{
    "info": {
        "nct_id": "NCT00962091",
        "official_title": "An Open-label, Phase 1 Study of the Relative Bioavailability, Food Effect, Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "Each participant must meet all of the following inclusion criteria to be enrolled in the study:\n\n* 18 years or older\n* Histologically or cytologically confirmed metastatic and/or advanced solid tumor\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse\n* Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse\n* Voluntary written consent\n* Suitable venous access for study-required blood sampling\n* Measurable disease\n* Recovered from effects of prior antineoplastic therapy\n* Meet required entry laboratory and organ function levels\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Participants meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n* Female participants who are pregnant or lactating\n* Serious medical or psychiatric illness that could interfere with protocol completion\n* Major surgery within 14 days of first dose of alisertib\n* Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of alisertib\n* Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.\n* Autologous stem cell transplant within 3 months before the first dose of alisertib, or prior allogeneic stem cell transplant at any time.\n* Active infection requiring systemic therapy, or other serious infection\n* Inability to swallow oral medication\n* Gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of alisertib\n* Symptomatic brain metastasis\n* Uncontrolled cardiovascular condition\n* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C\n* Lactose-intolerant (Parts A and B only)\n* Prior history of metabolic acidosis (Parts A and B only)\n* Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib\n* A medical condition requiring use of pancreatic enzymes; or daily, chronic , or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists. Participants who intermittently use these medications must meet the following:\n\n  * No use of PPI within 7 days of first dose of alisertib\n  * No use of H2 antagonist or pancreatic enzymes within 24 hours of first dose of alisertib\n* Participants requiring full systemic anticoagulation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* 18 years or older",
                "criterions": [
                    {
                        "exact_snippets": "18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse",
                "criterions": [
                    {
                        "exact_snippets": "Female participants",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "post menopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post menopausal"
                        }
                    },
                    {
                        "exact_snippets": "surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "surgically sterile"
                        }
                    },
                    {
                        "exact_snippets": "agree to practice 2 effective methods of contraception",
                        "criterion": "contraception methods",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    },
                    {
                        "exact_snippets": "abstain from heterosexual intercourse",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "abstain from heterosexual intercourse"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female participants",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "post menopausal",
                                "criterion": "menopausal status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "post menopausal"
                                }
                            },
                            {
                                "exact_snippets": "surgically sterile",
                                "criterion": "surgical sterility",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "surgically sterile"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "agree to practice 2 effective methods of contraception",
                                        "criterion": "contraception methods",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "methods"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "abstain from heterosexual intercourse",
                                        "criterion": "sexual activity",
                                        "requirement": {
                                            "requirement_type": "activity",
                                            "expected_value": "abstain from heterosexual intercourse"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse",
                "criterions": [
                    {
                        "exact_snippets": "Male participants",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "agree to practice effective barrier contraception",
                        "criterion": "contraception practice",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "effective barrier contraception"
                        }
                    },
                    {
                        "exact_snippets": "agree to abstain from heterosexual intercourse",
                        "criterion": "sexual abstinence",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "abstain from heterosexual intercourse"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male participants",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected_value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "or_criteria": [
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                                        "exact_snippets": "agree to practice effective barrier contraception",
                                        "criterion": "contraception practice",
                                        "requirement": {
                                            "requirement_type": "expected_value",
                                            "expected_value": "effective barrier contraception"
                                        }
                                    },
                                    {
                                        "exact_snippets": "agree to abstain from heterosexual intercourse",
                                        "criterion": "sexual abstinence",
                                        "requirement": {
                                            "requirement_type": "expected_value",
                                            "expected_value": "abstain from heterosexual intercourse"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Each participant must meet all of the following inclusion criteria to be enrolled in the study:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Female participants who are pregnant or lactating",
                "criterions": [
                    {
                        "exact_snippets": "Female participants",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female participants",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "pregnant",
                                        "criterion": "pregnancy status",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "lactating",
                                        "criterion": "lactation status",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serious medical or psychiatric illness that could interfere with protocol completion",
                "criterions": [
                    {
                        "exact_snippets": "Serious medical ... illness that could interfere with protocol completion",
                        "criterion": "serious medical illness",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious medical ... illness that could interfere with protocol completion",
                        "criterion": "serious medical illness",
                        "requirement": {
