{
"info": {
"nct_id": "NCT01743482",
"official_title": "Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).",
"inclusion_criteria": "* Male gender.\n* Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.\n* Unequivocal progression of measurable disease.\n* A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.\n* First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.\n* Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Failure to meet any of the above inclusion criteria.\n* Concurrent treatment with other cytotoxic drugs or targeted therapies.\n* Prior radiation therapy within 14 days of trial start.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Male gender.",
"criterions": [
{
"exact_snippets": "Male gender",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Male gender",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "* Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.",
"criterions": [
{
"exact_snippets": "Confirmation of GCT histology based on pathologic review",
"criterion": "GCT histology",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "pathologic review at Fondazione INT Milan",
"criterion": "pathologic review location",
"requirement": {
"requirement_type": "location",
"expected_value": "Fondazione INT Milan"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Confirmation of GCT histology based on pathologic review",
"criterion": "GCT histology",
"requirement": {
"requirement_type": "confirmation",
"expected_value": true
}
},
{
"exact_snippets": "pathologic review at Fondazione INT Milan",
"criterion": "pathologic review location",
"requirement": {
"requirement_type": "location",
"expected_value": "Fondazione INT Milan"
}
}
]
}
},
{
"identified_line": {
"line": "* Unequivocal progression of measurable disease.",
"criterions": [
{
"exact_snippets": "Unequivocal progression of measurable disease.",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "progression",
"expected_value": "unequivocal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Unequivocal progression of measurable disease.",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "progression",
"expected_value": "unequivocal"
}
}
]
}
},
{
"identified_line": {
"line": "* A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.",
"criterions": [
{
"exact_snippets": "A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.",
"criterion": "platinum-based chemotherapy lines for metastatic disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.",
"criterion": "platinum-based chemotherapy lines for metastatic disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.",
"criterions": [
{
"exact_snippets": "First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "composition",
"expected_value": "cisplatin-based chemotherapy"
}
},
{
"exact_snippets": "First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "cycles"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "composition",
"expected_value": "cisplatin-based chemotherapy"
}
},
{
"exact_snippets": "First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "cycles"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.",
"criterions": [
{
"exact_snippets": "Prior single, tandem or triple high-dose chemotherapy course",
"criterion": "high-dose chemotherapy course",
"requirement": {
"requirement_type": "quantity",
"expected_value": [
"single",
"tandem",
"triple"
]
}
},
{
"exact_snippets": "given as front-line or salvage therapy",
"criterion": "therapy type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"front-line",
"salvage"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior single, tandem or triple high-dose chemotherapy course",
"criterion": "high-dose chemotherapy course",
"requirement": {
"requirement_type": "quantity",
"expected_value": [
"single",
"tandem",
"triple"
]
}
},
{
"exact_snippets": "given as front-line or salvage therapy",
"criterion": "therapy type",
"requirement": {
"requirement_type": "type",
"expected_value": [
"front-line",
"salvage"
]
}
}
]
}
]
}
},
{
"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": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "male"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Failure to meet any of the above inclusion criteria.",
"criterions": [
{
"exact_snippets": "Failure to meet any of the above inclusion criteria",
"criterion": "inclusion criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Failure to meet any of the above inclusion criteria",
"criterion": "inclusion criteria",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Concurrent treatment with other cytotoxic drugs or targeted therapies.",
"criterions": [
{
"exact_snippets": "Concurrent treatment with other cytotoxic drugs",
"criterion": "concurrent treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "cytotoxic drugs"
}
},
{
"exact_snippets": "Concurrent treatment with other ... targeted therapies",
"criterion": "concurrent treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "targeted therapies"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Concurrent treatment with other cytotoxic drugs",
"criterion": "concurrent treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "cytotoxic drugs"
}
},
{
"exact_snippets": "Concurrent treatment with other ... targeted therapies",
"criterion": "concurrent treatment",
"requirement": {
"requirement_type": "type",
"expected_value": "targeted therapies"
}
}
]
}
},
{
"identified_line": {
"line": "* Prior radiation therapy within 14 days of trial start.",
"criterions": [
{
"exact_snippets": "Prior radiation therapy within 14 days of trial start.",
"criterion": "prior radiation therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior radiation therapy within 14 days of trial start.",
"criterion": "prior radiation therapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}