{
    "info": {
        "nct_id": "NCT00040391",
        "official_title": "A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Age 18 years or older\n* Diagnosis of colorectal cancer or adenocarcinoma of the appendix\n* A tumor mass that can be measured\n* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1\n* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women that are pregnant or lactating\n* Prior treatment with Irinotecan\n* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication\n* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization\n* Current enrollment in another clinical trial\n* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
        "miscellaneous_criteria": "Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary."
    },
    "inclusion_lines": [
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of colorectal cancer or adenocarcinoma of the appendix",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the appendix",
                    "criterion": "adenocarcinoma of the appendix",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A tumor mass that can be measured",
            "criterions": [
                {
                    "exact_snippets": "A tumor mass that can be measured",
                    "criterion": "tumor mass",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1",
            "criterions": [
                {
                    "exact_snippets": "Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1",
                    "criterion": "toxic effects of radiotherapy or surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTC grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... treatment plan",
                    "criterion": "compliance with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Women that are pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Women that are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with Irinotecan",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with Irinotecan",
                    "criterion": "Irinotecan treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication",
            "criterions": [
                {
                    "exact_snippets": "Partial or complete bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known chronic malabsorption",
                    "criterion": "chronic malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "total colectomy",
                    "criterion": "total colectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other major abdominal surgery ... substantial alteration in transit or absorption of oral medication",
                    "criterion": "major abdominal surgery affecting medication absorption",
                    "requirements": [
                        {
                            "requirement_type": "impact on medication absorption",
                            "expected_value": "substantial alteration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization",
            "criterions": [
                {
                    "exact_snippets": "Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization",
                    "criterion": "adjuvant therapy for colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current enrollment in another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Current enrollment in another clinical trial",
                    "criterion": "enrollment in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "current"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Administration of any prior systemic anticancer therapy for metastatic colorectal cancer",
                    "criterion": "prior systemic anticancer therapy for metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.",
            "criterions": []
        }
    ]
}