EUCTR2021-001010-10-NO进行中（未招募）1 期
A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee:
- •a. Aggressive Systemic Mastocytosis (ASM)
- •b. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
- •c. Mast Cell Leukemia (MCL)
- •2. Measurable disease according to modified IWG-MRT-ECNM criteria
- •3. ECOG Status 0 to 3
- •4. Have clinically acceptable laboratory screening results (clinical chemistry, hematology) within certain limits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Persistent toxicity from previous therapy for Advanced Systemic Mastocytosis that has not resolved to = Grade 1
- •2. Associated hematologic neoplasm requiring immediate antineoplastic therapy
- •3. Clinically significant cardiac disease
- •4. Known positivity for the FIP1L1 PDGFRA fusion (patients with eosinophilia without detectable KIT D816V mutation must also lack the PDGFRA fusion mutation prior to enrolment)
- •5. Seropositive for human immunodeficiency virus (HIV) 1 or 2, positive for hepatitis B surface antigen, or positive for hepatitis C virus (HCV) antibody
- •6. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
- •7. Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
- •8. 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
- •9. Received hematopoietic growth factor support within 14 days before the first dose of study drug.
- •10. Received strong CYP3A4 inhibitors or inducers before the first dose of study drug
- •11. Need for treatment with steroids
研究者
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