{
"info": {
"nct_id": "NCT00971191",
"official_title": "A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804",
"inclusion_criteria": "* Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.\n* Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.\n* Prior or concurrent radiation therapy to tumor at site of planned resection.\n* Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant ventricular arrythmia.\n* Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.\n* Prior or concurrent radiation therapy to tumor at site of planned resection.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.",
"criterions": [
{
"exact_snippets": "Radiographs consistent with lung cancer",
"criterion": "lung cancer",
"requirements": [
{
"requirement_type": "consistency",
"expected_value": "radiographs"
}
]
},
{
"exact_snippets": "resection is indicated",
"criterion": "resection",
"requirements": [
{
"requirement_type": "indication",
"expected_value": true
}
]
},
{
"exact_snippets": "histologic confirmation of non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologic"
}
]
}
]
},
{
"line": "* Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.",
"criterions": [
{
"exact_snippets": "Patient willing to take PF-00299804",
"criterion": "willingness to take PF-00299804",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "provide blood and tissue specimens",
"criterion": "provision of blood and tissue specimens",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.",
"criterions": [
{
"exact_snippets": "Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy)",
"criterion": "systemic anticancer therapy",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "prior or concurrent"
},
{
"requirement_type": "types",
"expected_value": [
"immunotherapy",
"hormonotherapy",
"biological therapy",
"chemotherapy"
]
}
]
},
{
"exact_snippets": "less than one year from time of consent",
"criterion": "time since last systemic anticancer therapy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "year"
}
}
]
}
]
},
{
"line": "* Prior or concurrent radiation therapy to tumor at site of planned resection.",
"criterions": [
{
"exact_snippets": "Prior or concurrent radiation therapy to tumor at site of planned resection.",
"criterion": "radiation therapy to tumor",
"requirements": [
{
"requirement_type": "timing",
"expected_value": [
"prior",
"concurrent"
]
},
{
"requirement_type": "location",
"expected_value": "site of planned resection"
}
]
}
]
},
{
"line": "* Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant ventricular arrythmia.",
"criterions": [
{
"exact_snippets": "Congestive heart failure (LVEF < 50%)",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "LVEF",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "%"
}
}
]
},
{
"exact_snippets": "uncontrolled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "significant ventricular arrythmia",
"criterion": "ventricular arrythmia",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "significant"
}
]
}
]
},
{
"line": "* Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.",
"criterions": [
{
"exact_snippets": "Drugs that are highly dependent on CYP2D6 for metabolism",
"criterion": "CYP2D6 metabolism dependency",
"requirements": [
{
"requirement_type": "dependency",
"expected_value": "high"
}
]
},
{
"exact_snippets": "Drugs that ... have a risk of causing Torsades de Pointes",
"criterion": "risk of causing Torsades de Pointes",
"requirements": [
{
"requirement_type": "risk",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior or concurrent radiation therapy to tumor at site of planned resection.",
"criterions": [
{
"exact_snippets": "Prior or concurrent radiation therapy to tumor at site of planned resection.",
"criterion": "radiation therapy to tumor",
"requirements": [
{
"requirement_type": "timing",
"expected_value": [
"prior",
"concurrent"
]
},
{
"requirement_type": "location",
"expected_value": "site of planned resection"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}