{
    "info": {
        "nct_id": "NCT03306394",
        "official_title": "An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)",
        "inclusion_criteria": "* Male or Female participant aged ≥18 years old.\n* Has definitive histologically confirmed adenocarcinoma of the colon or rectum.\n* Has metastatic lesion(s).\n* Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.\n* Is able to take medications orally (i.e., no feeding tube).\n* Has adequate organ function.\n* Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnancy, breastfeeding or possibility of becoming pregnant during the study.\n* Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.\n* Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.\n* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.\n* Has certain serious illness or medical condition(s) described in the protocol.\n* Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.\n* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or Female participant aged ≥18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Male or Female participant",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has definitive histologically confirmed adenocarcinoma of the colon or rectum.",
            "criterions": [
                {
                    "exact_snippets": "definitive histologically confirmed adenocarcinoma of the colon or rectum",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "colon",
                                "rectum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has metastatic lesion(s).",
            "criterions": [
                {
                    "exact_snippets": "Has metastatic lesion(s)",
                    "criterion": "metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.",
            "criterions": [
                {
                    "exact_snippets": "Has received at least 2 prior regimens of standard chemotherapies",
                    "criterion": "prior regimens of standard chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients",
                    "criterion": "types of chemotherapies received",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "fluoropyrimidines",
                                "irinotecan",
                                "oxaliplatin",
                                "anti-VEGF monoclonal antibody",
                                "anti-EGFR monoclonal antibodies for RAS wild-type patients"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "is refractory or intolerant to those chemotherapies",
                    "criterion": "refractory or intolerant to chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "refractory or intolerant"
                        }
                    ]
                },
                {
                    "exact_snippets": "is not candidate for those chemotherapies",
                    "criterion": "candidate for chemotherapies",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.",
            "criterions": [
                {
                    "exact_snippets": "Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is able to take medications orally (i.e., no feeding tube).",
            "criterions": [
                {
                    "exact_snippets": "Is able to take medications orally (i.e., no feeding tube).",
                    "criterion": "ability to take medications orally",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration.",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to first day of test drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication.",
                    "criterion": "birth control method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 6 months after the discontinuation of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women and female partners using hormonal contraceptive must also use a barrier method.",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal contraceptive",
                                "barrier method"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Pregnancy, breastfeeding or possibility of becoming pregnant during the study.",
            "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": "possibility of becoming pregnant during the study",
                    "criterion": "possibility of becoming pregnant",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.",
            "criterions": [
                {
                    "exact_snippets": "Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.",
                    "criterion": "enrolment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "study",
                            "expected_value": "another available ongoing clinical study of trifluridine / tipiracil"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.",
            "criterions": [
                {
                    "exact_snippets": "Has previously received trifluridine / tipiracil",
                    "criterion": "previous treatment with trifluridine / tipiracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to the active substances",
                    "criterion": "hypersensitivity to active substances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to any of the excipients of trifluridine / tipiracil",
                    "criterion": "hypersensitivity to excipients of trifluridine / tipiracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.",
            "criterions": [
                {
                    "exact_snippets": "Has rare hereditary problems of galactose intolerance",
                    "criterion": "galactose intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Has rare hereditary problems of ... the Lapp lactase deficiency",
                    "criterion": "Lapp lactase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Has rare hereditary problems of ... glucose-galactose malabsorption",
                    "criterion": "glucose-galactose malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has certain serious illness or medical condition(s) described in the protocol.",
            "criterions": [
                {
                    "exact_snippets": "certain serious illness or medical condition(s)",
                    "criterion": "serious illness or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. major surgery",
                    "criterion": "recent major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the specified time frames prior to first day of study drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... anticancer therapy",
                    "criterion": "recent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the specified time frames prior to first day of study drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... radiation therapy",
                    "criterion": "recent radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the specified time frames prior to first day of study drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has had certain other recent treatment e.g. ... participation in another interventional study",
                    "criterion": "recent participation in another interventional study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the specified time frames prior to first day of study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).",
            "criterions": [
                {
                    "exact_snippets": "unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2",
                    "criterion": "unresolved toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "attributed to any prior therapies",
                    "criterion": "attribution to prior therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity",
                    "criterion": "exclusion of specific conditions",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "anemia",
                                "alopecia",
                                "skin pigmentation",
                                "platinum-induced neurotoxicity"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}