{
    "info": {
        "nct_id": "NCT00462982",
        "official_title": "A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed melanoma or renal cell carcinoma\n\n  * Metastatic brain disease\n* Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection\n\n  * Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis\n\n    * True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis\n* No leptomeningeal metastases or primary dural metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Total leukocyte count ≥ 3,000/mm³\n* ANC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 2.0 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n* Hemoglobin ≥ 9.0 g/dL\n* Calcium ≤ 12.0 mg/dL\n* AST and ALT ≤ 1.5 times ULN\n* PT ≤ 1.5 times ULN\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No uncontrolled medical illness including, but not limited to, any of the following:\n\n  * Hypertension (i.e., blood pressure > 150/100 mm Hg)\n  * Thyroid disease\n  * Severe valvular disease\n  * Severe pulmonary disease\n  * HIV/AIDS\n  * Severe psychiatric illness\n* No cardiac dysrhythmia ≥ grade 2\n* No prolonged QTc interval on baseline EKG\n* No systemic hemorrhage ≥ grade 2 within the past 4 weeks\n\n  * No CNS hemorrhage ≥ grade 2\n\n    * Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion\n* None of the following within the past 6 months:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Symptomatic congestive heart failure\n  * Stroke/transient ischemic attack\n  * Pulmonary embolism\n* Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib)\n* No coronary/peripheral arterial bypass surgery within the past 6 months\n* More than 4 weeks since prior surgery and recovered\n* More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy\n* More than 4 weeks since prior immunotherapy\n* More than 2 weeks since prior stereotactic radiosurgery and recovered\n* More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)"
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed melanoma or renal cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed melanoma",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... renal cell carcinoma",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic brain disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic brain disease",
                    "criterion": "metastatic brain disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection",
            "criterions": [
                {
                    "exact_snippets": "assessable target intracranial lesion(s)",
                    "criterion": "intracranial lesion",
                    "requirements": [
                        {
                            "requirement_type": "assessability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease ≥ 10 mm in longest diameter",
                    "criterion": "intracranial lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not appropriate for stereotactic radiosurgery or surgical resection",
                    "criterion": "treatment appropriateness",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": [
                                "not appropriate for stereotactic radiosurgery",
                                "not appropriate for surgical resection"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis",
            "criterions": [
                {
                    "exact_snippets": "Lesions previously treated with radiosurgery",
                    "criterion": "lesions treated with radiosurgery",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "radiosurgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for resection",
                    "criterion": "eligibility for resection",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "true tumor progression on baseline scan",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 20% increase in longest diameter of lesion",
                    "criterion": "increase in longest diameter of lesion",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "rather than radionecrosis",
                    "criterion": "radionecrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis",
            "criterions": [
                {
                    "exact_snippets": "True progression must be confirmed by PET scan or other corroborating imaging",
                    "criterion": "true progression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "PET scan or other corroborating imaging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No leptomeningeal metastases or primary dural metastases",
            "criterions": [
                {
                    "exact_snippets": "No leptomeningeal metastases",
                    "criterion": "leptomeningeal metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... primary dural metastases",
                    "criterion": "primary dural metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status (PS) 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky PS 60-100%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total leukocyte count ≥ 3,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Total leukocyte count ≥ 3,000/mm³",
                    "criterion": "total leukocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥ 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1,500/mm³",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 2.0 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 2.0 times upper limit of normal (ULN)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison to ULN",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 times ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calcium ≤ 12.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Calcium ≤ 12.0 mg/dL",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ... ≤ 1.5 times ULN",
                    "criterion": "AST level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ≤ 1.5 times ULN",
                    "criterion": "ALT level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "PT ≤ 1.5 times ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled medical illness including, but not limited to, any of the following:",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled medical illness",
                    "criterion": "uncontrolled medical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypertension (i.e., blood pressure > 150/100 mm Hg)",
            "criterions": [
                {
                    "exact_snippets": "Hypertension (i.e., blood pressure > 150/100 mm Hg)",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thyroid disease",
            "criterions": [
                {
                    "exact_snippets": "Thyroid disease",
                    "criterion": "thyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe valvular disease",
            "criterions": [
                {
                    "exact_snippets": "Severe valvular disease",
                    "criterion": "valvular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe pulmonary disease",
            "criterions": [
                {
                    "exact_snippets": "Severe pulmonary disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV/AIDS",
            "criterions": [
                {
                    "exact_snippets": "HIV/AIDS",
                    "criterion": "HIV/AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe psychiatric illness",
            "criterions": [
                {
                    "exact_snippets": "Severe psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cardiac dysrhythmia ≥ grade 2",
            "criterions": [
                {
                    "exact_snippets": "No cardiac dysrhythmia ≥ grade 2",
                    "criterion": "cardiac dysrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prolonged QTc interval on baseline EKG",
            "criterions": [
                {
                    "exact_snippets": "No prolonged QTc interval",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No systemic hemorrhage ≥ grade 2 within the past 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "systemic hemorrhage ≥ grade 2 within the past 4 weeks",
                    "criterion": "systemic hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 4 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No CNS hemorrhage ≥ grade 2",
            "criterions": [
                {
                    "exact_snippets": "No CNS hemorrhage ≥ grade 2",
                    "criterion": "CNS hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion",
            "criterions": [
                {
                    "exact_snippets": "Grade 1 (asymptomatic) CNS hemorrhage allowed",
                    "criterion": "CNS hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "1"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* None of the following within the past 6 months:",
            "criterions": [
                {
                    "exact_snippets": "None of the following within the past 6 months",
                    "criterion": "recent medical events",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stroke/transient ischemic attack",
            "criterions": [
                {
                    "exact_snippets": "Stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pulmonary embolism",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study",
            "criterions": [
                {
                    "exact_snippets": "Ejection fraction ≥ 50% by baseline echocardiogram",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "baseline echocardiogram"
                        }
                    ]
                },
                {
                    "exact_snippets": "< 20% decrease in ejection fraction from a prior study",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "comparison",
                            "expected_value": "prior study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib)",
            "criterions": [
                {
                    "exact_snippets": "No prior multi-targeted tyrosine kinase inhibitor therapy",
                    "criterion": "multi-targeted tyrosine kinase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No coronary/peripheral arterial bypass surgery within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No coronary/peripheral arterial bypass surgery",
                    "criterion": "coronary/peripheral arterial bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 6 months",
                    "criterion": "time since coronary/peripheral arterial bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior surgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior surgery",
                    "criterion": "time since prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior ... cytotoxic chemotherapy",
                    "criterion": "prior cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no other concurrent experimental therapy",
                    "criterion": "concurrent experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no other concurrent ... cytotoxic chemotherapy",
                    "criterion": "concurrent cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior immunotherapy",
                    "criterion": "time since prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 2 weeks since prior stereotactic radiosurgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 2 weeks since prior stereotactic radiosurgery",
                    "criterion": "time since prior stereotactic radiosurgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior stereotactic radiosurgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)",
            "criterions": [
                {
                    "exact_snippets": "More than 7 days since prior ... drugs that interact with CYP3A4 family",
                    "criterion": "time since prior drugs interacting with CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent drugs that interact with CYP3A4 family",
                    "criterion": "concurrent drugs interacting with CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent ... enzyme-inducing antiepileptic drugs",
                    "criterion": "concurrent enzyme-inducing antiepileptic drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent ... warfarin",
                    "criterion": "concurrent warfarin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent ... Hypericum perforatum extract (St. John's wort)",
                    "criterion": "concurrent Hypericum perforatum extract (St. John's wort)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}