{
    "info": {
        "nct_id": "NCT00014365",
        "official_title": "The Food-Effect Bioavailability Study of Ro 31-7453, a Novel Cell Cycle Inhibitor, in Stable Patient Volunteers With Solid Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which no standard therapy is available No CNS metastases\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history or clinical signs of significant cardiovascular disease Other: No other serious concurrent illness No greater than grade II neuropathy No evidence of gastrointestinal dysfunction No intolerance to a high-fat meal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy: At least 2 weeks since prior endocrine therapy (except for antiandrogen therapy) Concurrent antiandrogen therapy allowed Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No prior enrollment in this study At least 4 weeks since prior investigational drugs No other concurrent investigational agents"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which no standard therapy is available No CNS metastases",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "locally advanced or metastatic solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "for which no standard therapy is available",
                        "criterion": "standard therapy availability",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Histologically or cytologically confirmed",
                                        "criterion": "solid tumor",
                                        "requirement": {
                                            "requirement_type": "confirmation method",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "locally advanced or metastatic solid tumor",
                                        "criterion": "solid tumor",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "locally advanced",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "for which no standard therapy is available",
                                "criterion": "standard therapy availability",
                                "requirement": {
                                    "requirement_type": "availability",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history or clinical signs of significant cardiovascular disease Other: No other serious concurrent illness No greater than grade II neuropathy No evidence of gastrointestinal dysfunction No intolerance to a high-fat meal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception",
                "criterions": [
                    {
                        "exact_snippets": "Age: 18 and over",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Performance status: Karnofsky 60-100%",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "scale",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy: Not specified",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    },
                    {
                        "exact_snippets": "Hematopoietic: Hemoglobin at least 9 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "WBC at least 3,000/mm3",
                        "criterion": "white blood cell count",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count at least 100,000/mm3",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
                        "criterion": "bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases)",
                        "criterion": "AST and ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases)",
                        "criterion": "AST and ALT",
                        "requirement": {
                            "requirement_type": "level for liver metastases",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases)",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases)",
                        "criterion": "alkaline phosphatase",
                        "requirement": {
                            "requirement_type": "level for liver or bone metastases",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal: Creatinine no greater than 1.5 times ULN",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Cardiovascular: No history or clinical signs of significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "history or clinical signs",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Other: No other serious concurrent illness",
                        "criterion": "serious concurrent illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No greater than grade II neuropathy",
                        "criterion": "neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No evidence of gastrointestinal dysfunction",
                        "criterion": "gastrointestinal dysfunction",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No intolerance to a high-fat meal",
                        "criterion": "intolerance to a high-fat meal",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Not pregnant or nursing",
                        "criterion": "pregnancy or nursing",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Fertile patients must use effective contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "necessity for fertile patients",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Age: 18 and over",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 18,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Performance status: Karnofsky 60-100%",
                                "criterion": "performance status",
                                "requirement": {
                                    "requirement_type": "scale",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 60,
                                                "unit": "%"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Hematopoietic: Hemoglobin at least 9 g/dL",
                                "criterion": "hemoglobin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "WBC at least 3,000/mm3",
                                "criterion": "white blood cell count",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3000,
                                        "unit": "mm3"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
                                "criterion": "absolute neutrophil count",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1500,
                                        "unit": "mm3"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Platelet count at least 100,000/mm3",
                                "criterion": "platelet count",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100000,
                                        "unit": "mm3"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
                                "criterion": "bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times ULN"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases)",
                                        "criterion": "AST and ALT",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1.5,
                                                "unit": "times ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases)",
                                        "criterion": "AST and ALT",
                                        "requirement": {
                                            "requirement_type": "level for liver metastases",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "times ULN"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases)",
                                        "criterion": "alkaline phosphatase",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 2.5,
                                                "unit": "times ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases)",
                                        "criterion": "alkaline phosphatase",
                                        "requirement": {
                                            "requirement_type": "level for liver or bone metastases",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "times ULN"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Renal: Creatinine no greater than 1.5 times ULN",
                                "criterion": "creatinine",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Cardiovascular: No history or clinical signs of significant cardiovascular disease",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "history or clinical signs",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Other: No other serious concurrent illness",
                                "criterion": "serious concurrent illness",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No greater than grade II neuropathy",
                                "criterion": "neuropathy",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "No evidence of gastrointestinal dysfunction",
                                "criterion": "gastrointestinal dysfunction",
                                "requirement": {
                                    "requirement_type": "evidence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "No intolerance to a high-fat meal",
                                "criterion": "intolerance to a high-fat meal",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Not pregnant or nursing",
                                "criterion": "pregnancy or nursing",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Negative pregnancy test",
                                "criterion": "pregnancy test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "Fertile patients must use effective contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "necessity for fertile patients",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy: At least 2 weeks since prior endocrine therapy (except for antiandrogen therapy) Concurrent antiandrogen therapy allowed Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No prior enrollment in this study At least 4 weeks since prior investigational drugs No other concurrent investigational agents",
                "criterions": [
                    {
                        "exact_snippets": "At least 3 weeks since prior biologic therapy",
                        "criterion": "prior biologic therapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "6 weeks for mitomycin or nitrosoureas",
                        "criterion": "prior mitomycin or nitrosoureas chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 2 weeks since prior endocrine therapy",
                        "criterion": "prior endocrine therapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Concurrent antiandrogen therapy allowed",
                        "criterion": "concurrent antiandrogen therapy",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study",
                        "criterion": "concurrent corticosteroids",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study",
                        "criterion": "concurrent corticosteroids",
                        "requirement": {
                            "requirement_type": "stable dose duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 3 weeks since prior radiotherapy",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No prior enrollment in this study",
                        "criterion": "prior enrollment in this study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "At least 4 weeks since prior investigational drugs",
                        "criterion": "prior investigational drugs",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No other concurrent investigational agents",
                        "criterion": "concurrent investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ]
}