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NCT02154529

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

Version 18 to 19 · Kadmon Corporation, LLC

Patch inspector

Version 18 to 19

8 operations 4 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
enrollment_count_changeenrollment_type_changeterminal_status_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-11-09",
    "old_value": "2017-04",
    "delta_days": 509,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Sponsor closed the study in order to review data from other ongoing tesevatinib oncology studies, and to determine feasibility of continuing this study",
    "signal": "why_stopped_low_information",
    "category": "status_termination",
    "severity": "high"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 17,
    "old_value": 80,
    "pct_change": 0.7875
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:56+00
Raw hash
5c8c32011e2bb04f2908e147c4bf0307067a52d4921e2ed1febcaaf82e91238a
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 7
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
80
After
17
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 8
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: High
Status Termination Operation 1
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
ACTIVE_NOT_RECRUITING
After
TERMINATED
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 6
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
Sponsor closed the study in order to review data from other ongoing tesevatinib oncology studies, and to determine feasibility of continuing this study
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2017-04
After
2015-11-09
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2017-02-28
After
2017-08-28
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2017-03-03
After
2017-08-30
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2015-11-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2017-08-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2017-08-30"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Sponsor closed the study in order to review data from other ongoing tesevatinib oncology studies, and to determine feasibility of continuing this study"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 17
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  }
]