{
    "info": {
        "nct_id": "NCT01563601",
        "official_title": "A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer",
        "inclusion_criteria": "* The patient has histologic or cytologic confirmation (upon local review) of small cell lung cancer (SCLC).\n* The patient has extensive-stage small cell lung cancer (ES-SCLC), as defined by National Comprehensive Cancer Network (NCCN) guidelines.\n* The patient has measurable disease as assessed by Response Evaluation Criteria Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).\n* The patient has not received any prior chemotherapy, biological agent, or investigational drug for SCLC.\n* The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* The patient is 18 years of age or older at the time informed consent is obtained.\n* The patient must be accessible for study treatment and follow-up. Patients enrolled in this study must be treated at participating study centers for all 3 days of study drug administration in either treatment group.\n* The patient has normal organ function.\n* Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to study enrollment. Women of childbearing potential and men with partners of childbearing potential must use a highly effective method of contraception throughout the entire study and up to 8 weeks after the last dose of any study drug (including obatoclax maintenance). Effective contraception or birth control is defined as those with a low failure rate (less than 1% per year) when used consistently and correctly.\n* Women must not be breastfeeding.\n* Written informed consent is obtained.\n* Patients with asymptomatic brain metastases may be enrolled and if clinically indicated, may be treated with steroids to be tapered as tolerated by the patient. Patients with symptomatic brain metastases will be eligible for the study after they have received therapeutic whole brain irradiation (WBI), which must be completed at least 7 days before the day of first treatment with study drugs. Since these patients will also be treated with steroids it is recommended that steroids be tapered as clinically indicated and tolerated by the patient. The use of chronic, low-dose steroids is not contraindicated for these patients (or any other patients). Stereotactic radiation will be allowed for 1 to 3 brain metastatic lesions that meet appropriate criteria for that procedure; however, this must be discussed with the study monitor prior to consideration for enrollment into this study.\n* The patient must be willing and able to comply with study restrictions and to remain at the study center for the required duration during the study period and willing to return to the study center for the follow-up evaluation as specified in this protocol.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery.\n* The patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy and is deemed by his or her treating physician to be at low risk for recurrence for 5 years.\n* The patient has a history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300) or to carboplatin or etoposide.\n* The patient currently has leptomeningeal disease or paraneoplastic syndromes.\n* The patient has uncontrolled intercurrent illness including, but not limited to, symptomatic neurologic illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness that would limit compliance with study requirements.\n* The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study but will be monitored for safety.)\n* The patient has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus (HCV Ab) or a known positive history of antibodies to human immunodeficiency virus (HIV) and is receiving combination antiretroviral therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The patient has histologic or cytologic confirmation (upon local review) of small cell lung cancer (SCLC).",
            "criterions": [
                {
                    "exact_snippets": "histologic or cytologic confirmation ... small cell lung cancer (SCLC)",
                    "criterion": "small cell lung cancer (SCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has extensive-stage small cell lung cancer (ES-SCLC), as defined by National Comprehensive Cancer Network (NCCN) guidelines.",
            "criterions": [
                {
                    "exact_snippets": "extensive-stage small cell lung cancer (ES-SCLC)",
                    "criterion": "extensive-stage small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as defined by National Comprehensive Cancer Network (NCCN) guidelines",
                    "criterion": "NCCN guidelines definition",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has measurable disease as assessed by Response Evaluation Criteria Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).",
            "criterions": [
                {
                    "exact_snippets": "measurable disease as assessed by Response Evaluation Criteria ... in Solid Tumors, version 1.1 (RECIST v1.1)",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has not received any prior chemotherapy, biological agent, or investigational drug for SCLC.",
            "criterions": [
                {
                    "exact_snippets": "The patient has not received any prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient has not received any prior ... biological agent",
                    "criterion": "prior biological agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient has not received any prior ... investigational drug for SCLC",
                    "criterion": "prior investigational drug for SCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is 18 years of age or older at the time informed consent is obtained.",
            "criterions": [
                {
                    "exact_snippets": "The patient is 18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must be accessible for study treatment and follow-up. Patients enrolled in this study must be treated at participating study centers for all 3 days of study drug administration in either treatment group.",
            "criterions": [
                {
                    "exact_snippets": "The patient must be accessible for study treatment and follow-up.",
                    "criterion": "patient accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients enrolled in this study must be treated at participating study centers for all 3 days of study drug administration",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "participating study centers"
                        }
                    ]
                },
                {
                    "exact_snippets": "for all 3 days of study drug administration",
                    "criterion": "study drug administration duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has normal organ function.",
            "criterions": [
                {
                    "exact_snippets": "normal organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to study enrollment. Women of childbearing potential and men with partners of childbearing potential must use a highly effective method of contraception throughout the entire study and up to 8 weeks after the last dose of any study drug (including obatoclax maintenance). Effective contraception or birth control is defined as those with a low failure rate (less than 1% per year) when used consistently and correctly.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to study enrollment.",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "72 hours prior to study enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential and men with partners of childbearing potential must use a highly effective method of contraception throughout the entire study and up to 8 weeks after the last dose of any study drug (including obatoclax maintenance).",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the entire study and up to 8 weeks after the last dose of any study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "Effective contraception or birth control is defined as those with a low failure rate (less than 1% per year) when used consistently and correctly.",
