{ "FullStudy":{ "Rank":217713, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517802", "OrgStudyIdInfo":{ "OrgStudyId":"CR100797" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"212082PCR3010", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Janssen Research & Development, LLC" },{ "SecondaryId":"2011-005243-28", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Janssen Research & Development, LLC", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate", "OfficialTitle":"A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study" }, "StatusModule":{ "StatusVerifiedDate":"August 2019", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 28, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 9, 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"April 9, 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 22, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 26, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Janssen Research & Development, LLC", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 6 years.", "DetailedDescription":"This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 6 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Metastatic Castration-resistant Prostate Cancer", "Metastatic Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Metastatic castration-resistant prostate cancer", "Metastatic breast cancer", "Abiraterone acetate", "Low-dose corticosteroid treatment", "Long-term access" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Abiraterone acetate", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Abiraterone acetate", "Drug: Prednisone" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Abiraterone acetate", "InterventionDescription":"Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Abiraterone acetate" ] } },{ "InterventionType":"Drug", "InterventionName":"Prednisone", "InterventionDescription":"Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Abiraterone acetate" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The number of participants affected by a serious adverse event", "PrimaryOutcomeTimeFrame":"Up to 30 days after the last dose of study drug" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nCurrently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.\n\nExclusion Criteria:\n\nMedical conditions that require hospitalization.\nAny condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.", "HealthyVolunteers":"No", "Gender":"All", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Janssen Research & Development, LLC Clinical Trial", "OverallOfficialAffiliation":"Janssen Research & Development, LLC", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Aurora", "LocationState":"Colorado", "LocationCountry":"United States" },{ "LocationCity":"Marrero", "LocationState":"Louisiana", "LocationCountry":"United States" },{ "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationCountry":"United States" },{ "LocationCity":"Omaha", "LocationState":"Nebraska", "LocationCountry":"United States" },{ "LocationCity":"East Setauket", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"New York", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"Myrtle Beach", "LocationState":"South Carolina", "LocationCountry":"United States" },{ "LocationCity":"Chattanooga", "LocationState":"Tennessee", "LocationCountry":"United States" },{ "LocationCity":"Dallas", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"Houston", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"Kogarah", "LocationCountry":"Australia" },{ "LocationCity":"Kurralta Park", "LocationCountry":"Australia" },{ "LocationCity":"South Brisbane", "LocationCountry":"Australia" },{ "LocationCity":"Subiaco", "LocationCountry":"Australia" },{ "LocationCity":"Antwerpen", "LocationCountry":"Belgium" },{ "LocationCity":"Hamburg", "LocationCountry":"Germany" },{ "LocationCity":"Barcelona", "LocationCountry":"Spain" },{ "LocationCity":"Uppsala", "LocationCountry":"Sweden" },{ "LocationCity":"Newcastle Upon Tyne", "LocationCountry":"United Kingdom" },{ "LocationCity":"Northwood", "LocationCountry":"United Kingdom" },{ "LocationCity":"Sutton", "LocationCountry":"United Kingdom" },{ "LocationCity":"Whitchurch", "LocationCountry":"United Kingdom" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Austria" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000011241", "InterventionMeshTerm":"Prednisone" },{ "InterventionMeshId":"D000069501", "InterventionMeshTerm":"Abiraterone Acetate" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000005938", "InterventionAncestorTerm":"Glucocorticoids" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018931", "InterventionAncestorTerm":"Antineoplastic Agents, Hormonal" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000065088", "InterventionAncestorTerm":"Steroid Synthesis Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000006727", "InterventionAncestorTerm":"Hormone Antagonists" },{ "InterventionAncestorId":"D000065607", "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M12704", "InterventionBrowseLeafName":"Prednisone", "InterventionBrowseLeafAsFound":"Prednisone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M451", "InterventionBrowseLeafName":"Abiraterone Acetate", "InterventionBrowseLeafAsFound":"Abiraterone acetate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7630", "InterventionBrowseLeafName":"Glucocorticoids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19550", "InterventionBrowseLeafName":"Antineoplastic Agents, Hormonal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M29124", "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011471", "ConditionMeshTerm":"Prostatic Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000005834", "ConditionAncestorTerm":"Genital Neoplasms, Male" },{ "ConditionAncestorId":"D000014565", "ConditionAncestorTerm":"Urogenital Neoplasms" },{ "ConditionAncestorId":"D000005832", "ConditionAncestorTerm":"Genital Diseases, Male" },{ "ConditionAncestorId":"D000011469", "ConditionAncestorTerm":"Prostatic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12918", "ConditionBrowseLeafName":"Prostatic Neoplasms", "ConditionBrowseLeafAsFound":"Prostate Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7529", "ConditionBrowseLeafName":"Genital Neoplasms, Male", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15898", "ConditionBrowseLeafName":"Urogenital Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7527", "ConditionBrowseLeafName":"Genital Diseases, Male", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12916", "ConditionBrowseLeafName":"Prostatic Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }