{
    "info": {
        "nct_id": "NCT04031872",
        "official_title": "MoTriColor: Phase I/II Study With LY3200882 Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature",
        "inclusion_criteria": "1. Histological or cytological proof of CRC;\n2. Disease progression or relapse upon at least one line of treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);\n3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia;\n4. Age ≥ 18 years;\n5. Able and willing to give written informed consent;\n6. WHO performance status of ≤ 1;\n7. LVEF ≥ 55%;\n8. Able and willing to undergo blood sampling for PK and PD analysis;\n9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment\n10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;\n11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);\n12. Minimal acceptable safety laboratory values\n\n    1. ANC of ≥ 1.5 x 109 /L\n    2. Platelet count of ≥ 100 x 109 /L\n    3. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases\n    4. Renal function as defined by serum creatinine ≤1.5 x ULN\n    5. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);\n13. Negative pregnancy test (urine or serum) for female patients with childbearing potential.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment;\n2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A>T genotype);\n3. Symptomatic or untreated leptomeningeal disease;\n4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;\n5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart.\n6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LY3200882 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection);\n7. Woman who are pregnant or breast feeding;\n8. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed;\n9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery;\n10. Active infection requiring systemic antibiotics or uncontrolled infectious disease;\n11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;\n12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;\n13. Known hypersensitivity to one of the study drugs or excipients.\n14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine. More information is available in section 5.2.4.\n15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in section 5.2.4.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histological or cytological proof of CRC;",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological proof of CRC",
                    "criterion": "CRC proof",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Disease progression or relapse upon at least one line of treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);",
            "criterions": [
                {
                    "exact_snippets": "Disease progression or relapse",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "progression",
                                "relapse"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one line of treatment",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "minimum number of treatments",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced CRC",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "specific type",
                            "expected_value": "advanced CRC"
                        }
                    ]
                },
                {
                    "exact_snippets": "fluoropyrimidine containing chemotherapy as single agent or in combination",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "fluoropyrimidine"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "allowed combinations",
                            "expected_value": [
                                "oxaliplatin",
                                "irinotecan",
                                "bevacizumab",
                                "cetuximab",
                                "panitumumab"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia;",
            "criterions": [
                {
                    "exact_snippets": "activated TGF-β signature-like gene signature",
                    "criterion": "TGF-β signature-like gene signature",
                    "requirements": [
                        {
                            "requirement_type": "activation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by the validated assay of Agendia",
                    "criterion": "validated assay of Agendia",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age ≥ 18 years;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Able and willing to give written informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to give written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. WHO performance status of ≤ 1;",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status of ≤ 1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. LVEF ≥ 55%;",
            "criterions": [
                {
                    "exact_snippets": "LVEF ≥ 55%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Able and willing to undergo blood sampling for PK and PD analysis;",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to undergo blood sampling for PK and PD analysis",
                    "criterion": "blood sampling for PK and PD analysis",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment",
                    "criterion": "tumor biopsies",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "before start",
                                "during treatment",
                                "at the end of treatment"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);",
            "criterions": [
                {
                    "exact_snippets": "Evaluable disease according to RECIST 1.1 criteria",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease for the phase II part",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "II"
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable disease is sufficient for the phase I part",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "I"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Minimal acceptable safety laboratory values",
            "criterions": [
                {
                    "exact_snippets": "Minimal acceptable safety laboratory values",
                    "criterion": "safety laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "minimal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ANC of ≥ 1.5 x 109 /L",
            "criterions": [
                {
                    "exact_snippets": "ANC of ≥ 1.5 x 109 /L",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9 /L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Platelet count of ≥ 100 x 109 /L",
            "criterions": [
                {
                    "exact_snippets": "Platelet count of ≥ 100 x 109 /L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9 /L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic function as defined by ... ALAT and ASAT ≤ 3.0 x ULN",
                    "criterion": "ALAT and ASAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic function as defined by ... ALAT and ASAT ≤ 5 x ULN in patients with liver metastases",
                    "criterion": "ALAT and ASAT in patients with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Renal function as defined by serum creatinine ≤1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Renal function as defined by serum creatinine ≤1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance ≥ 50 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Negative pregnancy test (urine or serum) for female patients with childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test (urine or serum)",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "female patients with childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment;",
            "criterions": [
                {
