{
    "info": {
        "nct_id": "NCT02250157",
        "official_title": "A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies",
        "inclusion_criteria": "* Signed written informed consent.\n* ≥ 18 years of age.\n* Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.\n* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.\n* Adequate bone marrow reserve as demonstrated by :\n* Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L.\n* Platelet count ≥ 100 x 10⁹/L.\n* Hemoglobin ≥ 9 g/L.\n* Adequate liver function as demonstrated by:\n* Total bilirubin of ≤ 1.5 mg/dL or ≤ 2.0 mg/dL for subjects with liver metastasis.\n* Alanine aminotransferase ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis is present.\n* Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present\n* Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN or 24-hour urine creatinine clearance calculation ≥ 60 mL/min.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n* Life expectancy of at least 3 months.\n* Woman must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of IP.\n* Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of IP.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects who are homozygous for the UGT1A1*28 allele\n* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous IPs.\n* Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer.\n* Are currently receiving other medications intended for the treatment of their malignancy.\n* Women who are pregnant or breast feeding.\n* Taking a medication known to be clinically significant P-gp inhibitors or inducers within 14 days of treatment with Oratecan.\n* Chronically taking an oral medication known to be a P-gp substrate within 7 days of starting treatment with Oratecan.\n* Taking a medication known to be a clinically significant cytochrome (CYP) 3A4 strong inhibitor (eg, ketoconazole within 14 days) or strong inducers (eg, rifampin and St. John's Wort within 14 days) of starting treatment with Oratecan. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm\n* Require therapeutic use of anticoagulation medications\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements.\n* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption.\n* Allergy or sensitivity to irinotecan or cranberry-grape juice, or any of the irinotecan tablet excipients. .",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Signed written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or unresectable",
                    "criterion": "tumor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "standard curative or palliative measures do not exist or are no longer effective",
                    "criterion": "treatment options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow reserve as demonstrated by :",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L.",
            "criterions": [
                {
                    "exact_snippets": "Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L",
                    "criterion": "Absolute Neutrophil Count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10⁹/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100 x 10⁹/L.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 x 10⁹/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10⁹/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9 g/L.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function as demonstrated by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin of ≤ 1.5 mg/dL or ≤ 2.0 mg/dL for subjects with liver metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin of ≤ 1.5 mg/dL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 2.0 mg/dL for subjects with liver metastasis",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis is present.",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase ≤ 3 x ULN",
                    "criterion": "alanine aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase ... ≤ 5 x ULN if liver metastasis is present",
                    "criterion": "alanine aminotransferase with liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN or 24-hour urine creatinine clearance calculation ≥ 60 mL/min.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function ... 24-hour urine creatinine clearance calculation ≥ 60 mL/min",
                    "criterion": "24-hour urine creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group performance status of 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status of 0 to 1.",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Woman must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of IP.",
            "criterions": [
                {
                    "exact_snippets": "Woman must be postmenopausal (> 12 months without menses)",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy)",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "oral contraceptives",
                                "intrauterine device",
                                "double barrier method of condom and spermicide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to continue use of contraception for 30 days after their last dose of IP",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of IP.",
            "criterions": [
                {
                    "exact_snippets": "Sexually active male subjects",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "Sexually active male subjects",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must use a barrier method of contraception during the study",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "barrier method"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to continue the use of male contraception for at least 30 days after the last dose of IP",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects who are homozygous for the UGT1A1*28 allele",
            "criterions": [
                {
                    "exact_snippets": "homozygous for the UGT1A1*28 allele",
                    "criterion": "UGT1A1*28 allele",
                    "requirements": [
                        {
                            "requirement_type": "genotype",
                            "expected_value": "homozygous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous IPs.",
            "criterions": [
                {
                    "exact_snippets": "Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments",
                    "criterion": "toxicity from previous anticancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Have not recovered to ≤ Grade 1 toxicity from ... previous IPs",
                    "criterion": "toxicity from previous IPs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer.",
            "criterions": [
                {
                    "exact_snippets": "Received IPs within 14 days or 5 half-lives of the first study dosing day",
                    "criterion": "IPs received",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are currently receiving other medications intended for the treatment of their malignancy.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving other medications intended for the treatment of their malignancy",
                    "criterion": "medications for malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant or breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Taking a medication known to be clinically significant P-gp inhibitors or inducers within 14 days of treatment with Oratecan.",
            "criterions": [
                {
                    "exact_snippets": "Taking a medication known to be clinically significant P-gp inhibitors or inducers",
                    "criterion": "medication",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "clinically significant P-gp inhibitors",
                                "inducers"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days of treatment with Oratecan",
                    "criterion": "time since last medication",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronically taking an oral medication known to be a P-gp substrate within 7 days of starting treatment with Oratecan.",
            "criterions": [
                {
                    "exact_snippets": "Chronically taking an oral medication known to be a P-gp substrate",
                    "criterion": "oral medication",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "P-gp substrate"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "chronically"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days of starting treatment with Oratecan",
                    "criterion": "time frame before starting Oratecan",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Taking a medication known to be a clinically significant cytochrome (CYP) 3A4 strong inhibitor (eg, ketoconazole within 14 days) or strong inducers (eg, rifampin and St. John's Wort within 14 days) of starting treatment with Oratecan. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm",
            "criterions": [
                {
                    "exact_snippets": "Taking a medication known to be a clinically significant cytochrome (CYP) 3A4 strong inhibitor (eg, ketoconazole within 14 days)",
                    "criterion": "CYP3A4 strong inhibitor medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Taking a medication known to be a clinically significant cytochrome (CYP) 3A4 ... strong inducers (eg, rifampin and St. John's Wort within 14 days)",
                    "criterion": "CYP3A4 strong inducer medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Require therapeutic use of anticoagulation medications",
            "criterions": [
                {
                    "exact_snippets": "Require therapeutic use of anticoagulation medications",
                    "criterion": "anticoagulation medications",
                    "requirements": [
                        {
                            "requirement_type": "therapeutic use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... chronic pulmonary disease requiring oxygen",
                    "criterion": "chronic pulmonary disease requiring oxygen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... known bleeding disorders",
                    "criterion": "known bleeding disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... any concomitant illness or social situation that would limit compliance with study requirements",
                    "criterion": "concomitant illness or social situation limiting compliance",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery to the upper gastrointestinal (GI) tract",
                    "criterion": "major surgery to the upper gastrointestinal (GI) tract",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of GI disease",
                    "criterion": "GI disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other medical condition that, in the opinion of the investigator may interfere with oral drug absorption",
                    "criterion": "medical condition interfering with oral drug absorption",
                    "requirements": [
                        {
                            "requirement_type": "interference with oral drug absorption",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy or sensitivity to irinotecan or cranberry-grape juice, or any of the irinotecan tablet excipients. .",
            "criterions": [
                {
                    "exact_snippets": "Allergy or sensitivity to irinotecan",
                    "criterion": "allergy or sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "irinotecan"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy or sensitivity to ... cranberry-grape juice",
                    "criterion": "allergy or sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "cranberry-grape juice"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy or sensitivity to ... any of the irinotecan tablet excipients",
                    "criterion": "allergy or sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "irinotecan tablet excipients"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 3 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 5 x ULN if bone metastasis is present",
                    "criterion": "alkaline phosphatase with bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}