{
    "info": {
        "nct_id": "NCT00319748",
        "official_title": "Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers",
        "inclusion_criteria": "* Adequate performance status:\n\n  * Breast - Karnofsky score > 50;\n  * Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2\n* If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.\n* Normal organ function within 14 days of study entry\n* Diagnosis of one of the following malignancies:\n\n  * Metastatic breast cancer (BR)\n  * Metastatic ovarian cancer (OV)\n  * Metastatic endometrial cancer (EM)\n  * Metastatic cervical cancer (CX)\n\nBreast Cancer Inclusion Criteria:\n\n* Measurable metastatic disease (>1cm) in at least one site other than bone-only\n* Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease\n* Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.\n\nOvarian Cancer Inclusion Criteria:\n\n* Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)\n* Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).\n* Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.\n\nEndometrial Cancer Inclusion Criteria:\n\n* Measurable metastatic disease\n* Histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens\n\nCervical Cancer Inclusion Criteria:\n\n* Measurable metastatic disease\n* Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Had/have the following prior/concurrent therapy:\n\n  * Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)\n  * Investigational drugs/agents within 14 days of first dose of 852A\n  * Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)\n  * Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions\n  * Radiotherapy within 3 weeks of the first dose of 852A\n  * Hematopoietic cell transplantation within 4 weeks of first dose of 852A\n  * Evidence of active infection within 3 days of first dose of 852A\n  * Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)\n  * Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication\n  * History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk\n  * Uncontrolled intercurrent or chronic illness\n  * Active autoimmune disease requiring immunosuppressive therapy within 30 days\n  * Active coagulation disorder not controlled with medication\n  * Pregnant or lactating\n  * Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated\n  * Any history of brain metastases or any other active central nervous system (CNS) disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Adequate performance status:",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Adequate performance status"
                        ],
                        "criterion": "performance status",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Adequate performance status"
                        ],
                        "criterion": "performance status",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Breast - Karnofsky score > 50;",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Karnofsky score > 50"
                        ],
                        "criterion": "Karnofsky score",
                        "requirement_type": "comparison",
                        "expected_value": {
                            "operator": ">",
                            "value": 50
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Karnofsky score > 50"
                        ],
                        "criterion": "Karnofsky score",
                        "requirement_type": "comparison",
                        "expected_value": {
                            "operator": ">",
                            "value": 50
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Ovarian, endometrial or cervical"
                        ],
                        "criterion": "cancer type",
                        "requirement_type": "specific types",
                        "expected_value": [
                            "ovarian",
                            "endometrial",
                            "cervical"
                        ]
                    },
                    {
                        "exact_snippets": [
                            "Gynecologic Oncology Group (GOG) performance score ≤2"
                        ],
                        "criterion": "GOG performance score",
                        "requirement_type": "maximum value",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": [
                                    "Ovarian, endometrial or cervical"
                                ],
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                                "requirement_type": "specific types",
                                "expected_value": [
                                    "ovarian"
                                ]
                            },
                            {
                                "exact_snippets": [
                                    "Ovarian, endometrial or cervical"
                                ],
                                "criterion": "cancer type",
                                "requirement_type": "specific types",
                                "expected_value": [
                                    "endometrial"
                                ]
                            },
                            {
                                "exact_snippets": [
                                    "Ovarian, endometrial or cervical"
                                ],
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                                "requirement_type": "specific types",
                                "expected_value": [
                                    "cervical"
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "Gynecologic Oncology Group (GOG) performance score ≤2"
                        ],
                        "criterion": "GOG performance score",
                        "requirement_type": "maximum value",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 2
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "female"
                        ],
                        "criterion": "gender",
                        "requirement_type": "specificity",
                        "expected_value": "female"
                    },
                    {
                        "exact_snippets": [
                            "childbearing potential"
                        ],
                        "criterion": "childbearing potential",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "willing to use adequate contraception"
                        ],
                        "criterion": "contraception use",
                        "requirement_type": "willingness",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "adequate contraception",
                            "hormonal, barrier method, abstinence"
                        ],
                        "criterion": "contraception type",
                        "requirement_type": "specificity",
                        "expected_value": [
                            "hormonal",
                            "barrier method",
                            "abstinence"
                        ]
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "female"
                            ],
                            "criterion": "gender",
                            "requirement_type": "specificity",
                            "expected_value": "female"
                        },
                        {
                            "exact_snippets": [
                                "childbearing potential"
                            ],
                            "criterion": "childbearing potential",
