NCT02422719

Radotinib as 3rd or Later Line Therapy in CP-CML

Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Ulsan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

Detailed description

The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Radotinib	Radotinib 400mg bid

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2015-04-21
• Last updated: 2016-05-11

Locations

1 site across 1 country: South Korea