{
    "info": {
        "nct_id": "NCT04719273",
        "official_title": "A Phase II Clinical Trial Evaluating the Combination of Onapristone With Anastrozole for Women With Refractory Hormone Receptor Positive Endometrial Cancer",
        "inclusion_criteria": "* Age greater than or equal to 18 years old\n* Histologically confirmed diagnosis of endometrial cancer with ER and/or PR expression >= 1% by IHC on archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available. IHC results do not have to be from Thomas Jefferson University\n* Patients who have failed one prior treatment with a platinum/taxane chemotherapy regimen for management of disease\n\n  * Patients cannot have treatment with more than 2 prior lines of therapy (one line must be platinum/taxane regimen)\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI\n* Patients with the following histologic epithelial cell types are eligible:\n\n  * Endometrioid adenocarcinoma\n  * Serous adenocarcinoma\n  * Undifferentiated carcinoma\n  * Clear cell adenocarcinoma\n  * Mixed epithelial carcinoma\n  * Adenocarcinoma not otherwise specified (NOS)\n  * Please note: patients with carcinosarcoma are ineligible for this trial\n* Patients must have had one prior treatment with a platinum/taxane chemotherapy regimen for management of disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Must have a life expectancy of at least 12 weeks as judged by the treating physician\n* Females are only eligible for this study if they are postmenopausal. This is defined as meeting one of the following criteria:\n\n  * S/p total abdominal hysterectomy and bilateral salpingo-oopherectomy\n  * Patients who are in menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 55 in the absence of other biological or physiological causes OR women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.\n* Body weight > 30 kg\n* Absolute neutrophil count 1500/ul or more\n* Platelets 100,000/ul or more\n* Hemoglobin 9 g/dl or more\n* Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)\n* Endocrine and targeted therapy protocols usually enroll patients with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) in patients without underlying liver metastasis and < 5.0 x ULN in patients with underlying liver metastasis\n* Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or measured creatinine clearance using 24 hours urine collection\n* International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* All subjects must be able to comprehend and sign a written informed consent document\n* Resolution of all acute toxic effects of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade =< 1, with the exception of unresolved grade 2 neuropathy and grade 2 alopecia, which are allowed\n* Patient has recovered from any prior radiotherapy\n* Patients must be able to swallow tablets whole, without crushing\n* Be able to read and speak English\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Concurrent or recent chemotherapy, radiotherapy, immunotherapy, or general anesthesia/major surgery within 3 weeks\n* History of prior hormonal therapy (i.e., megestrol acetate, tamoxifen or aromatase inhibitors) for treatment cancer within the past 2 months. Other concurrent hormonal therapy will not be allowed on this trial\n* Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy\n* If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment\n* Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to randomization\n* Known brain metastasis which have not been treated or showed stability for >= 6 months\n* Proteinuria > 1+ on urinalysis or > 1 gm/24 hours (hr)\n* Known history of New York Heart Association stage 3 or 4 cardiac disease\n* A pleural or pericardial effusion of greater than or equal to grade 3 severity\n* Women who are pregnant or nursing\n* Has an active infection requiring systemic therapy\n* Use of any prescription medication during the prior 28 days of first onapristone dosing that the investigator judges is likely to interfere with onapristone activity; specifically strong inhibitors or inducers, or sensitive substrates of cytochrome P450 CYP3A4\n* Patients may not be on a concurrent clinical trial, unless approved by investigator",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age greater than or equal to 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age greater than or equal to 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of endometrial cancer with ER and/or PR expression >= 1% by IHC on archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available. IHC results do not have to be from Thomas Jefferson University",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "ER and/or PR expression >= 1% by IHC",
                    "criterion": "ER and/or PR expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "IHC"
                        }
                    ]
                },
                {
                    "exact_snippets": "archival tissue taken within the prior 3 years or new biopsy if no archival tissue is available",
                    "criterion": "archival tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the prior 3 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have failed one prior treatment with a platinum/taxane chemotherapy regimen for management of disease",
            "criterions": [
                {
                    "exact_snippets": "Patients who have failed one prior treatment with a platinum/taxane chemotherapy regimen",
                    "criterion": "prior treatment with a platinum/taxane chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients cannot have treatment with more than 2 prior lines of therapy (one line must be platinum/taxane regimen)",
            "criterions": [
                {
                    "exact_snippets": "treatment with more than 2 prior lines of therapy",
                    "criterion": "prior lines of therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one line must be platinum/taxane regimen",
                    "criterion": "platinum/taxane regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion that can be accurately measured in at least one dimension",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI)",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI",
                    "criterion": "lymph node size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the following histologic epithelial cell types are eligible:",
            "criterions": [
                {
                    "exact_snippets": "histologic epithelial cell types",
                    "criterion": "histologic epithelial cell types",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endometrioid adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Endometrioid adenocarcinoma",
                    "criterion": "endometrioid adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serous adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Serous adenocarcinoma",
