{
    "info": {
        "nct_id": "NCT00543712",
        "official_title": "A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma",
        "inclusion_criteria": "* Ability to understand and willingness to sign a written informed consent document\n* Age ≥ 18 years\n* Histologic diagnosis of chondrosarcoma, verifiable after enrollment\n* Measurable disease\n* Previously treated or incurable disease without options for standard of care therapy\n* ECOG performance status of 0-2\n* Life expectancy of > 3 months\n* For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Systemic therapy or radiotherapy within 4 weeks prior to Day 1\n* Prior therapy with agents targeting the DR5 apoptosis pathway\n* Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study\n* Other invasive malignancies within 5 years prior to Day 1\n* Known active brain metastases\n* Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment\n* Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements\n* Known to be positive for hepatitis C or hepatitis B surface antigen\n* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications\n* Use of anticoagulation therapy\n* Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1\n* Pregnancy or breast feeding\n* Known sensitivity to any of the products administered during the study\n* Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ability to understand and willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ability to understand"
                    ],
                    "criterion": "understanding",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "willingness to sign a written informed consent document"
                    ],
                    "criterion": "informed consent document",
                    "requirement_type": "willingness to sign",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Histologic diagnosis of chondrosarcoma, verifiable after enrollment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologic diagnosis of chondrosarcoma"
                    ],
                    "criterion": "chondrosarcoma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Previously treated or incurable disease without options for standard of care therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previously treated"
                    ],
                    "criterion": "disease",
                    "requirement_type": "treatment history",
                    "expected_value": "previously treated"
                },
                {
                    "exact_snippets": [
                        "incurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "curability",
                    "expected_value": "incurable"
                },
                {
                    "exact_snippets": [
                        "without options for standard of care therapy"
                    ],
                    "criterion": "standard of care therapy options",
                    "requirement_type": "availability",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0-2",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG performance status of 0-2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Life expectancy of > 3 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy of > 3 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "patients of reproductive potential"
                    ],
                    "criterion": "reproductive potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "use of reliable means for contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "throughout the trial and for 1 year following their final exposure to study treatment"
                    ],
                    "criterion": "contraception duration",
                    "requirement_type": "duration",
                    "expected_value": "throughout the trial and for 1 year following their final exposure to study treatment"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Systemic therapy or radiotherapy within 4 weeks prior to Day 1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Systemic therapy",
                        "within 4 weeks prior to Day 1"
                    ],
                    "criterion": "systemic therapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "radiotherapy",
                        "within 4 weeks prior to Day 1"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Prior therapy with agents targeting the DR5 apoptosis pathway",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior therapy with agents targeting the DR5 apoptosis pathway"
                    ],
                    "criterion": "therapy with agents targeting the DR5 apoptosis pathway",
                    "requirement_type": "prior",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major surgical procedure",
                        "within 4 weeks prior to Day 1"
                    ],
                    "criterion": "major surgical procedure",
                    "requirement_type": "timing",
                    "expected_value": "within 4 weeks prior to Day 1"
                },
                {
                    "exact_snippets": [
                        "open biopsy",
                        "within 4 weeks prior to Day 1"
                    ],
                    "criterion": "open biopsy",
                    "requirement_type": "timing",
                    "expected_value": "within 4 weeks prior to Day 1"
                },
                {
                    "exact_snippets": [
                        "significant traumatic injury",
                        "within 4 weeks prior to Day 1"
                    ],
                    "criterion": "significant traumatic injury",
                    "requirement_type": "timing",
                    "expected_value": "within 4 weeks prior to Day 1"
                },
                {
                    "exact_snippets": [
                        "anticipation of need for major surgical procedure",
                        "during the course of the study"
                    ],
                    "criterion": "major surgical procedure",
                    "requirement_type": "anticipated need",
                    "expected_value": "during the course of the study"
                }
            ]
        },
        {
            "line": "* Other invasive malignancies within 5 years prior to Day 1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other invasive malignancies within 5 years prior to Day 1"
                    ],
                    "criterion": "invasive malignancies",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Known active brain metastases",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known active brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled intercurrent illness"
                    ],
                    "criterion": "intercurrent illness",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "ongoing or active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "status",
                    "expected_value": [
                        "ongoing",
                        "active"
                    ]
                },
                {
                    "exact_snippets": [
                        "requiring parenteral antibiotics at enrollment"
                    ],
                    "criterion": "parenteral antibiotics",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinically significant, symptomatic cardiovascular disease"
                    ],
                    "criterion": "cardiovascular disease",
                    "requirement_type": "severity",
                    "expected_value": "clinically significant, symptomatic"
                },
                {
                    "exact_snippets": [
                        "New York Heart Association (NYHA) Grade II or greater congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "serious cardiac arrhythmia"
                    ],
                    "criterion": "cardiac arrhythmia",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "Grade II or greater peripheral vascular disease"
                    ],
                    "criterion": "peripheral vascular disease",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "history of major heart surgery within 6 months of Day 1"
                    ],
                    "criterion": "major heart surgery",
                    "requirement_type": "history",
                    "expected_value": "within 6 months of Day 1"
                },
                {
                    "exact_snippets": [
                        "any situation that would likely limit compliance with study requirements"
                    ],
                    "criterion": "compliance with study requirements",
                    "requirement_type": "limitation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Use of anticoagulation therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Use of anticoagulation therapy"
                    ],
                    "criterion": "anticoagulation therapy",
                    "requirement_type": "use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Participation in clinical trials"
                    ],
                    "criterion": "clinical trial participation",
                    "requirement_type": "recency",
                    "expected_value": {
                        "operator": "<=",
                        "value": 30
                    }
                },
                {
                    "exact_snippets": [
                        "undergoing other investigational procedures"
                    ],
                    "criterion": "investigational procedures",
                    "requirement_type": "recency",
                    "expected_value": {
                        "operator": "<=",
                        "value": 30
                    }
                }
            ]
        },
        {
            "line": "* Pregnancy or breast feeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breast feeding"
                    ],
                    "criterion": "breast feeding",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Known sensitivity to any of the products administered during the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known sensitivity to any of the products administered during the study"
                    ],
                    "criterion": "sensitivity to study products",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": [
                        "disorder that compromises the ability of the patient to give written informed consent"
                    ],
                    "criterion": "disorder",
                    "requirement_type": "impact on consent ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "disorder that compromises the ability of the patient to",
                        "comply with study procedures"
                    ],
                    "criterion": "disorder",
                    "requirement_type": "impact on compliance",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Known to be positive for hepatitis C or hepatitis B surface antigen",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known to be positive for hepatitis C"
                    ],
                    "criterion": "hepatitis C",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "positive for hepatitis B surface antigen"
                    ],
                    "criterion": "hepatitis B surface antigen",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of other disease"
                    ],
                    "criterion": "other disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "metabolic dysfunction"
                    ],
                    "criterion": "metabolic dysfunction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "physical examination finding"
                    ],
                    "criterion": "physical examination finding",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinical laboratory finding"
                    ],
                    "criterion": "clinical laboratory finding",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "reasonable suspicion of a disease or condition that contraindicates use of an investigational drug"
                    ],
                    "criterion": "disease or condition",
                    "requirement_type": "contraindication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "disease or condition that might affect interpretation of the results of the study"
                    ],
                    "criterion": "disease or condition",
                    "requirement_type": "impact on study results",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "disease or condition that might",
                        "render the patient at high risk for treatment complications"
                    ],
                    "criterion": "disease or condition",
                    "requirement_type": "risk for treatment complications",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}