{
    "info": {
        "nct_id": "NCT01068782",
        "official_title": "A Phase 2 Non-Comparative Randomized Open-Label Study of Multiple Regimens of Single-Agent XL184 in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse",
        "inclusion_criteria": "* The subject has histologically confirmed diagnosis at any time of grade IV astrocytic tumor as determined by the investigator. Tumor samples will be required for pathology review.\n* The subject has received prior standard radiation for any grade astrocytic tumor.\n* The subject has received prior temozolomide (Temodar) therapy\n* The subject has had one or two progressions as grade IV astrocytic tumor from any grade, as determined by investigator\n* The subject must have a qualifying brain MRI scan within a specific timeframe prior to start of study treatment\n* For subjects with recent tumor resection or biopsy, starting on study must occur a specified amount of time after the surgery and the subject must have recovered from the effects of surgery\n* The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow whole capsules\n* The subject is capable of understanding the informed consent and has signed the informed consent document\n* The subject has adequate organ and marrow function\n* Sexually active subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 6 months following discontinuation of study treatment\n* The subject has had no other diagnosis of malignancy (certain exceptions apply)\n* Female subjects of childbearing potential must have a negative pregnancy test at screening\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The subject has received certain prior anticancer therapies within a certain amount of time before starting study treatment\n* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin\n* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible\n* The subject is unable to undergo MRI scan (eg, has pacemaker)\n* The subject has received enzyme-inducing anti-epileptic agents within a certain time prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital, primidone)\n* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, or other medications that were administered prior to study start\n* The subject has evidence of unhealed wounds\n* The subject is pregnant or breast-feeding\n* The subject has serious intercurrent illness or a recent history of serious disease\n* The subject has inherited bleeding diathesis or coagulopathy (disease affecting how blood clots) with the risk of bleeding\n* The subject has a history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection) that would potentially interfere with or alter gastrointestinal function\n* The subject has a history of idiopathic pulmonary fibrosis or interstitial lung disease\n* The subject has received any live virus vaccine or any inactivated vaccine within a certain amount of time before starting study treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The subject has histologically confirmed diagnosis at any time of grade IV astrocytic tumor as determined by the investigator. Tumor samples will be required for pathology review.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed diagnosis ... grade IV astrocytic tumor",
                    "criterion": "grade IV astrocytic tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor samples will be required for pathology review",
                    "criterion": "tumor samples",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has received prior standard radiation for any grade astrocytic tumor.",
            "criterions": [
                {
                    "exact_snippets": "The subject has received prior standard radiation",
                    "criterion": "prior standard radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any grade astrocytic tumor",
                    "criterion": "astrocytic tumor",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has received prior temozolomide (Temodar) therapy",
            "criterions": [
                {
                    "exact_snippets": "The subject has received prior temozolomide (Temodar) therapy",
                    "criterion": "temozolomide therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has had one or two progressions as grade IV astrocytic tumor from any grade, as determined by investigator",
            "criterions": [
                {
                    "exact_snippets": "one or two progressions as grade IV astrocytic tumor",
                    "criterion": "progressions of grade IV astrocytic tumor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by investigator",
                    "criterion": "determination by investigator",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject must have a qualifying brain MRI scan within a specific timeframe prior to start of study treatment",
            "criterions": [
                {
                    "exact_snippets": "qualifying brain MRI scan",
                    "criterion": "brain MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within a specific timeframe prior to start of study treatment",
                    "criterion": "timeframe for brain MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "specific timeframe prior to start of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For subjects with recent tumor resection or biopsy, starting on study must occur a specified amount of time after the surgery and the subject must have recovered from the effects of surgery",
            "criterions": [
                {
                    "exact_snippets": "recent tumor resection or biopsy",
                    "criterion": "recent tumor resection or biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting on study must occur a specified amount of time after the surgery",
                    "criterion": "time after surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": "a specified amount of time"
                        }
                    ]
                },
                {
                    "exact_snippets": "subject must have recovered from the effects of surgery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow whole capsules",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status ≥ 70%",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to swallow whole capsules",
                    "criterion": "ability to swallow whole capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is capable of understanding the informed consent and has signed the informed consent document",
            "criterions": [
                {
                    "exact_snippets": "The subject is capable of understanding the informed consent",
                    "criterion": "understanding of informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has signed the informed consent document",
                    "criterion": "informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has adequate organ and marrow function",
            "criterions": [
                {
                    "exact_snippets": "adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 6 months following discontinuation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Sexually active subjects (male and female) must agree to use medically accepted methods of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the course of the study and for 6 months following discontinuation of study treatment",
                    "criterion": "contraception use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the course of the study and for 6 months following discontinuation of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has had no other diagnosis of malignancy (certain exceptions apply)",
            "criterions": [
                {
                    "exact_snippets": "no other diagnosis of malignancy",
                    "criterion": "diagnosis of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female subjects of childbearing potential must have a negative pregnancy test at screening",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "female subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative pregnancy test at screening",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* The subject has received certain prior anticancer therapies within a certain amount of time before starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "The subject has received certain prior anticancer therapies",
                    "criterion": "prior anticancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within a certain amount of time before starting study treatment",
                    "criterion": "time since prior anticancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": "certain amount of time"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin",
            "criterions": [
                {
                    "exact_snippets": "The subject is receiving warfarin (or other coumarin derivatives)",
                    "criterion": "warfarin or other coumarin derivatives",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to switch to low molecular weight heparin",
                    "criterion": "ability to switch to low molecular weight heparin",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible",
            "criterions": [
                {
                    "exact_snippets": "evidence of acute intracranial or intratumoral hemorrhage",
                    "criterion": "acute intracranial or intratumoral hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resolving hemorrhage changes",
                    "criterion": "resolving hemorrhage changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "punctate hemorrhage",
                    "criterion": "punctate hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemosiderin",
                    "criterion": "hemosiderin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is unable to undergo MRI scan (eg, has pacemaker)",
            "criterions": [
                {
                    "exact_snippets": "unable to undergo MRI scan",
                    "criterion": "ability to undergo MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has received enzyme-inducing anti-epileptic agents within a certain time prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital, primidone)",
            "criterions": [
                {
                    "exact_snippets": "The subject has received enzyme-inducing anti-epileptic agents ... (eg, carbamazepine, phenytoin, phenobarbital, primidone)",
                    "criterion": "enzyme-inducing anti-epileptic agents",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, or other medications that were administered prior to study start",
            "criterions": [
                {
                    "exact_snippets": "The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs",
                    "criterion": "recovery from adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except alopecia and lymphopenia",
                    "criterion": "adverse events exceptions",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "alopecia",
                                "lymphopenia"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has evidence of unhealed wounds",
            "criterions": [
                {
                    "exact_snippets": "evidence of unhealed wounds",
                    "criterion": "unhealed wounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "The subject is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has serious intercurrent illness or a recent history of serious disease",
            "criterions": [
                {
                    "exact_snippets": "serious intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent history of serious disease",
                    "criterion": "history of disease",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has inherited bleeding diathesis or coagulopathy (disease affecting how blood clots) with the risk of bleeding",
            "criterions": [
                {
                    "exact_snippets": "inherited bleeding diathesis",
                    "criterion": "inherited bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulopathy (disease affecting how blood clots)",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of bleeding",
                    "criterion": "risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection) that would potentially interfere with or alter gastrointestinal function",
            "criterions": [
                {
                    "exact_snippets": "history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection)",
                    "criterion": "medical or surgical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere with or alter gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a history of idiopathic pulmonary fibrosis or interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "history of idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has received any live virus vaccine or any inactivated vaccine within a certain amount of time before starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "The subject has received any live virus vaccine",
                    "criterion": "live virus vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The subject has received ... any inactivated vaccine",
                    "criterion": "inactivated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}