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NCT02576431

A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

Version 21 to 22 · Bayer

Patch inspector

Version 21 to 22

338 operations 8 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
arms_or_interventions_changecontact_admin_changeeligibility_criteria_changeenrollment_count_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ACTUAL",
    "old_type": null,
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-09-30",
    "old_value": "2015-10",
    "delta_days": 1,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2021-05-31",
    "old_value": "2019-12",
    "delta_days": 547,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2021-05-31",
    "old_value": "2019-12",
    "delta_days": 547,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 320,
    "old_value": 176,
    "pct_change": 0.8182
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:18+00
Raw hash
122f53af1684011832a8e48a9d068a07cc03d79c0955a90df12018a6c4377593
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 119
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Overall Response Rate as determined by an independent radiology review committee and measured by the proportion of subjects with best overall confirmed response of complete response (CR) or partial response (PR) by RECISTv1.1 or RANO criteria
After
Best overall response rate by IRC
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 120
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Up to 30 Months
After
Up to 68 months
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 121
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Proportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria.
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 49 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 70
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
176
After
320
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 71
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Non Small Cell Lung Cancer
After
Arm 1_NSCLC
replace /protocolSection/armsInterventionsModule/armGroups/0/type
Triage: High
Arm Intervention Change Operation 72
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 73
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 74
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 75
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Thyroid
After
Arm 2_Thyroid
replace /protocolSection/armsInterventionsModule/armGroups/1/type
Triage: High
Arm Intervention Change Operation 76
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 77
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with solid thyroid tumors harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 78
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/2/label
Triage: High
Arm Intervention Change Operation 79
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Sarcoma
After
Arm 3_Sarcoma
replace /protocolSection/armsInterventionsModule/armGroups/2/type
Triage: High
Arm Intervention Change Operation 80
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/2/description
Triage: High
Arm Intervention Change Operation 81
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with soft-tissue sarcoma harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 82
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/3/label
Triage: High
Arm Intervention Change Operation 83
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Colorectal
After
Arm 4_Colorectal
replace /protocolSection/armsInterventionsModule/armGroups/3/type
Triage: High
Arm Intervention Change Operation 84
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/3/description
Triage: High
Arm Intervention Change Operation 85
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with solid colorectal tumors harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
Triage: High
Arm Intervention Change Operation 86
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/4/label
Triage: High
Arm Intervention Change Operation 87
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Salivary
After
Arm 5_Salivary
replace /protocolSection/armsInterventionsModule/armGroups/4/type
Triage: High
Arm Intervention Change Operation 88
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/4/description
Triage: High
Arm Intervention Change Operation 89
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with solid salivary tumors harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0
Triage: High
Arm Intervention Change Operation 90
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/5/label
Triage: High
Arm Intervention Change Operation 91
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biliary
After
Arm 6_Biliary
replace /protocolSection/armsInterventionsModule/armGroups/5/type
Triage: High
Arm Intervention Change Operation 92
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/5/description
Triage: High
Arm Intervention Change Operation 93
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral larotrectinib (LOXO-101)
After
Patients with solid biliary tumors harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0
Triage: High
Arm Intervention Change Operation 94
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/6/label
Triage: High
Arm Intervention Change Operation 95
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Primary CNS
After
Arm 7_Primary CNS
replace /protocolSection/armsInterventionsModule/armGroups/6/type
Triage: High
Arm Intervention Change Operation 96
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/6/description
Triage: High
Arm Intervention Change Operation 97
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Brain Tumor Measurable by RANO Oral larotrectinib (LOXO-101)
After
Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions
replace /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0
Triage: High
Arm Intervention Change Operation 98
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/7/label
Triage: High
Arm Intervention Change Operation 99
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
All Other Solid Tumors
After
Arm 8_Other tumors
replace /protocolSection/armsInterventionsModule/armGroups/7/type
Triage: High
Arm Intervention Change Operation 100
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/7/description
Triage: High
Arm Intervention Change Operation 101
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Tumor Histology not in Cohorts 1-7 Evaluable but not Measurable Disease Oral larotrectinib (LOXO-101)
After
Patients with breast cancer, kidney cancer, squamous cell cancer of head or neck, melanoma or ovarian solid tumors harboring NTRK fusions.
replace /protocolSection/armsInterventionsModule/armGroups/7/interventionNames/0
Triage: High
Arm Intervention Change Operation 102
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/armGroups/8/label
Triage: High
Arm Intervention Change Operation 103
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Eligible for cohorts 1-8 but lab certification not confirmed
After
Arm 9_Solid tumors without confirmed NTRK fusion
replace /protocolSection/armsInterventionsModule/armGroups/8/type
Triage: High
Arm Intervention Change Operation 104
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/8/description
Triage: High
Arm Intervention Change Operation 105
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Subjects eligible for Cohorts 1-8, but lab CLIA- or equivalent certification cannot be confirmed at time of Subjects eligible for Cohorts 1-8, but lab CLIA- or equivalent certification cannot be confirmed at time of consent Oral larotrectinib (LOXO-101)
After
Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent.
replace /protocolSection/armsInterventionsModule/armGroups/8/interventionNames/0
Triage: High
Arm Intervention Change Operation 106
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Larotrectinib LOXO-101
After
Drug: BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 107
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Larotrectinib LOXO-101
After
BAY2757556 (Larotrectinib, Vitrakvi)
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 108
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Oral capsule of larotrectinib (LOXO-101) - 100mg BID
After
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 109
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
All Other Solid Tumors
After
Arm 1_NSCLC
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 110
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biliary
After
Arm 2_Thyroid
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2
Triage: High
Arm Intervention Change Operation 111
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Colorectal
After
Arm 3_Sarcoma
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3
Triage: High
Arm Intervention Change Operation 112
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Eligible for cohorts 1-8 but lab certification not confirmed
After
Arm 4_Colorectal
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/4
Triage: High
Arm Intervention Change Operation 113
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Non Small Cell Lung Cancer
After
Arm 5_Salivary
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5
Triage: High
Arm Intervention Change Operation 114
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Primary CNS
After
Arm 6_Biliary
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6
Triage: High
Arm Intervention Change Operation 115
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Salivary
After
Arm 7_Primary CNS
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7
Triage: High
Arm Intervention Change Operation 116
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Sarcoma
After
Arm 8_Other tumors
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/8
Triage: High
Arm Intervention Change Operation 117
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Thyroid
After
Arm 9_Solid tumors without confirmed NTRK fusion
add /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 118
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "LOXO-101"
]
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 160
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Key Inclusion Criteria:</p><ol><li>Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
Subjects who have NTRK gene fusion identified in a lab where certification of the lab cannot be confirmed by the Sponsor at the time of consent may enroll to Cohort 9.</li><li>Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.</li><li><p>Adequate organ function as defined by the following criteria:</p><ul><li>Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) &lt; 2.5 upper limit of normal (ULN), or AST and ALT &lt; 5 ULN if liver function abnormalities are due to underlying malignancy.</li><li>Total bilirubin &lt; 2.5 x ULN, except in the setting of biliary obstruction.
Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible</li><li>Serum creatinine &lt; 2.0 x ULN OR an estimated glomerular filtration rate ≥ 30 mL&#x2F;minute using the Cockcroft-Gault formula</li><li>ECOG score &lt; 3 (age &gt;16 years) or Lansky Performance Score (LPS) &gt;40% (age &lt;16 years).
If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Score (KPS) (age &gt;16 years) or LPS (age &lt;16 years) &gt;50%</li><li>Archived tumor tissue.
If archival tissue is known to not be available, then an on-study tumor biopsy should be attempted if it can be safely performed.</li></ul></li></ol><p>Key Exclusion Criteria:</p><ol><li>Symptomatic or unstable brain metastases.
(Note: Subjects with asymptomatic brain metastases are eligible to participate in the study).
Subjects with primary CNS tumors are eligible.</li><li>Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib (LOXO-101) or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy.</li><li>Pregnancy or lactation.</li></ol>
After
<p>Inclusion Criteria:</p><ul><li>Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays</li><li>Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy</li><li>Subjects must have at least one measurable lesion as defined by RECIST v1.1</li></ul><p>Exclusion Criteria:</p><ul><li>Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK.
Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible.</li><li>Symptomatic or unstable brain metastases.
(Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.)
Subjects with primary CNS tumors are eligible.</li><li>Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.</li><li>Pregnancy or lactation.</li></ul>
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 38 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 122
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall Response Rate of confirmed CR or PR as determined by the treating investigator Overall Response Rate based on the treating Investigator&#x27;s response assessment using RECISTv1.1 or RANO criteria, as appropriate to tumor type.
After
Best overall response rate by investigator
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 123
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
add /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 124
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Proportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria.
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 125
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of response for subjects with best overall response of confirmed CR or PR by Independent Radiology Committee
After
Duration of response (DOR) by IRC
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 126
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
add /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 127
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death.
Complete response, partial response and disease progression are assessed by an independent radiology committee (IRC).
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 128
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of response for subjects with best overall response of confirmed CR or PR by the treating investigator
After
Duration of response (DOR) by investigator
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 129
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
add /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 130
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
<p>Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death.</p><p>Complete response, partial response and disease progression are assessed by the treating investigator.</p>
replace /protocolSection/outcomesModule/secondaryOutcomes/3/measure
Triage: High
Secondary Outcome Change Operation 131
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To estimate the proportion of subjects that has any tumor regression as a best response.
After
Clinical benefit rate (CBR)
replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
Triage: High
Secondary Outcome Change Operation 132
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
add /protocolSection/outcomesModule/secondaryOutcomes/3/description
Triage: High
Secondary Outcome Change Operation 133
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Proportion of subjects with best overall response of complete response, partial response or stable disease lasting 16 or more weeks following the initiation of larotrectinib.
replace /protocolSection/outcomesModule/secondaryOutcomes/4/measure
Triage: High
Secondary Outcome Change Operation 134
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of Progression Free Survival following initiation of larotrectinib (LOXO-101)
After
Progression-free survival (PFS) after Larotrectinib
replace /protocolSection/outcomesModule/secondaryOutcomes/4/description
Triage: High
Secondary Outcome Change Operation 135
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Number of months from initiation of larotrectinib (LOXO-101) to the earlier of disease progression or death due to any cause.
After
Number of months from initiation of larotrectinib to either disease progression or death due to any cause.
replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
Triage: High
Secondary Outcome Change Operation 136
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
replace /protocolSection/outcomesModule/secondaryOutcomes/5/measure
Triage: High
Secondary Outcome Change Operation 137
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Duration of overall survival (OS) following initiation of larotrectinib (LOXO-101)
After
Overall survival time
replace /protocolSection/outcomesModule/secondaryOutcomes/5/description
Triage: High
Secondary Outcome Change Operation 138
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Number of months from the initiation of larotrectinib (LOXO-101) to the date of death due to any cause.
After
Number of months from the initiation of larotrectinib to the date of death due to any cause.
replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
Triage: High
Secondary Outcome Change Operation 139
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Through study completion up to 42 months
After
Up to 68 months
replace /protocolSection/outcomesModule/secondaryOutcomes/6/measure
Triage: High
Secondary Outcome Change Operation 140
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
To assess the safety profile and tolerability of larotrectinib (LOXO-101).
After
Progression-free survival (PFS) after past cancer therapy
replace /protocolSection/outcomesModule/secondaryOutcomes/6/description
Triage: High
Secondary Outcome Change Operation 141
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Incidence, duration, and severity of adverse events
After
Number of months from initiation of the line of therapy preceding larotrectinib to either disease progression or death due to any cause.
replace /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame
Triage: High
Secondary Outcome Change Operation 142
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Through study completion up to 42 months
After
Up to 68 months
replace /protocolSection/outcomesModule/secondaryOutcomes/7/measure
Triage: High
Secondary Outcome Change Operation 143
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Comparison of Progression Free Survival following initiation of larotrectinib (LOXO-101) to that following the line of therapy immediately preceding larotrectinib (LOXO-101) in each subject who has received prior therapy.
