{
    "info": {
        "nct_id": "NCT00575562",
        "official_title": "Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer",
        "inclusion_criteria": "1. Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.\n2. Are not candidates for a surgically curative procedure.\n3. Have progressed despite, are intolerant of, or are not appropriate for current therapies.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Have an active, uncontrolled infection.\n2. Have known or suspected cerebral metastasis.\n3. Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).\n4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results.\n5. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.\n\n   -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable or assessable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "assessable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Are not candidates for a surgically curative procedure.",
            "criterions": [
                {
                    "exact_snippets": "Are not candidates for a surgically curative procedure",
                    "criterion": "surgically curative procedure candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have progressed despite, are intolerant of, or are not appropriate for current therapies.",
            "criterions": [
                {
                    "exact_snippets": "Have progressed despite ... current therapies.",
                    "criterion": "progression on current therapies",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are intolerant of ... current therapies.",
                    "criterion": "intolerance to current therapies",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are not appropriate for current therapies.",
                    "criterion": "appropriateness for current therapies",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Have an active, uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "active, uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have known or suspected cerebral metastasis.",
            "criterions": [
                {
                    "exact_snippets": "known or suspected cerebral metastasis",
                    "criterion": "cerebral metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).",
            "criterions": [
                {
                    "exact_snippets": "Have had a myocardial infarction (MI) ... within the last 6 months",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident (CVA) within the last 6 months",
                    "criterion": "cerebrovascular accident (CVA)",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "meet the criteria for AHA class III or IV congestive heart failure (CHF)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "AHA class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results.",
            "criterions": [
                {
                    "exact_snippets": "significant concurrent disease or illness",
                    "criterion": "concurrent disease or illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "male or female patients who do not agree to use effective contraceptive method(s) during the study",
                    "criterion": "use of effective contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "-",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}