{
    "info": {
        "nct_id": "NCT05669482",
        "official_title": "A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas",
        "inclusion_criteria": "* Male or female subjects ≥ 18 years of age\n* Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma.\n* An Eastern Cooperative Group (ECOG) performance status ≤ 1\n* Measurable disease according to RECIST 1.1\n* Adequate organ function\n* Adequate cardiac function\n* Agreement to use highly effective method of contraceptive\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with pancreatic neuroendocrine tumors\n* Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma\n* Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAK\n* History of prior malignancy, with the exception of curatively treated malignancies\n* Major surgery within 4 weeks (excluding placement of vascular access)\n* Concurrent heart disease or severe obstructive pulmonary disease\n* Concurrent ocular disorders\n* Active skin disorder that has required systemic therapy within the past 1 year\n* Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome\n* Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female subjects ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma",
                    "criterion": "metastatic pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "evidence type",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* An Eastern Cooperative Group (ECOG) performance status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Group (ECOG) performance status ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease according to RECIST 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac function",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agreement to use highly effective method of contraceptive",
            "criterions": [
                {
                    "exact_snippets": "Agreement to use highly effective method of contraceptive",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "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 pancreatic neuroendocrine tumors",
            "criterions": [
                {
                    "exact_snippets": "pancreatic neuroendocrine tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "pancreatic neuroendocrine tumors"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma",
                    "criterion": "treatment for metastatic pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "prior",
                                "concomitant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAK",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors]",
                    "criterion": "prior treatment with RAS/MAPK pathway inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... inhibitors of FAK",
                    "criterion": "prior treatment with FAK inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior malignancy, with the exception of curatively treated malignancies",
            "criterions": [
                {
                    "exact_snippets": "History of prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated malignancies",
                    "criterion": "curatively treated malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks (excluding placement of vascular access)",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding placement of vascular access",
                    "criterion": "placement of vascular access",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent heart disease or severe obstructive pulmonary disease",
            "criterions": [
                {
                    "exact_snippets": "Concurrent heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe obstructive pulmonary disease",
                    "criterion": "obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent ocular disorders",
            "criterions": [
                {
                    "exact_snippets": "Concurrent ocular disorders",
                    "criterion": "ocular disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active skin disorder that has required systemic therapy within the past 1 year",
            "criterions": [
                {
                    "exact_snippets": "Active skin disorder that has required systemic therapy within the past 1 year",
                    "criterion": "skin disorder",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy within the past 1 year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome",
            "criterions": [
                {
                    "exact_snippets": "interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe lung disease",
                    "criterion": "severe lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary edema",
                    "criterion": "pulmonary edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adult respiratory distress syndrome",
                    "criterion": "adult respiratory distress syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": "Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy",
                    "criterion": "SARS-Cov2 infection",
                    "requirements": [
                        {
                            "requirement_type": "time since infection",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}