CTRI/2010/091/000381进行中（未招募）1 期
A Phase I/II multicenter study of Radotinib HCl in Philadelphia chromosome positive chronic myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase inhibitors (Imatinib and/or Dasatinib, Nilotinib) - Nil
ILYang Pharmaceutical Co Ltd South Korea0 个研究点目标入组 111 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age greater than or equal to 18 years old
- •2. Ph+ CML patients in chronic or accelerated phase who are resistant or intolerant to Imatinib mesylate 3. WHO Performance status of less than or equal to 2 ,4. Written informed consent
- •5. Patients must have the following laboratory values:
- •With normal liver function
- •a.T-Bil less than or equal to 2.0 x ULN
- •b. ALT/AST less than or equal to 2.5 x ULN or less than or equal to 5.0 x ULN if considered due to leukemia
- •With normal renal function
- •a.Serum creatinine less than or equal to 1.5 x ULN
- •6. Patients who have received interferon, other anti cancer drug or radiotherapy greater than o 1 week prior to starting study drug. A group: Ph+ Chronic phase patients who have not been diagnosed with accelerated or blast phase before treatment and meet the standard definition of Imatinib mesylate resistance or intolerance , B group: Ph+ accelerated phase patients who have not been diagnosed with blast phase before treatment and meet the standard definition of Imatinib mesylate resistance or intolerance
排除标准
- •1.Blast phase CML 2.CNS infiltration 3.Impaired cardiac function, including any one of the following; LVEF 45% as determined by MUGA scan or echocardiogram; Complete left bundle branch block; Use of Cardiac pacemaker; ST depression 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads; Congenital long QT syndrome; History of, or presence of significant ventricular or atrial tachyarrhythmias; Clinically significant resting bradycardia(50 beats/min); QTcF 480 msec on screening ECG; Right bundle branch block + left anterior hemiblock, Bifascicular block; Myocardiac infarction within 3 months prior to starting Radotinib HCL; Angina pectoris; Other clinically significant heart disease(e.g., congestive heart failure, uncontrolled hypertension) 4.Severe GI disease that may cause drug absorption problem of study drug(e.g., ulcerative colonitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, GI operation ) 5.Use of therapeutic Warfarin 6.Acute or chronic liver or renal disease 7.Other concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes, active or uncontrolled infection) 8.Treatment with any hematopoietic colony-stimulating growth factors (e.g., EPO,G-CSF,GM-SCF);less than or equal to 1 week prior to starting study drug. 9. Patients who are currently receiving treatment with medications have the potential to prolong the QT interval or inhibit CYP3A4 and treatment cannot be either discontinued or switched to a different medication prior to starting study drug. 10.Patients who have received gleevac, interferon, other anti cancer drug or chemotherapy less than or equal to 1 week(6 weeks for Nitrosurea or Mitomycin C) or who are within 5 half-lives of their last dose chemotherapy dose prior to starting study drug or who have not recovered from side effects of such therapy 11. Patients who have received otinib and Dasatinib less than or equal to 4 weeks prior to starting study drug. 12.Patients who have received wide field radiotherapy less than or equal to 4 weeks prior to starting study drug. 13. Patients who have undergone major surgery less than or equal to 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 14. Patients who are pregnant or breast-feeding or adults of reproductive potential not employing an effective method of birth control.(Women of childbearing potential must have a negative serum or blood pregnancy test within 1 week prior to administration study drug). Post menopausal women can be skipped a pregnancy test and must be amenorrheic for at least 12 months to be considered of non-childbearing potential. 15. Patients not to agree using birth control during the study and for up 3 months following discontinuation of study drug 16. HIV infection 17. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention 18.Patients who do not sign informed consents 19. T315 mutation
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