After
Number of subjects with adverse events
remove /protocolSection/outcomesModule/secondaryOutcomes/7/description
Triage: High
Secondary Outcome Change Operation 144
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Number of months from initiation of larotrectinib (LOXO-101) to the earlier of disease progression or death due to any cause
replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame
Triage: High
Secondary Outcome Change Operation 145
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
replace /protocolSection/outcomesModule/secondaryOutcomes/8/measure
Triage: High
Secondary Outcome Change Operation 146
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Evaluate the clinical benefit rate (CBR) based on the proportion of subjects with best overall response of CR, PR, or stable disease lasting 16 or more weeks following initiation of larotrectinib (LOXO-101)
After
Number of subjects with serious adverse events
replace /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame
Triage: High
Secondary Outcome Change Operation 147
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
replace /protocolSection/outcomesModule/secondaryOutcomes/9/measure
Triage: High
Secondary Outcome Change Operation 148
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
&quot;Evaluate the concordance of prior molecular profiling that detected an NTRK fusion within the subject&#x27;s tumor with the diagnostic test being evaluated by the Sponsor&quot;
After
Number of subjects with treatment-related adverse events
replace /protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame
Triage: High
Secondary Outcome Change Operation 149
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 months
After
Up to 68 months
add /protocolSection/outcomesModule/secondaryOutcomes/10
Triage: High
Secondary Outcome Change Operation 150
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Severity of adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/11
Triage: High
Secondary Outcome Change Operation 151
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Severity of serious adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/12
Triage: High
Secondary Outcome Change Operation 152
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Severity of treatment-related adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/13
Triage: High
Secondary Outcome Change Operation 153
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Duration of adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/14
Triage: High
Secondary Outcome Change Operation 154
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Duration of serious adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/15
Triage: High
Secondary Outcome Change Operation 155
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Duration of treatment-related adverse events",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/16
Triage: High
Secondary Outcome Change Operation 156
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/17
Triage: High
Secondary Outcome Change Operation 157
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Severity of safety-relevant changes in clinical parameters or vital signs after drug administration",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/18
Triage: High
Secondary Outcome Change Operation 158
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Proportion of subjects that has any tumor regression as a best response",
  "timeFrame": "Up to 68 months"
}
add /protocolSection/outcomesModule/secondaryOutcomes/19
Triage: High
Secondary Outcome Change Operation 159
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Concordance coefficient",
  "timeFrame": "Up to 68 months",
  "description": "Describes the concordance of prior molecular profiling that detected an NTRK fusion within the subject&#x27;s tumor and a diagnostic test being evaluated by the sponsor."
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2015-10
After
2015-09-30
add /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 7
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
ACTUAL
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 8
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2019-12
After
2021-05-31
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 9
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2019-12
After
2021-05-31
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 176 ops
replace /protocolSection/contactsLocationsModule/centralContacts/0/name
Triage: Low
Administrative Contact Change Operation 161
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
Patient Advocacy
After
Bayer Clinical Trials Contact
replace /protocolSection/contactsLocationsModule/centralContacts/0/phone
Triage: Low
Administrative Contact Change Operation 162
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
1-855-NTRK-123
After
(+)1-888-84 22937
replace /protocolSection/contactsLocationsModule/centralContacts/0/email
Triage: Low
Administrative Contact Change Operation 163
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
clinicaltrials@loxooncology.com
After
clinical-trials-contact@bayer.com
remove /protocolSection/contactsLocationsModule/overallOfficials
Triage: Uncategorized
Uncategorized Operation 164
Before
[
  {
    "name": "Nora Ku, MD",
    "role": "STUDY_DIRECTOR",
    "affiliation": "Loxo Oncology"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/facility
Triage: Uncategorized
Uncategorized Operation 165
Before
University of California - Los Angeles
replace /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 166
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/0/city
Triage: Uncategorized
Uncategorized Operation 167
Before
Los Angeles
After
Palo Alto
replace /protocolSection/contactsLocationsModule/locations/0/zip
Triage: Uncategorized
Uncategorized Operation 168
Before
90095
After
94304
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 169
Before
[
  {
    "name": "Lee Rosen, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/0/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 170
Before
34.05223
After
37.44188
replace /protocolSection/contactsLocationsModule/locations/0/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 171
Before
-118.24368
After
-122.14302
remove /protocolSection/contactsLocationsModule/locations/1/facility
Triage: Uncategorized
Uncategorized Operation 172
Before
Stanford University
replace /protocolSection/contactsLocationsModule/locations/1/city
Triage: Uncategorized
Uncategorized Operation 173
Before
Stanford
After
Santa Monica
replace /protocolSection/contactsLocationsModule/locations/1/zip
Triage: Uncategorized
Uncategorized Operation 174
Before
94305
After
90404
remove /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 175
Before
[
  {
    "name": "Shivaani Kummar, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 176
Before
37.42411
After
34.01949
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 177
Before
-122.16608
After
-118.49138
remove /protocolSection/contactsLocationsModule/locations/2/facility
Triage: Uncategorized
Uncategorized Operation 178
Before
Medstar Hospital Washington
replace /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 179
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/2/contacts
Triage: Uncategorized
Uncategorized Operation 180
Before
[
  {
    "name": "Dennis Priebat, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/3/facility
Triage: Uncategorized
Uncategorized Operation 181
Before
Memorial Hospital
replace /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 182
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/3/city
Triage: Uncategorized
Uncategorized Operation 183
Before
Pembroke Pines
After
Pembroke
