{
    "info": {
        "nct_id": "NCT00090701",
        "official_title": "A Phase 2, Open-Label, Multicenter Study Of The GARFT Inhibitor AG2037 In Patients With MetastatIC Non Small Cell Lung Cancer Who Failed Two Or Three Prior Treatments",
        "inclusion_criteria": "* presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)\n* treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (Note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)\n* capable of understanding the nature of the trial and willing to give written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n* hemoglobin level of >=9 g/dL, absolute granulocyte count of >=1.5 &#215; 109/L, and platelet count of >=100 &#215; 109/L\n* adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (ULN) and a measured or calculated creatinine clearance of >=60 mL/min\n* adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times ULN; levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) <=2 times ULN. If the patient has liver involvement then AST and ALT should be <=5 times ULN\n* for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age\n* life expectancy estimated at greater than 12 weeks\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* history of blood transfusion within the last 14 days\n* need of concurrent administration of allopurinol\n* history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin C within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)\n* any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol\n* any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives\n* receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)\n* pregnant or breast-feeding\n* previous treatment with GARFT inhibitors\n* history of radiation therapy to more than 40% of the marrow space\n* history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years\n* active brain metastases (requiring treatment or progressing)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)",
            "criterions": [
                {
                    "exact_snippets": "presence of measurable, metastatic non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurable",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed at the time of original diagnosis",
                    "criterion": "non-small cell lung cancer confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of original diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (Note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)",
            "criterions": [
                {
                    "exact_snippets": "treatment failure (recurrence, disease progression, or intolerable toxicity)",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2 or 3 prior systemic treatments",
                    "criterion": "prior systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 3 prior systemic regimens for non-small cell lung cancer",
                    "criterion": "prior systemic regimens for non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* capable of understanding the nature of the trial and willing to give written informed consent",
            "criterions": [
                {
                    "exact_snippets": "capable of understanding the nature of the trial",
                    "criterion": "understanding of trial",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to give written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (ULN) and a measured or calculated creatinine clearance of >=60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (ULN)",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the institutional upper limit of normal (ULN)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate renal function, ... a measured or calculated creatinine clearance of >=60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times ULN; levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) <=2 times ULN. If the patient has liver involvement then AST and ALT should be <=5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times ULN",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ... <=2 times ULN",
                    "criterion": "serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) <=2 times ULN",
                    "criterion": "serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If the patient has liver involvement then AST and ALT should be <=5 times ULN",
                    "criterion": "AST and ALT levels with liver involvement",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study",
                    "criterion": "contraception or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy estimated at greater than 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "life expectancy estimated at greater than 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "estimate",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* history of blood transfusion within the last 14 days",
            "criterions": [
                {
                    "exact_snippets": "history of blood transfusion within the last 14 days",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* need of concurrent administration of allopurinol",
            "criterions": [
                {
                    "exact_snippets": "need of concurrent administration of allopurinol",
                    "criterion": "concurrent administration of allopurinol",
                    "requirements": [
                        {
                            "requirement_type": "need",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin C within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)",
            "criterions": [
                {
                    "exact_snippets": "history of radiotherapy or chemotherapy within 4 weeks",
                    "criterion": "history of radiotherapy or chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nitrosourea or mitomycin C within 6 weeks",
                    "criterion": "history of nitrosourea or mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy",
                    "criterion": "recovery from acute effects of prior chemotherapy or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": "fully recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol",
            "criterions": [
                {
                    "exact_snippets": "any psychological ... condition",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any ... sociological condition",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any ... addictive disorder",
                    "criterion": "addictive disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any ... family problems",
                    "criterion": "family problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives",
            "criterions": [
                {
                    "exact_snippets": "any unstable or severe intercurrent medical condition",
                    "criterion": "intercurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "unstable",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator might interfere with achievement of study objectives",
                    "criterion": "interference with study objectives",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)",
            "criterions": [
                {
                    "exact_snippets": "receipt of an investigational agent within 28 days before the anticipated first day of dosing",
                    "criterion": "receipt of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patient must have recovered from all acute effects of previously administered investigational agents",
                    "criterion": "recovery from acute effects of investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previous treatment with GARFT inhibitors",
            "criterions": [
                {
                    "exact_snippets": "previous treatment with GARFT inhibitors",
                    "criterion": "previous treatment with GARFT inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* history of radiation therapy to more than 40% of the marrow space",
            "criterions": [
                {
                    "exact_snippets": "history of radiation therapy",
                    "criterion": "radiation therapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 40% of the marrow space",
                    "criterion": "radiation therapy coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years",
            "criterions": [
                {
                    "exact_snippets": "history of a malignancy (other than non-small cell lung cancer)",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except those treated with curative intent for skin cancer (other than melanoma)",
                    "criterion": "treatment intent for skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "except those treated with curative intent for skin cancer (other than melanoma)",
                    "criterion": "type of skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-melanoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ breast or cervical cancer",
                    "criterion": "type of cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "in situ breast cancer",
                                "in situ cervical cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "those treated with curative intent for any other cancer with no evidence of disease for 5 years",
                    "criterion": "treatment intent for other cancers",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "those treated with curative intent for any other cancer with no evidence of disease for 5 years",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "those treated with curative intent for any other cancer with no evidence of disease for 5 years",
                    "criterion": "disease-free duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* active brain metastases (requiring treatment or progressing)",
            "criterions": [
                {
                    "exact_snippets": "active brain metastases (requiring treatment or progressing)",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* hemoglobin level of >=9 g/dL, absolute granulocyte count of >=1.5 &#215; 109/L, and platelet count of >=100 &#215; 109/L",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin level of >=9 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute granulocyte count of >=1.5 × 109/L",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count of >=100 × 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 109/L"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}