{
    "info": {
        "nct_id": "NCT02014129",
        "official_title": "A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer",
        "inclusion_criteria": "* Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic\n* Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease\n* Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline\n* Have adequate organ function\n* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy\n* Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug\n* Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.\n* A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration\n* Have an estimated life expectancy of ≥12 weeks\n* Are able to swallow capsules\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "* Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication\n* Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest\n* Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia\n* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)\n* Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases\n* Have evidence or history of a leukemia\n* Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug\n* Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic",
            "criterions": [
                {
                    "exact_snippets": "histological or cytological evidence of a diagnosis of cancer",
                    "criterion": "diagnosis of cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence type",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "solid tumor or a lymphoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "solid tumor",
                                "lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced and/or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease",
            "criterions": [
                {
                    "exact_snippets": "appropriate candidate for the experimental therapy",
                    "criterion": "candidate for experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "available standard therapies have failed to provide clinical benefit",
                    "criterion": "standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline",
            "criterions": [
                {
                    "exact_snippets": "presence of measurable or non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1",
                    "criterion": "disease evaluation criteria",
                    "requirements": [
                        {
                            "requirement_type": "guideline",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors Guideline Version 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "or the Revised Response Criteria for Malignant Lymphoma Guideline",
                    "criterion": "disease evaluation criteria",
                    "requirements": [
                        {
                            "requirement_type": "guideline",
                            "expected_value": "Revised Response Criteria for Malignant Lymphoma Guideline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy",
            "criterions": [
                {
                    "exact_snippets": "discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy",
                    "criterion": "previous cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 21 days before the first dose of study drug",
                    "criterion": "time since discontinuation of previous cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from the acute effects of any such therapy",
                    "criterion": "recovery from acute effects of previous therapies",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Males must agree to use medically approved barrier contraceptive precautions during the study",
                    "criterion": "contraceptive precautions",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "medically approved barrier"
                        }
                    ]
                },
                {
                    "exact_snippets": "for 3 months following the last dose of study drug",
                    "criterion": "contraceptive precautions duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Females with child bearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "females with child bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 3 months following the last dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "≤7 days before the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration",
            "criterions": [
                {
                    "exact_snippets": "A breastfeeding woman must not be breastfeeding.",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration",
                    "criterion": "breastfeeding cessation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from the day of the first study drug administration until at least 3 months after the last administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an estimated life expectancy of ≥12 weeks",
            "criterions": [
                {
                    "exact_snippets": "estimated life expectancy of ≥12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are able to swallow capsules",
            "criterions": [
                {
                    "exact_snippets": "able to swallow capsules",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "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 have minimum age of 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication",
            "criterions": [
                {
                    "exact_snippets": "Have received treatment within 21 days of the initial dose of study drug",
                    "criterion": "treatment timing",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with an experimental agent for noncancer indications",
                    "criterion": "experimental agent for noncancer indications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has not received regulatory approval for any indication",
                    "criterion": "regulatory approval",
                    "requirements": [
                        {
                            "requirement_type": "approval status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest",
            "criterions": [
                {
                    "exact_snippets": "medical history of ... presyncope or syncope of either unexplained or cardiovascular etiology",
                    "criterion": "presyncope or syncope",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation)",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... sudden cardiac arrest",
                    "criterion": "sudden cardiac arrest",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia",
            "criterions": [
                {
                    "exact_snippets": "baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline with any of the following findings on screening electrocardiogram (ECG): ... ventricular fibrillation",
                    "criterion": "ventricular fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline with any of the following findings on screening electrocardiogram (ECG): ... abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds)",
                    "criterion": "abnormal QTc using Bazett's formula (QTcB)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "milliseconds"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline with any of the following findings on screening electrocardiogram (ECG): ... evidence of acute myocardial ischemia",
                    "criterion": "acute myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)",
            "criterions": [
                {
                    "exact_snippets": "serious preexisting medical conditions",
                    "criterion": "serious preexisting medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of major surgical resection involving the stomach or small bowel",
                    "criterion": "history of major surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": [
                                "stomach",
                                "small bowel"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases",
            "criterions": [
                {
                    "exact_snippets": "symptomatic central nervous system (CNS) malignancy or metastasis",
                    "criterion": "CNS malignancy or metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic participants without history of CNS malignancy or metastases",
                    "criterion": "CNS malignancy or metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have evidence or history of a leukemia",
            "criterions": [
                {
                    "exact_snippets": "evidence or history of a leukemia",
                    "criterion": "leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Have received a stem-cell transplant",
                    "criterion": "stem-cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a participant with lymphoma who received an autologous stem-cell transplant is eligible ... if more than 75 days have passed before the initial dose of study drug",
                    "criterion": "autologous stem-cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "lymphoma"
                        },
                        {
                            "requirement_type": "time since transplant",
                            "expected_value": {
                                "operator": ">",
                                "value": 75,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)",
            "criterions": [
                {
                    "exact_snippets": "active bacterial ... infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... fungal ... infection",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ... known viral infection",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus [HIV]",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}