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

Source: https://onco.cc/trials/nct03459534/  
OnCo record `nct03459534` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Radotinib HCl in chronic myeloid leukaemia, run by Il-Yang Pharm. Co., Ltd., now recruiting.

## Summary

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs is a phase 3 interventional study registered as NCT03459534 by Il-Yang Pharm. Co., Ltd., with 173 participants planned, started 2018-06-25 and due to reach its primary completion in 2027-06-30. Interventions recorded: Radotinib HCl.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03459534
- Phase: 3
- Setting: A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib
- Sponsor: Il-Yang Pharm. Co., Ltd.
- Enrolled: 173

## Sources

- ClinicalTrials.gov NCT03459534: https://clinicaltrials.gov/study/NCT03459534

## Connected records

- cancers: [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/)

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