{
    "info": {
        "nct_id": "NCT00839631",
        "official_title": "A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "* histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists\n* measurable or evaluable disease\n* >= 18 years of age\n* ECOG of 0, 1 or 2\n* no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Clinically significant coronary artery disease or conduction system abnormality\n* Coagulation disorder\n* Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl\n* Any major surgery within 28 days prior to receipt of EC D-3263 HCl",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically confirmed advanced solid tumor malignancy",
                        "criterion": "advanced solid tumor malignancy",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "refractory to standard therapy",
                        "criterion": "refractory to standard therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for which no standard therapy exists",
                        "criterion": "standard therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically or cytologically confirmed advanced solid tumor malignancy",
                                "criterion": "advanced solid tumor malignancy",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "refractory to standard therapy",
                                "criterion": "refractory to standard therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically or cytologically confirmed advanced solid tumor malignancy",
                                "criterion": "advanced solid tumor malignancy",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "for which no standard therapy exists",
                                "criterion": "standard therapy availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* >= 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": ">= 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": ">= 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG of 0, 1 or 2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG of 0, 1 or 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG of 0, 1 or 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl",
                "criterions": [
                    {
                        "exact_snippets": "no treatement with chemotherapy",
                        "criterion": "chemotherapy treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no treatement with ... radiotherapy",
                        "criterion": "radiotherapy treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no treatement with ... other systemic therapy",
                        "criterion": "systemic therapy treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding depot LHRH agonist or antagonist for subjects with prostate cancer",
                        "criterion": "depot LHRH agonist or antagonist treatment",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with in 28 days prior to receipt of EC D-3263 HCl",
                        "criterion": "treatment timing",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "no treatement with chemotherapy",
                                            "criterion": "chemotherapy treatment",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "no treatement with ... radiotherapy",
                                            "criterion": "radiotherapy treatment",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "no treatement with ... other systemic therapy",
                                    "criterion": "systemic therapy treatment",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "excluding depot LHRH agonist or antagonist for subjects with prostate cancer",
                                "criterion": "depot LHRH agonist or antagonist treatment",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "excluding depot LHRH agonist or antagonist for subjects with prostate cancer",
                                    "criterion": "depot LHRH agonist or antagonist treatment",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "with in 28 days prior to receipt of EC D-3263 HCl",
                        "criterion": "treatment timing",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Clinically significant coronary artery disease or conduction system abnormality",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant coronary artery disease",
                        "criterion": "coronary artery disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "conduction system abnormality",
                        "criterion": "conduction system abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Clinically significant coronary artery disease",
                        "criterion": "coronary artery disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "conduction system abnormality",
                        "criterion": "conduction system abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Coagulation disorder",
                "criterions": [
                    {
                        "exact_snippets": "Coagulation disorder",
                        "criterion": "coagulation disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Coagulation disorder",
                    "criterion": "coagulation disorder",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any major surgery within 28 days prior to receipt of EC D-3263 HCl",
                "criterions": [
                    {
                        "exact_snippets": "Any major surgery within 28 days prior to receipt of EC D-3263 HCl",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any major surgery within 28 days prior to receipt of EC D-3263 HCl",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* measurable or evaluable disease",
                "criterions": [
                    {
                        "exact_snippets": "measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    },
                    {
                        "exact_snippets": "measurable or evaluable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "evaluable"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl",
                        "criterion": "use of systemic antimicrobial medications",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within seven days prior to receipt of EC D-3263 HCl"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl",
                        "criterion": "use of systemic antimicrobial medications",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within seven days prior to receipt of EC D-3263 HCl"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}