NCT04339400已完成1 期
A Single-group, Open-label, Multicenter, Phase I Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity(DLT)
研究概览
简要总结
TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.
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
- •1.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy ≥ 3 months.
- •2. Diagnosed as Primary Myelofibrosis(PMF), Polycythemia Vera(PV), Essential Thrombocythemia(ET), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia Myelofibrosis (PET-MF).
- •3. Myelofibrosis at intermediate risk -1 and above according to Dynamic International Prognostic Scoring System(DIPSS); PV or ET were resistant or intolerant to hydroxyurea and/or interferon therapy.
- •4. Adequate hematology laboratory index. 5.The most prominent part of the spleen ≥ 5cm to the lower edge of the ribs. 6.Bone marrow blasts and peripheral blood blasts <20%.
- •Appropriate liver and kidney functions. 8.The main blood coagulation function is appropriate.
- •Those who have used other MPN treatment drugs before first dose need to stop exceed 2 weeks. Those who have received major surgery before first dose need to exceed 4 weeks.
- •10.No pregnant or breastfeeding women, and a negative pregnancy test. 11.Understood and signed an informed consent form.
排除标准
- •1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ.
- •2. Has participated in other anticancer drug clinical trials within 4 weeks.
- •Has multiple factors affecting oral medication.
- •Has drug abuse history that unable to abstain from or mental disorders.
- •Has active hepatitis B or C, or immunodeficiency.
- •Has immunodeficiency.
- •Has arteriovenous thrombosis events within 4 weeks.
- •Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form.
- •9. Has serious systemic infections.
- •Has uncontrolled cardiovascular disease.
- •Has uncontrolled hypertension.
- •Has serious systemic infections.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQ05105 Tablet
Experimental
TQ05105 tablet 5mg administered orally once. Then TQ05105 tablet administered orally, twice daily in 28-day cycle after 3 days of first administration.
干预措施: TQ05105 (Drug)
结局指标
主要结局
Dose Limiting Toxicity(DLT)
时间窗: Baseline up to 28 days
DLT defined as any of the events occurring during the study related to drugs.
Maximal tolerance dose (MTD)
时间窗: Baseline up to 28 days
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
次要结局
- Tmax(Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.)
- Cmax(Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.)
- AUC0-t(Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.)
研究者
研究点 (2)
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