{
    "info": {
        "nct_id": "NCT01242631",
        "official_title": "A Single Arm, Open-label Multicenter Phase II Trial of Everolimus in Patients With Relapsed/Refractory Germ Cell Cancer",
        "inclusion_criteria": "* Male patients >= 18 years old.\n* Patients with histologically proven seminomatous or non-seminomatous germ cell cancer\n* Disease progression during cisplatin-based chemotherapy or\n* Disease progression or relapse after high-dose chemotherapy or\n* Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy.\n* Patients must have received prior combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel (GOP). Prior treatment with a combination of two of these drugs is allowed in case of contraindications for GOP.\n* Disease progression at study entry: progressive disease according to RECIST criteria in baseline examinations or tumor marker increase > 25% within 4 weeks before study entry.\n* ECOG performance status <= 2.\n* Life expectancy >= 3 months.\n* Adequate bone marrow function: absolute neutrophil count >= 1.5 x 109/1, platelets >= 75 x 109/1, hemoglobin >= 9 g/dl.\n* Adequate liver function: serum bilirubin: <= 1.5x ULN, ALT and AST <= 2.5x ULN. For patients with known liver metastases: AST and ALT <= 5x ULN.\n* Adequate renal function: serum creatinine <= 2.0x ULN.\n* Patients must be surgically sterile or must agree to use effective contraception during study treatment.\n* Signed written informed consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Systemic antitumor treatment within 21 days before study entry.\n* Simultaneous radiotherapy of the only target lesion(s).\n* Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above\n* Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus).\n* Patients receiving chronic systemic treatment with corticosteroids (dose of >= 20 mg/day methylprednisone equivalent) or another immunosuppressive agent.\n* Patients with unstable angina pectoris, myocardial infarction <= 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias.\n* Patients with severely impaired lung function: spirometry or DLCO < 50% of the normal predicted value.\n* Uncontrolled diabetes: fasting serum glucose > 2.0x ULN.\n* Patients with an active or uncontrolled infection, incl. chronic Hepatitis B or C\n* Patients who have a history of another primary malignancy and are off treatment for <= 3 years, with the exception of non-melanoma skin cancer.\n* Patients who have participated in another clinical trial within 30 days before study entry.\n* Other serious medical conditions that could impair the ability of the patient to participate in the study.\n* Patients unwilling or unable to comply with the protocol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male patients >= 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Male patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": ">= 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with histologically proven seminomatous or non-seminomatous germ cell cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically proven seminomatous ... germ cell cancer",
                    "criterion": "seminomatous germ cell cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically proven ... non-seminomatous germ cell cancer",
                    "criterion": "non-seminomatous germ cell cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression during cisplatin-based chemotherapy or",
            "criterions": [
                {
                    "exact_snippets": "Disease progression during cisplatin-based chemotherapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "cisplatin-based chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression or relapse after high-dose chemotherapy or",
            "criterions": [
                {
                    "exact_snippets": "Disease progression or relapse after high-dose chemotherapy",
                    "criterion": "disease progression or relapse",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "after high-dose chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Disease progression or relapse after at least 2 different cisplatin-based regimens",
                    "criterion": "disease progression or relapse",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cisplatin-based regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications for high-dose chemotherapy",
                    "criterion": "contraindications for high-dose chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have received prior combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel (GOP). Prior treatment with a combination of two of these drugs is allowed in case of contraindications for GOP.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have received prior combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel (GOP).",
                    "criterion": "prior combination chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "drugs",
                            "expected_value": [
                                "gemcitabine",
                                "oxaliplatin",
                                "paclitaxel"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with a combination of two of these drugs is allowed in case of contraindications for GOP.",
                    "criterion": "prior treatment with a combination of two drugs",
                    "requirements": [
                        {
                            "requirement_type": "drugs",
                            "expected_value": [
                                "gemcitabine",
                                "oxaliplatin",
                                "paclitaxel"
                            ]
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "contraindications for GOP"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease progression at study entry: progressive disease according to RECIST criteria in baseline examinations or tumor marker increase > 25% within 4 weeks before study entry.",
            "criterions": [
                {
                    "exact_snippets": "Disease progression at study entry: progressive disease according to RECIST criteria",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "progressive disease according to RECIST criteria"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor marker increase > 25% within 4 weeks before study entry",
                    "criterion": "tumor marker increase",
                    "requirements": [
                        {
