{
    "info": {
        "nct_id": "NCT00697476",
        "official_title": "Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC)",
        "inclusion_criteria": "* Histologically or cytologically proven diagnosis of SCLC;\n* Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse);\n* Age >/= 18 years;\n* ECOG Performance Status 0-2;\n* Life expectancy of at least 12 weeks;\n* Measurable lesions according to RECIST criteria;\n* Adequate cardiac, hepatic, renal, and bone marrow function;\n* Written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with an HDAC inhibitor;\n* Symptomatic and/or unstable pre-existing brain metastases;\n* Superior Vena Cava Syndrome;\n* Spinal cord compression;\n* Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections);\n* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ;\n* Pregnant or breastfeeding women.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically proven diagnosis of SCLC;",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven diagnosis of SCLC",
                    "criterion": "SCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method of diagnosis",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Limited or extensive-stage disease in patients who have received a single chemotherapy regimen or combined modality (chemotherapy + chest radiotherapy) regimen and relapsed after completion of first-line chemotherapy (sensitive relapse);",
            "criterions": [
                {
                    "exact_snippets": "Limited or extensive-stage disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "limited",
                                "extensive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have received a single chemotherapy regimen",
                    "criterion": "chemotherapy regimen count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "combined modality (chemotherapy + chest radiotherapy) regimen",
                    "criterion": "treatment modality",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": "combined (chemotherapy + chest radiotherapy)"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed after completion of first-line chemotherapy (sensitive relapse)",
                    "criterion": "relapse type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sensitive relapse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >/= 18 years;",
            "criterions": [
                {
                    "exact_snippets": "Age >/= 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status 0-2;",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status 0-2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable lesions according to RECIST criteria;",
            "criterions": [
                {
                    "exact_snippets": "Measurable lesions according to RECIST criteria",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac, hepatic, renal, and bone marrow function;",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac ... function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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": "* Prior treatment with an HDAC inhibitor;",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with an HDAC inhibitor",
                    "criterion": "HDAC inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic and/or unstable pre-existing brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic and/or unstable pre-existing brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Superior Vena Cava Syndrome;",
            "criterions": [
                {
                    "exact_snippets": "Superior Vena Cava Syndrome",
                    "criterion": "Superior Vena Cava Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Spinal cord compression;",
            "criterions": [
                {
                    "exact_snippets": "Spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe or uncontrolled medical diseases (Hypertension, diabetes, congestive heart failure, myocardial infarction within 6 months of study, chronic renal disease, or active uncontrolled infections);",
            "criterions": [
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases (Hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases ... diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases ... myocardial infarction within 6 months of study",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases ... chronic renal disease",
                    "criterion": "chronic renal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical diseases ... active uncontrolled infections",
                    "criterion": "active uncontrolled infections",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ;",
            "criterions": [
                {
                    "exact_snippets": "Other co-existing malignancies",
                    "criterion": "co-existing malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancies diagnosed within the last 5 years",
                    "criterion": "malignancies diagnosed within the last 5 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of basal cell carcinoma or cervical cancer in situ",
                    "criterion": "basal cell carcinoma or cervical cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}