{
    "info": {
        "nct_id": "NCT00256191",
        "official_title": "A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies",
        "inclusion_criteria": "Patients must be/have:\n\n* Histological evidence of malignancy\n* Advanced solid tumors that have recurred or progressed following standard therapy\n* Failed one prior therapy or have no standard therapy available\n* Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months\n* If female, negative pregnancy test\n* If of childbearing years, agree to use birth control\n* If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "Patients will be excluded if they are or have had:\n\n* Prior radiation within 4 weeks\n* Active medical condition or organ disease which may compromise safety or interfere with the study\n* Clinically significant cardiac co-morbidities or pulmonary impairment\n* Concomitant therapy needs\n* Treated with any investigational drugs within 30 days\n* Tumors involve major artery or vein\n* Prior or concurrent central nervous system (CNS) disease\n* Less than 4 weeks since major surgery\n* Known to be positive for HIV, hepatitis B or C\n* Concurrent use of aspirin\n* Use of thrombolytic agents\n* Uncontrolled hypertension\n* Grade II-IV peripheral vascular disease\n* Pregnant or lactating\n* Prior allergic history to compounds of similar chemical composition\n* Inpatients\n* Grade II-IV peripheral neuropathy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histological evidence of malignancy",
            "criterions": [
                {
                    "exact_snippets": "Histological evidence of malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "histological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Advanced solid tumors that have recurred or progressed following standard therapy",
            "criterions": [
                {
                    "exact_snippets": "Advanced solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurred",
                    "criterion": "tumor recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "following standard therapy",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failed one prior therapy or have no standard therapy available",
            "criterions": [
                {
                    "exact_snippets": "Failed one prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy available",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Ambulatory",
                    "criterion": "ambulatory status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated life expectancy of > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If female, negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "If female, negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If of childbearing years, agree to use birth control",
            "criterions": [
                {
                    "exact_snippets": "If of childbearing years",
                    "criterion": "childbearing years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to use birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month",
            "criterions": [
                {
                    "exact_snippets": "prior radiation therapy for brain metastases",
                    "criterion": "prior radiation therapy for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on steroids",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have been stable for 1 month",
                    "criterion": "stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior radiation within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation within 4 weeks",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active medical condition or organ disease which may compromise safety or interfere with the study",
            "criterions": [
                {
                    "exact_snippets": "Active medical condition or organ disease",
                    "criterion": "medical condition or organ disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "which may compromise safety",
                    "criterion": "safety",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "compromise"
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere with the study",
                    "criterion": "study participation",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "interfere"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiac co-morbidities or pulmonary impairment",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiac co-morbidities",
                    "criterion": "cardiac co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary impairment",
                    "criterion": "pulmonary impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant therapy needs",
            "criterions": [
                {
                    "exact_snippets": "Concomitant therapy needs",
                    "criterion": "concomitant therapy",
                    "requirements": [
                        {
                            "requirement_type": "needs",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treated with any investigational drugs within 30 days",
            "criterions": [
                {
                    "exact_snippets": "Treated with any investigational drugs within 30 days",
                    "criterion": "investigational drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumors involve major artery or vein",
            "criterions": [
                {
                    "exact_snippets": "Tumors involve major artery or vein",
                    "criterion": "tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "major artery",
                                "major vein"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior or concurrent central nervous system (CNS) disease",
            "criterions": [
                {
                    "exact_snippets": "Prior or concurrent central nervous system (CNS) disease",
                    "criterion": "central nervous system (CNS) disease",
                    "requirements": [
                        {
                            "requirement_type": "temporal presence",
                            "expected_value": [
                                "prior",
                                "concurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 4 weeks since major surgery",
            "criterions": [
                {
                    "exact_snippets": "Less than 4 weeks since major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent use of aspirin",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of aspirin",
                    "criterion": "aspirin use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of thrombolytic agents",
            "criterions": [
                {
                    "exact_snippets": "Use of thrombolytic agents",
                    "criterion": "thrombolytic agents",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade II-IV peripheral vascular disease",
            "criterions": [
                {
                    "exact_snippets": "Grade II-IV peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "Grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allergic history to compounds of similar chemical composition",
            "criterions": [
                {
                    "exact_snippets": "Prior allergic history to compounds of similar chemical composition",
                    "criterion": "allergic history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inpatients",
            "criterions": [
                {
                    "exact_snippets": "Inpatients",
                    "criterion": "patient status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "inpatient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade II-IV peripheral neuropathy",
            "criterions": [
                {
                    "exact_snippets": "Grade II-IV peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "Grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "Grade"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Patients must be/have:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Patients will be excluded if they are or have had:",
            "criterions": []
        },
        {
            "line": "* Known to be positive for HIV, hepatitis B or C",
            "criterions": [
                {
                    "exact_snippets": "Known to be positive for HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive for ... hepatitis B",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive for ... hepatitis C",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}