{
    "info": {
        "nct_id": "NCT03672773",
        "official_title": "A Phase 2 Study of Continuous Talazoparib Plus Intermittent Low-Dose Temozolomide in Patients With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer (TRIO-US L-07)",
        "inclusion_criteria": "* Able to provide informed consent.\n* Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.\n* Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).\n* Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Archival or fresh tissue biopsy available for exploratory analyses.\n* Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.\n* Able to swallow the study drugs, has no known intolerance to study drugs or excipients, and able to comply with study requirements.\n* Female participants of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment.\n* Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment. Contraception should be considered for a non-pregnant female partner of childbearing potential.\n* Male and female participants must agree not to donate sperm or eggs, respectively, from the first study drug treatment through 105 days and 45 days after the last study drug treatment, respectively.\n* Female participants may not be breastfeeding at baseline through 45 days after the last study drug treatment.\n* Absolute neutrophil count (ANC) >= 1,500/mcL\n* Platelets >= 100,000/mcL\n* Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)\n* Glomerular filtration rate (by Cockroft-Gault or equivalent estimation) >= 30 mL/min\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases\n* Serum total bilirubin =< 1.5 X upper limit or normal (ULN) OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN\n* International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 or return to baseline) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.\n* Best response of progressive disease per RECIST 1.1 to first-line platinum doublet chemotherapy.\n* Has received more than 1 line of cytotoxic therapy\n\n  * Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.\n* Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide.\n* Use of antineoplastic therapies within 14 days before study treatment initiation.\n* Use of any other investigational agent within 14 days before study treatment initiation.\n* Received radiation therapy within 14 day before study treatment initiation (single fraction palliative radiotherapy is allowed without a washout).\n\n  * Prior thoracic irradiation and prophylactic cranial irradiation are allowed.\n* Major surgery within 14 days before study treatment initiation.\n* Diagnosis of myelodysplastic syndrome (MDS).\n* Gastrointestinal disorder affecting absorption.\n* Current or anticipated use of a prohibited P-gp inhibitor or P-gp inducer or BCRP inhibitors.\n* History of another cancer within 2 years before study treatment initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, nonmelanomatous skin, thyroid, cervix and endometrial cancer.\n* Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Able to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.",
            "criterions": [
                {
                    "exact_snippets": "Cytologically or histologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "cytologically",
                                "histologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "small cell lung cancer (SCLC)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "small cell lung cancer (SCLC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive-stage disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "extensive-stage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).",
            "criterions": [
                {
                    "exact_snippets": "Relapsed (progressed within 6 months)",
                    "criterion": "relapsed",
                    "requirements": [
                        {
                            "requirement_type": "time since progression",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen)",
                    "criterion": "refractory",
                    "requirements": [
                        {
                            "requirement_type": "progression timing",
                            "expected_value": "during or within 4 weeks of completing 1st line platinum based regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Archival or fresh tissue biopsy available for exploratory analyses.",
            "criterions": [
                {
                    "exact_snippets": "Archival or fresh tissue biopsy available",
                    "criterion": "tissue biopsy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow the study drugs, has no known intolerance to study drugs or excipients, and able to comply with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow the study drugs",
                    "criterion": "ability to swallow study drugs",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no known intolerance to study drugs or excipients",
                    "criterion": "intolerance to study drugs or excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "able to comply with study requirements",
                    "criterion": "ability to comply with study requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female participants of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative pregnancy test at screening",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "from the time of the first study drug treatment through 45 days after the last study drug treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment. Contraception should be considered for a non-pregnant female partner of childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment.",
                    "criterion": "male participants",
                    "requirements": [
                        {
                            "requirement_type": "contraception",
                            "expected_value": "use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraception should be considered for a non-pregnant female partner of childbearing potential.",
                    "criterion": "female partner of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "contraception",
                            "expected_value": "should be considered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female participants may not be breastfeeding at baseline through 45 days after the last study drug treatment.",
            "criterions": [
                {
                    "exact_snippets": "Female participants may not be breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1,500/mcL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1,500/mcL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >= 9 g/dL or >= 5.6 mmol/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5.6,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without transfusion or erythropoietin (EPO) dependency",
                    "criterion": "transfusion or erythropoietin (EPO) dependency",
                    "requirements": [
                        {
                            "requirement_type": "dependency",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days of assessment",
                    "criterion": "timeframe for assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days of assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate (by Cockroft-Gault or equivalent estimation) >= 30 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate (by Cockroft-Gault or equivalent estimation) >= 30 mL/min",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "estimation method",
                            "expected_value": [
                                "Cockroft-Gault",
                                "equivalent"
                            ]
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) ... =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level for participants with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ... =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level for participants with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "X ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum total bilirubin =< 1.5 X upper limit or normal (ULN) OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin =< 1.5 X upper limit or normal (ULN)",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "direct bilirubin =< ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with total bilirubin levels > 1.5 ULN",
                    "criterion": "total bilirubin levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) 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": "participant is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants",
