A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
研究概览
简要总结
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
详细描述
This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor
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 —（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).
- •Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
- •At least 18 years of age.
- •ECOG PS 0, 1, or
- •Expected life expectancy is greater than 24 weeks.
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.
- •With suspected allergies to jaktinib or its excipient.
- •Another clinical trial of a new drug or medical instrument within 3 months before screening.
- •Females who are pregnant, currently breastfeeding, planning to become pregnant.
- •Unable to adopt effective contraceptive methods during the study.
研究组 & 干预措施
Jaktinib
干预措施: Jaktinib Hydrochloride Tablet (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
时间窗: 28 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Safety of jaktinib hydrochloride tablets
时间窗: At least 24 weeks, up to approximately 1 year for follow-up
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
次要结局
- Efficacy of jaktinib hydrochloride tablets(at least 24 weeks, up to approximately 1 year)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets(7 days)