{
    "info": {
        "nct_id": "NCT06059001",
        "official_title": "A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced Solid Tumours",
        "inclusion_criteria": "* 1. Male or female patients, 18 years of age or older who sign the ICF and are willing and able to comply with the study protocol.\n\n  2. Histologically or cytologically proven pancreatic cancer (pancreatic ductal adenocarcinoma [PDAC]).\n\n  3. Patients have to be treatment naïve in the metastatic setting (neo-or adjuvant treatment has to be finished at least six months before) and are suitable to receive the standard regimen gemcitabine and nab-paclitaxel.\n\n  4. Patients must show a specific biomarker signature, which will be analysed before inclusion into the study, comprising CD62E, MIP-1ß, MCP-1 and IL-8.\n\n  5. Patients must have measurable disease as per RECIST v1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:\n  1. not reside in a field that has been subjected to prior radiotherapy, or\n  2. have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.\n\n     6. Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained from the patients. NOTE: In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening.\n\n     7. For each patient undergoing pre- and on-treatment biopsies, the identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator.\n\n     8. ECOG performance status up to 1. 9. Adequate organ function as defined by the following criteria:\n\n     Haematological:\n\n     o Neutrophils ≥1,500/μL\n\n     o Platelets ≥100,000/μL\n     * Haemoglobin ≥10 g/dL\n\n     Renal:\n\n     o Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥50 mL/min\n\n     Hepatic:\n\n     o Serum total bilirubin ≤1.5 upper limit of normal (ULN) or\n\n     o Direct bilirubin ≤ULN for patients with total bilirubin >1.5 ULN\n\n     o Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤2.5 ULN or ≤5 ULN if liver metastases\n\n     Chemistry:\n     * Albumin >30 g/L. 10. If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control (defined as having a low failure rate) for at least a menstrual cycle before and for 1 month after last study drug administration:\n\n  <!-- -->\n\n  1. True abstinence, when this is in line with the preferred and usual lifestyle of the patient, from sexual intercourse with a member of the opposite sex;\n  2. Sexual intercourse with vasectomised male;\n  3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers);\n  4. Use of an intrauterine contraceptive device. 11. Male patients and their sexual partners must use an appropriate contraceptive from Screening for 6 months after last study drug administration, including:\n\n  <!-- -->\n\n  1. True abstinence\n  2. Male sterilisation\n  3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom\n  4. Intrauterine contraceptive device and condom.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Systemic anti-cancer therapy within four weeks prior to study drug administration.\n2. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.\n3. Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible.\n4. Previous treatment with either gemcitabine or nab-paclitaxel in any setting.\n5. Contraindication to receive gemcitabine/nab-paclitaxel.\n6. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure.\n7. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.\n8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.\n9. Pregnant or nursing.\n10. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis.\n11. Live vaccine in the last four weeks.\n12. Current participation in another trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Male or female patients, 18 years of age or older who sign the ICF and are willing and able to comply with the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Male or female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the ICF",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically proven pancreatic cancer (pancreatic ductal adenocarcinoma [PDAC]).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic ductal adenocarcinoma [PDAC]",
                    "criterion": "pancreatic cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "pancreatic ductal adenocarcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients have to be treatment naïve in the metastatic setting (neo-or adjuvant treatment has to be finished at least six months before) and are suitable to receive the standard regimen gemcitabine and nab-paclitaxel.",
            "criterions": [
                {
                    "exact_snippets": "Patients have to be treatment naïve in the metastatic setting",
                    "criterion": "treatment status in metastatic setting",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                },
                {
                    "exact_snippets": "neo-or adjuvant treatment has to be finished at least six months before",
                    "criterion": "neo-or adjuvant treatment completion",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "suitable to receive the standard regimen gemcitabine and nab-paclitaxel",
                    "criterion": "suitability for standard regimen",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "gemcitabine and nab-paclitaxel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must show a specific biomarker signature, which will be analysed before inclusion into the study, comprising CD62E, MIP-1ß, MCP-1 and IL-8.",
            "criterions": [
                {
                    "exact_snippets": "Patients must show a specific biomarker signature, ... comprising CD62E, MIP-1ß, MCP-1 and IL-8.",
                    "criterion": "biomarker signature",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CD62E",
                                "MIP-1ß",
                                "MCP-1",
                                "IL-8"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must have measurable disease as per RECIST v1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:",
            "criterions": [
                {
                    "exact_snippets": "measurable disease as per RECIST v1.1 criteria",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "documented by computed tomography (CT) and/or magnetic resonance imaging (MRI)",
                    "criterion": "disease documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "computed tomography (CT)",
                                "magnetic resonance imaging (MRI)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. not reside in a field that has been subjected to prior radiotherapy, or",
            "criterions": [
