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

PHASE3RecruitingINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

June 25, 2018

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2027

Conditions
Chronic Myeloid Leukemia, Chronic PhaseCML, Chronic PhaseCML, RefractoryCML - Philadelphia Chromosome
Interventions
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."

Trial Locations (18)

11749

RECRUITING

Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu-si

125167

NOT_YET_RECRUITING

Federal State Budgetary Institution, Moscow

191024

RECRUITING

Federal State Budgetary Institution, Saint Petersburg

197341

RECRUITING

Federal State Budgetary Institution, Saint Petersburg

610027

RECRUITING

Federal State Budgetary Institution of Science, Kirov

656024

NOT_YET_RECRUITING

Territorial State Budgetary Institution, Barnaul

300186883

RECRUITING

Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin, Moscow

Unknown

RECRUITING

Ankara University Medical Faculty, Ankara

RECRUITING

Gazi University Medical Faculty, Ankara

RECRUITING

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul

RECRUITING

Ege University Medical Faculty, Izmir

RECRUITING

Mersin University Medical Faculty, Mersin

RECRUITING

Ondokuz Mayis Univ. Med. Fac., Samsun

RECRUITING

CI Cherkasy Regional Oncological Dispensary of CRC, Cherkassy

RECRUITING

CTPI Chernihiv Regional Oncological Dispensary, Chernihiv

RECRUITING

CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC, Dnipro

RECRUITING

Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit, Kyiv

RECRUITING

SI Institute of Blood Pathology and Transfusion Medicine of AMSU, Lviv

All Listed Sponsors
lead

Il-Yang Pharm. Co., Ltd.

INDUSTRY