{
    "info": {
        "nct_id": "NCT00139620",
        "official_title": "An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function",
        "inclusion_criteria": "* Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is potentially responsive to erlotinib or for which no effective therapy is available,\n* Cohort 1: Adequate hepatic function: bilirubin <= ULN, ALT (SGPT) and AST (SGOT) <= 1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System, ECOG Performance Status 0-2\n* Life expectancy >= 12 weeks,\n* Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation) has elapsed and patients have recovered from acute toxic effects of radiotherapy,\n* Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have recovered from acute toxic effects of chemotherapy,\n* Adequate hematopoietic and renal function: ANC >= 1.5 x 10^9/L, platelets >= 75 x 10^9/L, and creatinine <= 1.5 x ULN,\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on study,\n* Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,\n* Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until Day 5,\n* Encephalopathy >= grade 2,\n* Significant history of cardiac disease unless well-controlled,\n* Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation,\n* Concurrent anticancer therapy or any other investigational agents within 4 weeks of Day 1 and while on study,\n* Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within the last 4 weeks,\n* Gastro-intestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is potentially responsive to erlotinib or for which no effective therapy is available,",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced solid tumor",
                    "criterion": "advanced solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable or nonmeasurable",
                    "criterion": "tumor measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "nonmeasurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "potentially responsive to erlotinib",
                    "criterion": "tumor responsiveness to erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "responsiveness",
                            "expected_value": "potentially responsive"
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no effective therapy is available",
                    "criterion": "availability of effective therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 1: Adequate hepatic function: bilirubin <= ULN, ALT (SGPT) and AST (SGOT) <= 1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System, ECOG Performance Status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Cohort 1: Adequate hepatic function: bilirubin <= ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cohort 1: Adequate hepatic function: ... ALT (SGPT) ... <= 1.5 x ULN",
                    "criterion": "ALT (SGPT) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cohort 1: Adequate hepatic function: ... AST (SGOT) <= 1.5 x ULN",
                    "criterion": "AST (SGOT) level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System",
                    "criterion": "Child-Pugh score",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 9,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cohort 2: ... ECOG Performance Status 0-2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy >= 12 weeks,",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >= 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation) has elapsed and patients have recovered from acute toxic effects of radiotherapy,",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation permitted",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "4 weeks (or 2 weeks for palliative radiation) has elapsed",
                    "criterion": "time elapsed since radiation",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have recovered from acute toxic effects of radiotherapy",
                    "criterion": "recovery from acute toxic effects of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have recovered from acute toxic effects of chemotherapy,",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy permitted",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "4 weeks has elapsed",
                    "criterion": "time since chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "elapsed time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have recovered from acute toxic effects of chemotherapy",
                    "criterion": "recovery from acute toxic effects of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematopoietic and renal function: ANC >= 1.5 x 10^9/L, platelets >= 75 x 10^9/L, and creatinine <= 1.5 x ULN,",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematopoietic ... ANC >= 1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematopoietic ... platelets >= 75 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function: ... creatinine <= 1.5 x ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on study,",
            "criterions": [
                {
                    "exact_snippets": "Use of tobacco or nicotine-containing products within 4 weeks of Day 1",
                    "criterion": "use of tobacco or nicotine-containing products",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks of Day 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "while on study",
                    "criterion": "use of tobacco or nicotine-containing products",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "while on study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,",
            "criterions": [
                {
                    "exact_snippets": "Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5",
                    "criterion": "CYP3A4 inhibitor or inducer use",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 14 days prior to Day 1 and until Day 5"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until Day 5,",
            "criterions": [
                {
                    "exact_snippets": "Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1",
                    "criterion": "warfarin-derivative anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to Day 1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of a warfarin-derivative anticoagulant ... until Day 5",
                    "criterion": "warfarin-derivative anticoagulant use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "until Day 5"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Encephalopathy >= grade 2,",
            "criterions": [
                {
                    "exact_snippets": "Encephalopathy >= grade 2,",
                    "criterion": "encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant history of cardiac disease unless well-controlled,",
            "criterions": [
                {
                    "exact_snippets": "Significant history of cardiac disease unless well-controlled",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "well-controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation,",
            "criterions": [
                {
                    "exact_snippets": "Active or uncontrolled infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "serious illnesses",
                    "criterion": "illnesses",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "medical conditions that could interfere with the patient's ongoing participation",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on participation",
                            "expected_value": "interfere with ongoing participation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent anticancer therapy or any other investigational agents within 4 weeks of Day 1 and while on study,",
            "criterions": [
                {
                    "exact_snippets": "Concurrent anticancer therapy",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other investigational agents within 4 weeks of Day 1",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within the last 4 weeks,",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastases ... are not stable",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic brain metastases ... require steroids",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "steroid requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic brain metastases ... are potentially life-threatening",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "potentially life-threatening"
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic brain metastases ... have required radiation within the last 4 weeks",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "radiation requirement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastro-intestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption.",
            "criterions": [
                {
                    "exact_snippets": "Gastro-intestinal abnormalities",
                    "criterion": "gastro-intestinal abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requirement for IV alimentation",
                    "criterion": "requirement for IV alimentation",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active peptic ulcer",
                    "criterion": "active peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior surgical procedures affecting absorption",
                    "criterion": "prior surgical procedures affecting absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}