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

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.

Trial Details

NCT ID
NCT03459534
Phase
PHASE3
Sponsor
Il-Yang Pharm. Co., Ltd.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Radotinib HCl
Locations (sample)
  • Barnaul, Russia|53.36199,83.72786
  • Kirov, Russia|58.59809,49.65783
  • Moscow, Russia|55.75204,37.61781
  • Moscow, Russia|55.75204,37.61781
  • Saint Petersburg, Russia|59.93863,30.31413

Key Eligibility Criteria

  • Male or female patients aged 18 years old
  • Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
  • ECOG scale 0, 1 or 2
  • Chronic phase is defined as all of the following conditions that subjects meet.

For full eligibility, visit ClinicalTrials.gov.

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