{
    "info": {
        "nct_id": "NCT00718562",
        "official_title": "A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib",
        "inclusion_criteria": "* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib\n* At least one measurable site of disease on CT/MRI scan\n* PS≤2\n* Normal organ, electrolyte, and bone marrow function\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Previous treatment with nilotinib or any other drug in this class or other targeted therapy\n* Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry\n* Impaired cardiac function\n* Use of coumarin derivatives (i.e. warfarin)\n* Women who are pregnant or lactating\n\nOther protocol-defined inclusion/exclusion criteria may apply.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* At least one measurable site of disease on CT/MRI scan",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable site of disease on CT/MRI scan",
                        "criterion": "measurable site of disease",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "site"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable site of disease on CT/MRI scan",
                        "criterion": "measurable site of disease",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "CT scan",
                                "MRI scan"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least one measurable site of disease on CT/MRI scan",
                        "criterion": "measurable site of disease",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "site"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable site of disease on CT/MRI scan",
                        "criterion": "measurable site of disease",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "CT scan",
                                "MRI scan"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* PS≤2",
                "criterions": [
                    {
                        "exact_snippets": "PS≤2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PS≤2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Normal organ, electrolyte, and bone marrow function",
                "criterions": [
                    {
                        "exact_snippets": "Normal organ",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... electrolyte",
                        "criterion": "electrolyte function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Normal organ",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... electrolyte",
                        "criterion": "electrolyte function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal ... bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 20 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 20 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Impaired cardiac function",
                "criterions": [
                    {
                        "exact_snippets": "Impaired cardiac function",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "impaired"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Impaired cardiac function",
                    "criterion": "cardiac function",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "impaired"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Use of coumarin derivatives (i.e. warfarin)",
                "criterions": [
                    {
                        "exact_snippets": "Use of coumarin derivatives (i.e. warfarin)",
                        "criterion": "coumarin derivatives",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Use of coumarin derivatives (i.e. warfarin)",
                    "criterion": "coumarin derivatives",
                    "requirement": {
                        "requirement_type": "use",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Women who are pregnant or lactating",
                "criterions": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Women who are ... lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Women who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Women who are ... lactating",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other protocol-defined inclusion/exclusion criteria may apply.",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol-defined inclusion/exclusion criteria",
                        "criterion": "protocol-defined criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other protocol-defined inclusion/exclusion criteria",
                    "criterion": "protocol-defined criteria",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib",
                "criterions": [
                    {
                        "exact_snippets": "Documented disease progression during imatinib and sunitinib therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documented disease progression during imatinib and sunitinib therapy",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "during therapy",
                            "expected_value": [
                                "imatinib",
                                "sunitinib"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "intolerance to imatinib and/or sunitinib",
                        "criterion": "intolerance",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": [
                                "imatinib",
                                "sunitinib"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Documented disease progression during imatinib and sunitinib therapy",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "documentation",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Documented disease progression during imatinib and sunitinib therapy",
                                "criterion": "disease progression",
                                "requirement": {
                                    "requirement_type": "during therapy",
                                    "expected_value": [
                                        "imatinib",
                                        "sunitinib"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "intolerance to imatinib and/or sunitinib",
                                "criterion": "intolerance",
                                "requirement": {
                                    "requirement_type": "medication",
                                    "expected_value": [
                                        "imatinib"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "intolerance to imatinib and/or sunitinib",
                                "criterion": "intolerance",
                                "requirement": {
                                    "requirement_type": "medication",
                                    "expected_value": [
                                        "sunitinib"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Previous treatment with nilotinib or any other drug in this class or other targeted therapy",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment with nilotinib",
                        "criterion": "previous treatment with nilotinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Previous treatment with ... any other drug in this class",
                        "criterion": "previous treatment with any other drug in the same class as nilotinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Previous treatment with ... other targeted therapy",
                        "criterion": "previous treatment with other targeted therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous treatment with nilotinib",
                                "criterion": "previous treatment with nilotinib",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Previous treatment with ... any other drug in this class",
                                "criterion": "previous treatment with any other drug in the same class as nilotinib",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Previous treatment with ... other targeted therapy",
                        "criterion": "previous treatment with other targeted therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry",
                        "criterion": "treatment with cytotoxic and/or investigational drug",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Treatment with any cytotoxic and/or investigational drug \u0010 4 weeks prior to study entry",
                    "criterion": "treatment with cytotoxic and/or investigational drug",
                    "requirement": {
                        "requirement_type": "time since last treatment",
                        "expected_value": {
                            "operator": "<=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        }
    ],
    "failed_miscellaneous": []
}