                    "exact_snippets": "treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment",
                    "criterion": "treatment with investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A>T genotype);",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected dihydropirimidine dehydrogenase deficit",
                    "criterion": "dihydropirimidine dehydrogenase deficit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mutant for DPD*2A genotype",
                    "criterion": "DPD*2A genotype",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    ]
                },
                {
                    "exact_snippets": "1236 GA genotype",
                    "criterion": "1236 GA genotype",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    ]
                },
                {
                    "exact_snippets": "1679TG genotype",
                    "criterion": "1679TG genotype",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    ]
                },
                {
                    "exact_snippets": "2846A>T genotype",
                    "criterion": "2846A>T genotype",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "mutant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Symptomatic or untreated leptomeningeal disease;",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic or untreated leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Brain metastasis must be stable with verification by imaging",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain MRI or CT (<21 days before start of treatment) completed at screening",
                    "criterion": "imaging verification",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrating no current evidence of progressive brain metastases",
                    "criterion": "progressive brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients are not permitted to receive enzyme inducing anti-epileptic drugs",
                    "criterion": "enzyme inducing anti-epileptic drugs",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients are not permitted to receive ... corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart.",
            "criterions": [
                {
                    "exact_snippets": "History of cardiac disease, including myocardial infarction within 6 months before study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiac disease, including ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiac disease, including ... New York Heart Association Class III/IV congestive heart failure",
                    "criterion": "New York Heart Association Class III/IV congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiac disease, including ... uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiac disease, including ... major cardiac abnormalities",
                    "criterion": "major cardiac abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a predisposition for developing aneurysms including family history of aneurysms",
                    "criterion": "family history of aneurysms",
                    "requirements": [
                        {
                            "requirement_type": "predisposition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a predisposition for developing aneurysms including ... Marfan syndrome",
                    "criterion": "Marfan syndrome",
                    "requirements": [
                        {
                            "requirement_type": "predisposition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a predisposition for developing aneurysms including ... bicuspid aortic valve",
                    "criterion": "bicuspid aortic valve",
                    "requirements": [
                        {
                            "requirement_type": "predisposition",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of damage to the large vessels of the heart",
                    "criterion": "damage to the large vessels of the heart",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LY3200882 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection);",
            "criterions": [
                {
                    "exact_snippets": "Impairment of gastrointestinal (GI) function or GI disease",
                    "criterion": "gastrointestinal (GI) function or GI disease",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative diseases",
                    "criterion": "ulcerative diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small bowel resection",
                    "criterion": "small bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Woman who are pregnant or breast feeding;",
            "criterions": [
                {
                    "exact_snippets": "Woman who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed;",
            "criterions": [
                {
                    "exact_snippets": "Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment.",
                    "criterion": "radio- or chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Palliative radiation (1x 8Gy) is allowed",
                    "criterion": "palliative radiation",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "1x 8Gy"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery;",
            "criterions": [
                {
                    "exact_snippets": "undergone any major surgery within the last 2 weeks prior to starting study drug",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "would not have fully recovered from previous surgery",
                    "criterion": "recovery from previous surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Active infection requiring systemic antibiotics or uncontrolled infectious disease;",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic antibiotics"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled infectious disease",
                    "criterion": "infectious disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;",
            "criterions": [
                {
                    "exact_snippets": "known history of hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of hepatitis ... C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known Human Immunodeficiency Virus HIV-1",
                    "criterion": "HIV-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known Human Immunodeficiency Virus ... HIV-2",
                    "criterion": "HIV-2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;",
            "criterions": [
                {
                    "exact_snippets": "Other severe, acute, or chronic medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Known hypersensitivity to one of the study drugs or excipients.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to one of the study drugs",
                    "criterion": "hypersensitivity to study drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... excipients",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine. More information is available in section 5.2.4.",
            "criterions": [
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "agreement to remain abstinent (refrain from heterosexual intercourse)",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use contraceptive methods with a failure rate of <1% per year",
                    "criterion": "contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in section 5.2.4.",
            "criterions": [
                {
                    "exact_snippets": "For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures",
                    "criterion": "contraceptive measures or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agreement to refrain from donating sperm",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}