NCT00586651已完成2 期
An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation
Cephalon4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
研究概览
简要总结
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).
详细描述
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has polycythemia vera (PV) or essential thrombocytosis (ET).
- •The patient has a detectable JAK2 V617F mutation.
- •Patients with PV have at least 1 of the following risk factors:
- •neutrophil count greater than 7000/mm3
- •receiving hydroxyurea treatment
- •Patients with ET are receiving concomitant hydroxyurea.
- •The patient has an ECOG performance score of 0, 1, or 2.
排除标准
- •The patient has bilirubin levels or aspartate transaminases (AST) levels within exclusionary ranges.
- •patient has serum creatinine concentrations within exclusionary ranges.
- •patient has an untreated or progressive infection.
- •patient has any physical or psychiatric condition that may compromise participation in the study.
- •has a history of venous or arterial thrombosis within 6 months.
- •use of hydroxyurea has been initiated or escalated in the month prior to screening.
- •has active gastrointestinal ulceration or bleeding.
- •patient has used an investigational drug within the past 30 days.
- •patient is being treated with anagrelide.
- •patient has previously taken CEP-701 (lestaurtinib).
- •patient has hypersensitivity to CEP-701 (lestaurtinib) or any component of CEP-701 (lestaurtinib).
- •patient has received interferon within the past 30 days.
研究组 & 干预措施
lestaurtinib
Experimental
干预措施: lestaurtinib (Drug)
结局指标
主要结局
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
时间窗: 18 weeks +
次要结局
- - improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy(18 weeks +)
研究者
研究点 (4)
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