Spots Global Cancer Trial Database for (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
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Trial Identification
Brief Title: (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
Official Title: A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of The Safety and Efficacy of CGT9486 in Subjects With Nonadvanced Systemic Mastocytosis
Study ID: NCT05186753
Study Description
Brief Summary: This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
One of a Kind Clinical Research Center, Scottsdale, Arizona, United States
Modena Allergy and Asthma Clinical, La Jolla, California, United States
Innovative Research of West Florida, Clearwater, Florida, United States
Maya Research Center, Hialeah, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Emory University, Atlanta, Georgia, United States
Rush University, Chicago, Illinois, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Allervie Clinical Research, Glenn Dale, Maryland, United States
Chesapeake Research Center, White Marsh, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic- Rochester, Rochester, Minnesota, United States
Washington University at St. Louis, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Duke University, Raleigh, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
AIR Care, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Antwerp University Hospital (UZA), Edegem, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
University of Alberta, Edmonton, Alberta, Canada
Toronto Allergy and Asthma Clinic, Toronto, Ontario, Canada
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
AP-HP- Hopital Pitie-Salpetriere, Paris, , France
CHU de Toulouse - Hopital Larrey, Toulouse, , France
Universitaetsklinikum Aachen, AoeR, Aachen, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
University Medical Centre Mannheim, Mannheim, , Germany
Attikon University General Hospital Athens, Athens, , Greece
St. James's Hospital, Dublin, , Ireland
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Policlinico Universitario Agostino Gemelli, Rome, , Italy
University Medical Center Groningen, Groningen, , Netherlands
Oslo University Hospital, Oslo, , Norway
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii, Gdańsk, , Poland
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Instituto de Estudios de Mastocitosis de Castilla La Mancha-Hospital Virgen del Valle, Toledo, , Spain
University Hospital Basel, Basel, , Switzerland
Guy's Hospital, London, , United Kingdom
Contact Details
Name: Rachael Easton, MD, PhD
Affiliation: Cogent Biosciences
Role: STUDY_DIRECTOR
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