A Randomized Study of the JAK Inhibitor INCB018424 Tablets Compared to Best Available Therapy in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) - COMFORT II

Incyte Corporation0 个研究点目标入组 150 人开始时间: 2009年7月2日最近更新: 2015年10月19日

适应症

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•Male or female subjects, aged 18 years or older, with diagnosis of PMF, PPV-MF or PET-MF. Subjects with a palpable spleen length of 5 cm or greater below the costal margin Subjects must have either 2 (Intermediate risk) or 3 or more (High risk) prognostic factors (Cervantes et al, 2008). These prognostic factors are: a) Age > 65 yrs b) Presence of constitutional symptoms (weight loss, fever, night sweats) c) Marked anemia (Hgb < 10g/dL) d) Leukocytosis (history of WBC > 25 x 109/L) e) Circulating blasts ≥ 1% Subjects with peripheral blood blasts of < 10% Subjects must have been on a stable therapeutic regimen for at least 2 weeks before Screening and at least 4 weeks prior to Baseline.
•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

•Subjects with a life expectancy of < 6 months. Subjects with inadequate bone marrow reserve as follows: a) Absolute neutrophil count (ANC) that is ≤ 1000/?L. b) Platelet count that is < 100,000/?L without the assistance of growth factors, thrombopoietic factors or platelet transfusions. Subjects with any history of platelet counts < 50,000/?L or ANC < 500/?L except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason. Subjects having clinically significant infections or current malignancies.

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