                    "criterion": "serous adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undifferentiated carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Undifferentiated carcinoma",
                    "criterion": "undifferentiated carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clear cell adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Clear cell adenocarcinoma",
                    "criterion": "clear cell adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mixed epithelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Mixed epithelial carcinoma",
                    "criterion": "mixed epithelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenocarcinoma not otherwise specified (NOS)",
            "criterions": [
                {
                    "exact_snippets": "Adenocarcinoma not otherwise specified (NOS)",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "not otherwise specified (NOS)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Please note: patients with carcinosarcoma are ineligible for this trial",
            "criterions": [
                {
                    "exact_snippets": "patients with carcinosarcoma are ineligible",
                    "criterion": "carcinosarcoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had one prior treatment with a platinum/taxane chemotherapy regimen for management of disease",
            "criterions": [
                {
                    "exact_snippets": "Patients must have had one prior treatment with a platinum/taxane chemotherapy regimen",
                    "criterion": "prior treatment with a platinum/taxane chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have a life expectancy of at least 12 weeks as judged by the treating physician",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females are only eligible for this study if they are postmenopausal. This is defined as meeting one of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Females are only eligible for this study",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "if they are postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* S/p total abdominal hysterectomy and bilateral salpingo-oopherectomy",
            "criterions": [
                {
                    "exact_snippets": "S/p total abdominal hysterectomy",
                    "criterion": "total abdominal hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral salpingo-oopherectomy",
                    "criterion": "bilateral salpingo-oopherectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are in menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 55 in the absence of other biological or physiological causes OR women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are in menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 55",
                    "criterion": "menopause",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 55,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL",
                    "criterion": "serum follicle stimulating hormone (FSH) level",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 55,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "FSH level",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "mIU/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body weight > 30 kg",
            "criterions": [
                {
                    "exact_snippets": "Body weight > 30 kg",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count 1500/ul or more",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count 1500/ul or more",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets 100,000/ul or more",
            "criterions": [
                {
                    "exact_snippets": "Platelets 100,000/ul or more",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin 9 g/dl or more",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin 9 g/dl or more",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than or equal to 1.5 x the upper limit of normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert syndrome, who can have total bilirubin < 3 mg/dl",
                    "criterion": "bilirubin level in subjects with Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Endocrine and targeted therapy protocols usually enroll patients with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) in patients without underlying liver metastasis and < 5.0 x ULN in patients with underlying liver metastasis",
            "criterions": [
                {
                    "exact_snippets": "aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) in patients without underlying liver metastasis",
                    "criterion": "AST/ALT levels in patients without underlying liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ... < 5.0 x ULN in patients with underlying liver metastasis",
                    "criterion": "AST/ALT levels in patients with underlying liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or measured creatinine clearance using 24 hours urine collection",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate (GFR) greater than or equal to 40 ml/min",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured creatinine clearance using 24 hours urine collection",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "24 hours urine collection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) ... =< 1.5 x ULN",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time (PT) ... =< 1.5 x ULN",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (aPTT) ... =< 1.5 x ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless participant is receiving anticoagulant therapy ... PT or aPTT is within therapeutic range of intended use of anticoagulants",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "PT or aPTT therapeutic range",
                            "expected_value": "within therapeutic range of intended use of anticoagulants"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All subjects must be able to comprehend and sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "All subjects must be able to comprehend",
                    "criterion": "comprehension ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign a written informed consent document",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has recovered from any prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Patient has recovered from any prior radiotherapy",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to swallow tablets whole, without crushing",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to swallow tablets whole, without crushing",
                    "criterion": "ability to swallow tablets whole",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Be able to read and speak English",
            "criterions": [
                {
                    "exact_snippets": "Be able to read and speak English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": [
