Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/identificationModule/briefTitle",
"value": "Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE)"
},
{
"op": "replace",
"path": "/protocolSection/identificationModule/officialTitle",
"value": "A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion-Positive Tumors"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2017-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/expandedAccessInfo/hasExpandedAccess",
"value": true
},
{
"op": "add",
"path": "/protocolSection/statusModule/expandedAccessInfo/nctId",
"value": "NCT03025360"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2019-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2017-05-26"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2017-05-31"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<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.\nPatients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.</p><p>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 8 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.</p>"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/15",
"value": "Pancreatic Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/16",
"value": "Ovarian Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/17",
"value": "Carcinoma, Renal Cell"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/18",
"value": "Cholangiocarcinoma"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/19",
"value": "Carcinoma"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/20",
"value": "Carcinoma, Bronchogenic"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/21",
"value": "Bronchial Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/22",
"value": "Lung Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/23",
"value": "Respiratory Tract Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/24",
"value": "Thoracic Neoplasms"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/25",
"value": "Neoplasms, Nerve Tissue"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/26",
"value": "Nevi and Melanomas"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/13",
"value": "larotrectinib"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/14",
"value": "fusion"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/15",
"value": "tumors"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/16",
"value": "CNS tumors"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/17",
"value": "solid tumors"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/18",
"value": "central nervous system tumors"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/19",
"value": "solid CNS tumors"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/20",
"value": "primary CNS tumor"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/21",
"value": "Advanced CNS tumor"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/22",
"value": "Metastatic CNS tumor"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/23",
"value": "NTRK1 fusion"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/24",
"value": "NTRK2 fusion"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/25",
"value": "NTRK3 fusion"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/26",
"value": "ETV6-NTRK3"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/27",
"value": "ETV6 fusion"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Overall Response Rate of confirmed CR or PR as determined by an Independent Radiology Committee using RECIST 1.1 or RANO criteria"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Overall Response Rate of confirmed CR or PR as determined by the treating investigator using RECIST 1.1 or RANO criteria"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Duration of response for subjects with best overall response of confirmed CR or PR by Independent Radiology Committee"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2",
"value": {
"measure": "Duration of response for subjects with best overall response of confirmed CR or PR by the treating investigator",
"timeFrame": "Up to 30 months"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
"value": {
"measure": "Progression Free Survival",
"timeFrame": "Up to 30 months",
"description": "Number of moths from initiation of Loxo-101 to the earlier of diease progression or death due to any cause"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Comparison of Progression Free Survival following initiation of Loxo-101 to that following the line of therapy immediately preceding Loxo-101"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "In each subject who has received prior therapy"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "UP to 30 months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
"value": {
"measure": "Incidence of Adverse Events",
"timeFrame": "Up to 30 months"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
"value": {
"measure": "Severity of Adverse Events",
"timeFrame": "Up to 30 months"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
"value": {
"measure": "Duration of Adverse Events",
"timeFrame": "Up to 30 months"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
"value": {
"measure": "Changes from baseline in clinical safety laboratory values",
"timeFrame": "Up to 30 months"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
"value": {
"measure": "Changes from baseline in vital signs",
"timeFrame": "Up to 30 months"
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<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.</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) < 2.5 upper limit of normal (ULN), or AST and ALT < 5 ULN if liver function abnormalities are due to underlying malignancy.</li><li>Total bilirubin < 2.5 ULN.\nSubjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.</li><li>Serum creatinine < 2.0 ULN OR an estimated glomerular filtration rate ≥ 30 mL/minute using the Cockroft-Gault formula.</li></ul></li></ol><p>Key Exclusion Criteria:</p><p>1. Pregnancy or lactation.</p>"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/minimumAge",
"value": "12 Years"
},
{
"op": "add",
"path": "/protocolSection/eligibilityModule/stdAges/0",
"value": "CHILD"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/centralContacts/0/name",
"value": "Patient Advocacy"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/centralContacts/0/email",
"value": "clinicaltrials@loxooncology.com"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/centralContacts/1"
},
{
"op": "add",
"path": "/protocolSection/ipdSharingStatementModule",
"value": {
"ipdSharing": "NO"
}
}
]