                            "requirement_type": "impact on protocol completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serious ... psychiatric illness that could interfere with protocol completion",
                        "criterion": "serious psychiatric illness",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "Serious ... psychiatric illness that could interfere with protocol completion",
                        "criterion": "serious psychiatric illness",
                        "requirement": {
                            "requirement_type": "impact on protocol completion",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious medical ... illness that could interfere with protocol completion",
                                "criterion": "serious medical illness",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            },
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                                "exact_snippets": "Serious medical ... illness that could interfere with protocol completion",
                                "criterion": "serious medical illness",
                                "requirement": {
                                    "requirement_type": "impact on protocol completion",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
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                        "and_criteria": [
                            {
                                "exact_snippets": "Serious ... psychiatric illness that could interfere with protocol completion",
                                "criterion": "serious psychiatric illness",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            },
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                                "exact_snippets": "Serious ... psychiatric illness that could interfere with protocol completion",
                                "criterion": "serious psychiatric illness",
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                                    "requirement_type": "impact on protocol completion",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery within 14 days of first dose of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 14 days of first dose of alisertib",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery within 14 days of first dose of alisertib",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since",
                        "expected_value": {
                            "operator": "<=",
                            "value": 14,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "Antineoplastic therapy ... 21 days prior to first dose of alisertib",
                        "criterion": "antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiation therapy ... 21 days prior to first dose of alisertib",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any experimental therapy 21 days prior to first dose of alisertib",
                        "criterion": "experimental therapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Antineoplastic therapy ... 21 days prior to first dose of alisertib",
                                "criterion": "antineoplastic therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "radiation therapy ... 21 days prior to first dose of alisertib",
                                "criterion": "radiation therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "any experimental therapy 21 days prior to first dose of alisertib",
                                "criterion": "experimental therapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Autologous stem cell transplant within 3 months before the first dose of alisertib, or prior allogeneic stem cell transplant at any time.",
                "criterions": [
                    {
                        "exact_snippets": "Autologous stem cell transplant within 3 months before the first dose of alisertib",
                        "criterion": "autologous stem cell transplant",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "prior allogeneic stem cell transplant at any time",
                        "criterion": "allogeneic stem cell transplant",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Autologous stem cell transplant within 3 months before the first dose of alisertib",
                                "criterion": "autologous stem cell transplant",
                                "requirement": {
                                    "requirement_type": "time since procedure",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
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                                "exact_snippets": "prior allogeneic stem cell transplant at any time",
                                "criterion": "allogeneic stem cell transplant",
                                "requirement": {
                                    "requirement_type": "prior occurrence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active infection requiring systemic therapy, or other serious infection",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    },
                    {
                        "exact_snippets": "other serious infection",
                        "criterion": "serious infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    },
                    {
                        "exact_snippets": "other serious infection",
                        "criterion": "serious infection",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inability to swallow oral medication",
                "criterions": [
                    {
                        "exact_snippets": "Inability to swallow oral medication",
                        "criterion": "ability to swallow oral medication",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Inability to swallow oral medication",
                    "criterion": "ability to swallow oral medication",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "Gastrointestinal (GI) disease",
                        "criterion": "Gastrointestinal disease",
                        "requirement": {
                            "requirement_type": "interference with oral absorption or tolerance of alisertib",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "GI procedure that could interfere with oral absorption or tolerance of alisertib",
                        "criterion": "GI procedure",
                        "requirement": {
                            "requirement_type": "interference with oral absorption or tolerance of alisertib",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Gastrointestinal (GI) disease",
                        "criterion": "Gastrointestinal disease",
                        "requirement": {
                            "requirement_type": "interference with oral absorption or tolerance of alisertib",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "GI procedure that could interfere with oral absorption or tolerance of alisertib",
                        "criterion": "GI procedure",
                        "requirement": {
                            "requirement_type": "interference with oral absorption or tolerance of alisertib",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic brain metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Symptomatic brain metastasis",
                    "criterion": "brain metastasis",
                    "requirement": {
                        "requirement_type": "symptomatic",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled cardiovascular condition",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled cardiovascular condition",
                        "criterion": "cardiovascular condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Uncontrolled cardiovascular condition",