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "willing to use adequate contraception"
                            ],
                            "criterion": "contraception use",
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "exact_snippets": [
                                "adequate contraception",
                                "hormonal, barrier method, abstinence"
                            ],
                            "criterion": "contraception type",
                            "requirement_type": "specificity",
                            "expected_value": [
                                "hormonal",
                                "barrier method",
                                "abstinence"
                            ]
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Normal organ function within 14 days of study entry",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Normal organ function"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "status",
                        "expected_value": "normal"
                    },
                    {
                        "exact_snippets": [
                            "within 14 days of study entry"
                        ],
                        "criterion": "timeframe for organ function assessment",
                        "requirement_type": "timeframe",
                        "expected_value": "within 14 days of study entry"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Normal organ function"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "status",
                        "expected_value": "normal"
                    },
                    {
                        "exact_snippets": [
                            "within 14 days of study entry"
                        ],
                        "criterion": "timeframe for organ function assessment",
                        "requirement_type": "timeframe",
                        "expected_value": "within 14 days of study entry"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of one of the following malignancies:",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Diagnosis of one of the following malignancies"
                        ],
                        "criterion": "malignancy",
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Diagnosis of one of the following malignancies"
                        ],
                        "criterion": "malignancy",
                        "requirement_type": "diagnosis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic breast cancer (BR)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Metastatic breast cancer"
                        ],
                        "criterion": "breast cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Metastatic breast cancer"
                        ],
                        "criterion": "breast cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic ovarian cancer (OV)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Metastatic ovarian cancer"
                        ],
                        "criterion": "ovarian cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Metastatic ovarian cancer"
                        ],
                        "criterion": "ovarian cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic endometrial cancer (EM)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Metastatic endometrial cancer"
                        ],
                        "criterion": "endometrial cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Metastatic endometrial cancer"
                        ],
                        "criterion": "endometrial cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Metastatic cervical cancer (CX)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Metastatic cervical cancer"
                        ],
                        "criterion": "cervical cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Metastatic cervical cancer"
                        ],
                        "criterion": "cervical cancer",
                        "requirement_type": "metastasis",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Breast Cancer Inclusion Criteria:",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Breast Cancer"
                        ],
                        "criterion": "breast cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Breast Cancer"
                        ],
                        "criterion": "breast cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable metastatic disease (>1cm) in at least one site other than bone-only",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Measurable metastatic disease"
                        ],
                        "criterion": "metastatic disease",
                        "requirement_type": "measurability",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "metastatic disease (>1cm)"
                        ],
                        "criterion": "metastatic disease",
                        "requirement_type": "size",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">",
                                    "value": 1
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "at least one site other than bone-only"
                        ],
                        "criterion": "metastatic disease site",
                        "requirement_type": "location",
                        "expected_value": "other than bone-only"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Measurable metastatic disease"
                                ],
                                "criterion": "metastatic disease",
                                "requirement_type": "measurability",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "metastatic disease (>1cm)"
                                ],
                                "criterion": "metastatic disease",
                                "requirement_type": "size",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": ">",
                                            "value": 1
                                        }
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "at least one site other than bone-only"
                        ],
                        "criterion": "metastatic disease site",
                        "requirement_type": "location",
                        "expected_value": "other than bone-only"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease"
                        ],
                        "criterion": "response to chemotherapy",
                        "requirement_type": "progression or failure",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "at least one previous chemotherapy regimen for metastatic disease"
                        ],
                        "criterion": "previous chemotherapy regimen",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease"
                        ],
                        "criterion": "response to chemotherapy",
                        "requirement_type": "progression or failure",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "at least one previous chemotherapy regimen for metastatic disease"
                        ],
                        "criterion": "previous chemotherapy regimen",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Ovarian Cancer Inclusion Criteria:",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Ovarian Cancer"
                        ],
                        "criterion": "ovarian cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Ovarian Cancer"
                        ],
