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Brief Title: A Study of AL102 in Patients With Progressing Desmoid Tumors
Official Title: RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors
Study ID: NCT04871282
Brief Summary: The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
Detailed Description: This is a Phase 2/3, randomized study in subjects with progressive desmoid tumors consisting of 2 parts. Phase2/Part A is an open-label, dose regimen finding study; Phase3/Part B is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Phase2/Part A.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
Sarcoma Oncology Research Center, Santa Monica, California, United States
University of California at Los Angeles Hematology/Oncology, Santa Monica, California, United States
Stanford University Medical Center, Stanford, California, United States
Mayo Clinic, Jacksonville, Florida, United States
NorthShore University Health System, Evanston, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Jefferson City Medical Group, Jefferson City, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
UTSW Simmons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Adelaide Cancer Centre, Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Universitair Ziekenhuis, Gent, , Belgium
Universitaire Ziekenhuizen Leuven, Leuven, , Belgium
Helios Klinikum Berlin-Buch, Berlin, , Germany
Mannheim university medical center, Mannheim, , Germany
Oncology Institute Barzilai Medical Center, Ashkelon, , Israel
Rambam MC, Haifa, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
IRCCS Istituto Ortopedico Rizzoli, Bologna, , Italy
IRCCS Fondazione Istituto Nazionale dei Tumori, Milano, , Italy
Campus Bio-Medico University Hospital, Rome, , Italy
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
ASAN Medical Center, Seoul, , Korea, Republic of
The Netherlands Cancer Institute, Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, , Poland
Vall d´Hebrón University Hospital, Barcelona, , Spain
Catalan Institute of Oncology (ICO), Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Western General Hospital, Edinburgh, Scotland, United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Name: Mrinal Gounder, MD
Affiliation: MSKCC
Role: PRINCIPAL_INVESTIGATOR