{
    "info": {
        "nct_id": "NCT01338831",
        "official_title": "A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer",
        "inclusion_criteria": "1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma\n2. Detectable metastases by bone scan, CT-scan, or MRI.\n3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)\n4. Suitable venous access for blood sampling\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior treatment with any anti-prolactin receptor antibody\n2. Major surgery within 28 days before study treatment\n3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug\n4. Prior anaphylactic or other severe infusion reaction to antibody formulations\n\nOther protocol-defined inclusion/exclusion criteria may apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma",
                "criterions": [
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of ... breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of ... uterine leiomyoma",
                        "criterion": "uterine leiomyoma",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of ... breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histologically confirmed diagnosis of ... uterine leiomyoma",
                        "criterion": "uterine leiomyoma",
                        "requirement": {
                            "requirement_type": "diagnosis confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)",
                "criterions": [
                    {
                        "exact_snippets": "Presence of prolactin receptor in primary or metastatic tumor",
                        "criterion": "prolactin receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Presence of prolactin receptor in primary or metastatic tumor",
                        "criterion": "prolactin receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Suitable venous access for blood sampling",
                "criterions": [
                    {
                        "exact_snippets": "Suitable venous access for blood sampling",
                        "criterion": "venous access",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "suitable for blood sampling"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Suitable venous access for blood sampling",
                        "criterion": "venous access",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "suitable for blood sampling"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Prior treatment with any anti-prolactin receptor antibody",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with any anti-prolactin receptor antibody",
                        "criterion": "anti-prolactin receptor antibody treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment with any anti-prolactin receptor antibody",
                    "criterion": "anti-prolactin receptor antibody treatment",
                    "requirement": {
                        "requirement_type": "prior treatment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Major surgery within 28 days before study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 28 days before study treatment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Major surgery within 28 days before study treatment",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since",
                        "expected_value": {
                            "operator": "<=",
                            "value": 28,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Prior anaphylactic or other severe infusion reaction to antibody formulations",
                "criterions": [
                    {
                        "exact_snippets": "Prior anaphylactic or other severe infusion reaction to antibody formulations",
                        "criterion": "infusion reaction to antibody formulations",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "anaphylactic or other severe"
                        }
                    },
                    {
                        "exact_snippets": "Prior anaphylactic or other severe infusion reaction to antibody formulations",
                        "criterion": "infusion reaction to antibody formulations",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior anaphylactic or other severe infusion reaction to antibody formulations",
                        "criterion": "infusion reaction to antibody formulations",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "anaphylactic or other severe"
                        }
                    },
                    {
                        "exact_snippets": "Prior anaphylactic or other severe infusion reaction to antibody formulations",
                        "criterion": "infusion reaction to antibody formulations",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other protocol-defined inclusion/exclusion criteria may apply",
                "criterions": [
                    {
                        "exact_snippets": "Other protocol-defined inclusion/exclusion criteria",
                        "criterion": "protocol-defined criteria",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other protocol-defined inclusion/exclusion criteria",
                    "criterion": "protocol-defined criteria",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Detectable metastases by bone scan, CT-scan, or MRI.",
                "criterions": [
                    {
                        "exact_snippets": "Detectable metastases by bone scan, CT-scan, or MRI.",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "bone scan",
                                "CT-scan",
                                "MRI"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Detectable metastases by bone scan, CT-scan, or MRI.",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "bone scan"
                        }
                    },
                    {
                        "exact_snippets": "Detectable metastases by bone scan, CT-scan, or MRI.",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "CT-scan"
                        }
                    },
                    {
                        "exact_snippets": "Detectable metastases by bone scan, CT-scan, or MRI.",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "MRI"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug",
                "criterions": [
                    {
                        "exact_snippets": "received radiotherapy ≤ 2 weeks prior to starting study drug",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "received radiotherapy \u0010 2 weeks prior to starting study drug",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}