NCT03459534

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (estimated)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia, Chronic Phase
• CML, Chronic Phase
• CML, Refractory
• CML - Philadelphia Chromosome

Interventions

Type	Name	Description
DRUG	Radotinib HCl	1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. 2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) 3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder 4. Storage conditions: Store in an airtight light proof container at room temperature.

Timeline

• Start date: 2018-06-25
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2018-03-09
• Last updated: 2024-10-28

Locations

18 sites across 4 countries: Russia, South Korea, Turkey (Türkiye), Ukraine