{
    "info": {
        "nct_id": "NCT04083976",
        "official_title": "A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations",
        "inclusion_criteria": "* Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion\n* Measurable disease\n* Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies\n* Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening\nHealthy volunteers allowed\nMust have minimum age of 6 Years",
        "exclusion_criteria": "* Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib\n* The presence of FGFR gatekeeper and resistance mutations\n* Histologic demonstration of urothelial carcinoma\n* Hematologic malignancy (i.e., myeloid and lymphoid neoplasms\n* For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS\n* Active malignancies other than for disease requiring therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion",
            "criterions": [
                {
                    "exact_snippets": "Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy",
                    "criterion": "solid tumor malignancy",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "unresectable",
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "fibroblast growth factor receptor (FGFR) mutation",
                    "criterion": "FGFR mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "FGFR gene fusion",
                    "criterion": "FGFR gene fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies",
            "criterions": [
                {
                    "exact_snippets": "Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "is a child or adolescent participant",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": [
                                "child",
                                "adolescent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "newly-diagnosed solid tumor",
                    "criterion": "solid tumor diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "newly-diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "no acceptable standard therapies",
                    "criterion": "availability of standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening",
            "criterions": [
                {
                    "exact_snippets": "Documented progression of disease",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progression that requires a change in treatment",
                    "criterion": "treatment change requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to full study screening",
                    "criterion": "timing of progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to full study screening"
                        }
                    ]
                }
            ]
        },
        {
            "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 6 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 6 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib",
            "criterions": [
                {
                    "exact_snippets": "Has had prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted therapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with an investigational anticancer agent",
                    "criterion": "treatment with an investigational anticancer agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The presence of FGFR gatekeeper and resistance mutations",
            "criterions": [
                {
                    "exact_snippets": "presence of FGFR gatekeeper",
                    "criterion": "FGFR gatekeeper mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of ... resistance mutations",
                    "criterion": "resistance mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic demonstration of urothelial carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologic demonstration of urothelial carcinoma",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "demonstration",
                            "expected_value": "histologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematologic malignancy (i.e., myeloid and lymphoid neoplasms",
            "criterions": [
                {
                    "exact_snippets": "Hematologic malignancy (i.e., myeloid and lymphoid neoplasms",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myeloid",
                    "criterion": "myeloid neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lymphoid neoplasms",
                    "criterion": "lymphoid neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS",
            "criterions": [
                {
                    "exact_snippets": "non-small cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-small cell lung cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathogenic somatic mutations or gene fusions",
                    "criterion": "genetic mutations or fusions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "EGFR",
                    "criterion": "EGFR mutation or fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK",
                    "criterion": "ALK mutation or fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ROS1",
                    "criterion": "ROS1 mutation or fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "NTRK",
                    "criterion": "NTRK mutation or fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BRAF V600E",
                    "criterion": "BRAF V600E mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "KRAS",
                    "criterion": "KRAS mutation or fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active malignancies other than for disease requiring therapy",
            "criterions": [
                {
                    "exact_snippets": "Active malignancies other than for disease requiring therapy",
                    "criterion": "active malignancies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}