{
    "info": {
        "nct_id": "NCT00674973",
        "official_title": "A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma",
        "inclusion_criteria": "* adult patients, >=18 years of age;\n* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;\n* measurable disease according to RECIST;\n* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;\n* ECOG performance status of 0-2.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* local or locally advanced-resectable pancreatic cancer;\n* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;\n* major surgery within 2 weeks prior to randomization.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* adult patients, >=18 years of age;",
            "criterions": [
                {
                    "exact_snippets": "adult patients, >=18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically documented",
                    "criterion": "documentation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced-unresectable or metastatic pancreatic cancer",
                    "criterion": "pancreatic cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced-unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* measurable disease according to RECIST;",
            "criterions": [
                {
                    "exact_snippets": "measurable disease according to RECIST",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "failure of at least one prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed unsuitable for chemotherapy",
                    "criterion": "suitability for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-2.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* local or locally advanced-resectable pancreatic cancer;",
            "criterions": [
                {
                    "exact_snippets": "local or locally advanced-resectable pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "local",
                                "locally advanced-resectable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;",
            "criterions": [
                {
                    "exact_snippets": "any other malignancies within last 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated cancer in situ of the cervix",
                    "criterion": "cancer in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell skin cancer",
                    "criterion": "basal or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* major surgery within 2 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "major surgery within 2 weeks prior to randomization",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}