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Brief Title: (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Official Title: A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis
Study ID: NCT04996875
Brief Summary: This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UCLA Medical Center, Los Angeles, California, United States
Stanford Cancer Institute, Stanford, California, United States
Galiz Research, Hialeah, Florida, United States
Winship Cancer Institute - Emory University, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Columbia University Irving Medical Center, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
MUSC Health University Medical Center, Charleston, South Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute - University of Utah Health, Salt Lake City, Utah, United States
Nepean Hospital, Kingswood, New South Wales, Australia
Gold Coast University Hospital, Southport, Queensland, Australia
Peter MacCallum Cancer Centre, Melbourne N., Victoria, Australia
AKH Wien, Universitatsklinikum, Vienna, , Austria
CHU de Liege, Liège, , Belgium
University of Alberta Hospital, Edmonton, Alberta, Canada
St. Michael's Hospital - Unity Health Toronto, Toronto, Ontario, Canada
Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, , France
Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse, , France
University Hospital Aachen, Aachen, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Mannheim, Mannheim, , Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, , Italy
University Medical Center Groningen, Groningen, , Netherlands
Oslo University Hospital, Oslo, , Norway
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Universitätsspital Basel, Basel, , Switzerland
University College London Hospital - NHS Foundation Trust, London, , United Kingdom
Guy's Hospital - NHS Foundation Trust, London, , United Kingdom
Name: Rachael Easton, MD, Ph.D.
Affiliation: Cogent Biosciences, Inc.
Role: STUDY_DIRECTOR