Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI (NCT01602952) | Clinical Trial Compass
CompletedPhase 1/2
Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI
India, South Korea85 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. Ph+ CML patients who are resistant at chronic, accelerate, and acute phase, or 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.
✓. WHO Performance status of ≤2
✓. Patients must have the following laboratory values With normal liver and renal function
✓. Patients who have received interferon, other anti cancer drug or radiotherapy \> 1 week prior to starting study drug.
✓. Age ≥ 18 years old
✓. Ph+ CML patients in chronic or accelerated phase who are resistant or intolerant to Imatinib mesylate
✓. WHO Performance status of ≤2
Exclusion criteria
✕. CNS infiltration
What they're measuring
1
To investigate the Maximum Tolerated Dose(Phase 1)
Timeframe: 12 month
2
Rate of Complete hematologic response(CHR)(Phase 2)