{
    "info": {
        "nct_id": "NCT04672460",
        "official_title": "A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE BETWEEN THE PROPOSED SOFT GEL TALAZOPARIB CAPSULE FORMULATION AND THE CURRENT TALAZOPARIB COMMERCIAL FORMULATION AND TO ESTIMATE THE FOOD EFFECT ON PHARMACOKINETICS OF THE PROPOSED TALAZOPARIB SOFT GEL CAPSULE FORMULATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.\n\n   * Solid tumors with known or likely pathogenic germline or somatic tumor gene defect (eg, one or more BRCA1 or BRCA2 gene defect except for ovarian cancer) that would benefit from PARPi therapy per current approvals for the tumor indication or supported by strong scientific evidence.\n   * Received at least 1 prior SOC regimen, if it exists, as appropriate for the respective tumor type unless deemed unsuitable or declined these therapies; ovarian cancer participants must have at least 1 prior cytotoxic chemotherapy regimen, including at least 1 course of platinum-based therapy. Participants must not have had disease progression within 6 months of initiation of platinum containing regimen.\n2. ECOG performance score of 0-1.\n3. Adequate bone marrow function:\n\n   * ANC ≥1500 cells/mm3\n   * Platelets ≥100,000 cells/mm3\n   * Hemoglobin ≥10.0 g/dL\n4. Adequate organ functions:\n\n   * CLCR ≥60 mL/min and no documented CLCR <60 mL/min and no change in CLCR >25% in the past 4 weeks\n   * AST and ALT ≤2.5 × ULN; if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤5 × ULN;\n   * Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome);\n\nExclusion Criteria\n\n1. For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.\n2. Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE <Grade 2, except for alopecia, sensory neuropathies ≤Grade 2, or other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.\n3. Diagnosed with MDS or AML.\n4. Active infection requiring systemic therapy within 2 weeks of enrollment.\n5. Any condition in which active bleeding or pathological conditions may carry a high risk of bleeding (eg, known bleeding disorder, coagulopathy or tumor involvement with major vessels).\n6. Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.\n7. Known history of testing positive for HIV, AIDS, positive HBV surface antigen, positive HCV RNA, or positive COVID-19 viral test. Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed.\n8. Current or anticipated use of P-gp inhibitors, BCRP inhibitors, and P-gp inducers within 2 weeks or 5 half-lives prior to randomization (whichever is longer) ."
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "Histological diagnosis of recurrent, locally advanced or metastatic solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "recurrent, locally advanced or metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable for treatment with curative intent",
                    "criterion": "treatment amenability",
                    "requirements": [
                        {
                            "requirement_type": "curative intent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Solid tumors with known or likely pathogenic germline or somatic tumor gene defect (eg, one or more BRCA1 or BRCA2 gene defect except for ovarian cancer) that would benefit from PARPi therapy per current approvals for the tumor indication or supported by strong scientific evidence.",
            "criterions": [
                {
                    "exact_snippets": "Solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "solid"
                        }
                    ]
                },
                {
                    "exact_snippets": "known or likely pathogenic germline or somatic tumor gene defect",
                    "criterion": "gene defect",
                    "requirements": [
                        {
                            "requirement_type": "pathogenicity",
                            "expected_value": [
                                "known",
                                "likely"
                            ]
                        },
                        {
                            "requirement_type": "origin",
                            "expected_value": [
                                "germline",
                                "somatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "one or more BRCA1 or BRCA2 gene defect",
                    "criterion": "specific gene defect",
                    "requirements": [
                        {
                            "requirement_type": "genes",
                            "expected_value": [
                                "BRCA1",
                                "BRCA2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ovarian cancer",
                    "criterion": "cancer type exclusion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "ovarian cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "benefit from PARPi therapy per current approvals for the tumor indication or supported by strong scientific evidence",
                    "criterion": "PARPi therapy benefit",
                    "requirements": [
                        {
                            "requirement_type": "benefit",
                            "expected_value": "per current approvals or supported by strong scientific evidence"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received at least 1 prior SOC regimen, if it exists, as appropriate for the respective tumor type unless deemed unsuitable or declined these therapies; ovarian cancer participants must have at least 1 prior cytotoxic chemotherapy regimen, including at least 1 course of platinum-based therapy. Participants must not have had disease progression within 6 months of initiation of platinum containing regimen.",
            "criterions": [
                {
                    "exact_snippets": "Received at least 1 prior SOC regimen, if it exists, as appropriate for the respective tumor type",
                    "criterion": "prior SOC regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian cancer participants must have at least 1 prior cytotoxic chemotherapy regimen",
                    "criterion": "prior cytotoxic chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including at least 1 course of platinum-based therapy",
                    "criterion": "platinum-based therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "course"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must not have had disease progression within 6 months of initiation of platinum containing regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "time since initiation of platinum containing regimen",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG performance score of 0-1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance score of 0-1",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequate bone marrow function:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ANC ≥1500 cells/mm3",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥1500 cells/mm3",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥100,000 cells/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥100,000 cells/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥10.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥10.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate organ functions:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CLCR ≥60 mL/min and no documented CLCR <60 mL/min and no change in CLCR >25% in the past 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "CLCR ≥60 mL/min",
