{
    "info": {
        "nct_id": "NCT01762280",
        "official_title": "A Phase I Study of Famitinib Malate in Patients With Solid Tumor",
        "inclusion_criteria": "* Histological confirmed advanced or metastatic solid tumor，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )\n* no standard therapy protocol available according to patients'condition\n* both sex, age 18 to 65\n* ECOG 0-1\n* Life expectancy more than 3 months\n* ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be corrected by medication\n* Subjects receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery\n* Understand and agree to sign informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)\n* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using single agent therapy, >Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia, arrhythmia,cardiac function insufficiency\n* PT, APTT, TT, Fbg abnormal(PT>16s,APTT>43s,TT>21s,Fbg<2g/L), or have hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation\n* Active peptic ulcer\n* Previously medication include sunitinib\n* More than 4 weeks since the last clinical trial\n* Pregnant or lactating women\n* Women of childbearing age do not take effective contraceptive measures\n* Allergies, or known allergy history to components of the drug",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological confirmed advanced or metastatic solid tumor，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmed advanced or metastatic solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histological"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "spiral CT scan(scanning layer ≤ 5 mm )",
                    "criterion": "spiral CT scan",
                    "requirements": [
                        {
                            "requirement_type": "scanning layer",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no standard therapy protocol available according to patients'condition",
            "criterions": [
                {
                    "exact_snippets": "no standard therapy protocol available according to patients'condition",
                    "criterion": "standard therapy protocol",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* both sex, age 18 to 65",
            "criterions": [
                {
                    "exact_snippets": "both sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "allowed",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age 18 to 65",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 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"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy more than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy more than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be corrected by medication",
            "criterions": [
                {
                    "exact_snippets": "ALT,AST,TB≤1.5(UNL)",
                    "criterion": "ALT, AST, TB levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "UNL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal serum creatinine level",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal electrolyte or can be corrected by medication",
                    "criterion": "electrolyte levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        },
                        {
                            "requirement_type": "correction",
                            "expected_value": "can be corrected by medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery",
            "criterions": [
                {
                    "exact_snippets": "damage caused by other therapeutic has been restored",
                    "criterion": "damage restoration",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "restored"
                        }
                    ]
                },
                {
                    "exact_snippets": "the interval more than six weeks since the last receiving nitroso or mitomycin",
                    "criterion": "interval since last nitroso or mitomycin",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 4 weeks since last receiving radiotherapy",
                    "criterion": "interval since last radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 4 weeks since last receiving ... other cytotoxic drugs",
                    "criterion": "interval since last cytotoxic drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 4 weeks since last receiving ... surgery",
                    "criterion": "interval since last surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Understand and agree to sign informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Understand and agree to sign informed consent form.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "agreement",
                            "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": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy ≥ Grade 2",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using single agent therapy, >Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia, arrhythmia,cardiac function insufficiency",
            "criterions": [
                {
                    "exact_snippets": "Preexisting uncontrolled hypertension defined as more than 140/90 mmHg",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia",
                    "criterion": "myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE 3.0)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">Grade 1 (NCI-CTCAE 3.0 ) ... arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE 3.0)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">Grade 1 (NCI-CTCAE 3.0 ) ... cardiac function insufficiency",
                    "criterion": "cardiac function insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade (NCI-CTCAE 3.0)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PT, APTT, TT, Fbg abnormal(PT>16s,APTT>43s,TT>21s,Fbg<2g/L), or have hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation",
            "criterions": [
                {
                    "exact_snippets": "PT>16s",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 16,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "APTT>43s",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 43,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TT>21s",
                    "criterion": "thrombin time (TT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 21,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Fbg<2g/L",
                    "criterion": "fibrinogen (Fbg)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemorrhagic tendency",
                    "criterion": "hemorrhagic tendency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving the therapy of thrombolysis",
                    "criterion": "thrombolysis therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving the therapy of ... anticoagulation",
                    "criterion": "anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active peptic ulcer",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously medication include sunitinib",
            "criterions": [
                {
                    "exact_snippets": "Previously medication include sunitinib",
                    "criterion": "previous medication",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "sunitinib"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since the last clinical trial",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since the last clinical trial",
                    "criterion": "time since last clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing age do not take effective contraceptive measures",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not take effective contraceptive measures",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergies, or known allergy history to components of the drug",
            "criterions": [
                {
                    "exact_snippets": "Allergies, or known allergy history to components of the drug",
                    "criterion": "allergy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergies, or known allergy history to components of the drug",
                    "criterion": "allergy to components of the drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}