{
    "info": {
        "nct_id": "NCT02673060",
        "official_title": "A Phase 1 Multicenter, Open-label, Dose-escalation Trial of MBC-11, an Etidronate-ara-C Conjugate in Patients With Malignant Tumors With Cancer-induced Bone Disease (CIBD)",
        "inclusion_criteria": "* Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)\n* Bone metastases, documented by radiographs, bone scan\n* No available standard chemotherapy or no indication for chemotherapy at the time of screening\n* Eastern Cooperative Oncology Group [ECOG] status 0-2\n* Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)\n* Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal [ULN], Alanine aminotransferase [ALT] ≤ 2.5 x ULN).\n* Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min [measured or calculated by nomogram]).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Systemic chemotherapy and/or investigational therapy within the previous 4 weeks\n* Fracture ≤ 6 month prior the inclusion in the study\n* Brain metastasis\n* Serum calcium levels < 8.5 mg/dL (< 2.2 mmol/L)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed malignant tumor",
                    "criterion": "malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone metastases, documented by radiographs, bone scan",
            "criterions": [
                {
                    "exact_snippets": "Bone metastases, documented by radiographs, bone scan",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "radiographs",
                                "bone scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No available standard chemotherapy or no indication for chemotherapy at the time of screening",
            "criterions": [
                {
                    "exact_snippets": "No available standard chemotherapy",
                    "criterion": "standard chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no indication for chemotherapy at the time of screening",
                    "criterion": "indication for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group [ECOG] status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group [ECOG] status 0-2",
                    "criterion": "ECOG status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function (hemoglobin ≥ 9 g/dL ...",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... with or without transfusion requirement",
                    "criterion": "transfusion requirement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... absolute neutrophil count ≥ 1500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function ... platelets ≥ 75,000/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal [ULN], Alanine aminotransferase [ALT] ≤ 2.5 x ULN).",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal [ULN]",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase [ALT] ≤ 2.5 x ULN",
                    "criterion": "Alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min [measured or calculated by nomogram]).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function (creatinine ≤ 1.5 x ULN)",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥ 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Systemic chemotherapy and/or investigational therapy within the previous 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Systemic chemotherapy ... within the previous 4 weeks",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "investigational therapy within the previous 4 weeks",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fracture ≤ 6 month prior the inclusion in the study",
            "criterions": [
                {
                    "exact_snippets": "Fracture ≤ 6 month prior the inclusion",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastasis",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum calcium levels < 8.5 mg/dL (< 2.2 mmol/L)",
            "criterions": [
                {
                    "exact_snippets": "Serum calcium levels < 8.5 mg/dL (< 2.2 mmol/L)",
                    "criterion": "serum calcium levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 8.5,
                                        "unit": "mg/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 2.2,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}