{
    "info": {
        "nct_id": "NCT03914794",
        "official_title": "Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors",
        "inclusion_criteria": "* Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to the following characteristics:\n\n  * Low Risk\n\n    * Initial tumor with all of the following:\n    * Solitary tumor\n    * Ta tumor\n    * Low-grade\n    * <3 cm\n    * No CIS\n  * Intermediate Risk\n\n    --- All tumors not defined in the two adjacent categories (between the category of low- and high-risk)\n  * High Risk\n\n    * T1 tumor\n    * High-grade\n    * CIS\n    * Multiple and recurrent and large (>3 cm) Ta low-grade tumors (all conditions must be met for this point on Ta low-grade tumors)\n* Documented tumor recurrence as noted in standard of care follow up cystoscopy.\n* ECOG (WHO) performance status 0-2\n* Age ≥ 18 years old\n* Patients must have the following laboratory values:\n\n  * White blood cell count (WBC) > 3.0 K/mm3\n  * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3\n  * Platelets ≥ 100 K/mm3\n  * Hemoglobin (Hgb) ≥ 9 g/dL\n  * Serum total bilirubin: ≤ 1.5 x ULN\n  * ALT and AST ≤ 3.0 x ULN\n  * Serum calcium < ULN\n  * Serum phosphate < ULN\n  * Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the modified Cockcroft-Gault equation\n* Patients who give a written informed consent obtained according to local guidelines\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma.\n* Patients with high grade urothelial carcinoma on their most recent urine cytology.\n* Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. (Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.)\n* Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy\n* Patients who have received prior selective fibroblast growth factor receptor targeting agents (i.e. pemigatinib, dovitinib, BGJ398, AZD4547, JNJ-42756493, etc.).\n* Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities\n* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to the following characteristics:",
            "criterions": [
                {
                    "exact_snippets": "Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC)",
                    "criterion": "non-muscle invasive urothelial carcinoma of the bladder (NMIBC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "low",
                                "intermediate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low Risk",
            "criterions": [
                {
                    "exact_snippets": "Low Risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initial tumor with all of the following:",
            "criterions": [
                {
                    "exact_snippets": "Initial tumor",
                    "criterion": "initial tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Solitary tumor",
            "criterions": [
                {
                    "exact_snippets": "Solitary tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "solitary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ta tumor",
            "criterions": [
                {
                    "exact_snippets": "Ta tumor",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Ta"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low-grade",
            "criterions": [
                {
                    "exact_snippets": "Low-grade",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* <3 cm",
            "criterions": [
                {
                    "exact_snippets": "<3 cm",
                    "criterion": "size",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No CIS",
            "criterions": [
                {
                    "exact_snippets": "No CIS",
                    "criterion": "CIS (carcinoma in situ)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intermediate Risk",
            "criterions": [
                {
                    "exact_snippets": "Intermediate Risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "intermediate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "--- All tumors not defined in the two adjacent categories (between the category of low- and high-risk)",
            "criterions": [
                {
                    "exact_snippets": "All tumors not defined in the two adjacent categories (between the category of low- and high-risk)",
                    "criterion": "tumor risk category",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": "not between low- and high-risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High Risk",
            "criterions": [
                {
                    "exact_snippets": "High Risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T1 tumor",
            "criterions": [
                {
                    "exact_snippets": "T1 tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High-grade",
            "criterions": [
                {
                    "exact_snippets": "High-grade",
                    "criterion": "tumor grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CIS",
            "criterions": [
                {
                    "exact_snippets": "CIS",
                    "criterion": "CIS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Multiple and recurrent and large (>3 cm) Ta low-grade tumors (all conditions must be met for this point on Ta low-grade tumors)",
            "criterions": [
                {
                    "exact_snippets": "Multiple and recurrent and large (>3 cm) Ta low-grade tumors",
                    "criterion": "Ta low-grade tumors",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented tumor recurrence as noted in standard of care follow up cystoscopy.",
            "criterions": [
                {
                    "exact_snippets": "Documented tumor recurrence",
                    "criterion": "tumor recurrence",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG (WHO) performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG (WHO) performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have the following laboratory values:",
            "criterions": [
                {
                    "exact_snippets": "Patients must have the following laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) > 3.0 K/mm3",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) > 3.0 K/mm3",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "K/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1.5 K/mm3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 K/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "K/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100 K/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100 K/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "K/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin (Hgb) ≥ 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin (Hgb) ≥ 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum total bilirubin: ≤ 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin: ≤ 1.5 x ULN",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT and AST ≤ 3.0 x ULN",
            "criterions": [
                {
                    "exact_snippets": "ALT ... ≤ 3.0 x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ≤ 3.0 x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum calcium < ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum calcium < ULN",
                    "criterion": "serum calcium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum phosphate < ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum phosphate < ULN",
                    "criterion": "serum phosphate",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the modified Cockcroft-Gault equation",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤ 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine > 1.5 - 3 x ULN ... calculated creatinine clearance (CrCl) is ≥ 30 mL/min",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance (CrCl) is ≥ 30 mL/min",
                    "criterion": "calculated creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who give a written informed consent obtained according to local guidelines",
            "criterions": [
                {
                    "exact_snippets": "Patients who give a written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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 with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma",
                    "criterion": "upper urinary tract non-invasive urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with high grade urothelial carcinoma on their most recent urine cytology.",
            "criterions": [
                {
                    "exact_snippets": "high grade urothelial carcinoma",
                    "criterion": "urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "most recent urine cytology",
                    "criterion": "urine cytology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. (Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.)",
            "criterions": [
                {
                    "exact_snippets": "another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer",
                    "criterion": "active second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse",
                    "criterion": "risk of relapse",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug",
                    "criterion": "time since last anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from the side effects of such therapy",
                    "criterion": "recovery from side effects of anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received prior selective fibroblast growth factor receptor targeting agents (i.e. pemigatinib, dovitinib, BGJ398, AZD4547, JNJ-42756493, etc.).",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior selective fibroblast growth factor receptor targeting agents",
                    "criterion": "prior treatment with selective fibroblast growth factor receptor targeting agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug",
                    "criterion": "time since radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from radiotherapy toxicities",
                    "criterion": "recovery from radiotherapy toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug",
                    "criterion": "major surgery, open biopsy, or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug",
                    "criterion": "minor procedures, percutaneous biopsies, or placement of vascular access device",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "who have not recovered from side effects of such procedure or injury",
                    "criterion": "recovery from side effects of procedure or injury",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}