remove /protocolSection/contactsLocationsModule/locations/3/contacts
Triage: Uncategorized
Uncategorized Operation 184
Before
[
  {
    "name": "Luis Raez, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 185
Before
26.00315
After
27.78642
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 186
Before
-80.22394
After
-81.80508
remove /protocolSection/contactsLocationsModule/locations/4/facility
Triage: Uncategorized
Uncategorized Operation 187
Before
University of Chicago
replace /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 188
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/4/contacts
Triage: Uncategorized
Uncategorized Operation 189
Before
[
  {
    "name": "Jyoti Patel, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/5/facility
Triage: Uncategorized
Uncategorized Operation 190
Before
Massachusetts General Hospital
replace /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 191
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/5/contacts
Triage: Uncategorized
Uncategorized Operation 192
Before
[
  {
    "name": "Anna Farago, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/6/facility
Triage: Uncategorized
Uncategorized Operation 193
Before
Dana-Farber Cancer Institute
replace /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 194
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/6/zip
Triage: Uncategorized
Uncategorized Operation 195
Before
02115
After
02215
remove /protocolSection/contactsLocationsModule/locations/6/contacts
Triage: Uncategorized
Uncategorized Operation 196
Before
[
  {
    "name": "George Demetri, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/7/facility
Triage: Uncategorized
Uncategorized Operation 197
Before
Roswell Park Cancer Institute
replace /protocolSection/contactsLocationsModule/locations/7/status
Triage: Uncategorized
Uncategorized Operation 198
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/7/contacts
Triage: Uncategorized
Uncategorized Operation 199
Before
[
  {
    "name": "Anne Grand&#x27;Maison, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/8/facility
Triage: Uncategorized
Uncategorized Operation 200
Before
Memorial Sloan Kettering Cancer Center
replace /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 201
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/8/zip
Triage: Uncategorized
Uncategorized Operation 202
Before
10065
After
10038
remove /protocolSection/contactsLocationsModule/locations/8/contacts
Triage: Uncategorized
Uncategorized Operation 203
Before
[
  {
    "name": "Alex Drilon, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/9/facility
Triage: Uncategorized
Uncategorized Operation 204
Before
University of North Carolina (UNC)
replace /protocolSection/contactsLocationsModule/locations/9/status
Triage: Uncategorized
Uncategorized Operation 205
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/9/contacts
Triage: Uncategorized
Uncategorized Operation 206
Before
[
  {
    "name": "Juneko Grilley-Olson, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/10/facility
Triage: Uncategorized
Uncategorized Operation 207
Before
Wake Forest Baptist Medical Center
replace /protocolSection/contactsLocationsModule/locations/10/status
Triage: Uncategorized
Uncategorized Operation 208
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/10/zip
Triage: Uncategorized
Uncategorized Operation 209
Before
27157
After
27157-1082
remove /protocolSection/contactsLocationsModule/locations/10/contacts
Triage: Uncategorized
Uncategorized Operation 210
Before
[
  {
    "name": "Stefan Grant, MD, JD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/11/facility
Triage: Uncategorized
Uncategorized Operation 211
Before
Cleveland Clinic
replace /protocolSection/contactsLocationsModule/locations/11/status
Triage: Uncategorized
Uncategorized Operation 212
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/11/zip
Triage: Uncategorized
Uncategorized Operation 213
Before
44195
After
44195-0002
remove /protocolSection/contactsLocationsModule/locations/11/contacts
Triage: Uncategorized
Uncategorized Operation 214
Before
[
  {
    "name": "Davendra Sohal, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/12/facility
Triage: Uncategorized
Uncategorized Operation 215
Before
Thomas Jefferson University
replace /protocolSection/contactsLocationsModule/locations/12/status
Triage: Uncategorized
Uncategorized Operation 216
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/12/contacts
Triage: Uncategorized
Uncategorized Operation 217
Before
[
  {
    "name": "Ashwin Sama, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/13/facility
Triage: Uncategorized
Uncategorized Operation 218
Before
Fox Chase Cancer Center
replace /protocolSection/contactsLocationsModule/locations/13/status
Triage: Uncategorized
Uncategorized Operation 219
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/13/contacts
Triage: Uncategorized
Uncategorized Operation 220
Before
[
  {
    "name": "Wafik El-Deiry, MD, PhD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/14/facility
Triage: Uncategorized
Uncategorized Operation 221
Before
Avera Cancer Institute
replace /protocolSection/contactsLocationsModule/locations/14/status
Triage: Uncategorized
Uncategorized Operation 222
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/14/contacts
Triage: Uncategorized
Uncategorized Operation 223
Before
[
  {
    "name": "Brian Leyland-Jones, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/15/facility
Triage: Uncategorized
Uncategorized Operation 224
Before
Vanderbilt University
replace /protocolSection/contactsLocationsModule/locations/15/status
Triage: Uncategorized
Uncategorized Operation 225
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/15/zip
Triage: Uncategorized
Uncategorized Operation 226
Before
37235
After
37232
remove /protocolSection/contactsLocationsModule/locations/15/contacts
Triage: Uncategorized
Uncategorized Operation 227
Before
[
  {
    "name": "Jordan Berlin, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/16/facility
Triage: Uncategorized
Uncategorized Operation 228
Before
MD Anderson Cancer Center
replace /protocolSection/contactsLocationsModule/locations/16/status
Triage: Uncategorized
Uncategorized Operation 229
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/16/contacts
Triage: Uncategorized
Uncategorized Operation 230
Before
[
  {
    "name": "David Hong, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/17/facility
Triage: Uncategorized
Uncategorized Operation 231
Before
Inova Health System
replace /protocolSection/contactsLocationsModule/locations/17/status
Triage: Uncategorized
Uncategorized Operation 232
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/17/city
Triage: Uncategorized
Uncategorized Operation 233
Before
Fairfax
After
Falls Church
replace /protocolSection/contactsLocationsModule/locations/17/zip
Triage: Uncategorized
Uncategorized Operation 234
Before
22031
After
22042
remove /protocolSection/contactsLocationsModule/locations/17/contacts
Triage: Uncategorized
Uncategorized Operation 235
Before
[
  {
    "name": "John Deeken, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/17/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 236
Before
38.84622
After
38.88233
replace /protocolSection/contactsLocationsModule/locations/17/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 237
Before
-77.30637
After
-77.17109
remove /protocolSection/contactsLocationsModule/locations/18/facility
Triage: Uncategorized
Uncategorized Operation 238
Before
University of Washington - Seattle Cancer Care Alliance
replace /protocolSection/contactsLocationsModule/locations/18/status
Triage: Uncategorized
Uncategorized Operation 239
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/18/contacts
Triage: Uncategorized
Uncategorized Operation 240
