{
    "info": {
        "nct_id": "NCT02282020",
        "official_title": "A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations.",
        "inclusion_criteria": "* Patients must be ≥ 18 years of age\n* Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.\n* Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)\n* At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.\n* Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive\n* Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice\n* Patients must have normal organ and bone marrow function measured within 28 days of randomisation,\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have a life expectancy ≥ 16 weeks\n* Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
        "exclusion_criteria": "* BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental\n* Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation\n* Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.\n* Patients who have platinum resistant or refractory disease\n* Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment\n* Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Patients must be ≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.",
            "criterions": [
                {
                    "exact_snippets": "histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "relapsed high grade serous ovarian cancer",
                                "primary peritoneal cancer",
                                "fallopian tube cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "high grade endometrioid cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "high grade endometrioid cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible to undergo BRCA testing",
                    "criterion": "BRCA testing eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy",
                    "criterion": "time since last platinum therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last platinum therapy",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 183,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)",
            "criterions": [
                {
                    "exact_snippets": "Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2",
                    "criterion": "germline mutation in Breast Cancer susceptibility genes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "genes",
                            "expected_value": [
                                "BRCA1",
                                "BRCA2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)",
                    "criterion": "mutation effect",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "deleterious or suspected deleterious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.",
            "criterions": [
                {
                    "exact_snippets": "At least one lesion that can be accurately assessed at baseline by CT/MRI",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "assessability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suitable for repeated assessment",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "suitability for repeated assessment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive",
            "criterions": [
                {
                    "exact_snippets": "Patients must have received at least 2 prior platinum based lines of chemotherapy",
                    "criterion": "prior platinum based lines of chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be partially platinum sensitive or platinum sensitive",
                    "criterion": "platinum sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": [
                                "partially platinum sensitive",
                                "platinum sensitive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice",
            "criterions": [
                {
                    "exact_snippets": "suitable to start treatment with single agent chemotherapy",
                    "criterion": "suitability for single agent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have normal organ and bone marrow function measured within 28 days of randomisation,",
            "criterions": [
                {
                    "exact_snippets": "Patients must have normal organ ... function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have normal ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 28 days of randomisation",
                    "criterion": "measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days of randomisation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have a life expectancy ≥ 16 weeks",
            "criterions": [
                {
                    "exact_snippets": "life expectancy ≥ 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.",
            "criterions": [
                {
                    "exact_snippets": "Formalin fixed, paraffin embedded tumour sample ... must be available",
                    "criterion": "formalin fixed, paraffin embedded tumour sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary or recurrent cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "recurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 130 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 130 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 130,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental",
            "criterions": [
                {
                    "exact_snippets": "BRCA 1 and/or BRCA2 mutations",
                    "criterion": "BRCA mutations",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "BRCA 1",
                                "BRCA2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "considered to be non detrimental",
                    "criterion": "mutation detriment",
                    "requirements": [
                        {
                            "requirement_type": "detriment",
                            "expected_value": "non detrimental"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation",
            "criterions": [
                {
                    "exact_snippets": "Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation",
                    "criterion": "exposure to investigational product",
                    "requirements": [
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "half lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.",
            "criterions": [
                {
                    "exact_snippets": "Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor",
                    "criterion": "previous treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including olaparib",
                    "criterion": "previous treatment with olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have platinum resistant or refractory disease",
            "criterions": [
                {
                    "exact_snippets": "platinum resistant or refractory disease",
                    "criterion": "platinum resistance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum resistant or refractory disease",
                    "criterion": "platinum refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 3 weeks prior to first dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).",
            "criterions": [
                {
                    "exact_snippets": "Previous single agent exposure to the selected chemotherapy regimen for randomisation.",
                    "criterion": "single agent exposure to chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior malignancy in the last 5 years, unless curatively treated and recurrence free",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated and recurrence free"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}