{
    "info": {
        "nct_id": "NCT00841191",
        "official_title": "A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors",
        "inclusion_criteria": "* Histologic (pertaining to body tissues) or cytologic (pertaining to cells) documentation of malignancy (cancer or other progressively enlarging and spreading tumor) as follows: malignant solid tumors (Cohort 1-4 only); Cohorts 5 and Phase 2: epithelial (tissue covering outer layers of most body organs and parts) ovarian cancers (abnormal tissue growth) that have progressed on or after standard therapy, or for which there is no effective therapy or platinum resistant and taxane resistant, defined as progression on or within 6 months of completing therapy with taxane and platinum either alone or in combination (unless contraindications for taxane or platinum exist), and for which there is no effective therapy, or participants with known KRAS mutant tumors or pancreatic cancer, or non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or head and neck (H&N) cancer that are refractory or resistant to anti-epidermal growth factor receptor (EGFR) therapy and all participants must have received at least 1 line of standard chemotherapy\n* Eastern cooperative oncology group (ECOG) performance status score less than or equal to 2\n* Participants must have recovered from reversible toxicity (any harmful effect of a drug or poison) of previous treatment to less than or equal to grade 1 or an acceptable baseline\n* Women of child bearing potential must have a negative pregnancy test at screening\n* Cohort 5 and Phase 2 cohorts must have evaluable or measurable disease (defined by response evaluation criteria in solid tumors [RECIST], as applicable)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Received any prior systemic therapy or had major surgery for the cancer under study within 4 weeks (in the case of nitrosoureas and mitomycin C within 6 weeks) prior to first siltuximab administration\n* Prior anti-interleukin 6 (IL-6) targeted therapy\n* Serious concurrent illness or history of uncontrolled heart disease such as: unstable angina (chest pain due to decreased oxygen being supplied to the heart), congestive heart failure (failure of the heart resulting in fluid build-up in the lungs, other body tissues, or both), myocardial infarction (heart attack) within preceding 12 months, clinically significant rhythm or conduction abnormality\n* Participants with known allergies (over sensitivity to a substance) or clinically significant reactions to murine, chimeric, or human proteins\n* Any uncontrolled medical condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk by participating in the study or confounds the ability to interpret data from the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eastern cooperative oncology group (ECOG) performance status score less than or equal to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern cooperative oncology group (ECOG) performance status score less than or equal to 2",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have recovered from reversible toxicity (any harmful effect of a drug or poison) of previous treatment to less than or equal to grade 1 or an acceptable baseline",
            "criterions": [
                {
                    "exact_snippets": "Participants must have recovered from reversible toxicity ... to less than or equal to grade 1",
                    "criterion": "reversible toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child bearing potential must have a negative pregnancy test at screening",
            "criterions": [
                {
                    "exact_snippets": "Women of child bearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "female and of child bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test at screening",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cohort 5 and Phase 2 cohorts must have evaluable or measurable disease (defined by response evaluation criteria in solid tumors [RECIST], as applicable)",
            "criterions": [
                {
                    "exact_snippets": "evaluable or measurable disease (defined by response evaluation criteria in solid tumors [RECIST]",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluable or measurable",
                            "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": "* Received any prior systemic therapy or had major surgery for the cancer under study within 4 weeks (in the case of nitrosoureas and mitomycin C within 6 weeks) prior to first siltuximab administration",
            "criterions": [
                {
                    "exact_snippets": "Received any prior systemic therapy ... within 4 weeks (in the case of nitrosoureas and mitomycin C within 6 weeks)",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "had major surgery for the cancer under study within 4 weeks",
                    "criterion": "major surgery for the cancer under study",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior anti-interleukin 6 (IL-6) targeted therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior anti-interleukin 6 (IL-6) targeted therapy",
                    "criterion": "anti-interleukin 6 (IL-6) targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious concurrent illness or history of uncontrolled heart disease such as: unstable angina (chest pain due to decreased oxygen being supplied to the heart), congestive heart failure (failure of the heart resulting in fluid build-up in the lungs, other body tissues, or both), myocardial infarction (heart attack) within preceding 12 months, clinically significant rhythm or conduction abnormality",
            "criterions": [
                {
                    "exact_snippets": "Serious concurrent illness",
                    "criterion": "serious concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of uncontrolled heart disease",
                    "criterion": "uncontrolled heart disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ... within preceding 12 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant rhythm or conduction abnormality",
                    "criterion": "clinically significant rhythm or conduction abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with known allergies (over sensitivity to a substance) or clinically significant reactions to murine, chimeric, or human proteins",
            "criterions": [
                {
                    "exact_snippets": "known allergies (over sensitivity to a substance)",
                    "criterion": "allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant reactions to murine, chimeric, or human proteins",
                    "criterion": "reactions to proteins",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "murine",
                                "chimeric",
                                "human"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any uncontrolled medical condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk by participating in the study or confounds the ability to interpret data from the study",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Histologic (pertaining to body tissues) or cytologic (pertaining to cells) documentation of malignancy (cancer or other progressively enlarging and spreading tumor) as follows: malignant solid tumors (Cohort 1-4 only); Cohorts 5 and Phase 2: epithelial (tissue covering outer layers of most body organs and parts) ovarian cancers (abnormal tissue growth) that have progressed on or after standard therapy, or for which there is no effective therapy or platinum resistant and taxane resistant, defined as progression on or within 6 months of completing therapy with taxane and platinum either alone or in combination (unless contraindications for taxane or platinum exist), and for which there is no effective therapy, or participants with known KRAS mutant tumors or pancreatic cancer, or non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or head and neck (H&N) cancer that are refractory or resistant to anti-epidermal growth factor receptor (EGFR) therapy and all participants must have received at least 1 line of standard chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Histologic (pertaining to body tissues) or cytologic (pertaining to cells) documentation of malignancy",
                    "criterion": "documentation of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant solid tumors (Cohort 1-4 only)",
                    "criterion": "malignant solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "cohort",
                            "expected_value": "Cohort 1-4 only"
                        }
                    ]
                },
                {
                    "exact_snippets": "Cohorts 5 and Phase 2: epithelial ovarian cancers",
                    "criterion": "epithelial ovarian cancers",
                    "requirements": [
                        {
                            "requirement_type": "cohort",
                            "expected_value": "Cohorts 5 and Phase 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "epithelial ovarian cancers ... that have progressed on or after standard therapy",
                    "criterion": "progression after standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "epithelial ovarian cancers"
                        }
                    ]
                },
                {
                    "exact_snippets": "epithelial ovarian cancers ... for which there is no effective therapy",
                    "criterion": "lack of effective therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "epithelial ovarian cancers"
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum resistant and taxane resistant, defined as progression on or within 6 months of completing therapy with taxane and platinum",
                    "criterion": "platinum and taxane resistance",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "on or within 6 months of completing therapy with taxane and platinum"
                        }
                    ]
                },
                {
                    "exact_snippets": "unless contraindications for taxane or platinum exist",
                    "criterion": "contraindications for taxane or platinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participants with known KRAS mutant tumors",
                    "criterion": "KRAS mutant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "colorectal cancer (CRC)",
                    "criterion": "colorectal cancer (CRC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "head and neck (H&N) cancer",
                    "criterion": "head and neck (H&N) cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory or resistant to anti-epidermal growth factor receptor (EGFR) therapy",
                    "criterion": "resistance to anti-EGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "refractory or resistant"
                        }
                    ]
                },
                {
                    "exact_snippets": "all participants must have received at least 1 line of standard chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}