{ "FullStudy":{ "Rank":218073, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513083", "OrgStudyIdInfo":{ "OrgStudyId":"BO25499" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-004591-10", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function", "OfficialTitle":"A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function" }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 1, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Breast Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"28", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Mild hepatic dysfunction", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: trastuzumab emtansine" ] } },{ "ArmGroupLabel":"Moderate hepatic dysfunction", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: trastuzumab emtansine" ] } },{ "ArmGroupLabel":"Normal hepatic function", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: trastuzumab emtansine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"trastuzumab emtansine", "InterventionDescription":"Multiple intravenous doses", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mild hepatic dysfunction", "Moderate hepatic dysfunction", "Normal hepatic function" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Pharmacokinetics: Area under the concentration-time curve", "PrimaryOutcomeTimeFrame":"Multiple sampling pre- and up to 21 days post-dose Cycles 1-3" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function", "SecondaryOutcomeTimeFrame":"approximately 2 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult patients, >/= 18 years of age\nHistologically or cytologically documented invasive metastatic breast cancer\nHuman epidermal growth factor receptor 2 (HER2) -positive disease\nAdequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\nLeft ventricular ejection fraction >/=50%\nNormal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)\n\nExclusion Criteria:\n\nHistory of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab\nInvestigational therapy or any other anticancer therapy /=2\nChild-Pugh Class C hepatic impairment\nEncephalopathy >/= Grade 2\nFor patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C\nActive hepatitis A, B and/or C\nCurrent unstable ventricular arrhythmia requiring treatment\nHistory of symptomatic CHF (NYHA Classes II-IV)\nHistory of myocardial infarction or unstable angina within 6 months of enrollment\nHistory of a decrease in LVEF to<40% or symptomatic CHF with previous trastuzumab treatment\nPregnant or lactating women\nKnown HIV infection", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Fort Myers", "LocationState":"Florida", "LocationZip":"33905", "LocationCountry":"United States" },{ "LocationCity":"Detroit", "LocationState":"Michigan", "LocationZip":"48201", "LocationCountry":"United States" },{ "LocationCity":"Portland", "LocationState":"Oregon", "LocationZip":"97239", "LocationCountry":"United States" },{ "LocationCity":"Nashville", "LocationState":"Tennessee", "LocationZip":"37203", "LocationCountry":"United States" },{ "LocationCity":"Ottawa", "LocationState":"Ontario", "LocationZip":"K1H8L6", "LocationCountry":"Canada" },{ "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M5G 2M9", "LocationCountry":"Canada" },{ "LocationCity":"Marseille", "LocationZip":"13273", "LocationCountry":"France" },{ "LocationCity":"Paris", "LocationZip":"75231", "LocationCountry":"France" },{ "LocationCity":"Toulouse", "LocationZip":"31059", "LocationCountry":"France" },{ "LocationCity":"Catanzaro", "LocationState":"Calabria", "LocationZip":"88100", "LocationCountry":"Italy" },{ "LocationCity":"Udine", "LocationState":"Friuli-Venezia Giulia", "LocationZip":"33100", "LocationCountry":"Italy" },{ "LocationCity":"Barcelona", "LocationZip":"08003", "LocationCountry":"Spain" },{ "LocationCity":"Madrid", "LocationZip":"28007", "LocationCountry":"Spain" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068878", "InterventionMeshTerm":"Trastuzumab" },{ "InterventionMeshId":"C000550911", "InterventionMeshTerm":"Ado-trastuzumab emtansine" },{ "InterventionMeshId":"D000008453", "InterventionMeshTerm":"Maytansine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000074322", "InterventionAncestorTerm":"Antineoplastic Agents, Immunological" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000000972", "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M325", "InterventionBrowseLeafName":"Trastuzumab", "InterventionBrowseLeafAsFound":"Trastuzumab", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M269023", "InterventionBrowseLeafName":"Ado-trastuzumab emtansine", "InterventionBrowseLeafAsFound":"Trastuzumab emtansine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2176", "InterventionBrowseLeafName":"Adenosine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10019", "InterventionBrowseLeafName":"Maytansine", "InterventionBrowseLeafAsFound":"Emtansine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1346", "InterventionBrowseLeafName":"Antineoplastic Agents, Immunological", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001943", "ConditionMeshTerm":"Breast Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000001941", "ConditionAncestorTerm":"Breast Diseases" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafAsFound":"Breast Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3800", "ConditionBrowseLeafName":"Breast Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }