CTRI/2017/03/008178进行中（未招募）1 期
A Phase 1 study to determine safety, tolerability, pharmacokinetics, and activity of K0706, a novel tyrosine kinase inhibitor (TKI) in subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 304
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
Part A: Recruitment is complete.
Part B: Closed to the recruitment of participants.
Part C: Not applicable (Part C of the study is not part ofthe India-specific protocol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study.
- •Willing and able to comply with the scheduled visits.
- •Male or female aged 18 to 65 years (both inclusive).
- •Minimum life expectancy of at least 12 months in the Investigator’s opinion.
排除标准
- •Any major surgery.
- •Blood transfusion within 4 weeks of IMP administration.
- •Inability to swallow oral medication.
- •Inability to undergo venipuncture and/or tolerate venous access.
结局指标
主要结局
Maximum tolerated dose
时间窗: 28 days
次要结局
- Cmax, AUC, Tmax(24 hours)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
1 期
A phase I study to assess the safety, tolerability, and pharmacokinetics of AMY109Healthy volunteers and patients with endometriosisjRCT2080223785CHUGAI PHARMACEUTICAL CO., LTD.100
已完成
1 期
Inhalation of Leukotriene B4 (LTB4) in patients suffering from BronchiectasisChronic Suppurative Lung DiseaseRespiratory - Other respiratory disorders / diseasesInfection - Other infectious diseasesBronchiectasisACTRN12614001199606TB4 Sweden AB30
已完成
1 期
Phase I trial to evaluate the safety and tolerability of GDC-0214 in healthy volunteers and patients with mild asthmaAsthmaRespiratory - AsthmaACTRN12617001227381Genentech, Inc.102
已完成
1 期
Phase I trial to evaluate the safety and tolerability of GDC-4379 in healthy volunteers and patients with mild asthmaRespiratory - AsthmaAsthmaACTRN12619000227190Genentech128
招募中
不适用
A Phase I study to evaluate the safety, tolerability, and pharmacokinetics of NTX-083 in healthy adult males.Alzheimer's DiseasejRCT203124066040