NL-OMON53808尚未招募2 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 - A Study of CGT9486 in Patients With Advanced Systemic Mastocytosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 5
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
- 年龄范围
- 18 至 99（—）
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. (A subset of
- •patients inevaluble per mIWG-MRT-ECNM will be included in the study).
- •3. ECOG (0 to 3)
- •4. Have clinically acceptable local laboratory screening results (clinical
- •chemistry, hematology) within certain limits.
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 enrollment)
- •5. Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for
- •hepatitis B surface antigen or 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
- •11. Need for treatment with steroids
研究者
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