                        "criterion": "ovarian cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Measurable metastatic disease"
                        ],
                        "criterion": "metastatic disease",
                        "requirement_type": "measurability",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Response Evaluation Criteria in Solid Tumors (RECIST)"
                        ],
                        "criterion": "evaluation criteria",
                        "requirement_type": "type",
                        "expected_value": "RECIST"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Measurable metastatic disease"
                        ],
                        "criterion": "metastatic disease",
                        "requirement_type": "measurability",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "Response Evaluation Criteria in Solid Tumors (RECIST)"
                        ],
                        "criterion": "evaluation criteria",
                        "requirement_type": "type",
                        "expected_value": "RECIST"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer"
                        ],
                        "criterion": "primary tumor",
                        "requirement_type": "histological diagnosis",
                        "expected_value": "epithelial ovarian cancer"
                    },
                    {
                        "exact_snippets": [
                            "Primary tumor must have been diagnosed histologically as either",
                            "fallopian tube cancer"
                        ],
                        "criterion": "primary tumor",
                        "requirement_type": "histological diagnosis",
                        "expected_value": "fallopian tube cancer"
                    },
                    {
                        "exact_snippets": [
                            "Primary tumor must have been diagnosed histologically as either",
                            "primary peritoneal cancer"
                        ],
                        "criterion": "primary tumor",
                        "requirement_type": "histological diagnosis",
                        "expected_value": "primary peritoneal cancer"
                    },
                    {
                        "exact_snippets": [
                            "not borderline or low malignant potential epithelial carcinoma"
                        ],
                        "criterion": "primary tumor",
                        "requirement_type": "exclusion",
                        "expected_value": [
                            "borderline epithelial carcinoma",
                            "low malignant potential epithelial carcinoma"
                        ]
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": [
                                    "Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer"
                                ],
                                "criterion": "primary tumor",
                                "requirement_type": "histological diagnosis",
                                "expected_value": "epithelial ovarian cancer"
                            },
                            {
                                "exact_snippets": [
                                    "Primary tumor must have been diagnosed histologically as either",
                                    "fallopian tube cancer"
                                ],
                                "criterion": "primary tumor",
                                "requirement_type": "histological diagnosis",
                                "expected_value": "fallopian tube cancer"
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                            {
                                "exact_snippets": [
                                    "Primary tumor must have been diagnosed histologically as either",
                                    "primary peritoneal cancer"
                                ],
                                "criterion": "primary tumor",
                                "requirement_type": "histological diagnosis",
                                "expected_value": "primary peritoneal cancer"
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": [
                                "not borderline or low malignant potential epithelial carcinoma"
                            ],
                            "criterion": "primary tumor",
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "borderline epithelial carcinoma",
                                "low malignant potential epithelial carcinoma"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "failed at least two previous chemotherapy regimens"
                        ],
                        "criterion": "previous chemotherapy regimens",
                        "requirement_type": "failure",
                        "expected_value": {
                            "operator": ">=",
                            "value": 2
                        }
                    },
                    {
                        "exact_snippets": [
                            "Paclitaxel must have been a component of one or both regimens"
                        ],
                        "criterion": "Paclitaxel",
                        "requirement_type": "component of previous regimens",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "cisplatin or carboplatin must have been a component of one or both regimens"
                        ],
                        "criterion": "cisplatin or carboplatin",
                        "requirement_type": "component of previous regimens",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "failed at least two previous chemotherapy regimens"
                                ],
                                "criterion": "previous chemotherapy regimens",
                                "requirement_type": "failure",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 2
                                }
                            },
                            {
                                "exact_snippets": [
                                    "Paclitaxel must have been a component of one or both regimens"
                                ],
                                "criterion": "Paclitaxel",
                                "requirement_type": "component of previous regimens",
                                "expected_value": true
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "failed at least two previous chemotherapy regimens"
                                ],
                                "criterion": "previous chemotherapy regimens",
                                "requirement_type": "failure",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 2
                                }
                            },
                            {
                                "exact_snippets": [
                                    "cisplatin or carboplatin must have been a component of one or both regimens"
                                ],
                                "criterion": "cisplatin or carboplatin",
                                "requirement_type": "component of previous regimens",
                                "expected_value": true
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Endometrial Cancer Inclusion Criteria:",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Endometrial Cancer"
                        ],
                        "criterion": "endometrial cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Endometrial Cancer"
