KCT0002194招募中未知
A Phase I/II Study of CG200745 PPA to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy in Patients with Myelodysplastic Syndrome (MDS) Who Failed to Respond to Prior Hypomethylating Therapy
CrystalGenomics0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1)Ages : 20 years and above
- •(2)Patient with MDS(myelodysplastic syndrome; MDS) according to FAB(Frech-American-British cooperative group) classification
- •(3)Patients who failed to respond to prior hypomethylating agents (5-azacytidine, decitabine)
- •(4)ECOG (Eastern Cooperative Oncology Group) performance status: 0-2
- •(5)Adequate renal and hepatic function
- •?Total serum bilirubin = 3 x ULN (except for the case of increased unconjugated bilirubin)
- •?AST, ALT, and ALP < 3 x ULN
- •?Calculated GFR (Glomerular filtration rate) = 50
- •* MDRD(Modification of Diet in Renal Disease study)-GFR(Glomerular filtration rate)(mL/min/1.73m2) (for female)
- •: 186 x (serum creatinine concentration)-1.154 x (age)-0.203 x 0.742 (for female)
- •(6)Fertile patients, except post-menopausal patients (no menstruation for at least 2 years) or proof of surgical sterility, must use effective contraception up to 3 months after the completion or withdrawal of the study.
- •(7)Negative pregnancy test
- •(8)Patient who understand the overall procedures and requirements of the study
排除标准
- •(1)Peripheral or bone marrow blasts: > 30%
- •(2)Less than 4 weeks since major surgery or radiotherapy
- •(3)Patient with clinically meaningful and relevant, active CNS disorder
- •(4)Patient with active liver disease
- •(5)Patient with HIV positive
- •(6)Hyper-sensitivity to study drug or similar substances of the drugs
- •(7)Prior Histone Deacetylase (HDAC) inhibitor therapy
- •(8)Less than 4 weeks since hypomethylating agent or cytotoxic drug therapy
- •(9)Less than 4 weeks since immunosuppressive drug therapy
- •(10)Patient who participated in another clinical trial within past 4 weeks
- •(11)Patient who have severe diseases:
- •?Severe cardiovascular diseases (severe or unstable angina, congestive heart failure, myocardial infarction within past 1 year, uncontrolled hypertension and uncontrolled arrhythmia)
- •?Neurological or psychiatric disorder
- •?Active uncontrolled infection
- •?Any other diseases that may interfere with the interpretation of study result (according to the judgment of investigator)
- •(12)Pregnancy or lactating
- •(13)Patient who is not considered to be appropriate for the study according to the judgment of investigator
研究者
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