Before
[
  {
    "name": "Christina Baik, MD, MPH",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/19/facility
Triage: Uncategorized
Uncategorized Operation 241
Before
West Virginia University
replace /protocolSection/contactsLocationsModule/locations/19/status
Triage: Uncategorized
Uncategorized Operation 242
Before
RECRUITING
After
NOT_YET_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/19/contacts
Triage: Uncategorized
Uncategorized Operation 243
Before
[
  {
    "name": "Patrick Ma, MD",
    "role": "CONTACT"
  }
]
remove /protocolSection/contactsLocationsModule/locations/20/facility
Triage: Uncategorized
Uncategorized Operation 244
Before
Copenhagen University Hospital
replace /protocolSection/contactsLocationsModule/locations/20/status
Triage: Uncategorized
Uncategorized Operation 245
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/20/city
Triage: Uncategorized
Uncategorized Operation 246
Before
Copenhagen
After
Guangzhou
replace /protocolSection/contactsLocationsModule/locations/20/country
Triage: Uncategorized
Uncategorized Operation 247
Before
Denmark
After
China
remove /protocolSection/contactsLocationsModule/locations/20/contacts
Triage: Uncategorized
Uncategorized Operation 248
Before
[
  {
    "name": "Ulrik Lassen, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/20/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 249
Before
55.67594
After
23.11667
replace /protocolSection/contactsLocationsModule/locations/20/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 250
Before
12.56553
After
113.25
add /protocolSection/contactsLocationsModule/locations/20/state
Triage: Uncategorized
Uncategorized Operation 251
After
Guangdong
add /protocolSection/contactsLocationsModule/locations/20/zip
Triage: Uncategorized
Uncategorized Operation 252
After
510060
remove /protocolSection/contactsLocationsModule/locations/21/facility
Triage: Uncategorized
Uncategorized Operation 253
Before
Institut Bergonie
replace /protocolSection/contactsLocationsModule/locations/21/status
Triage: Uncategorized
Uncategorized Operation 254
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/21/city
Triage: Uncategorized
Uncategorized Operation 255
Before
Bordeaux
After
Beijing
replace /protocolSection/contactsLocationsModule/locations/21/zip
Triage: Uncategorized
Uncategorized Operation 256
Before
33076
After
100142
replace /protocolSection/contactsLocationsModule/locations/21/country
Triage: Uncategorized
Uncategorized Operation 257
Before
France
After
China
remove /protocolSection/contactsLocationsModule/locations/21/contacts
Triage: Uncategorized
Uncategorized Operation 258
Before
[
  {
    "name": "Antoine Italiano",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/21/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 259
Before
44.84124
After
39.9075
replace /protocolSection/contactsLocationsModule/locations/21/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 260
Before
-0.58046
After
116.39723
remove /protocolSection/contactsLocationsModule/locations/22/facility
Triage: Uncategorized
Uncategorized Operation 261
Before
St. Vincent&#x27;s University Hospital
replace /protocolSection/contactsLocationsModule/locations/22/status
Triage: Uncategorized
Uncategorized Operation 262
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/22/city
Triage: Uncategorized
Uncategorized Operation 263
Before
Dublin
After
Chengdu
replace /protocolSection/contactsLocationsModule/locations/22/country
Triage: Uncategorized
Uncategorized Operation 264
Before
Ireland
After
China
remove /protocolSection/contactsLocationsModule/locations/22/contacts
Triage: Uncategorized
Uncategorized Operation 265
Before
[
  {
    "name": "Ray McDermott, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/22/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 266
Before
53.33306
After
30.66667
replace /protocolSection/contactsLocationsModule/locations/22/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 267
Before
-6.24889
After
104.06667
remove /protocolSection/contactsLocationsModule/locations/23/facility
Triage: Uncategorized
Uncategorized Operation 268
Before
National Cancer Center Hospital East
replace /protocolSection/contactsLocationsModule/locations/23/status
Triage: Uncategorized
Uncategorized Operation 269
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/23/city
Triage: Uncategorized
Uncategorized Operation 270
Before
Kashiwa
After
Shanghai
remove /protocolSection/contactsLocationsModule/locations/23/state
Triage: Uncategorized
Uncategorized Operation 271
Before
Chiba
replace /protocolSection/contactsLocationsModule/locations/23/zip
Triage: Uncategorized
Uncategorized Operation 272
Before
277-8577
After
200032
replace /protocolSection/contactsLocationsModule/locations/23/country
Triage: Uncategorized
Uncategorized Operation 273
Before
Japan
After
China
remove /protocolSection/contactsLocationsModule/locations/23/contacts
Triage: Uncategorized
Uncategorized Operation 274
Before
[
  {
    "name": "Makoto Tahara",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/23/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 275
Before
35.86224
After
31.22222
replace /protocolSection/contactsLocationsModule/locations/23/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 276
Before
139.97732
After
121.45806
remove /protocolSection/contactsLocationsModule/locations/24/facility
Triage: Uncategorized
Uncategorized Operation 277
Before
Instituto Português de Oncologia do Porto Francisco Gentil
replace /protocolSection/contactsLocationsModule/locations/24/status
Triage: Uncategorized
Uncategorized Operation 278
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/24/city
Triage: Uncategorized
Uncategorized Operation 279
Before
Porto
After
Copenhagen
replace /protocolSection/contactsLocationsModule/locations/24/zip
Triage: Uncategorized
Uncategorized Operation 280
Before
4200-072
After
2100
replace /protocolSection/contactsLocationsModule/locations/24/country
Triage: Uncategorized
Uncategorized Operation 281
Before
Portugal
After
Denmark
remove /protocolSection/contactsLocationsModule/locations/24/contacts
Triage: Uncategorized
Uncategorized Operation 282
Before
[
  {
    "name": "Nuno Sousa",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/24/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 283
Before
41.1485
After
55.67594
replace /protocolSection/contactsLocationsModule/locations/24/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 284
Before
-8.61097
After
12.56553
remove /protocolSection/contactsLocationsModule/locations/25/facility
Triage: Uncategorized
Uncategorized Operation 285
Before
National Cancer Centre
replace /protocolSection/contactsLocationsModule/locations/25/city
Triage: Uncategorized
Uncategorized Operation 286
Before
Outram
After
Bordeaux
replace /protocolSection/contactsLocationsModule/locations/25/zip
Triage: Uncategorized
Uncategorized Operation 287
Before
169608
After
33076
replace /protocolSection/contactsLocationsModule/locations/25/country
Triage: Uncategorized
Uncategorized Operation 288
Before
Singapore
After
France
remove /protocolSection/contactsLocationsModule/locations/25/contacts
Triage: Uncategorized
Uncategorized Operation 289
Before
[
  {
    "name": "Daniel Tan, MD",
    "role": "CONTACT"
  }
]
add /protocolSection/contactsLocationsModule/locations/25/geoPoint
Triage: Uncategorized
Uncategorized Operation 290
After
{
  "lat": 44.84124,
  "lon": -0.58046
}
replace /protocolSection/contactsLocationsModule/locations/26/facility
Triage: Uncategorized
Uncategorized Operation 291
Before
Seoul National University Hospital
After
St. Vincent&#x27;s University Hospital
replace /protocolSection/contactsLocationsModule/locations/26/status
Triage: Uncategorized
Uncategorized Operation 292