                        ],
                        "criterion": "endometrial cancer",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Measurable metastatic disease"
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                            "Measurable metastatic disease"
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        },
        {
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                            "Histologically proven recurrent or persistent endometrial cancer"
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                        "and_criteria": [
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                            "Cervical Cancer"
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                "line": "Healthy volunteers allowed",
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            "identified_line": {
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                    {
                        "exact_snippets": [
                            "minimum age of 18 Years"
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                        ],
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                            "Immunosuppressive therapy"
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                            "Drugs known to induce QT interval prolongation"
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                        "requirement_type": "induction of QT interval prolongation",
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                            "requirement_type": "induction of QT interval prolongation",
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                            "requirement_type": "induction of Torsades de pointes",
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                            "best available drug required to treat life-threatening conditions"
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        },
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                "line": "* Radiotherapy within 3 weeks of the first dose of 852A",
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                            "Radiotherapy within 3 weeks"
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                                {
                                    "operator": "<=",
                                    "value": 3
                                }
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                }
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        },
        {
            "identified_line": {
                "line": "* Hematopoietic cell transplantation within 4 weeks of first dose of 852A",
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                        ],
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                                {
                                    "operator": "<=",
                                    "value": 4
                                }
                            ]
                        }
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                    }
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        },
        {
            "identified_line": {
                "line": "* Evidence of active infection within 3 days of first dose of 852A",
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                    {
                        "exact_snippets": [
                            "Evidence of active infection"
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                                    "operator": "<=",
                                    "value": 3
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                            "Evidence of active infection"
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                    {
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                            "within 3 days of first dose"
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                                {
                                    "operator": "<=",
                                    "value": 3
                                }
                            ]
                        }
                    }
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        },
        {
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                "line": "* Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)",
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                    {
                        "exact_snippets": [
                            "Active fungal infection"
                        ],
                        "criterion": "fungal infection",
                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "pulmonary infiltrates"
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                        "criterion": "pulmonary infiltrates",
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                ]
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                            {
                                "exact_snippets": [
                                    "Active fungal infection"
                                ],
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                                "requirement_type": "activity",
                                "expected_value": true
                            },
                            {
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                                        "prior treated disease stable for 2 weeks is allowable"
                                    ],
                                    "criterion": "disease stability",
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2
                                    }
                                }
                            }
                        ]
                    },
                    {
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                            {
                                "exact_snippets": [
                                    "pulmonary infiltrates"
                                ],
                                "criterion": "pulmonary infiltrates",
                                "requirement_type": "presence",
                                "expected_value": true
                            },
                            {
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                                        "prior treated disease stable for 2 weeks is allowable"
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                                    "requirement_type": "duration",
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                                        "operator": ">=",
                                        "value": 2
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                                }
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                        ]
                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication",
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                            "Cardiac ischemia"
                        ],
                        "criterion": "cardiac ischemia",
                        "requirement_type": "control",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "cardiac arrhythmias"
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                        "criterion": "cardiac arrhythmias",
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                    {
