{
"info": {
"nct_id": "NCT01262820",
"official_title": "A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab",
"inclusion_criteria": "* Age 18 or older\n* Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement) or stage IV NSCLC\n* Evidence of progression while on bevacizumab\n* Patients treated for CNS metastases who are asymptomatic with no requirement for steroids for 2 weeks prior to first dose of study drug\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior malignancy\n* Clinically significant gastrointestinal abnormalities\n* Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer\n* History of cardiovascular conditions within the past 6 months",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age 18 or older",
"criterions": [
{
"exact_snippets": "Age 18 or older",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Age 18 or older",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
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{
"operator": ">=",
"value": 18,
"unit": "years"
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{
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"criterions": [
{
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"criterion": "NSCLC stage",
"requirement": {
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"expected_value": "IIIB"
}
},
{
"exact_snippets": "Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement)",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "complications",
"expected_value": [
"malignant pleural effusion",
"malignant pericardial effusion",
"supraclavicular lymph node involvement"
]
}
},
{
"exact_snippets": "stage IV NSCLC",
"criterion": "NSCLC stage",
"requirement": {
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"expected_value": "IV"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement)",
"criterion": "NSCLC stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIIB"
}
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{
"exact_snippets": "Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement)",
"criterion": "NSCLC stage",
"requirement": {
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"expected_value": [
"malignant pleural effusion",
"malignant pericardial effusion",
"supraclavicular lymph node involvement"
]
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}
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"requirement": {
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{
"identified_line": {
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"exact_snippets": "Evidence of progression while on bevacizumab",
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"requirement": {
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"expected_value": true
}
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"logical_structure": {
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"exact_snippets": "Evidence of progression while on bevacizumab",
"criterion": "progression on bevacizumab",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients treated for CNS metastases who are asymptomatic with no requirement for steroids for 2 weeks prior to first dose of study drug",
"criterions": [
{
"exact_snippets": "Patients treated for CNS metastases",
"criterion": "CNS metastases treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "asymptomatic",
"criterion": "symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no requirement for steroids",
"criterion": "steroid requirement",
"requirement": {
"requirement_type": "requirement",
"expected_value": false
}
},
{
"exact_snippets": "2 weeks prior to first dose of study drug",
"criterion": "steroid-free duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
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},
"logical_structure": {
"and_criteria": [
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"and_criteria": [
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"exact_snippets": "Patients treated for CNS metastases",
"criterion": "CNS metastases treatment",
"requirement": {
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"expected_value": true
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{
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"criterion": "symptoms",
"requirement": {
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"expected_value": false
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{
"and_criteria": [
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"exact_snippets": "no requirement for steroids",
"criterion": "steroid requirement",
"requirement": {
"requirement_type": "requirement",
"expected_value": false
}
},
{
"exact_snippets": "2 weeks prior to first dose of study drug",
"criterion": "steroid-free duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 18,
"unit": "Years"
}
}
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]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
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}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior malignancy",
"criterions": [
{
"exact_snippets": "Prior malignancy",
"criterion": "prior malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior malignancy",
"criterion": "prior malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Clinically significant gastrointestinal abnormalities",
"criterions": [
{
"exact_snippets": "Clinically significant gastrointestinal abnormalities",
"criterion": "gastrointestinal abnormalities",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Clinically significant gastrointestinal abnormalities",
"criterion": "gastrointestinal abnormalities",
"requirement": {
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}
}
]
}
},
{
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"criterions": [
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"criterion": "infection",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Presence of ... nonhealing wound",
"criterion": "wound",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "Presence of ... fracture",
"criterion": "fracture",
"requirement": {
"requirement_type": "healing",
"expected_value": false
}
},
{
"exact_snippets": "Presence of ... ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "healing",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
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"and_criteria": [
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"requirement": {
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"expected_value": false
}
}
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{
"and_criteria": [
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"expected_value": false
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{
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"expected_value": false
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{
"and_criteria": [
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"expected_value": false
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},
{
"identified_line": {
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"criterions": [
{
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"criterion": "cardiovascular conditions",
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"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
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"and_criteria": [
{
"exact_snippets": "History of cardiovascular conditions within the past 6 months",
"criterion": "cardiovascular conditions",
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"value": 6,
"unit": "months"
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}
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}