{
    "info": {
        "nct_id": "NCT01688960",
        "official_title": "A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies",
        "inclusion_criteria": "Inclusion criteria include, but are not limited to, the following:\n\n1. Confirmed diagnosis of solid tumor malignancy\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n3. Adequate hepatic, renal and bone marrow function\n4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Exclusion criteria include, but are not limited to, the following:\n\n1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement\n2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg\n3. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia\n4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months\n5. Patients with serious non healing wound or acute ulcer\n6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months\n7. Patients with history of abdominal or tracheal-esophageal fistula\n8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors\n9. Prior treatment with bevacizumab within last 6 weeks\n10. Pregnant or breast-feeding women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Confirmed diagnosis of solid tumor malignancy",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of solid tumor malignancy",
                    "criterion": "solid tumor malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequate hepatic, renal and bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1",
            "criterions": [
                {
                    "exact_snippets": "Resolution of toxicity from prior therapy ... to grade less than or equal to 1",
                    "criterion": "toxicity from prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other evidence of central nervous system involvement",
                    "criterion": "central nervous system involvement",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg",
            "criterions": [
                {
                    "exact_snippets": "systolic BP greater than 140 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic BP greater than 90 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "medical history of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... coronary/ peripheral artery bypass graft",
                    "criterion": "coronary/ peripheral artery bypass graft",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical history of ... ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months",
            "criterions": [
                {
                    "exact_snippets": "deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within last 3 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within last 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with serious non healing wound or acute ulcer",
            "criterions": [
                {
                    "exact_snippets": "serious non healing wound",
                    "criterion": "non healing wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "acute ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months",
            "criterions": [
                {
                    "exact_snippets": "treatment resistant or bleeding peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": "treatment resistant"
                        },
                        {
                            "requirement_type": "bleeding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "erosive esophagitis",
                    "criterion": "esophagitis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "erosive"
                        }
                    ]
                },
                {
                    "exact_snippets": "gastritis",
                    "criterion": "gastritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 3 or gastrointestinal bleeding/hemorrhage",
                    "criterion": "gastrointestinal bleeding/hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": ">= 3"
                        }
                    ]
                },
                {
                    "exact_snippets": "infectious or inflammatory bowel disease",
                    "criterion": "bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "infectious",
                                "inflammatory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "diverticulitis",
                    "criterion": "diverticulitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other uncontrolled thromboembolic event within last 3 months",
                    "criterion": "thromboembolic event",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": "within last 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with history of abdominal or tracheal-esophageal fistula",
            "criterions": [
                {
                    "exact_snippets": "history of abdominal or tracheal-esophageal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of abdominal or tracheal-esophageal fistula",
                    "criterion": "tracheal-esophageal fistula",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with aflibercept (ziv-aflibercept)",
                    "criterion": "prior treatment with aflibercept",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... Ang2",
                    "criterion": "prior treatment with Ang2 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... Tie2 inhibitors",
                    "criterion": "prior treatment with Tie2 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Prior treatment with bevacizumab within last 6 weeks",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with bevacizumab within last 6 weeks",
                    "criterion": "prior treatment with bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Pregnant or breast-feeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Inclusion criteria include, but are not limited to, the following:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Exclusion criteria include, but are not limited to, the following:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}