{
    "info": {
        "nct_id": "NCT02691793",
        "official_title": "Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors",
        "inclusion_criteria": "* Provision of fully informed consent prior to study specific procedures.\n* Patients must be >= 19 years of age\n* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.\n* ECOG Performance status0-2\n* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.\n* Adequate Organ Function Laboratory values\n\n  * Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL\n* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing\n* Adequate heart function\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.\n* Has known active central nervous system(CNS) metastases\n* Has an active infection requiring systemic therapy\n* Pregnancy or breast feeding\n* Patients with cardiac problem\n* Any previous treatment with sunitinib",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Provision of fully informed consent prior to study specific procedures.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Provision of fully informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must be >= 19 years of age",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must be >= 19 years of age"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 19
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "RET fusion positive"
                    ],
                    "criterion": "RET fusion",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "FGFR2 fusion/other FGFR mutation"
                    ],
                    "criterion": "FGFR2 fusion",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "FGFR2 fusion/other FGFR mutation"
                    ],
                    "criterion": "FGFR mutation",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Refractory solid tumor"
                    ],
                    "criterion": "solid tumor",
                    "requirement_type": "refractory",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "specific sensitivity to Sunitinib by Avatar scan"
                    ],
                    "criterion": "sensitivity to Sunitinib",
                    "requirement_type": "specific",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "progressed following standard therapy"
                    ],
                    "criterion": "progression after standard therapy",
                    "requirement_type": "occurrence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "has not responded to standard therapy"
                    ],
                    "criterion": "response to standard therapy",
                    "requirement_type": "lack of response",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "for which there is no standard therapy"
                    ],
                    "criterion": "standard therapy availability",
                    "requirement_type": "availability",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* ECOG Performance status0-2",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG Performance status",
                        "0-2"
                    ],
                    "criterion": "ECOG Performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.",
            "criterions": [
                {
                    "exact_snippets": [
                        "measurable or evaluated disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": [
                        "measurable",
                        "evaluated"
                    ]
                },
                {
                    "exact_snippets": [
                        "based on RECIST 1.1"
                    ],
                    "criterion": "RECIST 1.1",
                    "requirement_type": "compliance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "as determined by investigator"
                    ],
                    "criterion": "investigator determination",
                    "requirement_type": "necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Adequate Organ Function Laboratory values",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate Organ Function Laboratory values"
                    ],
                    "criterion": "organ function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL",
            "criterions": [
                {
                    "exact_snippets": [
                        "Absolute neutrophil count >= 1.5 x 109/L"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Hemoglobin >= 9g/dL"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 9
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Platelets>=100 x 109/L"
                    ],
                    "criterion": "platelets",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Bilirubin <= 1.5 x upper limit of normal"
                    ],
                    "criterion": "bilirubin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "AST/ALT <= 2.5 X upper limit of normal"
                    ],
                    "criterion": "AST/ALT",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "AST/ALT <= 2.5 X upper limit of normal",
                        "(5.0 x upper limit of normal, for subject with liver metastases)"
                    ],
                    "criterion": "AST/ALT",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Creatinine<= 1.5 X UNL"
                    ],
                    "criterion": "creatinine",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients of child-bearing potential"
                    ],
                    "criterion": "child-bearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "using adequate contraceptive measures"
                    ],
                    "criterion": "contraceptive measures",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "should not be breast feeding"
                    ],
                    "criterion": "breast feeding",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "must have a negative pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                }
            ]
        },
        {
            "line": "* Adequate heart function",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate heart function"
                    ],
                    "criterion": "heart function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 19 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 19
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.",
            "criterions": [
                {
                    "exact_snippets": [
                        "second primary cancer"
                    ],
                    "criterion": "second primary cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "adequately treated non-melanoma skin cancer"
                    ],
                    "criterion": "non-melanoma skin cancer",
                    "requirement_type": "treatment status",
                    "expected_value": "adequately treated"
                },
                {
                    "exact_snippets": [
                        "curatively treated in-situ cancer of the cervix"
                    ],
                    "criterion": "in-situ cancer of the cervix",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "other solid tumor",
                        "curatively treated",
                        "no evidence of disease for <= 5 years"
                    ],
                    "criterion": "other solid tumor",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "other solid tumor",
                        "curatively treated",
                        "no evidence of disease for <= 5 years"
                    ],
                    "criterion": "other solid tumor",
                    "requirement_type": "disease evidence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has known active central nervous system(CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": [
                        "known active central nervous system(CNS) metastases"
                    ],
                    "criterion": "central nervous system metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring systemic therapy"
                    ],
                    "criterion": "systemic therapy",
                    "requirement_type": "necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Pregnancy or breast feeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breast feeding"
                    ],
                    "criterion": "breast feeding",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients with cardiac problem",
            "criterions": [
                {
                    "exact_snippets": [
                        "cardiac problem"
                    ],
                    "criterion": "cardiac problem",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Any previous treatment with sunitinib",
            "criterions": [
                {
                    "exact_snippets": [
                        "previous treatment with sunitinib"
                    ],
                    "criterion": "sunitinib treatment",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}