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/26/city
Triage: Uncategorized
Uncategorized Operation 293
Before
Seoul
After
Dublin
replace /protocolSection/contactsLocationsModule/locations/26/zip
Triage: Uncategorized
Uncategorized Operation 294
Before
03080
After
D04 T6F4
replace /protocolSection/contactsLocationsModule/locations/26/country
Triage: Uncategorized
Uncategorized Operation 295
Before
South Korea
After
Ireland
remove /protocolSection/contactsLocationsModule/locations/26/contacts
Triage: Uncategorized
Uncategorized Operation 296
Before
[
  {
    "name": "Do-Youn Oh",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/26/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 297
Before
37.566
After
53.33306
replace /protocolSection/contactsLocationsModule/locations/26/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 298
Before
126.9784
After
-6.24889
remove /protocolSection/contactsLocationsModule/locations/27/facility
Triage: Uncategorized
Uncategorized Operation 299
Before
Samsung Medical Center
replace /protocolSection/contactsLocationsModule/locations/27/status
Triage: Uncategorized
Uncategorized Operation 300
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/27/city
Triage: Uncategorized
Uncategorized Operation 301
Before
Seoul
After
Kashiwa
replace /protocolSection/contactsLocationsModule/locations/27/country
Triage: Uncategorized
Uncategorized Operation 302
Before
South Korea
After
Japan
remove /protocolSection/contactsLocationsModule/locations/27/contacts
Triage: Uncategorized
Uncategorized Operation 303
Before
[
  {
    "name": "Keunchil Park, MD, PhD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/27/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 304
Before
37.566
After
35.86224
replace /protocolSection/contactsLocationsModule/locations/27/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 305
Before
126.9784
After
139.97732
add /protocolSection/contactsLocationsModule/locations/27/state
Triage: Uncategorized
Uncategorized Operation 306
After
Chiba
add /protocolSection/contactsLocationsModule/locations/27/zip
Triage: Uncategorized
Uncategorized Operation 307
After
277-8577
remove /protocolSection/contactsLocationsModule/locations/28/facility
Triage: Uncategorized
Uncategorized Operation 308
Before
Severance Hospital, Yonsei University Health System
replace /protocolSection/contactsLocationsModule/locations/28/status
Triage: Uncategorized
Uncategorized Operation 309
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/28/city
Triage: Uncategorized
Uncategorized Operation 310
Before
Seoul
After
Southampton
replace /protocolSection/contactsLocationsModule/locations/28/country
Triage: Uncategorized
Uncategorized Operation 311
Before
South Korea
After
United Kingdom
remove /protocolSection/contactsLocationsModule/locations/28/contacts
Triage: Uncategorized
Uncategorized Operation 312
Before
[
  {
    "name": "Hyun Cheol Chung, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/28/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 313
Before
37.566
After
50.90395
replace /protocolSection/contactsLocationsModule/locations/28/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 314
Before
126.9784
After
-1.40428
add /protocolSection/contactsLocationsModule/locations/28/state
Triage: Uncategorized
Uncategorized Operation 315
After
Hampshire
add /protocolSection/contactsLocationsModule/locations/28/zip
Triage: Uncategorized
Uncategorized Operation 316
After
SO16 6YD
remove /protocolSection/contactsLocationsModule/locations/29/facility
Triage: Uncategorized
Uncategorized Operation 317
Before
Hospital Universitario Vall d&#x27;Hebron
replace /protocolSection/contactsLocationsModule/locations/29/status
Triage: Uncategorized
Uncategorized Operation 318
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/29/city
Triage: Uncategorized
Uncategorized Operation 319
Before
Barcelona
After
London
replace /protocolSection/contactsLocationsModule/locations/29/zip
Triage: Uncategorized
Uncategorized Operation 320
Before
08035
After
EC1M 6BQ
replace /protocolSection/contactsLocationsModule/locations/29/country
Triage: Uncategorized
Uncategorized Operation 321
Before
Spain
After
United Kingdom
remove /protocolSection/contactsLocationsModule/locations/29/contacts
Triage: Uncategorized
Uncategorized Operation 322
Before
[
  {
    "name": "Cinta Hierro Carbó",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/29/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 323
Before
41.38879
After
51.50853
replace /protocolSection/contactsLocationsModule/locations/29/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 324
Before
2.15899
After
-0.12574
remove /protocolSection/contactsLocationsModule/locations/30/facility
Triage: Uncategorized
Uncategorized Operation 325
Before
Fundacion Jimenez Diaz
replace /protocolSection/contactsLocationsModule/locations/30/status
Triage: Uncategorized
Uncategorized Operation 326
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/30/city
Triage: Uncategorized
Uncategorized Operation 327
Before
Madrid
After
London
replace /protocolSection/contactsLocationsModule/locations/30/zip
Triage: Uncategorized
Uncategorized Operation 328
Before
28040
After
W1T 7HA
replace /protocolSection/contactsLocationsModule/locations/30/country
Triage: Uncategorized
Uncategorized Operation 329
Before
Spain
After
United Kingdom
remove /protocolSection/contactsLocationsModule/locations/30/contacts
Triage: Uncategorized
Uncategorized Operation 330
Before
[
  {
    "name": "Victor Moreno, MD",
    "role": "CONTACT"
  }
]
replace /protocolSection/contactsLocationsModule/locations/30/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 331
Before
40.4165
After
51.50853
replace /protocolSection/contactsLocationsModule/locations/30/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 332
Before
-3.70256
After
-0.12574
remove /protocolSection/contactsLocationsModule/locations/31
Triage: Uncategorized
Uncategorized Operation 333
Before
{
  "zip": "28050",
  "city": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "contacts": [
    {
      "name": "Valentina Boni",
      "role": "CONTACT"
    }
  ],
  "facility": "Centro Integral Oncologico Clara Campal",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
remove /protocolSection/contactsLocationsModule/locations/31
Triage: Uncategorized
Uncategorized Operation 334
Before
{
  "city": "London",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "David Propper",
      "role": "CONTACT"
    }
  ],
  "facility": "Barts Health NHS Trust Royal London Hospital",
  "geoPoint": {
    "lat": 51.50853,
    "lon": -0.12574
  }
}
remove /protocolSection/contactsLocationsModule/locations/31
Triage: Uncategorized
Uncategorized Operation 335
Before
{
  "city": "London",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "Martin Forster",
      "role": "CONTACT"
    }
  ],
  "facility": "University College Hospital",
  "geoPoint": {
    "lat": 51.50853,
    "lon": -0.12574
  }
}
remove /protocolSection/contactsLocationsModule/locations/31
Triage: Uncategorized
Uncategorized Operation 336
Before
{
  "zip": "S016 6YD",
  "city": "Southampton",
  "status": "RECRUITING",
  "country": "United Kingdom",
  "contacts": [
    {
      "name": "Simon Crabb",
      "role": "CONTACT"
    }
  ],
  "facility": "University Hospital Southampton (UHS)",
  "geoPoint": {
    "lat": 50.90395,
    "lon": -1.40428
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 59 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 10
Before
2019-02-13
After
2019-02-25
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 11
Before
2019-02-15
After
2019-02-27
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 15
Before
Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.