                        "exact_snippets": [
                            "congestive heart failure uncontrolled by medication"
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                        "requirement_type": "control",
                        "expected_value": false
                    }
                ]
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                            "Cardiac ischemia"
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                    {
                        "exact_snippets": [
                            "cardiac arrhythmias"
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                    {
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                            "congestive heart failure uncontrolled by medication"
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                        "expected_value": false
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                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk",
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                            "History of, or clinical evidence of, a condition"
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                        "criterion": "condition",
                        "requirement_type": "presence",
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                    {
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                            "in the opinion of the investigator, could confound the results of the study"
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                        "requirement_type": "potential to confound study results",
                        "expected_value": true
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                            "in the opinion of the investigator,",
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                        "requirement_type": "potential to put subject at risk",
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                ]
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                                    "History of, or clinical evidence of, a condition"
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                                "requirement_type": "presence",
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                                            "in the opinion of the investigator, could confound the results of the study"
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                                        "requirement_type": "potential to confound study results",
                                        "expected_value": true
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                                            "in the opinion of the investigator,",
                                            "put the subject at undue risk"
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        },
        {
            "identified_line": {
                "line": "* Uncontrolled intercurrent or chronic illness",
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                    {
                        "exact_snippets": [
                            "Uncontrolled intercurrent or chronic illness"
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                        "requirement_type": "control",
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                    {
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                            "Uncontrolled intercurrent or chronic illness"
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                    {
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                            "Uncontrolled intercurrent or chronic illness"
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                        "requirement_type": "control",
                        "expected_value": false
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active autoimmune disease requiring immunosuppressive therapy within 30 days",
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                    {
                        "exact_snippets": [
                            "Active autoimmune disease"
                        ],
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                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "requiring immunosuppressive therapy"
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                        "criterion": "immunosuppressive therapy",
                        "requirement_type": "requirement",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "within 30 days"
                        ],
                        "criterion": "time since last immunosuppressive therapy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 30
                                }
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": [
                                    "Active autoimmune disease"
                                ],
                                "criterion": "autoimmune disease",
                                "requirement_type": "activity",
                                "expected_value": true
                            },
                            {
                                "exact_snippets": [
                                    "requiring immunosuppressive therapy"
                                ],
                                "criterion": "immunosuppressive therapy",
                                "requirement_type": "requirement",
                                "expected_value": true
                            }
                        ]
                    },
                    {
                        "exact_snippets": [
                            "within 30 days"
                        ],
                        "criterion": "time since last immunosuppressive therapy",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 30
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active coagulation disorder not controlled with medication",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Active coagulation disorder"
                        ],
                        "criterion": "coagulation disorder",
                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "not controlled with medication"
                        ],
                        "criterion": "coagulation disorder",
                        "requirement_type": "control with medication",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": [
                            "Active coagulation disorder"
                        ],
                        "criterion": "coagulation disorder",
                        "requirement_type": "activity",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "not controlled with medication"
                        ],
                        "criterion": "coagulation disorder",
                        "requirement_type": "control with medication",
                        "expected_value": false
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lactating"
                        ],
                        "criterion": "lactation",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "Pregnant"
                        ],
                        "criterion": "pregnancy",
                        "requirement_type": "status",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "lactating"
                        ],
                        "criterion": "lactation",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Concurrent malignancy"
                        ],
