A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts * 50 x109/L and <100 x109/L (CINC424A2201) - CINC424A2201

ovartis Pharma BV0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•* 18 years of age or older
•* Diagnosed with Primary Myelofibrosis (MF), Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia-Myelofibrosis irrespective of JAK2 mutation status, guided by the criteria outlined in the 2008 WHO criteria for PMF.
•* MF requiring therapy must be classified at least as intermediate risk level 1, as defined by the International Working Group (see protocol page 42 for details).
•* Palpable spleen of at least 5 cm.
•* Active symptoms of MF (see protocol page 42 for details).
•* Baseline PLT count < 100 x 109/L and * 75 x 109/L (first stratum) and PLT count < 75 x 109/L and * 50 x 109/L (second stratum).
•* INR and PTT < 1.5 x ULN.
•* ECOG performance status 0, 1, 2.

•* Pregnant or nursing women.
•* Patients of childbearing potential who are unwilling to take appropriate contraceptive measures.
•* Treatment with hematopoietic growth factor receptor agonists for at least 30 days prior to receiving the first dose of study drug.
•* Any history of PLT counts <45 x 109/L within 30 days prior to Screening. See protocol page 43 for exceptions.
•* Any history or predisposition to clinically significant bleeding, platelet dysfunction and/or bleeding diathesis.
•* Treated concurrently with a potent systemic inhibitor or a potent systemic inducer of CYP3A4.
•* Life expectancy of less than 6 months.

发起方

ovartis Pharma BV