Leukemia Clinical Trial
Official title:
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)
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.
This study is a multi-center, open-label, Phase 1/2 clinical trial of Radotinib HCl, a targeted anticancer agent that inhibits the Bcr-Abl oncoprotein. It is aimed at determining the optimal therapeutic dose and confirming safety and efficacy of Radotinib HCl. Phase 1 study began at St. Mary's hospital in Korea and Phase 2 study is ongoing at 9 Korean sites and about 7 sites in China, India and Thailand will take part in Phase 2. After determination of a safe and proper therapeutic dose in Phase 1, Phase 2 began continuously to evaluate efficacy in chronic and accelerated phases. Before the start of the Phase 2 trial, interim or final reports for the Phase 1 trial were reviewed by the Korean Food and Drug Administration. ;
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