{
"info": {
"nct_id": "NCT00127127",
"official_title": "A Phase I Clinical Study of L-001079038 in Patients With Solid Tumors",
"inclusion_criteria": "* Participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.\n* Any uncontrolled concomitant illness\n* Are pregnant or breast-feeding\n* Serious drug or food allergy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy",
"criterions": [
{
"exact_snippets": "histologically or cytologically diagnosed solid tumor",
"criterion": "solid tumor diagnosis",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
},
{
"exact_snippets": "no standard therapy available",
"criterion": "standard therapy availability",
"requirements": [
{
"requirement_type": "availability",
"expected_value": false
}
]
},
{
"exact_snippets": "participant has failed to respond to standard therapy",
"criterion": "response to standard therapy",
"requirements": [
{
"requirement_type": "response",
"expected_value": "failed"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Any uncontrolled concomitant illness",
"criterions": [
{
"exact_snippets": "uncontrolled concomitant illness",
"criterion": "concomitant illness",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
}
]
},
{
"line": "* Are pregnant or breast-feeding",
"criterions": [
{
"exact_snippets": "Are pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding status",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "* Serious drug or food allergy",
"criterions": [
{
"exact_snippets": "Serious drug or food allergy",
"criterion": "drug allergy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "Serious drug or food allergy",
"criterion": "food allergy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.",
"criterions": [
{
"exact_snippets": "history of immunotherapy",
"criterion": "immunotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "history of radiotherapy",
"criterion": "radiotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "history of surgery",
"criterion": "surgery history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "history of chemotherapy",
"criterion": "chemotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "during the previous 4 weeks",
"criterion": "recent treatment",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "previous 4 weeks"
}
]
},
{
"exact_snippets": "previous treatment is 5 or more chemotherapeutic regimens",
"criterion": "previous chemotherapeutic regimens",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 5,
"unit": "regimens"
}
}
]
}
]
}
],
"failed_miscellaneous": []
}