{ "FullStudy":{ "Rank":218211, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511289", "OrgStudyIdInfo":{ "OrgStudyId":"IY5511A3001" }, "Organization":{ "OrgFullName":"Il-Yang Pharm. Co., Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients", "OfficialTitle":"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" }, "StatusModule":{ "StatusVerifiedDate":"January 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2015", "PrimaryCompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 3, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 22, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 24, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Il-Yang Pharm. Co., Ltd.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Leukemia", "Leukemia, Myeloid", "Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "Philadelphia Chromosome", "Bone Marrow Diseases", "Hematologic Diseases" ] }, "KeywordList":{ "Keyword":[ "Radotinib", "CML-CP", "Chronic Myeloid Leukemia, chronic phase" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"242", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Imatinib", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Imatinib 400mg QD", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Imatinib" ] } },{ "ArmGroupLabel":"Radotinib 600mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Radotinib 300mg BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Radotinib" ] } },{ "ArmGroupLabel":"Radotinib 800mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Radotinib 400mg BID", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Radotinib" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Imatinib", "InterventionDescription":"400mg/Tab, QD", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Imatinib" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Glivec", "Gleevec" ] } },{ "InterventionType":"Drug", "InterventionName":"Radotinib", "InterventionDescription":"100mg or 200mg/Capsule, 300mg or 400mg BID", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Radotinib 600mg", "Radotinib 800mg" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "IY5511HCl" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Rate of Major Molecular Response(MMR) by 12 months", "PrimaryOutcomeDescription":"Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months.\n\nA major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.", "PrimaryOutcomeTimeFrame":"12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Rate of complete cytogenetic response (CCyR) by 12 months", "SecondaryOutcomeDescription":"Complete cytogenetic response is defined as complete disappearance of Philadelphia-positive in at least 20 metaphases examined. Chromosome analysis performed on less than 20 metaphases will not be accepted for this study", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Rate of complete molecular response (CMR) by 12 months", "SecondaryOutcomeDescription":"Complete molecular response is defined as negative BCR-ABL transcript levels, as measured twice by the internationally standardized RQ-PCR assay.\n\nThe rate of complete molecular response by cycle 12 is defined as an at least 4.5 log reduction in BCR-ABL transcript levels from standardized baseline or BCR-ABL/ABL % ≤ 0.005% by the international scale.", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"Rate of major molecular response (MMR) at 12 months", "SecondaryOutcomeDescription":"Rate of Major Molecular response will be assessed at 12 months at that timepoint.\n\nNumber of Participants With Major Molecular Response (MMR) at 12 months.", "SecondaryOutcomeTimeFrame":"12 month" },{ "SecondaryOutcomeMeasure":"Rate of subjects with disease progression", "SecondaryOutcomeDescription":"Disease progression by month 12 will be compared between each groups.", "SecondaryOutcomeTimeFrame":"12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with confirmed diagnosis of chronic phase CML within last 3 months\nPatients with cytogenetically confirmed Ph positive CML in early chronic phase\n\nExclusion Criteria:\n\nPatients with Philadelphia chromosome negative but BCR-ABL positive CML\nPatients who used imatinib for 8 days or longer before study entry\nPatients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells\nPatients with impaired cardiac function\nCytologically confirmed CNS involvement\nSevere or uncontrolled chronic medical condition\nOther significant congenital or acquired bleeding disorders that are not related to underlying leukemia\nPatients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"IL-YANG PHARM", "OverallOfficialAffiliation":"IL-YANG Pharmaceutical. Co., LTD", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Local Institution", "LocationCity":"Jakarta", "LocationCountry":"Indonesia" },{ "LocationFacility":"Local