{
    "info": {
        "nct_id": "NCT00088101",
        "official_title": "Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors",
        "inclusion_criteria": "* Male and female patients 18 years or older with one of the following malignancies:\n* Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or,\n* Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available.\n* Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens\n* Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible\n* ECOG Performance Status of 0-2\n* Life expectancy of greater than 12 weeks.\n* Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator.\n* Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors\n* Platelets greater than 100,000/ul\n* Hgb greater than 8.5 g/dL\n* Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal\n* AST (SGOT) < 2.5 times the upper limit of normal\n* ALT (SGPT) < 2.5 times the upper limit of normal\n* Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min)\n* Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator.\n* NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing.\n* The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women who are pregnant or lactating.\n* Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry.\n* Patients with prior peripheral blood stem cell rescue or bone marrow transplantation.\n* History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment)\n* History of stroke or other significant neurologic limitations within 6 months prior to study enrollment\n* Use of any investigational agents within 4 weeks of study enrollment.\n* History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.\n* History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.\n* Grade 2 or higher sensory or motor neuropathy at screening.\n* Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male and female patients 18 years or older with one of the following malignancies:",
            "criterions": [
                {
                    "exact_snippets": "Male and female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or,",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed hematological malignancy",
                    "criterion": "hematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "other than Acute Myeloid Leukemia and Myelodysplastic Syndrome",
                    "criterion": "hematological malignancy type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "Acute Myeloid Leukemia",
                                "Myelodysplastic Syndrome"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "if treatment is medically indicated",
                    "criterion": "treatment indication",
                    "requirements": [
                        {
                            "requirement_type": "medical necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available.",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed non-hematological malignancy",
                    "criterion": "non-hematological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or unresectable",
                    "criterion": "malignancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy is available",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens",
            "criterions": [
                {
                    "exact_snippets": "Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CLL",
                                "PLL",
                                "CML",
                                "CTCL",
                                "ATL",
                                "Non-Hodgkin's Lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to or have relapsed following conventional chemotherapy regimens",
                    "criterion": "response to conventional chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "refractory",
                                "relapsed"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not currently being considered for re-treatment with conventional regimens",
                    "criterion": "consideration for re-treatment with conventional regimens",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible",
            "criterions": [
                {
                    "exact_snippets": "Patients with CLL and other leukemic malignancies",
                    "criterion": "leukemic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "staged according to the modified Rai staging criteria",
                    "criterion": "Rai staging",
                    "requirements": [
                        {
                            "requirement_type": "staging",
                            "expected_value": [
                                "low-risk",
                                "intermediate-risk",
                                "high-risk"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "All patients in the high-risk group (Stage III and IV) are eligible",
                    "criterion": "Rai staging",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage III",
                                "Stage IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Intermediate risk patients (Stage I and II) with one or more criteria of active disease",
                    "criterion": "Rai staging",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage I",
                                "Stage II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive lymphocytosis",
                    "criterion": "progressive lymphocytosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lymphadenopathy",
                    "criterion": "lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "splenomegaly",
                    "criterion": "splenomegaly",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "weight loss > 10% within 6 months",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "extreme fatigue",
                    "criterion": "extreme fatigue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fever and/or night sweats without evidence of infection",
                    "criterion": "fever and/or night sweats",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status of 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 greater than 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of greater than 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator.",
            "criterions": [
                {
                    "exact_snippets": "acceptable organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies",
                    "criterion": "absolute neutrophils count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "cells/ul"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophils count ... ≥1,500 cells/ul for patients with solid tumors",
                    "criterion": "absolute neutrophils count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets greater than 100,000/ul",
            "criterions": [
                {
                    "exact_snippets": "Platelets greater than 100,000/ul",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "/ul"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hgb greater than 8.5 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hgb greater than 8.5 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.5,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 1.5,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "X upper limit of normal"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT) < 2.5 times the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) < 2.5 times the upper limit of normal",
                    "criterion": "AST (SGOT) level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT (SGPT) < 2.5 times the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "ALT (SGPT) < 2.5 times the upper limit of normal",
                    "criterion": "ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min)",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function (serum creatinine < 2.0 mg/dL ...",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function (... a calculated creatinine clearance greater than 50 mL/min)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Electrocardiogram without evidence of clinically significant conduction abnormalities",
                    "criterion": "conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Electrocardiogram without evidence of ... active ischemia",
                    "criterion": "active ischemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing.",
            "criterions": [
                {
                    "exact_snippets": "NCI grade 0-1 left ventricular ejection fraction",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "NCI grade 0-1"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days of dosing",
                    "criterion": "timing of left ventricular ejection fraction assessment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 30 days of dosing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately.",
            "criterions": [
                {
                    "exact_snippets": "women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "notification",
                            "expected_value": "inform the treating physician immediately"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to 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": "* Women who are pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "The use of nitrosoureas ... within 6 weeks prior to study entry.",
                    "criterion": "use of nitrosoureas",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of ... mitomycin C within 6 weeks prior to study entry.",
                    "criterion": "use of mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with prior peripheral blood stem cell rescue or bone marrow transplantation.",
            "criterions": [
                {
                    "exact_snippets": "prior peripheral blood stem cell rescue",
                    "criterion": "peripheral blood stem cell rescue",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... bone marrow transplantation",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment)",
            "criterions": [
                {
                    "exact_snippets": "History of primary brain tumors",
                    "criterion": "primary brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active brain metastases",
                    "criterion": "active brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases ... not receiving corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated brain metastases ... not receiving ... anticonvulsants",
                    "criterion": "anticonvulsants",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of stroke or other significant neurologic limitations within 6 months prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "History of stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant neurologic limitations",
                    "criterion": "significant neurologic limitations",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any investigational agents within 4 weeks of study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Use of any investigational agents within 4 weeks of study enrollment.",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312.",
            "criterions": [
                {
                    "exact_snippets": "History of severe allergic reactions to excipients (e.g. Tween 80)",
                    "criterion": "severe allergic reactions to excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312",
                    "criterion": "hypersensitivity reactions to chemotherapeutic agents",
                    "requirements": [
                        {
                            "requirement_type": "similarity",
                            "expected_value": "similar in structure to STA-5312"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.",
            "criterions": [
                {
                    "exact_snippets": "History of active CNS-lymphoma",
                    "criterion": "CNS-lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AIDS-related lymphoma",
                    "criterion": "AIDS-related lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any uncontrolled severe medical illness",
                    "criterion": "uncontrolled severe medical illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any uncontrolled severe ... infection",
                    "criterion": "uncontrolled severe infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade 2 or higher sensory or motor neuropathy at screening.",
            "criterions": [
                {
                    "exact_snippets": "Grade 2 or higher sensory or motor neuropathy at screening.",
                    "criterion": "sensory or motor neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had chemotherapy ... within 4 weeks prior to entering the study",
                    "criterion": "recent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have had radiotherapy (except palliative radiation delivered to < 20% of bone marrow) ... within 4 weeks prior to entering the study",
                    "criterion": "recent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have had immunotherapy ... within 4 weeks prior to entering the study",
                    "criterion": "recent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have had corticosteroids ( > 10 mg/day of prednisone or equivalent) ... within 4 weeks prior to entering the study",
                    "criterion": "recent corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day of prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 4 weeks earlier",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}