Spots Global Cancer Trial Database for Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
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Trial Identification
Brief Title: Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients
Official Title: A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
Study ID: NCT01511289
Study Description
Brief Summary: In this study, the efficacy and safety of two radotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution, Jakarta, , Indonesia
Local Institution, Busan, , Korea, Republic of
Local Institution, Busan, , Korea, Republic of
Local Institution, Busan, , Korea, Republic of
Local Institution, Daegu, , Korea, Republic of
Local Institution, Daejeon, , Korea, Republic of
Local Institution, Gyeonggi-do, , Korea, Republic of
Local Institution, Gyeonggi-do, , Korea, Republic of
Local Institution, Gyeonggi-do, , Korea, Republic of
Local Institution, Incheon, , Korea, Republic of
Local Institution, Jeollabuk-do, , Korea, Republic of
Local Institution, Jeonnam, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Seoul, , Korea, Republic of
Local Institution, Ulsan, , Korea, Republic of
Local Institution, Wonju, , Korea, Republic of
Local Institution, Batangas, , Philippines
Local Institution, Manilla, , Philippines
Local Institution, Bangkok, , Thailand
Contact Details
Name: IL-YANG PHARM
Affiliation: IL-YANG Pharmaceutical. Co., LTD
Role: STUDY_DIRECTOR
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