{
    "info": {
        "nct_id": "NCT00772876",
        "official_title": "An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies",
        "inclusion_criteria": "* Histologically and/ or cytologically confirmed solid malignant tumor or Malignant Lymphoma (excluding CNS Lymphoma and multiple myeloma) that is refractory to currently available treatment or for which no standard treatment exists\n* Measurable disease\n* Must have completed any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C; 3 months for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before study entry and subjects must have recovered (to ≤grade 1) from the toxic effects from any prior therapy.\n* Must not have had more than 40% of their bone marrow radiated and must have either measurable disease outside the field or progression post radiation therapy.\n* Age ≥ 18 years\n* ECOG performance status ≤ 2\n* Life expectancy of at least 12 weeks\n* Normal organ and marrow function as defined below:\n\nHemoglobin >/= 90 g/L Leukocytes >/=3 x 109/L Absolute Neutrophil Count (ANC) >/=1.5 x 109/L Platelets >/=100 x 109/L Total bilirubin </= 1.5 X institutional Upper Limit of Normal (ULN) AST(SGOT) </=2.5 X institutional ULN ALT(SGPT) </=2.5 X institutional ULN Creatinine </=1.5 X institutional ULN\n\n- Ability to understand and willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration\n* Known brain metastases at the time of screening\n* Any other investigational drug within 1 month prior to day 1 of study drug administration or not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period.\n* History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.\n* On immunosuppressive therapy.\n* History of unstable angina or myocardial infarction or stroke within 6 months prior to Day 1 of study drug administration.\n* Uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.\n* Pregnant or lactating women\n* Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence) prior to study entry (after signing the informed consent document), during the duration of study participation and for at least 4 weeks after withdrawal from the study drug, unless they are surgically sterilised.\n* Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically and/ or cytologically confirmed solid malignant tumor or Malignant Lymphoma (excluding CNS Lymphoma and multiple myeloma) that is refractory to currently available treatment or for which no standard treatment exists",
                "criterions": [
                    {
                        "exact_snippets": "Histologically and/ or cytologically confirmed solid malignant tumor",
                        "criterion": "solid malignant tumor",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Malignant Lymphoma (excluding CNS Lymphoma and multiple myeloma)",
                        "criterion": "Malignant Lymphoma",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "CNS Lymphoma",
                                "multiple myeloma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "refractory to currently available treatment",
                        "criterion": "refractory to treatment",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "refractory"
                        }
                    },
                    {
                        "exact_snippets": "for which no standard treatment exists",
                        "criterion": "standard treatment availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Histologically and/ or cytologically confirmed solid malignant tumor",
                                        "criterion": "solid malignant tumor",
                                        "requirement": {
                                            "requirement_type": "confirmation method",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "refractory to currently available treatment",
                                        "criterion": "refractory to treatment",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "refractory"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "for which no standard treatment exists",
                                "criterion": "standard treatment availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Malignant Lymphoma (excluding CNS Lymphoma and multiple myeloma)",
                                "criterion": "Malignant Lymphoma",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": [
                                        "CNS Lymphoma",
                                        "multiple myeloma"
                                    ]
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "refractory to currently available treatment",
                                        "criterion": "refractory to treatment",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "refractory"
                                        }
                                    },
                                    {
                                        "exact_snippets": "for which no standard treatment exists",
                                        "criterion": "standard treatment availability",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have completed any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C; 3 months for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before study entry and subjects must have recovered (to ≤grade 1) from the toxic effects from any prior therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Must have completed any prior chemotherapy ... at least 4 weeks",
                        "criterion": "prior chemotherapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Must have completed any prior ... radiotherapy ... at least 4 weeks",
                        "criterion": "prior radiotherapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Must have completed any prior ... biologic/targeted anti-cancer therapy ... at least 4 weeks",
                        "criterion": "prior biologic/targeted anti-cancer therapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Must have completed any prior ... surgery at least 4 weeks",
                        "criterion": "prior surgery completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 6 weeks for nitrosureas",
                        "criterion": "prior nitrosureas completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 6 weeks for ... mitomycin C",
                        "criterion": "prior mitomycin C completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "3 months for monoclonal antibodies",
                        "criterion": "prior monoclonal antibodies completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "3 months for ... radioactive monoclonal antibodies",
                        "criterion": "prior radioactive monoclonal antibodies completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "3 months for ... any radio- or toxin- immunoconjugates",
                        "criterion": "prior radio- or toxin- immunoconjugates completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subjects must have recovered (to ≤grade 1) from the toxic effects from any prior therapy",
                        "criterion": "recovery from toxic effects of prior therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Must have completed any prior chemotherapy ... at least 4 weeks",
                                        "criterion": "prior chemotherapy completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Must have completed any prior ... radiotherapy ... at least 4 weeks",
                                        "criterion": "prior radiotherapy completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Must have completed any prior ... biologic/targeted anti-cancer therapy ... at least 4 weeks",
                                        "criterion": "prior biologic/targeted anti-cancer therapy completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Must have completed any prior ... surgery at least 4 weeks",
                                        "criterion": "prior surgery completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "at least 6 weeks for nitrosureas",
                                        "criterion": "prior nitrosureas completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 6,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "at least 6 weeks for ... mitomycin C",
                                        "criterion": "prior mitomycin C completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 6,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "3 months for monoclonal antibodies",
                                        "criterion": "prior monoclonal antibodies completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "3 months for ... radioactive monoclonal antibodies",
                                        "criterion": "prior radioactive monoclonal antibodies completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "3 months for ... any radio- or toxin- immunoconjugates",
                                        "criterion": "prior radio- or toxin- immunoconjugates completion",
                                        "requirement": {
                                            "requirement_type": "time since completion",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "months"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "subjects must have recovered (to ≤grade 1) from the toxic effects from any prior therapy",
                        "criterion": "recovery from toxic effects of prior therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hemoglobin >/= 90 g/L Leukocytes >/=3 x 109/L Absolute Neutrophil Count (ANC) >/=1.5 x 109/L Platelets >/=100 x 109/L Total bilirubin </= 1.5 X institutional Upper Limit of Normal (ULN) AST(SGOT) </=2.5 X institutional ULN ALT(SGPT) </=2.5 X institutional ULN Creatinine </=1.5 X institutional ULN",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin >/= 90 g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Leukocytes >/=3 x 109/L",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) >/=1.5 x 109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets >/=100 x 109/L",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin </= 1.5 X institutional Upper Limit of Normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST(SGOT) </=2.5 X institutional ULN",
                        "criterion": "AST (SGOT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT(SGPT) </=2.5 X institutional ULN",
                        "criterion": "ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine </=1.5 X institutional ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin >/= 90 g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Leukocytes >/=3 x 109/L",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute Neutrophil Count (ANC) >/=1.5 x 109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets >/=100 x 109/L",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin </= 1.5 X institutional Upper Limit of Normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST(SGOT) </=2.5 X institutional ULN",
                        "criterion": "AST (SGOT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT(SGPT) </=2.5 X institutional ULN",
                        "criterion": "ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine </=1.5 X institutional ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "- Ability to understand and willingness to sign a written informed consent document.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "ability to understand",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to sign informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "ability to understand",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to sign informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Known brain metastases at the time of screening",
                "criterions": [
                    {
                        "exact_snippets": "Known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any other investigational drug within 1 month prior to day 1 of study drug administration or not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period.",
                "criterions": [
                    {
                        "exact_snippets": "Any other investigational drug within 1 month prior to day 1 of study drug administration",
                        "criterion": "investigational drug administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    },
                    {
                        "exact_snippets": "not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period",
                        "criterion": "recovery from adverse effects",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other investigational drug within 1 month prior to day 1 of study drug administration",
                                "criterion": "investigational drug administration",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "month"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period",
                                "criterion": "recovery from adverse effects",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.",
                        "criterion": "allergic reactions",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.",
                        "criterion": "allergic reactions",
                        "requirement": {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical structure to P1446A-05"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.",
                        "criterion": "allergic reactions",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.",
                        "criterion": "allergic reactions",
                        "requirement": {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical structure to P1446A-05"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* On immunosuppressive therapy.",
                "criterions": [
                    {
                        "exact_snippets": "On immunosuppressive therapy.",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "On immunosuppressive therapy.",
                    "criterion": "immunosuppressive therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of unstable angina or myocardial infarction or stroke within 6 months prior to Day 1 of study drug administration.",
                "criterions": [
                    {
                        "exact_snippets": "History of unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... stroke",
                        "criterion": "stroke",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... stroke",
                        "criterion": "stroke",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... stroke",
                                "criterion": "stroke",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... stroke",
                                "criterion": "stroke",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled inter-current illness ... active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled inter-current illness ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled inter-current illness ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled inter-current illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled inter-current illness ... active infection",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled inter-current illness ... symptomatic congestive heart failure",
                                "criterion": "symptomatic congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled inter-current illness ... cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled inter-current illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                                "criterion": "psychiatric illness/social situations",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.",
                "criterions": [
                    {
                        "exact_snippets": "infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Tuberculosis",
                        "criterion": "Tuberculosis infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Hepatitis C",
                        "criterion": "Hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Hepatitis B",
                        "criterion": "Hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Tuberculosis",
                        "criterion": "Tuberculosis infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Hepatitis C",
                        "criterion": "Hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "infection with ... Hepatitis B",
                        "criterion": "Hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence) prior to study entry (after signing the informed consent document), during the duration of study participation and for at least 4 weeks after withdrawal from the study drug, unless they are surgically sterilised.",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)]",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months"
                        }
                    },
                    {
                        "exact_snippets": "men, not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence)",
                        "criterion": "men contraception agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Women of childbearing potential ... not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence)",
                        "criterion": "women contraception agreement",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unless they are surgically sterilised",
                        "criterion": "surgical sterilization",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)]",
                                                "criterion": "women of childbearing potential",
                                                "requirement": {
                                                    "requirement_type": "definition",
                                                    "expected_value": "sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Women of childbearing potential ... not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence)",
                                                "criterion": "women contraception agreement",
                                                "requirement": {
                                                    "requirement_type": "agreement",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "unless they are surgically sterilised",
                                        "criterion": "surgical sterilization",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "men, not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence)",
                                        "criterion": "men contraception agreement",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "unless they are surgically sterilised",
                                        "criterion": "surgical sterilization",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.",
                "criterions": [
                    {
                        "exact_snippets": "Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "risk assessment",
                            "expected_value": "unacceptable risk"
                        }
                    },
                    {
                        "exact_snippets": "Any condition, including laboratory abnormalities, that in the opinion of the investigator ... deems the subject not suitable for participation in the study",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "not suitable for participation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "risk assessment",
                                    "expected_value": "unacceptable risk"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition, including laboratory abnormalities, that in the opinion of the investigator ... deems the subject not suitable for participation in the study",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "suitability",
                                    "expected_value": "not suitable for participation"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Must not have had more than 40% of their bone marrow radiated and must have either measurable disease outside the field or progression post radiation therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Must not have had more than 40% of their bone marrow radiated",
                        "criterion": "bone marrow radiation",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Must not have had more than 40% of their bone marrow radiated",
                        "criterion": "bone marrow radiation",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "not radiated"
                        }
                    },
                    {
                        "exact_snippets": "must have either measurable disease outside the field",
                        "criterion": "measurable disease outside the field",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progression post radiation therapy",
                        "criterion": "disease progression post radiation therapy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "progression"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Age ≥ 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status ≤ 2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status ≤ 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy of at least 12 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of at least 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Normal organ and marrow function as defined below:",
                "criterions": [
                    {
                        "exact_snippets": "Normal organ and marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    },
                    {
                        "exact_snippets": "Normal organ and marrow function",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                "criterions": [
                    {
                        "exact_snippets": "autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                        "criterion": "bone marrow transplant",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "autologous",
                                "allogeneic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                        "criterion": "bone marrow transplant",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                                "criterion": "bone marrow transplant",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "autologous"
                                }
                            },
                            {
                                "exact_snippets": "autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                                "criterion": "bone marrow transplant",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "allogeneic"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration",
                        "criterion": "bone marrow transplant",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}