{
    "info": {
        "nct_id": "NCT00195260",
        "official_title": "Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors",
        "inclusion_criteria": "* Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\n* Other inclusion applies.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.\n* Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).\n* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).\n* Other exclusion applies.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.",
                "criterions": [
                    {
                        "exact_snippets": "Advanced or recurrent solid malignancy",
                        "criterion": "solid malignancy",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "recurrent"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "confirmed histologically or cytologically",
                        "criterion": "confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "for which no effective therapy is available",
                        "criterion": "effective therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Advanced or recurrent solid malignancy",
                                        "criterion": "solid malignancy",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "advanced",
                                                "recurrent"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "confirmed histologically or cytologically",
                                        "criterion": "confirmation method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "for which no effective therapy is available",
                                "criterion": "effective therapy availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "modified RECIST criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "modified RECIST criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other inclusion applies.",
                "criterions": [
                    {
                        "exact_snippets": "Other inclusion applies.",
                        "criterion": "other inclusion",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "applies"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other inclusion applies.",
                        "criterion": "other inclusion",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "applies"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).",
                "criterions": [
                    {
                        "exact_snippets": "Prior exposure to SKI-606 or any other Src-kinase inhibitor",
                        "criterion": "exposure to Src-kinase inhibitor",
                        "requirement": {
                            "requirement_type": "prior exposure",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "major surgery ... within 14 days before the first dose",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "radiotherapy within 14 days before the first dose",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "recovery from previous surgery should be complete before day 1",
                        "criterion": "recovery from previous surgery",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "complete"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Prior exposure to SKI-606 or any other Src-kinase inhibitor",
                                "criterion": "exposure to Src-kinase inhibitor",
                                "requirement": {
                                    "requirement_type": "prior exposure",
                                    "expected_value": false
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "major surgery ... within 14 days before the first dose",
                                        "criterion": "major surgery",
                                        "requirement": {
                                            "requirement_type": "time since event",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 14,
                                                "unit": "days"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "recovery from previous surgery should be complete before day 1",
                                        "criterion": "recovery from previous surgery",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "complete"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "radiotherapy within 14 days before the first dose",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Other exclusion applies.",
                "criterions": [
                    {
                        "exact_snippets": "Other exclusion applies.",
                        "criterion": "other exclusion",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "applies"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other exclusion applies.",
                        "criterion": "other exclusion",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "applies"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).",
                "criterions": [
                    {
                        "exact_snippets": "Active central nervous system (CNS) metastases",
                        "criterion": "active CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Treated CNS metastases must be stable for >= 2 weeks before day 1",
                        "criterion": "treated CNS metastases stability",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active central nervous system (CNS) metastases",
                                "criterion": "active CNS metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Active central nervous system (CNS) metastases",
                                        "criterion": "active CNS metastases",
                                        "requirement": {
                                            "requirement_type": "clinical symptoms",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Active central nervous system (CNS) metastases",
                                        "criterion": "active CNS metastases",
                                        "requirement": {
                                            "requirement_type": "cerebral edema",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Active central nervous system (CNS) metastases",
                                        "criterion": "active CNS metastases",
                                        "requirement": {
                                            "requirement_type": "requirement for corticosteroids",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Active central nervous system (CNS) metastases",
                                        "criterion": "active CNS metastases",
                                        "requirement": {
                                            "requirement_type": "progressive growth",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treated CNS metastases must be stable for >= 2 weeks before day 1",
                                "criterion": "treated CNS metastases stability",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Treated CNS metastases must be stable for >= 2 weeks before day 1",
                                "criterion": "treated CNS metastases stability",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.",
                "criterions": [
                    {
                        "exact_snippets": "Use of any systemic antitumor agents",
                        "criterion": "systemic antitumor agents",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "use of any ... investigational agent",
                        "criterion": "investigational agent",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Use of any systemic antitumor agents",
                                "criterion": "systemic antitumor agents",
                                "requirement": {
                                    "requirement_type": "use",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "use of any ... investigational agent",
                                "criterion": "investigational agent",
                                "requirement": {
                                    "requirement_type": "use",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "within 28 days before the first dose of test article is administered",
                        "criterion": "time since last use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}