                    "criterion": "PT or partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "therapeutic range",
                            "expected_value": "intended use of anticoagulants"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "Activated partial thromboplastin time (aPTT) =< 1.5 X ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless participant is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
                    "criterion": "PT or PTT within therapeutic range",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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": "* Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 or return to baseline) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.",
            "criterions": [
                {
                    "exact_snippets": "Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 or return to baseline) from the acute toxicities of previous therapy",
                    "criterion": "recovery from acute toxicities of previous therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "CTCAE v4 grade"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "return to baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment-related alopecia",
                    "criterion": "treatment-related alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities otherwise meeting eligibility requirements",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "meeting eligibility requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Best response of progressive disease per RECIST 1.1 to first-line platinum doublet chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Best response of progressive disease per RECIST 1.1",
                    "criterion": "progressive disease response",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "first-line platinum doublet chemotherapy",
                    "criterion": "chemotherapy type",
                    "requirements": [
                        {
                            "requirement_type": "line of treatment",
                            "expected_value": "first-line"
                        },
                        {
                            "requirement_type": "drug combination",
                            "expected_value": "platinum doublet"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received more than 1 line of cytotoxic therapy",
            "criterions": [
                {
                    "exact_snippets": "received more than 1 line of cytotoxic therapy",
                    "criterion": "cytotoxic therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.",
                    "criterion": "prior targeted therapies",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.",
                    "criterion": "prior rovalpituzumab tesirine",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a PARP inhibitor",
                    "criterion": "prior treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... temozolomide",
                    "criterion": "prior treatment with temozolomide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of antineoplastic therapies within 14 days before study treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Use of antineoplastic therapies within 14 days before study treatment initiation.",
                    "criterion": "antineoplastic therapies",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any other investigational agent within 14 days before study treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Use of any other investigational agent within 14 days before study treatment initiation.",
                    "criterion": "use of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received radiation therapy within 14 day before study treatment initiation (single fraction palliative radiotherapy is allowed without a washout).",
            "criterions": [
                {
                    "exact_snippets": "Received radiation therapy within 14 day before study treatment initiation",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "single fraction palliative radiotherapy is allowed without a washout",
                    "criterion": "single fraction palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior thoracic irradiation and prophylactic cranial irradiation are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior thoracic irradiation",
                    "criterion": "prior thoracic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prophylactic cranial irradiation are allowed",
                    "criterion": "prophylactic cranial irradiation",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 14 days before study treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 14 days before study treatment initiation.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of myelodysplastic syndrome (MDS).",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastrointestinal disorder affecting absorption.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal disorder affecting absorption",
                    "criterion": "gastrointestinal disorder",
                    "requirements": [
                        {
                            "requirement_type": "affecting absorption",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or anticipated use of a prohibited P-gp inhibitor or P-gp inducer or BCRP inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Current or anticipated use of a prohibited P-gp inhibitor",
                    "criterion": "use of P-gp inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or anticipated use of a ... P-gp inducer",
                    "criterion": "use of P-gp inducer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or anticipated use of a ... BCRP inhibitors",
                    "criterion": "use of BCRP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another cancer within 2 years before study treatment initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, nonmelanomatous skin, thyroid, cervix and endometrial cancer.",
            "criterions": [
                {
                    "exact_snippets": "History of another cancer within 2 years before study treatment initiation",
                    "criterion": "history of another cancer",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, nonmelanomatous skin, thyroid, cervix and endometrial cancer",
                    "criterion": "fully treated cancers",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "unlikely to affect the assessment of the study treatment safety or efficacy"
                        },
                        {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "early stage breast",
                                "prostate",
                                "nonmelanomatous skin",
                                "thyroid",
                                "cervix",
                                "endometrial"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study",
                    "criterion": "condition interfering with study participation",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition (concurrent disease, infection, or comorbidity) ... causes undue risk",
                    "criterion": "condition causing undue risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "undue"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition (concurrent disease, infection, or comorbidity) ... complicates the interpretation of safety data",
                    "criterion": "condition complicating safety data interpretation",
                    "requirements": [
                        {
                            "requirement_type": "complication",
                            "expected_value": "interpretation of safety data"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Male and female participants must agree not to donate sperm or eggs, respectively, from the first study drug treatment through 105 days and 45 days after the last study drug treatment, respectively.",
            "criterions": [
                {
                    "exact_snippets": "Male ... must agree not to donate sperm ... from the first study drug treatment through 105 days ... after the last study drug treatment",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Female ... must agree not to donate ... eggs ... from the first study drug treatment through ... 45 days after the last study drug treatment",
                    "criterion": "egg donation",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}