{
    "info": {
        "nct_id": "NCT01650376",
        "official_title": "Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients",
        "inclusion_criteria": "* Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:\n\n  * Platinum sensitive: relapsed at least 6 months following platinum treatment\n  * Platinum refractory: the cancer grew while on platinum treatment\n  * Platinum resistant: recurrence within 6 months of platinum treatment\n* Must have failed first line treatment\n* ECOG performance status 0-2\n* Must be able to swallow and retain oral medication\n* Life expectancy greater than 16 weeks\n* Must have normal organ and bone marrow function defined as follows:\n\n  * Hemoglobin ≥ 9.0 g/dL\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\n  * White blood cells (WBC) > 3 x 10^9/L\n  * Platelet count ≥ 100 10^9/L\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal\n  * AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 ULN\n  * Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any previous treatment with a PARP inhibitor, including olaparib\n* Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)\n* Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors\n* Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years\n* Symptomatic uncontrolled brain metastases\n* Major surgery within 2 weeks of starting study treatment\n* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)\n* Known active hepatic disease (i.e. Hepatitis B or C)\n* Uncontrolled seizures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:",
            "criterions": [
                {
                    "exact_snippets": "Advanced (stage III or IV)",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically documented",
                    "criterion": "documentation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian cancer or serious uterine cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "ovarian cancer",
                                "serious uterine cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed after primary therapy with a platinum and a taxane",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "relapse after",
                            "expected_value": "primary therapy with a platinum and a taxane"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platinum sensitive: relapsed at least 6 months following platinum treatment",
            "criterions": [
                {
                    "exact_snippets": "Platinum sensitive: relapsed at least 6 months following platinum treatment",
                    "criterion": "platinum sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "relapse timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platinum refractory: the cancer grew while on platinum treatment",
            "criterions": [
                {
                    "exact_snippets": "Platinum refractory: the cancer grew while on platinum treatment",
                    "criterion": "platinum treatment",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "cancer grew"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platinum resistant: recurrence within 6 months of platinum treatment",
            "criterions": [
                {
                    "exact_snippets": "Platinum resistant: recurrence within 6 months of platinum treatment",
                    "criterion": "platinum resistance",
                    "requirements": [
                        {
                            "requirement_type": "recurrence time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have failed first line treatment",
            "criterions": [
                {
                    "exact_snippets": "Must have failed first line treatment",
                    "criterion": "first line treatment",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "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": "* Must be able to swallow and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Must be able to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy greater than 16 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy greater than 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have normal organ and bone marrow function defined as follows:",
            "criterions": [
                {
                    "exact_snippets": "normal organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cells (WBC) > 3 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "White blood cells (WBC) > 3 x 10^9/L",
                    "criterion": "white blood cells (WBC)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 1.5 x institutional upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 ULN",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal",
                    "criterion": "AST (SGOT)/ALT (SGPT) levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "institutional upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless liver metastases are present",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in which case it must be ≤ 5 ULN",
                    "criterion": "AST (SGOT)/ALT (SGPT) levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any previous treatment with a PARP inhibitor, including olaparib",
            "criterions": [
                {
                    "exact_snippets": "previous treatment with a PARP inhibitor, including olaparib",
                    "criterion": "previous treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)",
            "criterions": [
                {
                    "exact_snippets": "Any systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy (except for palliative reasons)",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals",
                    "criterion": "azole antifungals",
                    "requirements": [
                        {
                            "requirement_type": "currently receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving the following classes of inhibitors of CYP3A4: ... macrolide antibiotics",
                    "criterion": "macrolide antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "currently receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving the following classes of inhibitors of CYP3A4: ... protease inhibitors",
                    "criterion": "protease inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "currently receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years",
            "criterions": [
                {
                    "exact_snippets": "Second primary cancer except adequately treated non-melanoma skin cancer",
                    "criterion": "second primary cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated in-situ cancer of the cervix",
                    "criterion": "in-situ cancer of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "other solid tumors curatively treated with no evidence of disease for ≥ 5 years",
                    "criterion": "other solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        },
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic uncontrolled brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 2 weeks of starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 2 weeks of starting study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)",
            "criterions": [
                {
                    "exact_snippets": "Immunocompromised patients",
                    "criterion": "immunocompromised status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
                    "criterion": "HIV serological status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled seizures",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin",
                    "criterion": "allergic reactions to carboplatin-like compounds",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... paclitaxel",
                    "criterion": "allergic reactions to paclitaxel-like compounds",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Known active hepatic disease (i.e. Hepatitis B or C)",
            "criterions": [
                {
                    "exact_snippets": "Known active hepatic disease (i.e. Hepatitis B or C)",
                    "criterion": "active hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}