After
This research study is done to test how well different types of cancer respond to the drug called larotrectinib.
The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
Larotrectinib is an experimental drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 16
Before
<p>This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.
Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.</p><p>Larotrectinib (LOXO-101) will be administered orally at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.</p><p>The study will analyze 9 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.
Cohort 9 will include patients who meet criteria for Cohorts 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the Sponsor at the time of consent.</p>
After
<p>The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults.</p><p>Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.</p>
replace /protocolSection/conditionsModule/conditions/0
Triage: Uncategorized
Uncategorized Operation 17
Before
Carcinoma, Non-Small-Cell Lung
After
Solid Tumors Harboring NTRK Fusion
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 18
Before
Thyroid Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 19
Before
Sarcoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 20
Before
Colorectal Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 21
Before
Salivary Gland Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 22
Before
Biliary Tract Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 23
Before
Brain Neoplasm, Primary
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 24
Before
Carcinoma, Ductal, Breast
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 25
Before
Melanoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 26
Before
Solid Tumors
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 27
Before
Glioblastoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 28
Before
Bile Duct Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 29
Before
Astrocytoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 30
Before
Head and Neck Squamous Cell Carcinoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 31
Before
Pontine Glioma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 32
Before
Pancreatic Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 33
Before
Ovarian Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 34
Before
Carcinoma, Renal Cell
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 35
Before
Cholangiocarcinoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 36
Before
Carcinoma
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 37
Before
Carcinoma, Bronchogenic
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 38
Before
Bronchial Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 39
Before
Lung Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 40
Before
Respiratory Tract Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 41
Before
Thoracic Neoplasms
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 42
Before
Neoplasms, Nerve Tissue
remove /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 43
Before
Nevi and Melanomas
replace /protocolSection/conditionsModule/keywords/0
Triage: Uncategorized
Uncategorized Operation 44
Before
NTRK Fusion Positive
After
Non-small cell lung cancer
replace /protocolSection/conditionsModule/keywords/1
Triage: Uncategorized
Uncategorized Operation 45
Before
LOXO-101
After
Thyroid cancer
replace /protocolSection/conditionsModule/keywords/2
Triage: Uncategorized
Uncategorized Operation 46
Before
Loxo
After
Sarcoma
replace /protocolSection/conditionsModule/keywords/3
Triage: Uncategorized
Uncategorized Operation 47
Before
TRK
After
Colorectal cancer
replace /protocolSection/conditionsModule/keywords/4
Triage: Uncategorized
Uncategorized Operation 48
Before
TRK Fusion
After
Salivary gland cancer
add /protocolSection/conditionsModule/keywords/5
Triage: Uncategorized
Uncategorized Operation 49
After
Biliary cancer
add /protocolSection/conditionsModule/keywords/6
Triage: Uncategorized
Uncategorized Operation 50
After
Central nervous system (CNS) tumor
add /protocolSection/conditionsModule/keywords/7
Triage: Uncategorized
Uncategorized Operation 51
After
Neurotrophic tyrosine receptor kinase (NTRK)
add /protocolSection/conditionsModule/keywords/11
Triage: Uncategorized
Uncategorized Operation 52
After
Fusion Positive
add /protocolSection/conditionsModule/keywords/12
Triage: Uncategorized
Uncategorized Operation 53
After
TRK fusion
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 54
Before
NTRK
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 55
Before
larotrectinib
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 56
Before
fusion
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 57
Before
tumors
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 58
Before
CNS tumors
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 59
Before
solid tumors
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 60
Before
central nervous system tumors
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 61
Before
solid CNS tumors
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 62
Before
primary CNS tumor
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 63
Before
Advanced CNS tumor
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 64
Before
Metastatic CNS tumor
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 65
Before
NTRK1 fusion
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 66
Before
NTRK2 fusion
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 67
Before
NTRK3 fusion
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 68
Before
ETV6-NTRK3
remove /protocolSection/conditionsModule/keywords/17
Triage: Uncategorized
Uncategorized Operation 69
Before
ETV6 fusion
replace /protocolSection/ipdSharingStatementModule/ipdSharing
Triage: Uncategorized
Uncategorized Operation 337
Before
NO
After
UNDECIDED
add /protocolSection/ipdSharingStatementModule/description
Triage: Uncategorized
Uncategorized Operation 338
After
<p>Availability of this study&#x27;s data will be determined according to Bayer&#x27;s commitment to the EFPIA&#x2F;PhRMA &quot;Principles for responsible clinical trial data sharing&quot;.
This pertains to scope, timepoint and process of data access.</p><p>As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.</p><p>Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</p>
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 8 ops
replace /protocolSection/identificationModule/secondaryIdInfos/0/domain
Triage: Uncategorized
Uncategorized Operation 1
Before
Loxo Oncology, Inc.
