{
    "info": {
        "nct_id": "NCT04439266",
        "official_title": "MATCH Treatment Subprotocol F: Crizotinib in Patients With Tumors (Other Than Adenocarcinoma of Lung or ALCL) With ALK Rearrangements",
        "inclusion_criteria": "* Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol\n* Patients must have an ALK rearrangement as defined via the MATCH Master Protocol\n* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients must not have non small cell lung cancer or anaplastic large cell lymphoma (ALCL)\n* Patients with a history of interstitial lung disease or pneumonitis are excluded\n* Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition\n* Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922\n* Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment\n* Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol",
            "criterions": [
                {
                    "exact_snippets": "met applicable eligibility criteria in the Master MATCH Protocol",
                    "criterion": "eligibility criteria in the Master MATCH Protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an ALK rearrangement as defined via the MATCH Master Protocol",
            "criterions": [
                {
                    "exact_snippets": "ALK rearrangement",
                    "criterion": "ALK rearrangement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)",
            "criterions": [
                {
                    "exact_snippets": "electrocardiogram (ECG) within 8 weeks prior to treatment assignment",
                    "criterion": "electrocardiogram (ECG) timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 8 weeks prior to treatment assignment"
                        }
                    ]
                },
                {
                    "exact_snippets": "no clinically important abnormalities in rhythm, conduction or morphology of resting ECG",
                    "criterion": "ECG abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "complete left bundle branch block",
                    "criterion": "complete left bundle branch block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "third degree heart block",
                    "criterion": "third degree heart block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients must not have non small cell lung cancer or anaplastic large cell lymphoma (ALCL)",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have non small cell lung cancer",
                    "criterion": "non small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must not have ... anaplastic large cell lymphoma (ALCL)",
                    "criterion": "anaplastic large cell lymphoma (ALCL)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of interstitial lung disease or pneumonitis are excluded",
            "criterions": [
                {
                    "exact_snippets": "history of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to crizotinib",
                    "criterion": "hypersensitivity to crizotinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... compounds of similar chemical or biologic composition",
                    "criterion": "hypersensitivity to compounds of similar chemical or biologic composition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922",
            "criterions": [
                {
                    "exact_snippets": "Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922",
                    "criterion": "prior ALK-targeted inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "specific inhibitors",
                            "expected_value": [
                                "crizotinib",
                                "ceritinib",
                                "alectinib",
                                "AP26113",
                                "TSR-011",
                                "X-396",
                                "RXDX-101",
                                "CEP-37440",
                                "PF-06463922"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases ... treated and neurologically stable for at least 2 weeks",
                    "criterion": "treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "neurological stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases ... untreated, asymptomatic, and treatment is not indicated",
                    "criterion": "untreated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "treatment indication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "dose stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will be excluded",
            "criterions": [
                {
                    "exact_snippets": "Patients using drugs or foods that are known potent CYP3A4 inhibitors",
                    "criterion": "use of potent CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients using drugs or foods that are known potent CYP3A4 ... inducers",
                    "criterion": "use of potent CYP3A4 inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}