                        "criterion": "cardiovascular condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C",
                "criterions": [
                    {
                        "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... hepatitis B",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known history of ... hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lactose-intolerant (Parts A and B only)",
                "criterions": [
                    {
                        "exact_snippets": "Lactose-intolerant (Parts A and B only)",
                        "criterion": "lactose intolerance",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Lactose-intolerant (Parts A and B only)",
                                "criterion": "lactose intolerance",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Lactose-intolerant (Parts A and B only)",
                                        "criterion": "trial part",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "A"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Lactose-intolerant (Parts A and B only)",
                                        "criterion": "trial part",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": "B"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior history of metabolic acidosis (Parts A and B only)",
                "criterions": [
                    {
                        "exact_snippets": "Prior history of metabolic acidosis",
                        "criterion": "metabolic acidosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior history of metabolic acidosis",
                                "criterion": "metabolic acidosis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Parts A only",
                                        "criterion": "trial part",
                                        "requirement": {
                                            "requirement_type": "inclusion",
                                            "expected_value": "A"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Parts B only",
                                        "criterion": "trial part",
                                        "requirement": {
                                            "requirement_type": "inclusion",
                                            "expected_value": "B"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A medical condition requiring use of pancreatic enzymes; or daily, chronic , or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists. Participants who intermittently use these medications must meet the following:",
                "criterions": [
                    {
                        "exact_snippets": "medical condition requiring use of pancreatic enzymes",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "use of pancreatic enzymes",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "daily, chronic , or regular use of proton pump inhibitors (PPI)",
                        "criterion": "use of proton pump inhibitors (PPI)",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": [
                                "daily",
                                "chronic",
                                "regular"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "use of ... histamine (H2) receptor antagonists",
                        "criterion": "use of histamine (H2) receptor antagonists",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "medical condition requiring use of pancreatic enzymes",
                                "criterion": "medical condition",
                                "requirement": {
                                    "requirement_type": "use of pancreatic enzymes",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "daily, chronic , or regular use of proton pump inhibitors (PPI)",
                                "criterion": "use of proton pump inhibitors (PPI)",
                                "requirement": {
                                    "requirement_type": "frequency",
                                    "expected_value": [
                                        "daily",
                                        "chronic",
                                        "regular"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "use of ... histamine (H2) receptor antagonists",
                                "criterion": "use of histamine (H2) receptor antagonists",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No use of PPI within 7 days of first dose of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "No use of PPI within 7 days of first dose of alisertib",
                        "criterion": "PPI use",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No use of PPI within 7 days of first dose of alisertib",
                    "criterion": "PPI use",
                    "requirement": {
                        "requirement_type": "time since last use",
                        "expected_value": {
                            "operator": ">=",
                            "value": 7,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* No use of H2 antagonist or pancreatic enzymes within 24 hours of first dose of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "No use of H2 antagonist",
                        "criterion": "H2 antagonist use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No use of ... pancreatic enzymes",
                        "criterion": "pancreatic enzyme use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 24 hours of first dose of alisertib",
                        "criterion": "time since last use of H2 antagonist or pancreatic enzymes",
                        "requirement": {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<",
                                "value": 24,
                                "unit": "hours"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No use of H2 antagonist",
                                "criterion": "H2 antagonist use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 24 hours of first dose of alisertib",
                                "criterion": "time since last use of H2 antagonist or pancreatic enzymes",
                                "requirement": {
                                    "requirement_type": "time",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 24,
                                        "unit": "hours"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "No use of ... pancreatic enzymes",
                                "criterion": "pancreatic enzyme use",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "within 24 hours of first dose of alisertib",
                                "criterion": "time since last use of H2 antagonist or pancreatic enzymes",
                                "requirement": {
                                    "requirement_type": "time",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 24,
                                        "unit": "hours"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants requiring full systemic anticoagulation",
                "criterions": [
                    {
                        "exact_snippets": "Participants requiring full systemic anticoagulation",
                        "criterion": "systemic anticoagulation",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participants requiring full systemic anticoagulation",
                    "criterion": "systemic anticoagulation",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "Participants meeting any of the following exclusion criteria are not to be enrolled in the study:",
                "criterions": []
            },
            "logical_structure": {
                "or_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed metastatic and/or advanced solid tumor",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed",
