-Holstein, Kiel
Caromont Regional Medical Center, Gastonia
Columbus Regional Research Institute, Columbus
UF Health Cancer Center, Orlando
Hospital Kassel, Kassel
University Hospital Giessen and Marburg, Giessen
Norton Cancer Institute, Multicisciplinary Clinic, Louisville
Clinics Maria Hilf - Hospital St. Franziskus, Mönchengladbach
Ohio State University Comprehensive Cancer Center, Columbus
Mercy Medical Center, Canton
St. Vincent Anderson Regional, Cancer Center, Anderson
Helios Hospital Krefeld, Krefeld
University Hospital Aachen, Aachen
University Hospital Johannes Gutenberg - University of Mainz, Mainz
Decatur Memorial Hospital, Decatur
University Hospital Mannheim, Mannheim
Ochsner Clinic Foundation, New Orleans
Willis-Knighton Cancer Center, Shreveport
University of Texas MD Anderson Cancer Center, Houston
University Hospital Freiburg, Freiburg im Breisgau
Ludwig Maximilians University Hospital, Munich
Huntsman Cancer Hospital, Salt Lake City
Amper Hospital, Dachau
Caritas Klinikum, Saarbrücken
Comprehensive Cancer Centers of Nevada-Henderson, Henderson
Renown Regional Medical Center, Reno
University Hospital Regensburg, Regensburg
PeaceHealth St. Joseph Medical Center, Bellingham
Multicare Health Center, Gig Harbor
Cancer Care NW, Spokane
University of Connecticut Health Center, Farmington
University of Michigan, Ann Arbor
East Carolina Univ School of Dental Medicine, Greenville
Derriford Hospital, Plymouth
Beatson West of Scotland Cancer Center, Glasgow
Guy's Hospital, London
The Christie NHS Foundation Trust, Manchester
Royal Cornwall Hospital, Truro
Lead Sponsor
Oragenics, Inc.
INDUSTRY