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Brief Title: Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
Official Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Study ID: NCT03234465
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 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.
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 formulation of Lactococcus lactis strain sAGX0085, deficient in the gene coding for thymidylate synthase and producing human TFF1 (Trefoil Factor 1). Approximately 200 subjects will be enrolled in the study. To protect subjects from unanticipated safety risks, enrollment and treatment in the double-blind study will continue until 10 subjects on AG013 have been recruited. The Data Safety Monitoring Board (DSMB) will review safety data after these 10 subjects on AG013 have completed study treatment. If there are no safety signals identified, the study will continue to recruit the planned number of subjects. There are 4 study periods as described below: screening, active treatment, short term follow-up and long term follow-up. The screening phase will be no longer than 4 weeks. The active treatment phase will be between 7 and 9 weeks depending on the subject's prescribed CRT (chemoradiation therapy) plan. The short term follow-up phase will be 4 weeks in duration. The long term follow-up will continue until 12 months post CRT. Oral mucositis (OM) assessments will begin at the start of CRT and continue until the subject has completed short term follow-up or until the OM resolves (as defined by a WHO (World Health Organization) score of ≤ 1), whichever comes first. Long term follow-up will continue for 12 months to assure that AG013 does not adversely impact the tumor response to anti-neoplastic therapy.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Montefiore Medical Center, Albert Einstein College of Medicine, Department of Radiation Oncology, Bronx, New York, 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
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
Multicare Health Center, Gig Harbor, Washington, United States
Cancer Care NW, Spokane, Washington, United States
Jules Bordet Institute, Brussels, , Belgium
University Hospital Brussels, Brussels, , Belgium
University Hospital Antwerp, Edegem, , Belgium
University Hospitals Leuven, Leuven, , Belgium
St. Maarten General Hospital, Mechelen, , Belgium
University Hospital Aachen, Aachen, , Germany
Amper Hospital, Dachau, , Germany
University Hospital Freiburg, Freiburg, , Germany
University Hospital Giessen and Marburg, Gießen, , Germany
Hospital Kassel, Kassel, , Germany
University Hospital Schleswig-Holstein, Kiel, , Germany
Helios Hospital Krefeld, Krefeld, , Germany
University Hospital Johannes Gutenberg - University of Mainz, Mainz, , Germany
University Hospital Mannheim, Mannheim, , Germany
Ludwig Maximilians University Hospital, Munich, , Germany
Clinics Maria Hilf - Hospital St. Franziskus, Mönchengladbach, , Germany
University Hospital Regensburg, Regensburg, , Germany
Caritas Klinikum, Saarbrücken, , Germany
Derriford Hospital, Plymouth, Devon, United Kingdom
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
Guy's Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Name: Alan Joslyn, Ph.D.
Affiliation: Sponsor GmbH
Role: STUDY_DIRECTOR