{
    "info": {
        "nct_id": "NCT03031691",
        "official_title": "A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer",
        "inclusion_criteria": "* Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy\n* ECOG performance status 0 or 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors\n* Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible\n* Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug\n* Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:\n\n  * Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)\n  * Active peptic ulcer disease\n  * Known intraluminal metastatic lesion(s) with risk of bleeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed metastatic colorectal cancer (mCRC)",
                    "criterion": "metastatic colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": [
                                "fluoropyrimidine-based",
                                "oxaliplatin-based",
                                "irinotecan-based"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated with ... an anti-VEGF biological therapy",
                    "criterion": "anti-VEGF biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if KRAS wild-type, an anti-EGFR therapy",
                    "criterion": "KRAS status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "if KRAS wild-type, an anti-EGFR therapy",
                    "criterion": "anti-EGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "allowed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with gamma secretase inhibitors",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "gamma secretase inhibitors"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with ... other Notch 1 inhibitors",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "other Notch 1 inhibitors"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible",
            "criterions": [
                {
                    "exact_snippets": "known active HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV that are under a stable anti-retroviral regimen",
                    "criterion": "anti-retroviral regimen",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of immune deficiency (normal CD4 counts)",
                    "criterion": "immune deficiency",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable viral load",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "no HIV-related infections",
                    "criterion": "HIV-related infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled diarrhea <30 days prior to first administration of study drug",
                    "criterion": "uncontrolled diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "any history of or current clinically significant gastrointestinal disease",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "current presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)",
            "criterions": [
                {
                    "exact_snippets": "Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active peptic ulcer disease",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer disease",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known intraluminal metastatic lesion(s) with risk of bleeding",
            "criterions": [
                {
                    "exact_snippets": "Known intraluminal metastatic lesion(s)",
                    "criterion": "intraluminal metastatic lesion(s)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of bleeding",
                    "criterion": "risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}