After
Loxo Oncology, Inc
add /protocolSection/identificationModule/secondaryIdInfos/1
Triage: Uncategorized
Uncategorized Operation 2
After
{
  "id": "2015-003582-28",
  "type": "EUDRACT_NUMBER"
}
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 3
Before
Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE)
After
A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 4
Before
A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion-Positive Tumors
After
A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects With NTRK Fusion-positive Tumors
add /protocolSection/identificationModule/acronym
Triage: Uncategorized
Uncategorized Operation 5
After
NAVIGATE
remove /protocolSection/sponsorCollaboratorsModule/collaborators
Triage: Uncategorized
Uncategorized Operation 12
Before
[
  {
    "name": "Loxo Oncology, Inc.",
    "class": "INDUSTRY"
  }
]
add /protocolSection/oversightModule/isFdaRegulatedDrug
Triage: Uncategorized
Uncategorized Operation 13
After
true
add /protocolSection/oversightModule/isFdaRegulatedDevice
Triage: Uncategorized
Uncategorized Operation 14
After
false
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/0/domain",
    "value": "Loxo Oncology, Inc"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
    "value": {
      "id": "2015-003582-28",
      "type": "EUDRACT_NUMBER"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects With NTRK Fusion-positive Tumors"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/acronym",
    "value": "NAVIGATE"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-09-30"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2021-05-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2021-05-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-02-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-02-27"
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDrug",
    "value": true
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDevice",
    "value": false
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This research study is done to test how well different types of cancer respond to the drug called larotrectinib.\nThe cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).\nLarotrectinib is an experimental drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer."
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults.</p><p>Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "Solid Tumors Harboring NTRK Fusion"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/0",
    "value": "Non-small cell lung cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/1",
    "value": "Thyroid cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/2",
    "value": "Sarcoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/3",
    "value": "Colorectal cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/4",
    "value": "Salivary gland cancer"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/5",
    "value": "Biliary cancer"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/6",
    "value": "Central nervous system (CNS) tumor"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/7",
    "value": "Neurotrophic tyrosine receptor kinase (NTRK)"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/11",
    "value": "Fusion Positive"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/12",
    "value": "TRK fusion"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/keywords/17"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 320
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Arm 1_NSCLC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Arm 2_Thyroid"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "Patients with solid thyroid tumors harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/label",
    "value": "Arm 3_Sarcoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
    "value": "Patients with soft-tissue sarcoma harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/label",
    "value": "Arm 4_Colorectal"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/description",
    "value": "Patients with solid colorectal tumors harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/label",
    "value": "Arm 5_Salivary"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/description",
    "value": "Patients with solid salivary tumors harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/label",
    "value": "Arm 6_Biliary"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/description",
    "value": "Patients with solid biliary tumors harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/label",
    "value": "Arm 7_Primary CNS"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/description",
    "value": "Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/7/label",
    "value": "Arm 8_Other tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/7/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/7/description",
    "value": "Patients with breast cancer, kidney cancer, squamous cell cancer of head or neck, melanoma or ovarian solid tumors harboring NTRK fusions."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/7/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/8/label",
    "value": "Arm 9_Solid tumors without confirmed NTRK fusion"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/8/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/8/description",
    "value": "Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/8/interventionNames/0",
    "value": "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "BAY2757556 (Larotrectinib, Vitrakvi)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Arm 1_NSCLC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "value": "Arm 2_Thyroid"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
    "value": "Arm 3_Sarcoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/3",
    "value": "Arm 4_Colorectal"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/4",
    "value": "Arm 5_Salivary"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/5",
    "value": "Arm 6_Biliary"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/6",
    "value": "Arm 7_Primary CNS"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/7",
    "value": "Arm 8_Other tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/8",
    "value": "Arm 9_Solid tumors without confirmed NTRK fusion"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "value": [
      "LOXO-101"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Best overall response rate by IRC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to 68 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Proportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Best overall response rate by investigator"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Up to 68 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Proportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Duration of response (DOR) by IRC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to 68 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death.\nComplete response, partial response and disease progression are assessed by an independent radiology committee (IRC)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Duration of response (DOR) by investigator"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Up to 68 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "<p>Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death.</p><p>Complete response, partial response and disease progression are assessed by the treating investigator.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "value": "Clinical benefit rate (CBR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "Up to 68 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "value": "Proportion of subjects with best overall response of complete response, partial response or stable disease lasting 16 or more weeks following the initiation of larotrectinib."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "Progression-free survival (PFS) after Larotrectinib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Number of months from initiation of larotrectinib to either disease progression or death due to any cause."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/26/zip",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/26/country",
    "value": "Ireland"
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    "op": "replace",
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    "op": "replace",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/city",
    "value": "Kashiwa"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/country",
    "value": "Japan"
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  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/27/contacts"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/geoPoint/lat",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/geoPoint/lon",
    "value": 139.97732
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  {
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/28/facility"
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  {
    "op": "replace",
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/28/city",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/28/country",
    "value": "United Kingdom"
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    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/28/contacts"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/28/geoPoint/lat",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/28/geoPoint/lon",
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/29/status",
    "value": "NOT_YET_RECRUITING"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/city",
    "value": "London"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/zip",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/country",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/geoPoint/lat",
    "value": 51.50853
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/geoPoint/lon",
    "value": -0.12574
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/30/status",
    "value": "NOT_YET_RECRUITING"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/30/city",
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  {
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    "path": "/protocolSection/contactsLocationsModule/locations/30/zip",
    "value": "W1T 7HA"
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/30/country",
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  {
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/30/geoPoint/lat",
    "value": 51.50853
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  {
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  {
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  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/31"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/31"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/ipdSharing",
    "value": "UNDECIDED"
  },
  {
    "op": "add",
    "path": "/protocolSection/ipdSharingStatementModule/description",
    "value": "<p>Availability of this study&#x27;s data will be determined according to Bayer&#x27;s commitment to the EFPIA&#x2F;PhRMA &quot;Principles for responsible clinical trial data sharing&quot;.\nThis pertains to scope, timepoint and process of data access.</p><p>As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.\nThis applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.</p><p>Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.\nInformation on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</p>"
  }
]