Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Purpose
The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.
Conditions
- Systemic Mastocytoses, Indolent
- Systemic Mastocytoses, Aggressive
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Able to provide written informed consent and commit to EAP assessments. - ≥18 years of age. - Able to swallow tablets. - Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM - Not receiving adequate disease control on current therapy(ies). - Have clinically acceptable laboratory screening results.
Exclusion Criteria
- Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial. - Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent. - Pregnant or currently breastfeeding. - Prior or ongoing clinically significant illness or medical or physical condition Other protocol-defined criteria apply.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Orso Health/Modena Asthma Allergy
La Jolla, California 92037
La Jolla, California 92037
Scripps Green Hospital
La Jolla, California 92037
La Jolla, California 92037
UCLA Ronald Reagan Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
Sneeze Wheeze & Itch Associates LLC Clinical Research Center
Normal, Illinois 61761
Normal, Illinois 61761
Contact:
Stephanie Oliver
309-451-7509
Stephanie Oliver
309-451-7509
AllerVie Health
Glenn Dale, Maryland 20769
Glenn Dale, Maryland 20769
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Michigan Medicine- University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Duke Blood Cancer Center
Durham, North Carolina 27705
Durham, North Carolina 27705
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT06915766
- Status
- Available
- Sponsor
- Cogent Biosciences, Inc.