A Phase 2 Study of LY2784544 in Patients with Myeloproliferative Neoplasms - JHTB

ELI LILLY AND COMPANY0 个研究点目标入组 188 人开始时间: 2012年9月3日最近更新: 2014年2月10日

适应症

试验速览

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•Patients must have a diagnosis of PV, ET, or MF as defined by the World Health Organization diagnostic criteria for MPNs. Patients must have discontinued all previous approved therapies for MPNs. Patients must be greater than 18 years of age and both males and females can be enrolled. Patients must have adequate bone marrow reserve: absolute neutrophil count =1000/mcL, platelets =50,000/mcL for patients with ET or PV, and =25,000/mcL for patients with MF.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 138
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Patients will be excluded if they have a corrected QT (QTc) interval >470 msec, are currently being treated with agents that are metabolized by CYP3A4 or CYP2B6 with a narrow therapeutic margin, are currently being treated with warfarin, have received a hematopoietic stem cell transplant, or have a history of congestive heart failure with New York Heart Association Class >2, unstable angina, recent myocardial infarction or documented history of ventricular arrhythmia.

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