{
    "info": {
        "nct_id": "NCT00996957",
        "official_title": "A Phase 1 Open-Label, Multiple Dose, Dose Escalation Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma",
        "inclusion_criteria": "* Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Central nervous system (CNS) metastases.\n* Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1.\n* Lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia.\n* Radiation therapy within 4 weeks prior to study day 1.\n* Clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma\n* Significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1).\n* Diagnosis or family history of hereditary hemorrhagic telangiectasia.\n* Major surgery within 6 weeks prior to study day 1.\n* Parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1.\n* Therapeutic anti-coagulation.\n* Uncontrolled hypertension.\n* Autoimmune or hereditary hemolysis.\n* Clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1.\n* Treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1.\n* Pregnancy or lactation for female patients.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic or unresectable advanced solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "metastatic or unresectable advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "solid tumors must be measurable",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed/refractory multiple myeloma",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "relapsed/refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease has progressed despite available standard therapies",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "progression despite therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy exists",
                    "criterion": "standard therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1).",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not declining within 2 weeks prior to study day 1",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "not declining within 2 weeks prior to study day 1"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Central nervous system (CNS) metastases.",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1",
                    "criterion": "chemotherapy or other anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nitrosoureas within the 6 weeks prior to study day 1",
                    "criterion": "nitrosoureas",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Lack of recovery from all toxic effects of previous chemotherapy",
                    "criterion": "recovery from toxic effects of previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from all toxic effects of previous ... radiation therapy",
                    "criterion": "recovery from toxic effects of previous radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from all toxic effects of previous ... biologic therapy",
                    "criterion": "recovery from toxic effects of previous biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from all toxic effects of previous ... experimental therapy",
                    "criterion": "recovery from toxic effects of previous experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy within 4 weeks prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within 4 weeks prior to study day 1.",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant pulmonary ... disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... cardiovascular ... disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... endocrine ... disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "endocrine disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... neurologic ... disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "neurologic disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... gastrointestinal ... disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant ... genitourinary disease unrelated to underlying solid tumor or multiple myeloma",
                    "criterion": "genitourinary disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "relation to underlying condition",
                            "expected_value": "unrelated to underlying solid tumor or multiple myeloma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1).",
            "criterions": [
                {
                    "exact_snippets": "history of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary hypertension",
                    "criterion": "pulmonary hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant arrhythmia",
                    "criterion": "clinically significant arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure within 1 year prior to study day 1",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis or family history of hereditary hemorrhagic telangiectasia.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis ... hereditary hemorrhagic telangiectasia",
                    "criterion": "hereditary hemorrhagic telangiectasia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history of hereditary hemorrhagic telangiectasia",
                    "criterion": "hereditary hemorrhagic telangiectasia",
                    "requirements": [
                        {
                            "requirement_type": "family history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 6 weeks prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 6 weeks prior to study day 1.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Parenteral antibiotics",
                    "criterion": "parenteral antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1",
                    "criterion": "life-threatening or active infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 month prior to study day 1"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "parenteral antibiotic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Therapeutic anti-coagulation.",
            "criterions": [
                {
                    "exact_snippets": "Therapeutic anti-coagulation",
                    "criterion": "anti-coagulation",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "therapeutic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autoimmune or hereditary hemolysis.",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune ... hemolysis",
                    "criterion": "autoimmune hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hereditary hemolysis",
                    "criterion": "hereditary hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other clinically significant active bleeding within 3 months prior to study day 1",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to study day 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with another investigational drug or device",
                    "criterion": "treatment with investigational drug or device",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "approved therapy for investigational use within 28 days prior to study day 1",
                    "criterion": "approved therapy for investigational use",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation for female patients.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation for female patients",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}