Institution", "LocationCity":"Busan", "LocationZip":"602-715", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Busan", "LocationZip":"602-739", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Busan", "LocationZip":"633-165", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Daegu", "LocationZip":"700-712", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Daejeon", "LocationZip":"301-721", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Gyeonggi-do", "LocationZip":"431-070", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Gyeonggi-do", "LocationZip":"442-723", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Gyeonggi-do", "LocationZip":"443-721", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Incheon", "LocationZip":"405-760", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Jeollabuk-do", "LocationZip":"561-712", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Jeonnam", "LocationZip":"519-763", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Seoul", "LocationZip":"110-746", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Seoul", "LocationZip":"137-701", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Seoul", "LocationZip":"138-736", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Seoul", "LocationZip":"152-703", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Seoul", "LocationZip":"158-710", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Ulsan", "LocationZip":"682-714", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Wonju", "LocationZip":"220-701", "LocationCountry":"Korea, Republic of" },{ "LocationFacility":"Local Institution", "LocationCity":"Batangas", "LocationCountry":"Philippines" },{ "LocationFacility":"Local Institution", "LocationCity":"Manilla", "LocationCountry":"Philippines" },{ "LocationFacility":"Local Institution", "LocationCity":"Bangkok", "LocationCountry":"Thailand" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28939746", "ReferenceType":"derived", "ReferenceCitation":"Kwak JY, Kim SH, Oh SJ, Zang DY, Kim H, Kim JA, Do YR, Kim HJ, Park JS, Choi CW, Lee WS, Mun YC, Kong JH, Chung JS, Shin HJ, Kim DY, Park J, Jung CW, Bunworasate U, Comia NS, Jootar S, Reksodiputro AH, Caguioa PB, Lee SE, Kim DW. Phase III Clinical Trial (RERISE study) Results of Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia. Clin Cancer Res. 2017 Dec 1;23(23):7180-7188. doi: 10.1158/1078-0432.CCR-17-0957. Epub 2017 Sep 22." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "India" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068877", "InterventionMeshTerm":"Imatinib Mesylate" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000047428", "InterventionAncestorTerm":"Protein Kinase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M324", "InterventionBrowseLeafName":"Imatinib Mesylate", "InterventionBrowseLeafAsFound":"Imatinib", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M24407", "InterventionBrowseLeafName":"Protein Kinase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007938", "ConditionMeshTerm":"Leukemia" },{ "ConditionMeshId":"D000015464", "ConditionMeshTerm":"Leukemia, Myelogenous, Chronic, BCR-ABL Positive" },{ "ConditionMeshId":"D000007951", "ConditionMeshTerm":"Leukemia, Myeloid" },{ "ConditionMeshId":"D000006402", "ConditionMeshTerm":"Hematologic Diseases" },{ "ConditionMeshId":"D000001855", "ConditionMeshTerm":"Bone Marrow Diseases" },{ "ConditionMeshId":"D000010677", "ConditionMeshTerm":"Philadelphia Chromosome" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000009196", "ConditionAncestorTerm":"Myeloproliferative Disorders" },{ "ConditionAncestorId":"D000014178", "ConditionAncestorTerm":"Translocation, Genetic" },{ "ConditionAncestorId":"D000002869", "ConditionAncestorTerm":"Chromosome Aberrations" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafAsFound":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9528", "ConditionBrowseLeafName":"Leukemia", "ConditionBrowseLeafAsFound":"Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9538", "ConditionBrowseLeafName":"Leukemia, Myeloid", "ConditionBrowseLeafAsFound":"Leukemia, Myeloid", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12165", "ConditionBrowseLeafName":"Philadelphia Chromosome", "ConditionBrowseLeafAsFound":"Philadelphia Chromosome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3716", "ConditionBrowseLeafName":"Bone Marrow Diseases", "ConditionBrowseLeafAsFound":"Bone Marrow Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16706", "ConditionBrowseLeafName":"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "ConditionBrowseLeafAsFound":"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10732", "ConditionBrowseLeafName":"Myeloproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15515", "ConditionBrowseLeafName":"Translocation, Genetic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21607", "ConditionBrowseLeafName":"Chromosome Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4692", "ConditionBrowseLeafName":"Chromosome Aberrations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4021", "ConditionBrowseLeafName":"Myeloid Leukemia", "ConditionBrowseLeafAsFound":"Leukemia, Myelogenous", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T1316", "ConditionBrowseLeafName":"Chronic Myeloid Leukemia", "ConditionBrowseLeafAsFound":"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T1318", "ConditionBrowseLeafName":"Chronic Myeloproliferative Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }