{
    "info": {
        "nct_id": "NCT00777582",
        "official_title": "A Phase I, Randomised, 2 Period Cross Over Study to Determine the Comparative Bioavailability of Two Different Oral Formulations of AZD2281 in Cancer Patients With Advanced Solid Tumours",
        "inclusion_criteria": "* Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists\n* Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment\n* Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
        "exclusion_criteria": "* Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids\n* Patients with symptomatic uncontrolled brain metastases\n* Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery\n* Patients who are platinum refractory (Group 8 only)\n* Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed malignant advanced solid tumour",
                        "criterion": "malignant advanced solid tumour",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "refractory to standard therapies",
                        "criterion": "tumour refractory status",
                        "requirement": {
                            "requirement_type": "refractory status",
                            "expected_value": "refractory to standard therapies"
                        }
                    },
                    {
                        "exact_snippets": "no suitable effective standard therapy exists",
                        "criterion": "availability of suitable effective standard therapy",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Group 8 patients ... must not be platinum refractory",
                        "criterion": "platinum refractory status for Group 8 patients",
                        "requirement": {
                            "requirement_type": "refractory status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically confirmed malignant advanced solid tumour",
                                "criterion": "malignant advanced solid tumour",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histologically confirmed"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "refractory to standard therapies",
                                        "criterion": "tumour refractory status",
                                        "requirement": {
                                            "requirement_type": "refractory status",
                                            "expected_value": "refractory to standard therapies"
                                        }
                                    },
                                    {
                                        "exact_snippets": "no suitable effective standard therapy exists",
                                        "criterion": "availability of suitable effective standard therapy",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "Group 8 patients ... must not be platinum refractory",
                                    "criterion": "platinum refractory status for Group 8 patients",
                                    "requirement": {
                                        "requirement_type": "refractory status",
                                        "expected_value": false
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Group 8 patients ... must not be platinum refractory",
                                "criterion": "platinum refractory status for Group 8 patients",
                                "requirement": {
                                    "requirement_type": "refractory status",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ and bone marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate organ and bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate organ and bone marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate organ and bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status",
                "criterions": [
                    {
                        "exact_snippets": "Female patients must have evidence of non-child bearing status",
                        "criterion": "non-child bearing status",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of study treatment"
                        }
                    },
                    {
                        "exact_snippets": "postmenopausal status",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patients must have evidence of non-child bearing status",
                                "criterion": "non-child bearing status",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing",
                                                "criterion": "pregnancy test",
                                                "requirement": {
                                                    "requirement_type": "result",
                                                    "expected_value": "negative"
                                                }
                                            },
                                            {
                                                "exact_snippets": "negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing",
                                                "criterion": "pregnancy test",
                                                "requirement": {
                                                    "requirement_type": "timing",
                                                    "expected_value": "within 7 days of study treatment"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "postmenopausal status",
                                        "criterion": "menopausal status",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "postmenopausal"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "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": "Must have maximum age of 130 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 130 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 130,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 130 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 130,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids",
                "criterions": [
                    {
                        "exact_snippets": "Patients receiving chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients receiving ... radiotherapy (except for palliative reasons)",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients receiving ... radiotherapy (except for palliative reasons)",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "purpose",
                            "expected_value": "palliative reasons"
                        }
                    },
                    {
                        "exact_snippets": "Patients receiving ... any other anti-cancer therapy",
                        "criterion": "anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients may continue the use of biphosphonates for bone metastases",
                        "criterion": "biphosphonates",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients may continue the use of ... corticosteroids",
                        "criterion": "corticosteroids",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients receiving chemotherapy",
                                        "criterion": "chemotherapy",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients receiving ... radiotherapy (except for palliative reasons)",
                                        "criterion": "radiotherapy",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "Patients receiving ... radiotherapy (except for palliative reasons)",
                                            "criterion": "radiotherapy",
                                            "requirement": {
                                                "requirement_type": "purpose",
                                                "expected_value": "palliative reasons"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients receiving ... any other anti-cancer therapy",
                                        "criterion": "anti-cancer therapy",
                                        "requirement": {
                                            "requirement_type": "timing",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Patients may continue the use of biphosphonates for bone metastases",
                                    "criterion": "biphosphonates",
                                    "requirement": {
                                        "requirement_type": "use",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Patients may continue the use of ... corticosteroids",
                                    "criterion": "corticosteroids",
                                    "requirement": {
                                        "requirement_type": "use",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with symptomatic uncontrolled brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "symptomatic uncontrolled brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic uncontrolled brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "symptomatic uncontrolled brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic uncontrolled brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 2 weeks of starting study",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "patients must have recovered from any effects of any major surgery",
                        "criterion": "recovery from major surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Major surgery within 2 weeks of starting study",
                            "criterion": "major surgery",
                            "requirement": {
                                "requirement_type": "time since surgery",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 2,
                                    "unit": "weeks"
                                }
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "patients must have recovered from any effects of any major surgery",
                            "criterion": "recovery from major surgery",
                            "requirement": {
                                "requirement_type": "recovery status",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who are platinum refractory (Group 8 only)",
                "criterions": [
                    {
                        "exact_snippets": "Patients who are platinum refractory",
                        "criterion": "platinum refractory",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Group 8 only",
                    "criterion": "group",
                    "requirement": {
                        "requirement_type": "membership",
                        "expected_value": "8"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Patients who are platinum refractory",
                    "criterion": "platinum refractory",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).",
                "criterions": [
                    {
                        "exact_snippets": "myelodysplastic syndrome",
                        "criterion": "myelodysplastic syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acute myeloid leukaemia",
                        "criterion": "acute myeloid leukaemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "myelodysplastic syndrome",
                                "criterion": "myelodysplastic syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "acute myeloid leukaemia",
                                "criterion": "acute myeloid leukaemia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Group 8 only",
                        "criterion": "Group",
                        "requirement": {
                            "requirement_type": "membership",
                            "expected_value": "Group 8"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}