NCT00279773终止1 期
A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).
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
- •Confirmed diagnosis of Acute Myeloid Leukemia
- •Eighteen years of age or older
- •Life expectancy of at least 2 months
排除标准
- •Intracranial disease or epidural disease
- •Clinically significant cardiac disease
- •Diabetes mellitus uncontrolled with medication
- •Pregnant or breast feeding women
- •Dementia or altered mental status
- •Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands
- •Previous pericarditis
- •Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting
研究组 & 干预措施
TKI258 - dose escalation
Experimental
Dose-Escalation
干预措施: TKI258 (Drug)
TKI258 - dose expansion
Experimental
Dose-Expansion
干预措施: TKI258 (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: 28 days - dose-escalation; 4 months - dose-expansion
Dose limiting toxicity
时间窗: 28 days - dose-escalation; 4 months - dose-expansion
Safety profile
时间窗: 28 days - dose-escalation; 4 months - dose-expansion
次要结局
- Evaluation of plasma pharmacokinetics and pharmacodynamics(28 days - dose-escalation; 4 months - dose-expansion)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
TKI258 in Subjects With Refractory or Relapsed Multiple MyelomaMultiple MyelomaNCT00243763Novartis64
已完成
1 期
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced AlopeciaNCT01588522BPGbio28
已完成
1 期
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced MalignanciesAdvanced CancerSolid TumorsNCT00629200M.D. Anderson Cancer Center33
已完成
1 期
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic CarcinomaNeoplasms, LiverNCT00629759Jennerex Biotherapeutics14
Unknown
1 期
Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma PatientsHigh-grade GliomasNCT03904628Lee's Pharmaceutical Limited15