{
    "info": {
        "nct_id": "NCT01113476",
        "official_title": "Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies",
        "inclusion_criteria": "1. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.\n2. Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.\n3. ECOG performance status </= 2 (Karnofsky >/= 60%).\n4. Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 X ULN; total bilirubin </= 3.0; ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.\n5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.\n6. Ability to understand and the willingness to sign a written informed consent document.\n7. Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with hemoptysis within 28 days prior to entering the study.\n2. Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.\n3. Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg on medication).\n4. Pregnant or lactating women.\n5. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.\n6. History of hypersensitivity to gemcitabine.\n7. History of hypersensitivity to nab-paclitaxel or paclitaxel.\n8. Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure.\n9. History of CVA within 6 months.\n10. History of surgery within last 28 days.\n11. Grade 3/4 proteinuria.\n12. Nephrotic syndrome.\n13. Incompletely healed wound.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.",
            "criterions": [
                {
                    "exact_snippets": "advanced or metastatic cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed after standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "relapsed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy that induces a CR rate of at least 10%",
                    "criterion": "standard therapy CR rate",
                    "requirements": [
                        {
                            "requirement_type": "CR rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy that ... improves survival by at least three months",
                    "criterion": "standard therapy survival improvement",
                    "requirements": [
                        {
                            "requirement_type": "survival improvement",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.",
            "criterions": [
                {
                    "exact_snippets": "Patients should be at least four weeks from the last day of therapeutic radiation",
                    "criterion": "time since therapeutic radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients should be at least four weeks from the last day of ... cytotoxic chemotherapy",
                    "criterion": "time since cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients should be at least four weeks from the last day of ... antibody therapy",
                    "criterion": "time since antibody therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least five half-lives from non-cytotoxic targeted or biologic therapy",
                    "criterion": "time since non-cytotoxic targeted or biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available",
                    "criterion": "palliative radiation to target lesion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "not to the only target lesion available"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status </= 2 (Karnofsky >/= 60%).",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status </= 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky >/= 60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 X ULN; total bilirubin </= 3.0; ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count >/= 1,000/mL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets >/=50,000/mL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine </= 3 X ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin </= 3.0",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT(SGPT) </= 5 X ULN",
                    "criterion": "ALT(SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting level of total cholesterol of no more than 350mg/dL",
                    "criterion": "fasting level of total cholesterol",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 350,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "triglyceride level of no more than 400mg/dL",
                    "criterion": "triglyceride level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 400,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "women of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "agreement to use contraception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "men",
                    "requirements": [
                        {
                            "requirement_type": "agreement to use contraception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. 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": "7. Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.",
            "criterions": [
                {
                    "exact_snippets": "Patients may not be receiving any other investigational agents",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients may not be receiving ... any other concurrent anticancer agents or therapies",
                    "criterion": "concurrent anticancer agents or therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Patients with hemoptysis within 28 days prior to entering the study.",
            "criterions": [
                {
                    "exact_snippets": "hemoptysis within 28 days prior to entering the study",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior to entering the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant unexplained bleeding",
                    "criterion": "unexplained bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to entering the study",
                    "criterion": "time since last unexplained bleeding",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg on medication).",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled systemic vascular hypertension",
                    "criterion": "systemic vascular hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Systolic blood pressure > 140mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure > 90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on medication",
                    "criterion": "medication",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to bevacizumab",
                    "criterion": "hypersensitivity to bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... murine products",
                    "criterion": "hypersensitivity to murine products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any component of the formulation",
                    "criterion": "hypersensitivity to any component of the formulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of hypersensitivity to gemcitabine.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to gemcitabine",
                    "criterion": "hypersensitivity to gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of hypersensitivity to nab-paclitaxel or paclitaxel.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to nab-paclitaxel",
                    "criterion": "hypersensitivity to nab-paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... paclitaxel",
                    "criterion": "hypersensitivity to paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Myocardial Infarction ... within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris within the last 6 months",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Class III/IV NYHA heart failure",
                    "criterion": "NYHA heart failure",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of CVA within 6 months.",
            "criterions": [
                {
                    "exact_snippets": "History of CVA within 6 months",
                    "criterion": "CVA (cerebrovascular accident)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. History of surgery within last 28 days.",
            "criterions": [
                {
                    "exact_snippets": "History of surgery within last 28 days",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Grade 3/4 proteinuria.",
            "criterions": [
                {
                    "exact_snippets": "Grade 3/4 proteinuria",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Grade 3",
                                "Grade 4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Nephrotic syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Nephrotic syndrome",
                    "criterion": "nephrotic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Incompletely healed wound.",
            "criterions": [
                {
                    "exact_snippets": "Incompletely healed wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "incomplete"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}