{
    "info": {
        "nct_id": "NCT00422682",
        "official_title": "A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "* ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)\n* At least a 14-day period from end of last dose of chemotherapy received\n* Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents\n* Hematological malignancies\n* Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.\n* History of seizure disorder\n* Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension\n* Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)\n* Specified concomitant medications\n* Serum creatinine > 1.5 x upper limit of normal (ULN)\n* Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases; total bilirubin > 1.5 x ULN\n* Radiation therapy within 14 days of study day 1\n* Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1\n* Concurrent radiation therapy is not permitted throughout the course of the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically documented",
                    "criterion": "tumor documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced solid tumor",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1)",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        },
                        {
                            "requirement_type": "support",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100.0,
                                "unit": "x 10^9/L"
                            }
                        },
                        {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        },
                        {
                            "requirement_type": "erythropoietic agents",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least a 14-day period from end of last dose of chemotherapy received",
            "criterions": [
                {
                    "exact_snippets": "At least a 14-day period from end of last dose of chemotherapy",
                    "criterion": "time since last chemotherapy dose",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1",
            "criterions": [
                {
                    "exact_snippets": "Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1",
                    "criterion": "toxicity from prior chemotherapeutic treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents",
            "criterions": [
                {
                    "exact_snippets": "Subject enrolled in another investigational device or drug trial",
                    "criterion": "enrollment in another investigational trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving other investigational agents",
                    "criterion": "receiving investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematological malignancies",
            "criterions": [
                {
                    "exact_snippets": "Hematological malignancies",
                    "criterion": "hematological malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic or untreated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids",
                    "criterion": "concurrent treatment",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "surgery",
                                "radiation",
                                "corticosteroids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of seizure disorder",
            "criterions": [
                {
                    "exact_snippets": "History of seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction (MI) within 6 months of study day 1",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (CHF) with New York Heart Association (NYHA) > class II",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "New York Heart Association (NYHA) class",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent or prior (within 7 days of study day 1) anticoagulation therapy",
                    "criterion": "anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "concurrent or prior (within 7 days of study day 1)"
                        }
                    ]
                },
                {
                    "exact_snippets": "low dose for port maintenance allowed",
                    "criterion": "anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "low dose for port maintenance allowed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Specified concomitant medications",
            "criterions": [
                {
                    "exact_snippets": "Specified concomitant medications",
                    "criterion": "concomitant medications",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "specified"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine > 1.5 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine > 1.5 x upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases; total bilirubin > 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases",
                    "criterion": "liver enzymes (AST/ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5.0,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 5.0,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin > 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 14 days of study day 1",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 14 days of study day 1",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1",
            "criterions": [
                {
                    "exact_snippets": "Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1",
                    "criterion": "antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent radiation therapy is not permitted throughout the course of the study",
            "criterions": [
                {
                    "exact_snippets": "Concurrent radiation therapy is not permitted",
                    "criterion": "concurrent radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}