                            "requirement_type": "percentage increase",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status <= 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status <= 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy >= 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >= 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function: absolute neutrophil count >= 1.5 x 109/1, platelets >= 75 x 109/1, hemoglobin >= 9 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function: absolute neutrophil count >= 1.5 x 109/1",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/1"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function: ... platelets >= 75 x 109/1",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "x 109/1"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function: ... hemoglobin >= 9 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function: serum bilirubin: <= 1.5x ULN, ALT and AST <= 2.5x ULN. For patients with known liver metastases: AST and ALT <= 5x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function: serum bilirubin: <= 1.5x ULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST <= 2.5x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST <= 2.5x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with known liver metastases: AST and ALT <= 5x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with known liver metastases: AST and ALT <= 5x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function: serum creatinine <= 2.0x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function: serum creatinine <= 2.0x ULN.",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be surgically sterile or must agree to use effective contraception during study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use effective contraception during study treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "written",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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 antitumor treatment within 21 days before study entry.",
            "criterions": [
                {
                    "exact_snippets": "Systemic antitumor treatment within 21 days before study entry.",
                    "criterion": "systemic antitumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Simultaneous radiotherapy of the only target lesion(s).",
            "criterions": [
                {
                    "exact_snippets": "Simultaneous radiotherapy of the only target lesion(s).",
                    "criterion": "simultaneous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "only target lesion(s)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgery within 4 weeks prior to starting study drug",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant traumatic injury",
                    "criterion": "significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not recovered from the side effects of any of the above",
                    "criterion": "recovery from side effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus).",
            "criterions": [
                {
                    "exact_snippets": "previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus)",
                    "criterion": "mTOR inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving chronic systemic treatment with corticosteroids (dose of >= 20 mg/day methylprednisone equivalent) or another immunosuppressive agent.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving chronic systemic treatment with corticosteroids",
                    "criterion": "chronic systemic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dose of >= 20 mg/day methylprednisone equivalent",
                    "criterion": "corticosteroid dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mg/day methylprednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving ... another immunosuppressive agent",
                    "criterion": "immunosuppressive agent treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with unstable angina pectoris, myocardial infarction <= 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias.",
            "criterions": [
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction <= 6 months prior to first study treatment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure NYHA III-IV",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmias",
                    "criterion": "serious uncontrolled cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with severely impaired lung function: spirometry or DLCO < 50% of the normal predicted value.",
            "criterions": [
                {
                    "exact_snippets": "severely impaired lung function: spirometry or DLCO < 50% of the normal predicted value.",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severely impaired"
                        }
                    ]
                },
                {
                    "exact_snippets": "spirometry ... < 50% of the normal predicted value.",
                    "criterion": "spirometry",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "% of the normal predicted value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "DLCO < 50% of the normal predicted value.",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "% of the normal predicted value"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled diabetes: fasting serum glucose > 2.0x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting serum glucose > 2.0x ULN",
                    "criterion": "fasting serum glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have a history of another primary malignancy and are off treatment for <= 3 years, with the exception of non-melanoma skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "history of another primary malignancy",
                    "criterion": "history of another primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "off treatment for <= 3 years",
                    "criterion": "off treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have participated in another clinical trial within 30 days before study entry.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have participated in another clinical trial within 30 days before study entry.",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other serious medical conditions that could impair the ability of the patient to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Other serious medical conditions that could impair the ability of the patient to participate in the study.",
                    "criterion": "serious medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "could impair"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unwilling or unable to comply with the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Patients unwilling ... to comply with the protocol.",
                    "criterion": "willingness to comply with the protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients ... unable to comply with the protocol.",
                    "criterion": "ability to comply with the protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with an active or uncontrolled infection, incl. chronic Hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active or uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "chronic"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}