NCT00631462已完成1 期
A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered TG101348 in Patients With Primary, Post-polycythemia Vera, or Post-essential Thrombocythemia Myelofibrosis
TargeGen6 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 6
- 主要终点
- Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of orally administered TG101348 in patients with myelofibrosis.
详细描述
TG101348 is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is a first-in-human study that will include a dose-escalation phase, to establish the maximum tolerated dose, and an expanded cohort, dose-confirmation phase. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348 in patients with myelofibrosis will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia)
- •At least 18 years of age.
- •ECOG PS 0, 1, or 2.
排除标准
- •Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
- •Major surgery or radiation therapy within 28 days prior to initiation of study drug.
研究组 & 干预措施
1
Experimental
干预措施: TG101348 (Drug)
结局指标
主要结局
Safety (i.e., adverse events; effects on laboratory parameters, vital signs, and ECGs; dose-limiting toxicities), tolerability, and MTD
时间窗: 28 days
次要结局
- Pharmacokinetics and pharmacodynamics(28 days)
研究者
研究点 (6)
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