{
    "info": {
        "nct_id": "NCT02826772",
        "official_title": "A Phase 1/2, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC)",
        "inclusion_criteria": "1. Written informed consent obtained prior to any study-related procedure being performed.\n2. Subjects at least 18 years of age or older at the time of consent.\n3. Histologically confirmed metastatic castrate resistant cancer (mCRPC) who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel, for example); or cannot tolerate either or both of these classes of therapies.\n4. Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) \"super-agonist\" or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.\n5. Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.\n6. Progressive disease despite ongoing androgen deprivation or chemotherapy. Progressive disease is defined by 1 or more of the following criteria:\n\n   * Subjects with a rising PSA value > 2 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.\n   * Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n   * Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.\n7. ECOG performance status of 0-2 (dose escalation phase); ECOG performance status of 0-1 (expansion phase).\n8. Screening blood counts of the following:\n\n   * Absolute neutrophil count ≥ 1500/μL\n   * Platelets ≥ 100,000/μL\n   * Hemoglobin > 9 g/dL\n9. Screening chemistry values of the following:\n\n   * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)\n   * Total bilirubin ≤ 2 × ULN\n   * Creatinine ≤ 1.5 × ULN\n   * Albumin > 2.8 g/dL.\n10. At screening, life expectancy of at least 3 months.\n11. Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug.\n12. Subject is willing and able to comply with all protocol required visits and assessments.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Subjects with life expectancy less than 3 months.\n2. Discontinuation of bicalutamide or nilutamide less than 6 weeks, and other antiandrogens less than 4 weeks, abiraterone less than 3 weeks, prior to the start of study medication.\n3. Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication.\n4. Prior chemotherapies more than 2 lines (Phase II part only) .\n5. Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.\n6. History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).\n7. Known gastrointestinal disease or condition that affects the absorption of GT0918.\n8. History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.\n9. History or family history of long QT syndrome.\n10. History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.\n11. Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.\n12. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.\n13. Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.\n14. Major surgery within 30 days prior to the start of study medication.\n15. Blood transfusion (including blood products) within 1 week of screening.\n16. Serious persistent infection within 14 days prior to the start of study medication.\n17. Serious concurrent medical condition including CNS disorders.\n18. Previous history of difficulty swallowing capsules.\n19. Known hypersensitivity to GT0918 or its excipients.\n20. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written informed consent obtained prior to any study-related procedure being performed.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects at least 18 years of age or older at the time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Subjects at least 18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed metastatic castrate resistant cancer (mCRPC) who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel, for example); or cannot tolerate either or both of these classes of therapies.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed metastatic castrate resistant cancer (mCRPC)",
                    "criterion": "metastatic castrate resistant cancer (mCRPC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed after both hormonal therapy (abiraterone or enzalutamide)",
                    "criterion": "progression after hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed after ... chemotherapy (docetaxel, for example)",
                    "criterion": "progression after chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot tolerate either or both of these classes of therapies",
                    "criterion": "tolerance to therapies",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) \"super-agonist\" or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) \"super-agonist\" or antagonist, or bilateral orchiectomy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "computed tomography (CT)",
                                "magnetic resonance imaging (MRI)",
                                "bone scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Progressive disease despite ongoing androgen deprivation or chemotherapy. Progressive disease is defined by 1 or more of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease despite ongoing androgen deprivation",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "androgen deprivation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive disease despite ongoing ... chemotherapy",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a rising PSA value > 2 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.",
            "criterions": [
                {
                    "exact_snippets": "rising PSA value > 2 ng/mL",
                    "criterion": "PSA value",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 2 measurements, at least 1 week apart",
                    "criterion": "PSA measurements",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "measurements"
                            }
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required",
                    "criterion": "confirmatory PSA value",
                    "requirements": [
                        {
                            "requirement_type": "comparison to screening PSA value",
                            "expected_value": "less than"
                        },
                        {
                            "requirement_type": "additional test requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST 1.1 criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.",
            "criterions": [
                {
                    "exact_snippets": "metastatic bone disease",
                    "criterion": "metastatic bone disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression defined by 2 or more new lesions in a radionuclide bone scan",
                    "criterion": "progression",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "2 or more new lesions in a radionuclide bone scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG performance status of 0-2 (dose escalation phase); ECOG performance status of 0-1 (expansion phase).",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-2 (dose escalation phase)",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status of 0-1 (expansion phase)",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Screening blood counts of the following:",
            "criterions": [
                {
                    "exact_snippets": "Screening blood counts",
                    "criterion": "blood counts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1500/μL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1500/μL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/μL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Screening chemistry values of the following:",
            "criterions": [
                {
                    "exact_snippets": "Screening chemistry values",
                    "criterion": "screening chemistry values",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 × upper limit of the normal reference range (ULN)",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)",
                    "criterion": "aspartate transaminase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤ 2 × ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 2 × ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 × ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin > 2.8 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Albumin > 2.8 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. At screening, life expectancy of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Subjects whose partners are women of childbearing potential (WOCBP)",
                    "criterion": "partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use an adequate method of birth control",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while on study drug and at least for 3 weeks after discontinuation of study drug",