                        "criterion": "concurrent malignancy",
                        "requirement_type": "presence",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "if in remission, at least 5 years disease free"
                        ],
                        "criterion": "remission duration",
                        "requirement_type": "duration",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 5
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "localized (in-situ) disease"
                        ],
                        "criterion": "localized (in-situ) disease",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "basal carcinomas"
                        ],
                        "criterion": "basal carcinomas",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "cutaneous squamous cell carcinomas"
                        ],
                        "criterion": "cutaneous squamous cell carcinomas",
                        "requirement_type": "presence",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "adequately treated"
                        ],
                        "criterion": "adequate treatment",
                        "requirement_type": "status",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "not_criteria": {
                                "exact_snippets": [
                                    "Concurrent malignancy"
                                ],
                                "criterion": "concurrent malignancy",
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        },
                        {
                            "or_criteria": [
                                {
                                    "exact_snippets": [
                                        "localized (in-situ) disease"
                                    ],
                                    "criterion": "localized (in-situ) disease",
                                    "requirement_type": "presence",
                                    "expected_value": true
                                },
                                {
                                    "exact_snippets": [
                                        "basal carcinomas"
                                    ],
                                    "criterion": "basal carcinomas",
                                    "requirement_type": "presence",
                                    "expected_value": true
                                },
                                {
                                    "exact_snippets": [
                                        "cutaneous squamous cell carcinomas"
                                    ],
                                    "criterion": "cutaneous squamous cell carcinomas",
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": [
                        "adequately treated"
                    ],
                    "criterion": "adequate treatment",
                    "requirement_type": "status",
                    "expected_value": true
                },
                "else_criteria": {
                    "exact_snippets": [
                        "if in remission, at least 5 years disease free"
                    ],
                    "criterion": "remission duration",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 5
                            }
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any history of brain metastases or any other active central nervous system (CNS) disease",
                "criterions": [
                    {
                        "exact_snippets": [
                            "history of brain metastases"
                        ],
                        "criterion": "brain metastases",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "active central nervous system (CNS) disease"
                        ],
                        "criterion": "central nervous system (CNS) disease",
                        "requirement_type": "activity",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": [
                            "history of brain metastases"
                        ],
                        "criterion": "brain metastases",
                        "requirement_type": "history",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "active central nervous system (CNS) disease"
                        ],
                        "criterion": "central nervous system (CNS) disease",
                        "requirement_type": "activity",
                        "expected_value": true
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Progression on prior therapy with a hormonal agent",
                            "estrogen receptor or progesterone receptor positive"
                        ],
                        "criterion": "hormonal therapy",
                        "requirement_type": "progression",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "estrogen receptor or progesterone receptor positive"
                        ],
                        "criterion": "estrogen receptor or progesterone receptor",
                        "requirement_type": "status",
                        "expected_value": "positive"
                    },
                    {
                        "exact_snippets": [
                            "Progression on prior therapy",
                            "trastuzumab",
                            "HER2-neu positive"
                        ],
                        "criterion": "trastuzumab therapy",
                        "requirement_type": "progression",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "HER2-neu positive"
                        ],
                        "criterion": "HER2-neu",
                        "requirement_type": "status",
                        "expected_value": "positive"
                    },
                    {
                        "exact_snippets": [
                            "progressed through hormone or trastuzumab therapy only",
                            "must have received one chemotherapy regimen"
                        ],
                        "criterion": "chemotherapy regimen",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": [
                    "failed"
                ],
                "criterion": "failed",
                "requirement_type": "failed",
                "expected_value": "failed"
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A"
                        ],
                        "criterion": "systemic corticosteroids",
                        "requirement_type": "usage",
                        "expected_value": false
                    },
                    {
                        "exact_snippets": [
                            "topical or inhaled steroids are allowed"
                        ],
                        "criterion": "topical or inhaled steroids",
                        "requirement_type": "usage",
                        "expected_value": true
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": [
                                "Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A"
                            ],
                            "criterion": "systemic corticosteroids",
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": [
                            "Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A"
                        ],
                        "criterion": "systemic corticosteroids",
                        "requirement_type": "usage",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        }
    ],
    "failed_miscellaneous": []
}