Health Condition 1: null- Chronic myeloid leukemia
Conditions
Interventions
Intervention1: Radotinib HCL 100mg or 200mg capsule: Radotinib HCL 100mg or 200mg capsule (Radotinib HCL is a hard capsule designed for twice daily administration, Radotinib HCL 100mg or 200mg capsul
Sponsors
ILYang Pharmaceutical Co Ltd South Korea
Max Neeman Medical Intermational Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Nilotinib 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To investigate safety of oral Radotinib HCL in CML patients who are resistant or intolerable to Imatinib in the chronic and accelerated phases. 2.To evaluate hematologic and cytogenetic efficacy of oral Radotinib HCL in CML patients who are resistant or intolerable to Imatinib in the chronic and accelerated phasesTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate and compare changes in Bcr-Abl transcripts, CrkL phosphorylation, and Abl point mutation using samples taken from human subjects before and after Radotinib HCL treatment. 2. To investigate the pharmacokinetic characteristics of Radotinib HCLTimepoint: 12 Months | — |
Countries
China, India, Republic of Korea, Thailand
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed