Spots Global Cancer Trial Database for A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
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Trial Identification
Brief Title: A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
Official Title: 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
Study ID: NCT03459534
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Territorial State Budgetary Institution, Barnaul, , Russian Federation
Federal State Budgetary Institution of Science, Kirov, , Russian Federation
Federal State Budgetary Institution, Moscow, , Russian Federation
Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin, Moscow, , Russian Federation
Federal State Budgetary Institution, Saint-Petersburg, , Russian Federation
Federal State Budgetary Institution, Saint-Petersburg, , Russian Federation
Ankara University Medical Faculty, Ankara, , Turkey
Gazi University Medical Faculty, Ankara, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Ege University Medical Faculty, Izmir, , Turkey
Mersin University Medical Faculty, Mersin, , Turkey
Ondokuz Mayis Univ. Med. Fac., Samsun, , Turkey
CI Cherkasy Regional Oncological Dispensary of CRC, Cherkassy, , Ukraine
CTPI Chernihiv Regional Oncological Dispensary, Chernihiv, , Ukraine
CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC, Dnipro, , Ukraine
Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit, Kyiv, , Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of AMSU, Lviv, , Ukraine
Contact Details
Name: Dong Wook Kim
Affiliation: the Catholic University of Korea's St. Mary's Hospital
Role: PRINCIPAL_INVESTIGATOR
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