                {
                    "exact_snippets": "reside in a field that has been subjected to prior radiotherapy",
                    "criterion": "prior radiotherapy field residence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.",
            "criterions": [
                {
                    "exact_snippets": "demonstrated clear evidence of radiographic progression",
                    "criterion": "radiographic progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "clear"
                        }
                    ]
                },
                {
                    "exact_snippets": "since the completion of prior radiotherapy",
                    "criterion": "prior radiotherapy completion",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "since completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to study enrolment",
                    "criterion": "study enrolment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained from the patients. NOTE: In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening.",
            "criterions": [
                {
                    "exact_snippets": "Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained",
                    "criterion": "tumour biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "In case a patient has had a tumour biopsy in the previous 6 months",
                    "criterion": "tumour biopsy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a paraffin block is available",
                    "criterion": "paraffin block",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. For each patient undergoing pre- and on-treatment biopsies, the identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator.",
            "criterions": [
                {
                    "exact_snippets": "the identified lesion to be biopsied should not have been previously irradiated",
                    "criterion": "lesion irradiation history",
                    "requirements": [
                        {
                            "requirement_type": "irradiation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment",
                    "criterion": "measurable-disease target lesion",
                    "requirements": [
                        {
                            "requirement_type": "exclusivity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator",
                    "criterion": "tumour lesion accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "acceptable clinical risk"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. ECOG performance status up to 1. 9. Adequate organ function as defined by the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status up to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Haematological:",
            "criterions": [
                {
                    "exact_snippets": "Haematological",
                    "criterion": "haematological",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Neutrophils ≥1,500/μL",
            "criterions": [
                {
                    "exact_snippets": "Neutrophils ≥1,500/μL",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Platelets ≥100,000/μL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥100,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Haemoglobin ≥10 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Haemoglobin ≥10 g/dL",
                    "criterion": "haemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine Clearance ... ≥50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft-Gault Equation"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Serum total bilirubin ≤1.5 upper limit of normal (ULN) or",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin ≤1.5 upper limit of normal (ULN)",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Direct bilirubin ≤ULN for patients with total bilirubin >1.5 ULN",
            "criterions": [
                {
                    "exact_snippets": "Direct bilirubin ≤ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin >1.5 ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "o Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤2.5 ULN or ≤5 ULN if liver metastases",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) ... ≤2.5 ULN or ≤5 ULN if liver metastases",
                    "criterion": "AST/SGOT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) ... ≤2.5 ULN or ≤5 ULN if liver metastases",
                    "criterion": "AST/SGOT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ... ≤2.5 ULN or ≤5 ULN if liver metastases",
                    "criterion": "ALT/SGPT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ... ≤2.5 ULN or ≤5 ULN if liver metastases",
                    "criterion": "ALT/SGPT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemistry:",
            "criterions": [
                {
                    "exact_snippets": "Chemistry",
                    "criterion": "chemistry",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin >30 g/L. 10. If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control (defined as having a low failure rate) for at least a menstrual cycle before and for 1 month after last study drug administration:",
            "criterions": [
                {
                    "exact_snippets": "Albumin >30 g/L",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. True abstinence, when this is in line with the preferred and usual lifestyle of the patient, from sexual intercourse with a member of the opposite sex;",
            "criterions": [
                {
                    "exact_snippets": "True abstinence ... from sexual intercourse with a member of the opposite sex",
                    "criterion": "abstinence from sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Sexual intercourse with vasectomised male;",
            "criterions": [
                {
                    "exact_snippets": "Sexual intercourse with vasectomised male",
                    "criterion": "sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "partner status",
                            "expected_value": "vasectomised male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers);",
            "criterions": [
                {
                    "exact_snippets": "Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal)",
                    "criterion": "hormonal female contraceptive",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "oral",
                                "parenteral",
                                "intravaginal",
                                "implantable",