                    "criterion": "contraception effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "% per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must not be breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Women must not be breastfeeding.",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent is obtained.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent is obtained.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with asymptomatic brain metastases may be enrolled and if clinically indicated, may be treated with steroids to be tapered as tolerated by the patient. Patients with symptomatic brain metastases will be eligible for the study after they have received therapeutic whole brain irradiation (WBI), which must be completed at least 7 days before the day of first treatment with study drugs. Since these patients will also be treated with steroids it is recommended that steroids be tapered as clinically indicated and tolerated by the patient. The use of chronic, low-dose steroids is not contraindicated for these patients (or any other patients). Stereotactic radiation will be allowed for 1 to 3 brain metastatic lesions that meet appropriate criteria for that procedure; however, this must be discussed with the study monitor prior to consideration for enrollment into this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients with asymptomatic brain metastases may be enrolled",
                    "criterion": "asymptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with symptomatic brain metastases will be eligible for the study after they have received therapeutic whole brain irradiation (WBI)",
                    "criterion": "symptomatic brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "therapeutic whole brain irradiation (WBI)"
                        }
                    ]
                },
                {
                    "exact_snippets": "therapeutic whole brain irradiation (WBI), which must be completed at least 7 days before the day of first treatment with study drugs",
                    "criterion": "completion of WBI",
                    "requirements": [
                        {
                            "requirement_type": "time before treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Stereotactic radiation will be allowed for 1 to 3 brain metastatic lesions that meet appropriate criteria for that procedure",
                    "criterion": "stereotactic radiation for brain metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "number of lesions",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "lesions"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "lesions"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must be willing and able to comply with study restrictions and to remain at the study center for the required duration during the study period and willing to return to the study center for the follow-up evaluation as specified in this protocol.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to comply with study restrictions",
                    "criterion": "compliance with study restrictions",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to return to the study center for the follow-up evaluation",
                    "criterion": "return for follow-up evaluation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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": "* The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery.",
            "criterions": [
                {
                    "exact_snippets": "The patient has had any prior systemic therapy for ES-SCLC other than radiation therapy or surgery.",
                    "criterion": "prior systemic therapy for ES-SCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell or squamous cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy and is deemed by his or her treating physician to be at low risk for recurrence for 5 years.",
            "criterions": [
                {
                    "exact_snippets": "history of prior malignancy",
                    "criterion": "history of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical intraepithelial neoplasia",
                    "criterion": "cervical intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell or squamous cell carcinoma of the skin",
                    "criterion": "basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other localized malignancy ... undergone potentially curative therapy",
                    "criterion": "other localized malignancy with potentially curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed by his or her treating physician to be at low risk for recurrence for 5 years",
                    "criterion": "risk of recurrence",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "5 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient currently has leptomeningeal disease or paraneoplastic syndromes.",
            "criterions": [
                {
                    "exact_snippets": "The patient currently has leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient currently has ... paraneoplastic syndromes",
                    "criterion": "paraneoplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has uncontrolled intercurrent illness including, but not limited to, symptomatic neurologic illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic neurologic illness",
                    "criterion": "neurologic illness",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "opportunistic",
                                "life-threatening",
                                "clinically significant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant pulmonary disease or hypoxia",
                    "criterion": "pulmonary disease or hypoxia",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness that would limit compliance with study requirements",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study but will be monitored for safety.)",
            "criterions": [
                {
                    "exact_snippets": "The patient is a pregnant ... woman.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient is a ... lactating woman.",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus (HCV Ab) or a known positive history of antibodies to human immunodeficiency virus (HIV) and is receiving combination antiretroviral therapy.",
            "criterions": [
                {
                    "exact_snippets": "positive test result for hepatitis B surface antigen (HBsAg)",
                    "criterion": "hepatitis B surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive test result for ... antibodies to hepatitis C virus (HCV Ab)",
                    "criterion": "antibodies to hepatitis C virus (HCV Ab)",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "known positive history of antibodies to human immunodeficiency virus (HIV)",
                    "criterion": "antibodies to human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving combination antiretroviral therapy",
                    "criterion": "combination antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* The patient has a history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300) or to carboplatin or etoposide.",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity or allergic reactions attributed to components of the obatoclax mesylate formulation (ie, polysorbate 20 and polyethylene glycol [PEG] 300)",
                    "criterion": "hypersensitivity or allergic reactions to obatoclax mesylate components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity or allergic reactions attributed ... to carboplatin",
                    "criterion": "hypersensitivity or allergic reactions to carboplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity or allergic reactions attributed ... to etoposide",
                    "criterion": "hypersensitivity or allergic reactions to etoposide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}