Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorCogent Biosciences, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bezuclastinib
Treatment groups
No treatment groups listed
Locations
23California
Orso Health/Modena Asthma Allergy92037, La Jolla United States
Scripps Green Hospital92037, La Jolla United States
UCLA Ronald Reagan Medical Center90095, Los Angeles United States
Illinois
Sneeze Wheeze & Itch Associates LLC Clinical Research Center61761, Normal United States
Sponsors and collaborators
Cogent Biosciences, Inc.
Lead sponsor
Source ClinicalTrials.gov