Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2009-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2009-06-09"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2009-06-11"
},
{
"op": "add",
"path": "/protocolSection/statusModule/completionDateStruct",
"value": {
"date": "2011-11",
"type": "ESTIMATED"
}
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Drug: eribulin mesylate"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "eribulin mesylate"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "<p>Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.</p><p>The Treatment Phase will include six cycles.\nPatients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Percent of subjects with neuropathy adverse events (AEs) graded according to NCI CTCAE (version 3.0) and coded according to the current version of Medical Dictionary for Regulatory Activities (MedDRA)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Neuropathy assessments are performed at the start of Cycles 2-6 and subsequently at every third cycle, end-of-treatment visit, and post-treatment follow-up."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Assessments are performed at the start of Cycles 2-6 and every third cycle, end-of-treatment visit, and post-treatment follow-up."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "Safety is assessed from the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Objective response rate, clinical benefit rate and progression-free survival based on investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "At Baseline, at the end of Cycles 2, 4 and 6, subsequently at the end of every third cycle, at the end-of-treatment, and at the post-treatment follow-up."
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion criteria:</p><p>1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.</p><p>Exclusion criteria:</p><ol><li>Subjects who have received prior ixabepilone therapy.</li><li>Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.</li><li>Subjects with pre-existing neuropathy Grade ≥ 2.</li><li>Subjects with a history of diabetes mellitus Type 1 or 2.</li><li>Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.\nSubjects with missing digits required for vibration assessment.\nSubjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.</li></ol>"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/centralContacts/0/name",
"value": "Eisai Eisai Medical Services"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0",
"value": {
"zip": "86336",
"city": "Sedona",
"state": "Arizona",
"status": "RECRUITING",
"country": "United States",
"facility": "Northern AZ Hematology and Oncology Associates",
"geoPoint": {
"lat": 34.86974,
"lon": -111.76099
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/2",
"value": {
"zip": "90250",
"city": "Hawthorne",
"state": "California",
"status": "RECRUITING",
"country": "United States",
"facility": "Healing Hands Oncology and Medical Care",
"geoPoint": {
"lat": 33.9164,
"lon": -118.35257
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/4",
"value": {
"zip": "33428",
"city": "Boca Raton",
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"country": "United States",
"facility": "Comprehensive Cancer Care Specialist of Boca",
"geoPoint": {
"lat": 26.35869,
"lon": -80.0831
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/6",
"value": {
"zip": "34471",
"city": "Ocala",
"state": "Florida",
"status": "RECRUITING",
"country": "United States",
"facility": "Ocala Oncology Center",
"geoPoint": {
"lat": 29.1872,
"lon": -82.14009
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/9",
"value": {
"zip": "46219",
"city": "Indianapolis",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"facility": "Central Indiana Cancer Centers",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/12",
"value": {
"zip": "07922",
"city": "Berkeley Heights",
"state": "New Jersey",
"status": "RECRUITING",
"country": "United States",
"facility": "Summit Medical Group",
"geoPoint": {
"lat": 40.68343,
"lon": -74.44265
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/13",
"value": {
"zip": "27607",
"city": "Raleigh",
"state": "North Carolina",
"status": "RECRUITING",
"country": "United States",
"facility": "Cancer Center of North Carolina",
"geoPoint": {
"lat": 35.7721,
"lon": -78.63861
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/14",
"value": {
"zip": "97213-2996",
"city": "Portland",
"state": "Oregon",
"status": "RECRUITING",
"country": "United States",
"facility": "Northwest Cancer Specialists Hoyt",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/15",
"value": {
"zip": "97225",
"city": "Portland",
"state": "Oregon",
"status": "RECRUITING",
"country": "United States",
"facility": "Northwest Cancer Specialists St. Vincent",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/16",
"value": {
"zip": "97227",
"city": "Portland",
"state": "Oregon",
"status": "RECRUITING",
"country": "United States",
"facility": "Northwest Cancer Specialists Rose Quarter",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/20",
"value": {
"zip": "75230-2510",
"city": "Dallas",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "Texas Cancer Center at Medical City",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/21",
"value": {
"zip": "75231-4400",
"city": "Dallas",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "Texas Oncology, PA",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/22",
"value": {
"zip": "76033",
"city": "Houston",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "Texas Oncology, PA Bedford",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/23",
"value": {
"zip": "77024",
"city": "Houston",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "Texas Oncology, PA",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/24",
"value": {
"zip": "75075-7787",
"city": "Plano",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "North Texas Regional Cancer Center",
"geoPoint": {
"lat": 33.01984,
"lon": -96.69889
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/25",
"value": {
"zip": "75702",
"city": "Tyler",
"state": "Texas",
"status": "RECRUITING",
"country": "United States",
"facility": "Tyler Cancer Center",
"geoPoint": {
"lat": 32.35126,
"lon": -95.30106
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/27",
"value": {
"zip": "98684",
"city": "Vancouver",
"state": "Washington",
"status": "RECRUITING",
"country": "United States",
"facility": "Northwest Cancer Specialist Vancouver",
"geoPoint": {
"lat": 45.63873,
"lon": -122.66149
}
}
}
]