EUCTR2011-005226-21-GB进行中（未招募）1 期
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated with Ruxolitinib and with a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
- •Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days and discontinued the treatment for at least 30 days prior to study entry
- •MF classified as high-risk or intermediate-risk level 2 (IWG-MRT response criteria IPSS assess myelofibrosis score, Cervantes, et al, Blood 2009)
- •Spleen =5 cm below costal margin as measured by palpation
- •Male and female subjects =18 years of age
- •Signed written informed consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Splenectomy
- •Eastern Cooperative Oncology Group (ECOG) performance status of >2 at study entry
- •The following laboratory values within 14 days prior to the initiation of SAR302503:
- •Absolute Neutrophil Count (ANC) <1.0 x 10exp9/L
- •Platelet count <50 x 10exp9/L
- •Serum creatinine >1.5 x Upper limit of normal (ULN)
- •Serum amylase and lipase >1.5 x ULN
- •Direct bilirubin >2.0 x ULN
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN; higher values (ie, >5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis
- •Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years
- •Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503
- •Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503
研究者
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