                        "criterion": "tumor confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "metastatic and/or advanced solid tumor",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "advanced"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Histologically or cytologically confirmed",
                                "criterion": "tumor confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "histologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Histologically or cytologically confirmed",
                                "criterion": "tumor confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": [
                                        "cytologically"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "metastatic and/or advanced solid tumor",
                                "criterion": "tumor stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "metastatic"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "metastatic and/or advanced solid tumor",
                                "criterion": "tumor stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "advanced"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Voluntary written consent",
                "criterions": [
                    {
                        "exact_snippets": "Voluntary written consent",
                        "criterion": "consent",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "voluntary written"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Suitable venous access for study-required blood sampling",
                "criterions": [
                    {
                        "exact_snippets": "Suitable venous access for study-required blood sampling",
                        "criterion": "venous access",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Recovered from effects of prior antineoplastic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Recovered from effects of prior antineoplastic therapy",
                        "criterion": "recovery from prior antineoplastic therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Meet required entry laboratory and organ function levels",
                "criterions": [
                    {
                        "exact_snippets": "Meet required entry laboratory and organ function levels",
                        "criterion": "laboratory levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "required entry"
                        }
                    },
                    {
                        "exact_snippets": "Meet required entry laboratory and organ function levels",
                        "criterion": "organ function levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "required entry"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Nitrosoureas or mitomycin-C within 6 weeks before the first dose of alisertib.",
                "criterions": [
                    {
                        "exact_snippets": "Nitrosoureas ... within 6 weeks before the first dose of alisertib.",
                        "criterion": "nitrosoureas",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "mitomycin-C within 6 weeks before the first dose of alisertib.",
                        "criterion": "mitomycin-C",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Nitrosoureas ... within 6 weeks before the first dose of alisertib.",
                                "criterion": "nitrosoureas",
                                "requirement": {
                                    "requirement_type": "time since last dose",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "mitomycin-C within 6 weeks before the first dose of alisertib.",
                                "criterion": "mitomycin-C",
                                "requirement": {
                                    "requirement_type": "time since last dose",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis ... of another malignancy within 2 years preceding first dose of study drug",
                        "criterion": "diagnosis of another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "treatment of another malignancy within 2 years preceding first dose of study drug",
                        "criterion": "treatment of another malignancy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "except nonmelanoma skin cancer",
                        "criterion": "nonmelanoma skin cancer",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except ... in situ malignancy completely resected",
                        "criterion": "in situ malignancy",
                        "requirement": {
                            "requirement_type": "resection status",
                            "expected_value": "completely resected"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Diagnosis ... of another malignancy within 2 years preceding first dose of study drug",
                                        "criterion": "diagnosis of another malignancy",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "years"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "treatment of another malignancy within 2 years preceding first dose of study drug",
                                        "criterion": "treatment of another malignancy",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "nonmelanoma skin cancer",
                                        "criterion": "nonmelanoma skin cancer",
                                        "requirement": {
                                            "requirement_type": "exclusion",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "in situ malignancy",
                                        "criterion": "in situ malignancy",
                                        "requirement": {
                                            "requirement_type": "resection status",
                                            "expected_value": "completely resected"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib",
                "criterions": [
                    {
                        "exact_snippets": "Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital",
                        "criterion": "enzyme-inducing antiepileptic drugs",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "rifampin, rifabutin, rifapentine or St. John's wort",
                        "criterion": "rifampin, rifabutin, rifapentine, St. John's wort",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within 14 days prior to the first dose of alisertib",
                        "criterion": "time since last use of specified drugs",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital",
                                        "criterion": "enzyme-inducing antiepileptic drugs",
                                        "requirement": {
                                            "requirement_type": "use",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "within 14 days prior to the first dose of alisertib",
                                        "criterion": "time since last use of specified drugs",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 14,
                                                "unit": "days"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "rifampin, rifabutin, rifapentine or St. John's wort",
                                        "criterion": "rifampin, rifabutin, rifapentine, St. John's wort",
                                        "requirement": {
                                            "requirement_type": "use",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "within 14 days prior to the first dose of alisertib",
                                        "criterion": "time since last use of specified drugs",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 14,
                                                "unit": "days"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}