Clinical Trial

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

Recruiting Phase 3
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Record status
This record was last updated October 28, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2018-03-07; most recent amendment 2024-10-24.
Status change: Not Yet Recruiting → Recruiting 2018-07-20
Trial Details
NCT Number NCT03459534
Lead Sponsor Il-Yang Pharm. Co., Ltd.
Conditions Chronic Myeloid Leukemia, Chronic Phase, CML, Chronic Phase, CML, Refractory, CML - Philadelphia Chromosome
Enrollment 173 participants
Start Date 2018-06-25
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-28