                    "criterion": "creatinine clearance (CLCR)",
                    "requirements": [
                        {
                            "requirement_type": "minimum value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no documented CLCR <60 mL/min",
                    "criterion": "creatinine clearance (CLCR)",
                    "requirements": [
                        {
                            "requirement_type": "documented minimum value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no change in CLCR >25% in the past 4 weeks",
                    "criterion": "creatinine clearance (CLCR)",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 4 weeks"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT ≤2.5 × ULN; if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤5 × ULN;",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT ≤2.5 × ULN",
                    "criterion": "AST and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤5 × ULN",
                    "criterion": "AST and ALT levels with hepatic metastasis",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome);",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤1.5 × ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ... (≤3 × ULN for Gilbert's syndrome)",
                    "criterion": "total bilirubin in Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.",
            "criterions": [
                {
                    "exact_snippets": "ovarian participants: Non-epithelial tumors",
                    "criterion": "ovarian tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-epithelial"
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian tumors with low malignant potential (ie, borderline tumors)",
                    "criterion": "ovarian tumor malignancy",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous tumors",
                    "criterion": "ovarian tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mucinous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE <Grade 2, except for alopecia, sensory neuropathies ≤Grade 2, or other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.",
            "criterions": [
                {
                    "exact_snippets": "Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE <Grade 2",
                    "criterion": "toxicities from previous anti-cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia, sensory neuropathies ≤Grade 2",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia, sensory neuropathies ≤Grade 2",
                    "criterion": "sensory neuropathies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment",
                    "criterion": "other adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "NCI CTCAE Grade"
                            }
                        },
                        {
                            "requirement_type": "safety risk",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosed with MDS or AML.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed with MDS",
                    "criterion": "MDS",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosed with ... AML",
                    "criterion": "AML",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active infection requiring systemic therapy within 2 weeks of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy within 2 weeks of enrollment.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Any condition in which active bleeding or pathological conditions may carry a high risk of bleeding (eg, known bleeding disorder, coagulopathy or tumor involvement with major vessels).",
            "criterions": [
                {
                    "exact_snippets": "active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological conditions may carry a high risk of bleeding",
                    "criterion": "pathological conditions with high risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor involvement with major vessels",
                    "criterion": "tumor involvement with major vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active leptomeningeal disease undergoing or requiring treatment",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "undergoing or requiring treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Asymptomatic brain metastases currently not undergoing treatment",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "not undergoing treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known history of testing positive for HIV, AIDS, positive HBV surface antigen, positive HCV RNA, or positive COVID-19 viral test. Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Known history of testing positive for HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "history of positive test",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of testing positive for ... AIDS",
                    "criterion": "AIDS",
                    "requirements": [
                        {
                            "requirement_type": "history of positive test",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of testing positive for ... positive HBV surface antigen",
                    "criterion": "HBV surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "history of positive test",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of testing positive for ... positive HCV RNA",
                    "criterion": "HCV RNA",
                    "requirements": [
                        {
                            "requirement_type": "history of positive test",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of testing positive for ... positive COVID-19 viral test",
                    "criterion": "COVID-19 viral test",
                    "requirements": [
                        {
                            "requirement_type": "history of positive test",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed",
                    "criterion": "asymptomatic with positive antibody tests",
                    "requirements": [
                        {
                            "requirement_type": "active infection",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "antibody test",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "8. Current or anticipated use of P-gp inhibitors, BCRP inhibitors, and P-gp inducers within 2 weeks or 5 half-lives prior to randomization (whichever is longer) .",
            "criterions": [
                {
                    "exact_snippets": "Current or anticipated use of P-gp inhibitors",
                    "criterion": "P-gp inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or anticipated use of BCRP inhibitors",
                    "criterion": "BCRP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Current or anticipated use of ... P-gp inducers",
                    "criterion": "P-gp inducers",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}