(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis (NCT04996875) | Clinical Trial Compass
RecruitingPhase 2
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
United States140 participantsStarted 2021-11-09
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosed with one of the following advanced mastocytosis diagnoses by Eligibility Committee
✓. Aggressive Systemic Mastocytosis (ASM)
✓. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
✓. Mast Cell Leukemia (MCL)
✓. Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).
✓. ECOG (0 to 3)
✓. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Exclusion criteria
✕. Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1
✕. Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment
✕. Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
What they're measuring
1
Part I: Identify clinically active and tolerable exposures of bezuclastinib in patients with AdvSM
Timeframe: 18 months
2
Part II: - Determine efficacy of bezuclastinib as measured by mIWG Objective Response Rate (ORR) - Confirm the exposure-response relationship of bezuclastinib
. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
✕. Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
✕. Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy