{
    "info": {
        "nct_id": "NCT01048320",
        "official_title": "A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas",
        "inclusion_criteria": "* age > 18 years\n* gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment)\n* locally advanced or metastatic disease with measurable or non-measurable disease\n* life expectancy of greater than 10 weeks\n* prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered>4 weeks prior to start of therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* any serious uncontrolled medical condition\n* prior radiation treatment is not allowed\n* no prior chemotherapy within the previous 4 weeks\n* known peripheral neuropathy > CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible\n* known brain metastases\n* lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication\n* fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception\n* pregnancy or breast feeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* age > 18 years",
            "criterions": [
                {
                    "exact_snippets": "age > 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment)",
            "criterions": [
                {
                    "exact_snippets": "gemcitabine-refractory",
                    "criterion": "gemcitabine-refractory",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression during or within 6 months of first-line treatment",
                    "criterion": "progression after first-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during or within 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* locally advanced or metastatic disease with measurable or non-measurable disease",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable or non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* life expectancy of greater than 10 weeks",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of greater than 10 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered>4 weeks prior to start of therapy",
            "criterions": [
                {
                    "exact_snippets": "prior treatment with investigational therapies",
                    "criterion": "prior treatment with investigational therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EGFR and VEGF antagonists",
                    "criterion": "prior treatment with EGFR and VEGF antagonists",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "administered>4 weeks prior to start of therapy",
                    "criterion": "time since last administration of investigational therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "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": "* any serious uncontrolled medical condition",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrolled medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* prior radiation treatment is not allowed",
            "criterions": [
                {
                    "exact_snippets": "prior radiation treatment is not allowed",
                    "criterion": "prior radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* no prior chemotherapy within the previous 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "no prior chemotherapy within the previous 4 weeks",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known peripheral neuropathy > CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible",
            "criterions": [
                {
                    "exact_snippets": "known peripheral neuropathy > CTCAE v 3.0 grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE v 3.0 grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of the deep tendon reflexes as the sole neurological abnormality",
                    "criterion": "deep tendon reflexes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication",
            "criterions": [
                {
                    "exact_snippets": "lack of physical integrity of the upper GI tract",
                    "criterion": "physical integrity of the upper GI tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "fertile women (<2 years after last menstruation)",
                    "criterion": "fertile women",
                    "requirements": [
                        {
                            "requirement_type": "time since last menstruation",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "men of childbearing potential",
                    "criterion": "men of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to use effective contraception",
                    "criterion": "willingness to use effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pregnancy or breast feeding",
            "criterions": [
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}