NCT03886415已完成2 期
A Phase 2,Multi-center, Open-label Study Evaluating Safety and Efficacy of Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- effective rate
研究概览
简要总结
This was an open-label, multi-center, randomized phase 2 study. This is a two-stage design.In the first stage, two dose groups were set up, the 100 mg bid dose group and the 200 mg qd dose group, which were randomized at 1:1, with 50 subjects in each group, and a total of 100 cases in the two groups. In the second stage, approximately 36 subjects were added to the randomized group.
详细描述
According to the results of the interim analysis of the ZGJAK002 of Jaktinib, a comprehensive evaluation of the benefits and risks of subjects in the 100mg bid and 200mg qd groups, the investigator and the sponsor decided to expand the enrollment of approximately 36 subjects taking 100mg bid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- •Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (> 250 mg/dL, or 13.9 mmol > / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure < 160 mmHg, diastolic pressure < 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v4.03 standard grade 2 or above), d. thyroid dysfunction (> NCI - CTC AE v4.03 standard grade 2 or above);
- •The patients had a history of congestive heart failure, uncontrollable or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism in the first 6 months;
- •Screening of patients who have not fully recovered from surgery within the first 4 weeks;
- •Screening for patients with arrhythmia requiring treatment or QTc interval (QTcB) >480ms;
- •Screening for bacterial, viral, parasitic or fungal infections with any clinical symptoms that require treatment;
- •Patients with a history of congenital or acquired hemorrhagic diseases;
- •Patients who had previously undergone splenectomy or who had received radiotherapy of the splenic region within the first 12 months of screening;
- •Screening for HIV positive, active hepatitis b virus positive (HBsAg positive, hbv- dna positive or greater than 1000 copies /ml), anti-hcv antibody or hcv-rna positive;
- •Patients suffering from epilepsy or using psychotropic or sedative drugs at the time of screening;
- •Women who are planning to become pregnant or who are pregnant or breast- feeding, as well as those who were unable to use effective contraceptives throughout the trial;Male patients who do not use condoms during the administration and within 2 days (approximately 5 half-lives) after the last administration;
- •Patients who have suffered from malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years;
- •Combined with other serious diseases, the researchers believe that patients' safety or compliance may be affected;
- •Suspected allergic to Jakatinib hydrochloride or similar drugs;
- •Patients who have participated in the clinical trials of other new drugs or medical devices within the first 3 months;
- •Patients who were treated with any MF drug (e.g., hydroxyl urea), any immunomulator (e.g., thalidomide), any immunosuppressant, prednisone at or above 10mg/ day or equivalent bioactive level of glucocorticoid, growth factor (e.g.,erythropoietin ), or who were within 6 half-lives of the drug within 2 weeks prior to randomization;
研究组 & 干预措施
Jaktinib hydrochloride tablets 1
Experimental
This is the dose group was given once a day. Jaktinib hydrochloride tablets 1 200mg qd dose group
干预措施: Jaktinib hydrochloride tablets (Drug)
Jaktinib hydrochloride tablets 2
Experimental
This is the dose group was given twice a day. Jaktinib hydrochloride tablets 2 100mg bid dose group
干预措施: Jaktinib hydrochloride tablets (Drug)
结局指标
主要结局
effective rate
时间窗: 24 weeks
The proportion of all subjects whose spleen volume decreased by 35% or more at 24 weeks
次要结局
- Overall response rate （CR+PR）(24 weeks)
- MF related symptom response rate(24 weeks)
- Progression-free survival (PFS)(24 weeks)
- Overall survival (OS)(2 years)
- The spleen response(24 weeks)
- Anemia response(24 weeks)
- Leukemia-free survival（LFS）(24 weeks)
研究者
研究点 (1)
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