{
    "info": {
        "nct_id": "NCT01283373",
        "official_title": "A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer",
        "inclusion_criteria": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Life expectancy of at least 12 weeks\n* Histologic documentation of adenocarcinoma of the prostate\n* Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone\n* Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone\n* For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting\n* Evaluable or measurable disease\n* Documented willingness to use an effective means of contraception\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1\n* Major surgical procedure within 4 weeks prior to Day 1\n* Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)\n* Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent\n* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is >/= 8 weeks since completion of radiotherapy and >/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants\n* Dose expansion cohort (B): no prior chemotherapy is allowed",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic documentation of adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologic documentation of adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone",
            "criterions": [
                {
                    "exact_snippets": "Surgical castration",
                    "criterion": "surgical castration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing use of gonadotropin-releasing hormone agonists",
                    "criterion": "use of gonadotropin-releasing hormone agonists",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed castrate levels of testosterone",
                    "criterion": "testosterone levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "castrate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone",
            "criterions": [
                {
                    "exact_snippets": "Metastatic progressive CRPC",
                    "criterion": "metastatic progressive CRPC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists",
                    "criterion": "progressive disease despite castration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed castrate levels of testosterone",
                    "criterion": "castrate levels of testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "castrate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "not more than two prior lines of cytotoxic chemotherapy in the metastatic setting",
                    "criterion": "prior lines of cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evaluable or measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Evaluable or measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": [
                                "evaluable",
                                "measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented willingness to use an effective means of contraception",
            "criterions": [
                {
                    "exact_snippets": "Documented willingness to use an effective means of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "documentation",
                            "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 be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1",
            "criterions": [
                {
                    "exact_snippets": "Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1",
                    "criterion": "anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "maintenance hormonal therapy for metastatic prostate cancer",
                    "criterion": "maintenance hormonal therapy for metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "palliative radiation to bone metastases within 2 weeks prior to Day 1",
                    "criterion": "palliative radiation to bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgical procedure within 4 weeks prior to Day 1",
            "criterions": [
                {
                    "exact_snippets": "Major surgical procedure within 4 weeks prior to Day 1",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)",
            "criterions": [
                {
                    "exact_snippets": "Known active bacterial ... infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... viral ... infection",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... fungal ... infection",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... mycobacterial ... infection",
                    "criterion": "mycobacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... other infection",
                    "criterion": "other infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... HIV ... infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known active ... atypical mycobacterial disease",
                    "criterion": "atypical mycobacterial disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding fungal infections of the nail beds",
                    "criterion": "fungal infections of the nail beds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing corticosteroid use with > 10 mg of daily prednisone or equivalent",
            "criterions": [
                {
                    "exact_snippets": "Ongoing corticosteroid use",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "... > 10 mg of daily prednisone or equivalent",
                    "criterion": "daily prednisone or equivalent",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy",
                    "criterion": "symptomatic hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring continued use of bisphosphonate therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events",
                    "criterion": "bisphosphonate therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "specifically to prevent skeletal events"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not have a history of clinically significant hypercalcemia",
                    "criterion": "history of clinically significant hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)",
            "criterions": [
                {
                    "exact_snippets": "History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)",
                    "criterion": "severe allergic or anaphylactic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "monoclonal antibody therapy",
                                "recombinant antibody-related fusion proteins"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant history of liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "viral or other hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "current",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is >/= 8 weeks since completion of radiotherapy and >/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants",
            "criterions": [
                {
                    "exact_snippets": "Untreated or active central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "untreated",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of treated CNS metastases",
                    "criterion": "history of treated CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluable or measurable disease outside the CNS",
                    "criterion": "disease outside the CNS",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "evaluable",
                                "measurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic demonstration of improvement upon the completion of CNS-directed therapy",
                    "criterion": "CNS-directed therapy improvement",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "improvement"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study",
                    "criterion": "interim progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "screening CNS radiographic study is >/= 8 weeks since completion of radiotherapy",
                    "criterion": "time since completion of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "screening CNS radiographic study is ... >/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants",
                    "criterion": "time since discontinuation of corticosteroids and anticonvulsants",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dose expansion cohort (B): no prior chemotherapy is allowed",
            "criterions": [
                {
                    "exact_snippets": "no prior chemotherapy is allowed",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}