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Spots Global Cancer Trial Database for Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day

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Trial Identification

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

Conditions

Oral Mucositis

Interventions

AG013
Placebo

Study Description

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.

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Alan Joslyn, Ph.D.

Affiliation: Sponsor GmbH

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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