{
    "info": {
        "nct_id": "NCT02679131",
        "official_title": "An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients With Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Mild, Moderate, and Severe Renal Impairment",
        "inclusion_criteria": "1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.\n2. Patient must have received at least 1 prior therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.\n3. Patient has either normal or impaired renal functions.\n4. Patient has adequate hematological and hepatic functions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis.\n2. Patient has acute HBV or HCV\n3. Patient has known human immunodeficiency virus (HIV) positive diagnosis.\n4. Patient has had previous exposure to belinostat.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Patient is diagnosed with advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced hematological malignancy",
                    "criterion": "advanced hematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed/refractory",
                    "criterion": "relapsed/refractory",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for which no standard salvage therapy exists",
                    "criterion": "standard salvage therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient must have received at least 1 prior therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have received at least 1 prior therapy for the current malignancy",
                    "criterion": "prior therapy for current malignancy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has recovered from any toxicity of the prior therapy at screening",
                    "criterion": "recovery from toxicity of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient has either normal or impaired renal functions.",
            "criterions": [
                {
                    "exact_snippets": "normal or impaired renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "normal",
                                "impaired"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has adequate hematological and hepatic functions.",
            "criterions": [
                {
                    "exact_snippets": "adequate hematological ... functions",
                    "criterion": "hematological functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic functions",
                    "criterion": "hepatic functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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": "1. Patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis.",
            "criterions": [
                {
                    "exact_snippets": "acute or progressive renal impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "acute",
                                "progressive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "related to disease or any other cause",
                    "criterion": "cause of renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requires dialysis",
                    "criterion": "dialysis requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patient has acute HBV or HCV",
            "criterions": [
                {
                    "exact_snippets": "Patient has acute HBV",
                    "criterion": "acute HBV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has acute ... HCV",
                    "criterion": "acute HCV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient has known human immunodeficiency virus (HIV) positive diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "known human immunodeficiency virus (HIV) positive diagnosis",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has had previous exposure to belinostat.",
            "criterions": [
                {
                    "exact_snippets": "Patient has had previous exposure to belinostat.",
                    "criterion": "previous exposure to belinostat",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}