(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis, ISM, BMM, Smoldering Systemic Mastocytosis, Bone Marrow Mastocytosis
In brief
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. Additionally, a substudy of subjects will investigate the efficacy, safety, and tolerability of bezuclastinib in patients who are experiencing inadequate symptom control with avapritinib.
Key facts
- Study ID
- NCT05186753
- Run by
- Cogent Biosciences, Inc.
- People needed
- 237
- Starts
- 2022-06-27
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- University of South Florida — Tampa, 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
- Institute for Asthma and Allergy — Wheaton, 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
- Washington University at St. Louis — St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, 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
- Metrodora Institute of Technology — West Valley City, Utah, United States
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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