                                "read",
                                "speak"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of prior hormonal therapy (i.e., megestrol acetate, tamoxifen or aromatase inhibitors) for treatment cancer within the past 2 months. Other concurrent hormonal therapy will not be allowed on this trial",
            "criterions": [
                {
                    "exact_snippets": "History of prior hormonal therapy (i.e., megestrol acetate, tamoxifen or aromatase inhibitors) for treatment cancer within the past 2 months",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the past 2 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other concurrent hormonal therapy will not be allowed",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy",
            "criterions": [
                {
                    "exact_snippets": "Patient has a concurrent malignancy",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of invasive malignancy within 3 years of enrollment",
                    "criterion": "history of invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy",
                    "criterion": "exceptions to malignancy history",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "basal cell skin cancer",
                                "squamous cell skin cancer",
                                "superficial bladder cancer",
                                "carcinoma in situ of the cervix"
                            ]
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "completed curative therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "If participant received major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "they must have recovered adequately from the toxicity and/or complications from the intervention",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "adequate recovery from toxicity and/or complications"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to randomization",
                    "criterion": "prior systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known brain metastasis which have not been treated or showed stability for >= 6 months",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "which have not been treated",
                    "criterion": "treatment of brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "showed stability for >= 6 months",
                    "criterion": "stability of brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "duration of stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Proteinuria > 1+ on urinalysis or > 1 gm/24 hours (hr)",
            "criterions": [
                {
                    "exact_snippets": "Proteinuria > 1+ on urinalysis",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Proteinuria ... > 1 gm/24 hours (hr)",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "gm/24 hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of New York Heart Association stage 3 or 4 cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Known history of New York Heart Association stage 3 or 4 cardiac disease",
                    "criterion": "New York Heart Association cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A pleural or pericardial effusion of greater than or equal to grade 3 severity",
            "criterions": [
                {
                    "exact_snippets": "pleural or pericardial effusion ... greater than or equal to grade 3 severity",
                    "criterion": "pleural or pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any prescription medication during the prior 28 days of first onapristone dosing that the investigator judges is likely to interfere with onapristone activity; specifically strong inhibitors or inducers, or sensitive substrates of cytochrome P450 CYP3A4",
            "criterions": [
                {
                    "exact_snippets": "Use of any prescription medication during the prior 28 days of first onapristone dosing",
                    "criterion": "prescription medication use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "prior 28 days of first onapristone dosing"
                        }
                    ]
                },
                {
                    "exact_snippets": "the investigator judges is likely to interfere with onapristone activity",
                    "criterion": "interference with onapristone activity",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "specifically strong inhibitors or inducers, or sensitive substrates of cytochrome P450 CYP3A4",
                    "criterion": "interaction with cytochrome P450 CYP3A4",
                    "requirements": [
                        {
                            "requirement_type": "interaction type",
                            "expected_value": [
                                "strong inhibitors",
                                "inducers",
                                "sensitive substrates"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may not be on a concurrent clinical trial, unless approved by investigator",
            "criterions": [
                {
                    "exact_snippets": "Patients may not be on a concurrent clinical trial",
                    "criterion": "concurrent clinical trial participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless approved by investigator",
                    "criterion": "investigator approval for concurrent trial",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Resolution of all acute toxic effects of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade =< 1, with the exception of unresolved grade 2 neuropathy and grade 2 alopecia, which are allowed",
            "criterions": [
                {
                    "exact_snippets": "Resolution of all acute toxic effects of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade =< 1",
                    "criterion": "acute toxic effects of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unresolved grade 2 neuropathy ... allowed",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unresolved grade 2 alopecia ... allowed",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "NCI CTCAE grade"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Concurrent or recent chemotherapy, radiotherapy, immunotherapy, or general anesthesia/major surgery within 3 weeks",
            "criterions": [
                {
                    "exact_snippets": "Concurrent or recent chemotherapy ... within 3 weeks",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent or recent radiotherapy ... within 3 weeks",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent or recent immunotherapy ... within 3 weeks",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent or recent ... general anesthesia/major surgery within 3 weeks",
                    "criterion": "general anesthesia/major surgery",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}