EUCTR2011-001897-25-DE进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
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
- 性别
- All
入选标准
- •Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
- •MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria.
- •Enlarged spleen, palpable at least 5 cm below costal margin.
- •At least 18 years of age.
- •Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
- •The following laboratory values within 14 days prior to the initiation of IMP or placebo:
- •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
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
排除标准
- •Splenectomy.
- •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 IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
- •Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
- •Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
- •Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers
- •AST or ALT =2.5 x ULN
- •Total Bilirubin: Exclude if =3.0 x ULN
- •Subjects with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is =25% of the total
- •Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])
研究者
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