{
    "info": {
        "nct_id": "NCT02009631",
        "official_title": "A Randomized, Placebo-Controlled Crossover Study to Evaluate the Effect of Veliparib (ABT-888) on Cardiac Repolarization in Subjects With Relapsed or Refractory Solid Tumors",
        "inclusion_criteria": "* Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.\n* Subjects with brain metastases must have clinically controlled neurologic symptoms.\n* Subject is able to swallow and retain oral medications and does not have uncontrolled emesis.\n* Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia.\n* Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult.\n* Subject has a history of cardiac conduction abnormalities.\n* Subject has a significant history of cardiovascular disease.\n* Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy.\n* Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose.\n* Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed solid malignancy",
                    "criterion": "solid malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or unresectable",
                    "criterion": "malignancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective",
                    "criterion": "availability of effective therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with brain metastases must have clinically controlled neurologic symptoms.",
            "criterions": [
                {
                    "exact_snippets": "Subjects with brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically controlled neurologic symptoms",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "clinically controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is able to swallow and retain oral medications and does not have uncontrolled emesis.",
            "criterions": [
                {
                    "exact_snippets": "Subject is able to swallow and retain oral medications",
                    "criterion": "ability to swallow and retain oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "does not have uncontrolled emesis",
                    "criterion": "uncontrolled emesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges.",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow ... per local laboratory reference ranges",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per local laboratory reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal ... function per local laboratory reference ranges",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per local laboratory reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic function per local laboratory reference ranges",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "per local laboratory reference ranges"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult.",
            "criterions": [
                {
                    "exact_snippets": "severe ECG morphologic abnormalities",
                    "criterion": "ECG morphologic abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "make QTc evaluation difficult",
                    "criterion": "QTc evaluation",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has a history of cardiac conduction abnormalities.",
            "criterions": [
                {
                    "exact_snippets": "history of cardiac conduction abnormalities",
                    "criterion": "cardiac conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has a significant history of cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "significant history of cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug",
                    "criterion": "anti-cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy",
                    "criterion": "adverse effect(s)/toxicity(s) of the previous therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose.",
            "criterions": [
                {
                    "exact_snippets": "Use of drugs with a known risk for QT prolongation",
                    "criterion": "use of drugs with a known risk for QT prolongation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to the first study dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of drugs with a known risk for ... Torsades de Pointes",
                    "criterion": "use of drugs with a known risk for Torsades de Pointes",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to the first study dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.",
            "criterions": [
                {
                    "exact_snippets": "Use of tobacco or nicotine-containing products",
                    "criterion": "tobacco or nicotine use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 hours prior to the first study dose"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia.",
            "criterions": [
                {
                    "exact_snippets": "Uncorrected serum potassium ... outside of normal reference ranges",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncorrected serum magnesium ... outside of normal reference ranges",
                    "criterion": "serum magnesium",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncorrected serum calcium ... outside of normal reference ranges",
                    "criterion": "serum calcium",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncorrected ... free thyroxin (FT4) ... outside of normal reference ranges",
                    "criterion": "free thyroxin (FT4)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncorrected ... thyroid stimulating hormone (TSH) outside of normal reference ranges",
                    "criterion": "thyroid stimulating hormone (TSH)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "outside of normal reference ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 hyponatremia",
                    "criterion": "hyponatremia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 ... hypernatremia",
                    "criterion": "hypernatremia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 2"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}