                                "transdermal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 3 consecutive months prior to investigational product administration",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "when not clinically contraindicated as in breast, ovarian and endometrial cancers",
                    "criterion": "clinical contraindication",
                    "requirements": [
                        {
                            "requirement_type": "absence of contraindication",
                            "expected_value": [
                                "breast cancer",
                                "ovarian cancer",
                                "endometrial cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Use of an intrauterine contraceptive device. 11. Male patients and their sexual partners must use an appropriate contraceptive from Screening for 6 months after last study drug administration, including:",
            "criterions": [
                {
                    "exact_snippets": "Use of an intrauterine contraceptive device.",
                    "criterion": "intrauterine contraceptive device",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients and their sexual partners must use an appropriate contraceptive from Screening for 6 months after last study drug administration",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. True abstinence",
            "criterions": [
                {
                    "exact_snippets": "True abstinence",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Male sterilisation",
            "criterions": [
                {
                    "exact_snippets": "Male sterilisation",
                    "criterion": "male sterilisation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom",
            "criterions": [
                {
                    "exact_snippets": "Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal)",
                    "criterion": "hormonal female contraceptive",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condom",
                    "criterion": "condom",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Intrauterine contraceptive device and condom.",
            "criterions": [
                {
                    "exact_snippets": "Intrauterine contraceptive device",
                    "criterion": "intrauterine contraceptive device",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "condom",
                    "criterion": "condom",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Systemic anti-cancer therapy within four weeks prior to study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Systemic anti-cancer therapy within four weeks prior to study drug administration.",
                    "criterion": "systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy within four weeks prior to study entry",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Localised palliative radiotherapy to non-target lesions is allowed",
                    "criterion": "localised palliative radiotherapy to non-target lesions",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients curatively treated more than 2 years prior to enrolment",
                    "criterion": "curative treatment timing",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ",
                    "criterion": "specific cancer types",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "basal cell skin cancer",
                                "squamous cell skin cancer",
                                "carcinoma in situ"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Previous treatment with either gemcitabine or nab-paclitaxel in any setting.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with either gemcitabine",
                    "criterion": "previous treatment with gemcitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... nab-paclitaxel",
                    "criterion": "previous treatment with nab-paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Contraindication to receive gemcitabine/nab-paclitaxel.",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to receive gemcitabine/nab-paclitaxel",
                    "criterion": "gemcitabine/nab-paclitaxel contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure.",
            "criterions": [
                {
                    "exact_snippets": "Non-malignant systemic disease",
                    "criterion": "non-malignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable atrial fibrillation",
                    "criterion": "unstable atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable cardiac arrhythmia",
                    "criterion": "unstable cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction in the last six months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) Class III or IV heart failure",
                    "criterion": "NYHA Class III or IV heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.",
            "criterions": [
                {
                    "exact_snippets": "active uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically positive for human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically positive for ... hepatitis B (except after vaccination)",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "vaccination status",
                            "expected_value": "not applicable if vaccinated"
                        }
                    ]
                },
                {
                    "exact_snippets": "serologically positive for ... hepatitis C infection",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this 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"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic or unstable central nervous system primary tumour",
                    "criterion": "central nervous system primary tumour",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Live vaccine in the last four weeks.",
            "criterions": [
                {
                    "exact_snippets": "Live vaccine in the last four weeks.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Current participation in another trial.",
            "criterions": [
                {
                    "exact_snippets": "Current participation in another trial",
                    "criterion": "participation in another trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "<!-- -->",
            "criterions": []
        },
        {
            "line": "<!-- -->",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}