Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI
Status:
Completed
Trial end date:
2018-07-13
Target enrollment:
Participant gender:
Summary
A Phase I/II multicenter study of IY5511HCl in Philadelphia chromosome positive chronic
myeloid leukemia patients without optimal response or tolerance to Bcr-Abl tyrosine kinase
inhibitors (Imatinib and/ or Dasatinib, Nilotinib) In this study, The efficacy and safety of
CML patients who are resistant or intolerable to imatinib in the Chronic and Accelerated
phases.
Phase 1
1. To investigate the Maximum Tolerated Dose (MTD) and the Dose Limiting Toxicity (DLT) of
oral Radotinib HCl bid (twice daily) in the Philadelphia chromosome-positive CML subjects who
are resistant, suboptimal responsive, or intolerant to imatinib OR resistant or intolerant to
at least one second-generation targeted anticancer agent while being resistant, suboptimal
responsive, or intolerant to imatinib simultaneously.
Phase 2
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 phases.