Spots Global Cancer Trial Database for Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)
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Trial Identification
Brief Title: Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)
Official Title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome
Study ID: NCT03703310
Conditions
Study Description
Brief Summary: This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.
Detailed Description: An open-label, extension safety and tolerability study is planned for at least 12 months duration following the end of this study. All participants who complete the Month 12 Exit Visit having demonstrated adequate compliance with application of the Investigational Product (IP) without major Protocol Deviations (PDs) during the study will be eligible for participation in the extension study. All participants will be contacted by phone approximately 30 days following the Exit or Discontinuation Visit to determine if the participant has experienced any new adverse events (AEs)/serious AEs (SAEs) since discontinuation/completion of study treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinical Cancer Center, Phoenix, Arizona, United States
Dermatology Center of Newport, Newport Beach, California, United States
Stanford University, Department of Dermatology, Redwood City, California, United States
University of California, San Francisco, San Francisco, California, United States
Yale School of Medicine, New Haven, Connecticut, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
Leavitt Medical Associates of Florida, Ormond Beach, Florida, United States
The University of Chicago, Chicago, Illinois, United States
Laser & Skin Surgery Center of Indiana, Carmel, Indiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Dept of Dermatology, Ann Arbor, Michigan, United States
University of Minnesota, Department of Dermatology, Minneapolis, Minnesota, United States
Saint Louis University Dermatology, Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Columbia University Medical Center, New York, New York, United States
Duke University, Durham, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah Midvalley Dermatology, Murray, Utah, United States
PellePharm Investigative Site, Brussels, , Belgium
PellePharm Investigative Site, Leuven, , Belgium
Clinical Trials Unit - The Skin Care Centre, Vancouver, British Columbia, Canada
Pellepharm Investigative Site, Toronto, , Canada
PellePharm Investigative Site, Copenhagen, , Denmark
Hopital Saint-Andre - CHU Bordeaux, Bordeaux Cedex, , France
CHRU de Lille - Hopital Claude HURIEZ, Lille Cedex, , France
CHU La Timone, Marseille, , France
PellePharm Investigative Site, Nantes, , France
Hopital Saint-Louis, Paris, , France
PellePharm Investigative Site, Pierre-Bénite, , France
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Klinik und Poliklinik fur Dermatologie und Allergologie, Munich, , Germany
Universitatsklinikum Münster, Münster, , Germany
Universitats Hautklinik, Tübingen, , Germany
Ospedale Vanvitelli-University della Campania-Dermatologia Edificio 9, Napoli, , Italy
Catholic University of the Sacred Heart, Roma, , Italy
Humanitas University Milan, Rozzano, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Maastricht University Medical Center - Dept of Dermatology, Maastricht, , Netherlands
Hospital Clinic I Provincial, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitiario Virgen de la Macarena, Sevilla, , Spain
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
Royal London Hospital, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Salford Royal Hospital, Salford, , United Kingdom
Contact Details
Name: VP, Clinical Operations
Affiliation: PellePharm, Inc.
Role: STUDY_DIRECTOR
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