{
    "info": {
        "nct_id": "NCT01463631",
        "official_title": "A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer",
        "inclusion_criteria": "* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease\n* For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma\n* For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma\n* Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma\n* Have adequate hematologic, hepatic and renal function\n* Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale\n* Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents\n* Have an estimated life expectancy of greater than or equal to 12 weeks\n* Are able to swallow capsules\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have an echocardiogram with clinically significant abnormalities\n* For Dose Escalation (Part A): Have central nervous system malignancy or metastasis\n* For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis\n* Have an acute leukemia\n* Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years\n* Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease",
            "criterions": [
                {
                    "exact_snippets": "histological or cytological evidence of a diagnosis of cancer",
                    "criterion": "diagnosis of cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer that is advanced and/or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "available standard therapies have failed to provide clinical benefit",
                    "criterion": "response to standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed to provide clinical benefit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma",
            "criterions": [
                {
                    "exact_snippets": "cancer, either a solid tumor or a lymphoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "solid tumor",
                                "lymphoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma",
            "criterions": [
                {
                    "exact_snippets": "cancer, either a solid tumor or a lymphoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "solid tumor",
                                "lymphoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma",
            "criterions": [
                {
                    "exact_snippets": "presence of measureable or non-measureable disease (Part A)",
                    "criterion": "disease presence (Part A)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "measureable disease (Part B)",
                    "criterion": "disease presence (Part B)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have adequate hematologic, hepatic and renal function",
            "criterions": [
                {
                    "exact_snippets": "adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale",
            "criterions": [
                {
                    "exact_snippets": "performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents",
            "criterions": [
                {
                    "exact_snippets": "Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents",
                    "criterion": "discontinuation of myelosuppressive cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) ... 14 days for nonmyelosuppressive agents",
                    "criterion": "discontinuation of nonmyelosuppressive cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an estimated life expectancy of greater than or equal to 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "estimated life expectancy of greater than or equal to 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are able to swallow capsules",
            "criterions": [
                {
                    "exact_snippets": "able to swallow capsules",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Have an echocardiogram with clinically significant abnormalities",
            "criterions": [
                {
                    "exact_snippets": "echocardiogram with clinically significant abnormalities",
                    "criterion": "echocardiogram",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Dose Escalation (Part A): Have central nervous system malignancy or metastasis",
            "criterions": [
                {
                    "exact_snippets": "central nervous system malignancy",
                    "criterion": "central nervous system malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis",
            "criterions": [
                {
                    "exact_snippets": "Have symptomatic central nervous system malignancy",
                    "criterion": "central nervous system malignancy",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an acute leukemia",
            "criterions": [
                {
                    "exact_snippets": "Have an acute leukemia",
                    "criterion": "acute leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years",
            "criterions": [
                {
                    "exact_snippets": "Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix)",
                    "criterion": "history of other cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless in complete remission",
                    "criterion": "complete remission of other cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stopped all therapy for that disease for a minimum of 3 years",
                    "criterion": "therapy cessation for other cancer",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug",
                    "criterion": "stem-cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "autologous",
                                "allogeneic"
                            ]
                        },
                        {
                            "requirement_type": "time since transplant",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}