                    "criterion": "duration of birth control use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on study drug and at least for 3 weeks after discontinuation of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Subject is willing and able to comply with all protocol required visits and assessments.",
            "criterions": [
                {
                    "exact_snippets": "Subject is willing and able to comply with all protocol required visits and assessments.",
                    "criterion": "compliance with protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Subjects with life expectancy less than 3 months.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy less than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Discontinuation of bicalutamide or nilutamide less than 6 weeks, and other antiandrogens less than 4 weeks, abiraterone less than 3 weeks, prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Discontinuation of bicalutamide or nilutamide less than 6 weeks",
                    "criterion": "discontinuation of bicalutamide or nilutamide",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Discontinuation of ... other antiandrogens less than 4 weeks",
                    "criterion": "discontinuation of other antiandrogens",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Discontinuation of ... abiraterone less than 3 weeks",
                    "criterion": "discontinuation of abiraterone",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy ... less than 4 weeks prior to the start of study medication.",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... radiation ... less than 4 weeks prior to the start of study medication.",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... sipuleucel-T ... less than 4 weeks prior to the start of study medication.",
                    "criterion": "prior sipuleucel-T",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... other experimental immunotherapy less than 4 weeks prior to the start of study medication.",
                    "criterion": "prior experimental immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior chemotherapies more than 2 lines (Phase II part only) .",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapies more than 2 lines",
                    "criterion": "prior chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing acute treatment-related toxicity associated with a previous therapy",
                    "criterion": "acute treatment-related toxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than grade 1",
                    "criterion": "toxicity grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for grade 2 alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for grade 2 ... neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).",
            "criterions": [
                {
                    "exact_snippets": "impaired adrenal gland function",
                    "criterion": "adrenal gland function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Addison's disease",
                    "criterion": "Addison's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cushing's syndrome",
                    "criterion": "Cushing's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known gastrointestinal disease or condition that affects the absorption of GT0918.",
            "criterions": [
                {
                    "exact_snippets": "Known gastrointestinal disease or condition that affects the absorption of GT0918.",
                    "criterion": "gastrointestinal disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "effect on absorption",
                            "expected_value": "affects the absorption of GT0918"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.",
            "criterions": [
                {
                    "exact_snippets": "History of congestive heart failure New York Heart Association (NYHA) class III or IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension at screening",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History or family history of long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "History ... of long QT syndrome.",
                    "criterion": "long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of long QT syndrome.",
                    "criterion": "long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "family history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancy within the previous 3 years",
                    "criterion": "history of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except basal cell or squamous cell carcinoma",
                    "criterion": "basal cell or squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... non-muscle invasive bladder cancer",
                    "criterion": "non-muscle invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.",
                    "criterion": "systemic glucocorticoid use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days prior to the start of study medication"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.",
            "criterions": [
                {
                    "exact_snippets": "Co-administration of CYP3A4 ligands that serve as substrates",
                    "criterion": "CYP3A4 ligands",
                    "requirements": [
                        {
                            "requirement_type": "co-administration",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "function",
                            "expected_value": "substrates"
                        }
                    ]
                },
                {
                    "exact_snippets": "Co-administration of CYP3A4 ligands that ... induce ... the enzyme",
                    "criterion": "CYP3A4 ligands",
                    "requirements": [
                        {
                            "requirement_type": "co-administration",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "function",
                            "expected_value": "induce"
                        }
                    ]
                },
                {
                    "exact_snippets": "Co-administration of CYP3A4 ligands that ... inhibit the enzyme",
                    "criterion": "CYP3A4 ligands",
                    "requirements": [
                        {
                            "requirement_type": "co-administration",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "function",
                            "expected_value": "inhibit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.",
                    "criterion": "use of herbal products known to decrease PSA levels",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days prior to the start of study medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Major surgery within 30 days prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 30 days prior to the start of study medication.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Blood transfusion (including blood products) within 1 week of screening.",
            "criterions": [
                {
                    "exact_snippets": "Blood transfusion (including blood products) within 1 week of screening.",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "time since last transfusion",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Serious persistent infection within 14 days prior to the start of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Serious persistent infection within 14 days prior to the start of study medication.",
                    "criterion": "serious persistent infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Serious concurrent medical condition including CNS disorders.",
            "criterions": [
                {
                    "exact_snippets": "Serious concurrent medical condition",
                    "criterion": "concurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS disorders",
                    "criterion": "CNS disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Previous history of difficulty swallowing capsules.",
            "criterions": [
                {
                    "exact_snippets": "Previous history of difficulty swallowing capsules.",
                    "criterion": "difficulty swallowing capsules",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Known hypersensitivity to GT0918 or its excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to GT0918",
                    "criterion": "hypersensitivity to GT0918",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... its excipients",
                    "criterion": "hypersensitivity to excipients of GT0918",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.",
                    "criterion": "condition impairing compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}