{
    "info": {
        "nct_id": "NCT01888965",
        "official_title": "A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers",
        "inclusion_criteria": "* Patients with a confirmed diagnosis of:\n\n  1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance \"standard of care\", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1.\n  2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.\n* Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.\n* No concomitant anti-cancer treatment is allowed\n* Age >/= 18 years\n* Performance status of 0-1\n* Adequate hepatic, bone marrow, and renal function\n* Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5.\n* Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts\n* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.\n* Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.\n* Women who are breast-feeding\n* Fertile males unwilling to use contraception\n* Patients with brain metastases or any history of brain metastases\n* Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy\n* Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib\n* The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.\n* Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n* Patients who are currently receiving prasugrel\n* No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate\n* No concurrent use of other investigational drugs or antineoplastic therapies.\n* Patients with impaired cardiac function or clinically significant cardiac diseases.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a confirmed diagnosis of:",
            "criterions": [
                {
                    "exact_snippets": [
                        "confirmed diagnosis"
                    ],
                    "criterion": "diagnosis",
                    "requirement_type": "confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance \"standard of care\", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Stage 4 colon cancer"
                    ],
                    "criterion": "colon cancer",
                    "requirement_type": "stage",
                    "expected_value": "4"
                },
                {
                    "exact_snippets": [
                        "s/p metastasectomy"
                    ],
                    "criterion": "metastasectomy",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "post-initial chemotherapy"
                    ],
                    "criterion": "initial chemotherapy",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "maintenance \"standard of care\""
                    ],
                    "criterion": "standard of care",
                    "requirement_type": "maintenance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "5-fluorouracil/leucovorin (5-FU/LV)"
                    ],
                    "criterion": "chemotherapy regimen",
                    "requirement_type": "involvement",
                    "expected_value": "5-fluorouracil/leucovorin (5-FU/LV)"
                },
                {
                    "exact_snippets": [
                        "continual bevacizumab"
                    ],
                    "criterion": "chemotherapy regimen",
                    "requirement_type": "involvement",
                    "expected_value": "bevacizumab"
                },
                {
                    "exact_snippets": [
                        "2 consecutive CT scans showing stable disease"
                    ],
                    "criterion": "CT scans",
                    "requirement_type": "stability",
                    "expected_value": "stable disease"
                },
                {
                    "exact_snippets": [
                        "not be experiencing significant prior treatment-related toxicity above Grade 1"
                    ],
                    "criterion": "treatment-related toxicity",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pancreas cancer"
                    ],
                    "criterion": "pancreas cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "s/p resection"
                    ],
                    "criterion": "resection",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "adjuvant chemotherapy"
                    ],
                    "criterion": "adjuvant chemotherapy",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "locally advanced pancreas cancer"
                    ],
                    "criterion": "locally advanced pancreas cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "s/p chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "radiation"
                    ],
                    "criterion": "radiation",
                    "requirement_type": "status",
                    "expected_value": "post"
                },
                {
                    "exact_snippets": [
                        "Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start"
                    ],
                    "criterion": "chemotherapy or radiation therapy",
                    "requirement_type": "time since cessation",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            },
                            {
                                "operator": "<=",
                                "value": 8
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "patients must have recovered from prior treatment related toxicity to grade 1 or less"
                    ],
                    "criterion": "treatment related toxicity",
                    "requirement_type": "severity",
                    "expected_value": {
                        "operator": "<=",
                        "value": 1
                    }
                }
            ]
        },
        {
            "line": "* Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior surgery, including tumor resection or metastasectomy"
                    ],
                    "criterion": "prior surgery",
                    "requirement_type": "type",
                    "expected_value": [
                        "tumor resection",
                        "metastasectomy"
                    ]
                },
                {
                    "exact_snippets": [
                        "must have been performed at least 4 weeks prior to study enrollment"
                    ],
                    "criterion": "prior surgery",
                    "requirement_type": "timing",
                    "expected_value": ">= 4 weeks prior to study enrollment"
                }
            ]
        },
        {
            "line": "* No concomitant anti-cancer treatment is allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "No concomitant anti-cancer treatment is allowed"
                    ],
                    "criterion": "concomitant anti-cancer treatment",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Age >/= 18 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age >/= 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Performance status of 0-1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Performance status of 0-1"
                    ],
                    "criterion": "performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Adequate hepatic, bone marrow, and renal function",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate hepatic"
                    ],
                    "criterion": "hepatic function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Adequate",
                        "bone marrow"
                    ],
                    "criterion": "bone marrow function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Adequate",
                        "renal function"
                    ],
                    "criterion": "renal function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Partial thromboplastin time (PTT)",
                        "must be </= 1.5 x upper normal limit"
                    ],
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "INR (International Normalized Ratio)",
                        "< 1.5"
                    ],
                    "criterion": "INR (International Normalized Ratio)",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women of childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative serum pregnancy test"
                    ],
                    "criterion": "serum pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "within 14 days prior to initiation of treatment"
                    ],
                    "criterion": "serum pregnancy test",
                    "requirement_type": "timing",
                    "expected_value": "within 14 days prior to initiation of treatment"
                },
                {
                    "exact_snippets": [
                        "must not be lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "capable of understanding and complying with protocol demands"
                    ],
                    "criterion": "understanding and compliance",
                    "requirement_type": "capability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "able to sign and date the informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "ability to sign and date",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women of child-bearing potential"
                    ],
                    "criterion": "child-bearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "biologically able to conceive"
                    ],
                    "criterion": "ability to conceive",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "not employing two forms of highly effective contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "quantity",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "who are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Women who are breast-feeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women who are breast-feeding"
                    ],
                    "criterion": "breast-feeding",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Fertile males unwilling to use contraception",
            "criterions": [
                {
                    "exact_snippets": [
                        "Fertile males"
                    ],
                    "criterion": "fertility",
                    "requirement_type": "status",
                    "expected_value": "fertile"
                },
                {
                    "exact_snippets": [
                        "unwilling to use contraception"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "willingness",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients with brain metastases or any history of brain metastases",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients with brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "any history of brain metastases"
                    ],
                    "criterion": "brain metastases",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "undergone major surgery"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "intra-thoracic, -abdominal, or -pelvic"
                    ],
                    "criterion": "surgery type",
                    "requirement_type": "specificity",
                    "expected_value": [
                        "intra-thoracic",
                        "intra-abdominal",
                        "intra-pelvic"
                    ]
                },
                {
                    "exact_snippets": [
                        "</= 4 weeks prior to starting study treatment"
                    ],
                    "criterion": "time since surgery",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of pulmonary embolism"
                    ],
                    "criterion": "pulmonary embolism",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "untreated deep vein thrombosis",
                        "within the past 6 months"
                    ],
                    "criterion": "deep vein thrombosis",
                    "requirement_type": "treatment status and time frame",
                    "expected_value": "untreated within the past 6 months"
                }
            ]
        },
        {
            "line": "* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib",
            "criterions": [
                {
                    "exact_snippets": [
                        "Impairment of gastrointestinal (GI) function"
                    ],
                    "criterion": "gastrointestinal function",
                    "requirement_type": "impairment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "GI disease that may significantly alter the absorption of dovitinib"
                    ],
                    "criterion": "GI disease",
                    "requirement_type": "impact on absorption of dovitinib",
                    "expected_value": "significant alteration"
                }
            ]
        },
        {
            "line": "* The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": [
                        "another active malignancy",
                        "within the past 5 years"
                    ],
                    "criterion": "active malignancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "cervical cancer in situ"
                    ],
                    "criterion": "cervical cancer in situ",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "in situ carcinoma of the bladder"
                    ],
                    "criterion": "in situ carcinoma of the bladder",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "non-melanoma carcinoma of the skin"
                    ],
                    "criterion": "non-melanoma carcinoma of the skin",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug"
                    ],
                    "criterion": "time since last anticancer therapy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "have not recovered from the side effects of such therapy"
                    ],
                    "criterion": "recovery from side effects of anticancer therapy",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis",
            "criterions": [
                {
                    "exact_snippets": [
                        "Cirrhosis"
                    ],
                    "criterion": "cirrhosis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "chronic active hepatitis"
                    ],
                    "criterion": "chronic active hepatitis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "chronic persistent hepatitis"
                    ],
                    "criterion": "chronic persistent hepatitis",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who are currently receiving prasugrel",
            "criterions": [
                {
                    "exact_snippets": [
                        "currently receiving prasugrel"
                    ],
                    "criterion": "prasugrel",
                    "requirement_type": "current use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* No concurrent use of other investigational drugs or antineoplastic therapies.",
            "criterions": [
                {
                    "exact_snippets": [
                        "No concurrent use of other investigational drugs"
                    ],
                    "criterion": "investigational drugs",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No concurrent use of other",
                        "antineoplastic therapies"
                    ],
                    "criterion": "antineoplastic therapies",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients with impaired cardiac function or clinically significant cardiac diseases.",
            "criterions": [
                {
                    "exact_snippets": [
                        "impaired cardiac function"
                    ],
                    "criterion": "cardiac function",
                    "requirement_type": "impairment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinically significant cardiac diseases"
                    ],
                    "criterion": "cardiac diseases",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy >/= 4 months",
                        "maintenance cohorts"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "minimum duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Life expectancy >/= 6 months",
                        "adjuvant cohorts"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "minimum duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate",
            "criterions": [
                {
                    "exact_snippets": [
                        "No concurrent use of isoniazid"
                    ],
                    "criterion": "isoniazid",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No concurrent use of labetolol"
                    ],
                    "criterion": "labetolol",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No concurrent use of trovafloxacin"
                    ],
                    "criterion": "trovafloxacin",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No concurrent use of tolcapone"
                    ],
                    "criterion": "tolcapone",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No concurrent use of felbamate"
                    ],
                    "criterion": "felbamate",
                    "requirement_type": "concurrent use",
                    "expected_value": false
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}