{
    "info": {
        "nct_id": "NCT00359476",
        "official_title": "A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer",
        "inclusion_criteria": "* Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.\n* EGOC performance status of 0,1 or 2\n* Men and women, 18 years of age and older\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients having received more than one previous systemic chemotherapy regimen in any setting.\n* Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks\n* Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)\n* Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment\n* Acute or chronic hepatitis\n* Known HIV infection\n* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms\n* A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the gastroesophageal junction",
                    "criterion": "adenocarcinoma of the gastroesophageal junction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed on a fluoropyrimidine or taxane-containing regimen",
                    "criterion": "progression on fluoropyrimidine or taxane-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one prior first line treatment",
                    "criterion": "prior first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "prior first line treatment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* EGOC performance status of 0,1 or 2",
            "criterions": [
                {
                    "exact_snippets": "EGOC performance status of 0,1 or 2",
                    "criterion": "EGOC performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men and women, 18 years of age and older",
            "criterions": [
                {
                    "exact_snippets": "Men and women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients having received more than one previous systemic chemotherapy regimen in any setting.",
            "criterions": [
                {
                    "exact_snippets": "Patients having received more than one previous systemic chemotherapy regimen",
                    "criterion": "previous systemic chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Major abdominal surgery within 2 months",
                    "criterion": "major abdominal surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other surgery under general anesthesia within 4 weeks",
                    "criterion": "surgery under general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)",
            "criterions": [
                {
                    "exact_snippets": "Unresolved occlusive or sub-occlusive intestinal disease",
                    "criterion": "occlusive or sub-occlusive intestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any significant chronic intestinal disease (e.g. ulcerative colitis)",
                    "criterion": "chronic intestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation to >=30% of the bone marrow",
                    "criterion": "radiation to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation within 4 weeks prior to enrollment",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute or chronic hepatitis",
            "criterions": [
                {
                    "exact_snippets": "Acute or chronic hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV infection",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms",
            "criterions": [
                {
                    "exact_snippets": "baseline prolongation of QT/QTc interval ... QTc interval >450 ms",
                    "criterion": "QT/QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)",
            "criterions": [
                {
                    "exact_snippets": "A history of additional risk factors for Torsade de Pointes",
                    "criterion": "risk factors for Torsade de Pointes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypokalemia",
                    "criterion": "hypokalemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of Long QT Syndrome",
                    "criterion": "family history of Long QT Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}