{
    "info": {
        "nct_id": "NCT00169520",
        "official_title": "A Phase I, Open-Label Study of SB-715992 in Combination With Docetaxel in Patients With Advanced Solid Tumors.",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria:\n\n* Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.\n* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.\n\nExclusion criteria:\n\n* Females who are pregnant or nursing.\n* Pre-existing hemolytic anemia.\n* Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.\n* Absolute neutrophil count less than 1,500/mm3.\n* Platelets less than 100,000/mm3.\n* Hemoglobin less than 9 g/dL.\n* Total bilirubin greater than1.5 mg/dL.\n* AST/ALT greater than 2.5 X upper limit of normal.\n* Creatinine clearance less than or equal to 60 mL/min (calculated by the Cockcroft Gault Formula).\n* Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80."
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "* Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced solid tumor malignancy",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "advanced solid tumor malignancy"
                        }
                    ]
                },
                {
                    "exact_snippets": "not responsive to standard therapies",
                    "criterion": "response to standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for which there is no standard therapy",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) 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": "* Females who are pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who are ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing hemolytic anemia.",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing hemolytic anemia",
                    "criterion": "hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing peripheral neuropathy greater than or equal grade 2.",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Greater than or equal to 4 prior chemotherapy regimens",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer subjects who may have received more than 4 prior chemotherapy regimens.",
                    "criterion": "breast cancer prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "more than 4 regimens"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count less than 1,500/mm3.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count less than 1,500/mm3.",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets less than 100,000/mm3.",
            "criterions": [
                {
                    "exact_snippets": "Platelets less than 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin less than 9 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin less than 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin greater than1.5 mg/dL.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin greater than1.5 mg/dL.",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST/ALT greater than 2.5 X upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "AST/ALT greater than 2.5 X upper limit of normal.",
                    "criterion": "AST/ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "X upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance less than or equal to 60 mL/min (calculated by the Cockcroft Gault Formula).",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance less than or equal to 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.",
            "criterions": [
                {
                    "exact_snippets": "Known contraindications to the use of docetaxel",
                    "criterion": "contraindications to docetaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications ... to other drugs formulated with polysorbate 80",
                    "criterion": "contraindications to drugs formulated with polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}