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NCT02154529

Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

A Phase 1b/2a Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

ClinicalTrials.gov
Sponsor
Kadmon Corporation, LLC
Status
Terminated
Versions
25
Adjacent patches
24
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

14 shown
Triage: High
2014-10-07
Eligibility Change
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2014-11-25
Eligibility Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2015-01-21
Primary Outcome Change
v5 to v6 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
2015-03-29
Arm Intervention Change
v6 to v7 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/3
/protocolSection/armsInterventionsModule/armGroups/4
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3
Triage: Critical
2015-06-09
Primary Outcome Change
v9 to v10 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/7
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7
/protocolSection/designModule/enrollmentInfo/count
Triage: Medium
2016-08-29
Timeline Shift
v15 to v16 Late Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
2016-11-29
Timeline Significant Shift
v16 to v17 Late Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
2017-02-28
Timeline Shift
v17 to v18 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/type
Triage: High
2017-08-28
Status Termination
v18 to v19 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/statusModule/completionDateStruct/date
Triage: High
2018-03-08
Arm Intervention Change
v19 to v20 Post Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
2021-04-01
Arm Intervention Change
v20 to v21 Post Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1
Triage: Critical
2021-05-07
Primary Outcome Change
v21 to v22 Post Recruitment Inspect patch Evidence Record
/annotationSection
/protocolSection/designModule/designInfo/interventionModel
/protocolSection/designModule/designInfo/interventionModelDescription
Triage: High
2022-02-28
Design Change
v22 to v23 Post Recruitment Inspect patch Evidence Record
/annotationSection
/hasResults
/protocolSection/armsInterventionsModule/armGroups/0/description
Triage: Low
2022-04-06
Timeline Actual Date Correction
v23 to v24 Post Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate