{
    "info": {
        "nct_id": "NCT03349073",
        "official_title": "An Extension Study of T-1101 (Tosylate) Administered Orally to Patients With Advanced Refractory Solid Tumors",
        "inclusion_criteria": "1. Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.\n2. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.\n3. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.\n4. Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.\n5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.\n6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "1. Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.\n2. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).\n3. Progressive or untreated metastatic brain or meningeal tumors.\n4. Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, or a vasectomized partner.\n5. Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients with advanced malignancy",
                    "criterion": "advanced malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study",
                    "criterion": "T-1101 (Tosylate) treatment in previous study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "study that has reached its endpoint",
                    "criterion": "previous study endpoint",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "reached"
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to continue to have an overall positive benefit/risk from continuing treatment",
                    "criterion": "overall positive benefit/risk from continuing treatment",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential ... must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test within 7 days of the first dose",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of the first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have completed the End of Study assessments in their originating study",
                    "criterion": "completion of End of Study assessments",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patient does not have any interruption in T-1101 (Tosylate) dosing",
                    "criterion": "T-1101 (Tosylate) dosing",
                    "requirements": [
                        {
                            "requirement_type": "interruption",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Signed and dated informed consent document",
                    "criterion": "informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed and dated"
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that the patient has been informed of all the pertinent aspects of the trial",
                    "criterion": "patient information",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": "all pertinent aspects of the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.",
            "criterions": [
                {
                    "exact_snippets": "Willingness and ability to comply with scheduled visits",
                    "criterion": "compliance with scheduled visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... treatment plans",
                    "criterion": "compliance with treatment plans",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... laboratory tests",
                    "criterion": "compliance with laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willingness and ability to comply with ... other study procedures",
                    "criterion": "compliance with other study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.",
            "criterions": [
                {
                    "exact_snippets": "Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).",
            "criterions": [
                {
                    "exact_snippets": "Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "blood pressure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 150,
                                        "unit": "mmHg"
                                    },
                                    {
                                        "operator": ">",
                                        "value": 100,
                                        "unit": "mmHg"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Progressive or untreated metastatic brain or meningeal tumors.",
            "criterions": [
                {
                    "exact_snippets": "Progressive or untreated metastatic brain or meningeal tumors",
                    "criterion": "metastatic brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progressive or untreated metastatic brain or meningeal tumors",
                    "criterion": "meningeal tumors",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, or a vasectomized partner.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients must be surgically sterile",
                    "criterion": "male surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients ... must agree to use effective contraception during the period of therapy",
                    "criterion": "male contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients must be surgically sterile",
                    "criterion": "female surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients ... be postmenopausal",
                    "criterion": "female postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients ... must agree to the use of highly effective contraception during the period of therapy",
                    "criterion": "female contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year)",
                    "criterion": "contraception effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "percent per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological ... conditions that may interfere",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social conditions that may interfere",
                    "criterion": "social conditions",
                    "requirements": [
                        {
                            "requirement_type": "interference with participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}