{
    "info": {
        "nct_id": "NCT01242072",
        "official_title": "A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice",
        "inclusion_criteria": "* 18 years old or greater\n* Malignancy scheduled to receive etoposide and carboplatin therapy\n* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1\n* Adequate bone marrow, liver, renal function and coagulation status\n* Informed consent\n* Agree to use birth control through 28 days of last treatment dose\n* Pregnancy test for women of child-bearing potential\n* No available standard therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Allergy to the the study treatment drugs\n* Unstable current medical condition\n* Presence or history of injury to the urinary tract\n* Active infection\n* Major surgery within 4 weeks prior to treatment\n* Minor surgery within 2 weeks prior to treatment\n* Current acute steroid therapy or taper\n* Currently pregnant or nursing\n* Substance abuse or condition that may interfere with participation\n* Received other investigational drugs within 30 days\n* Within 4 weeks of their last chemotherapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 years old or greater",
            "criterions": [
                {
                    "exact_snippets": "18 years old or greater",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malignancy scheduled to receive etoposide and carboplatin therapy",
            "criterions": [
                {
                    "exact_snippets": "Malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled treatment",
                            "expected_value": [
                                "etoposide",
                                "carboplatin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow, liver, renal function and coagulation status",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... coagulation status",
                    "criterion": "coagulation status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent",
            "criterions": [
                {
                    "exact_snippets": "Informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use birth control through 28 days of last treatment dose",
            "criterions": [
                {
                    "exact_snippets": "Agree to use birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "through 28 days of last treatment dose",
                    "criterion": "duration of birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "through 28 days of last treatment dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy test for women of child-bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy test for women of child-bearing potential",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "test",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No available standard therapy",
            "criterions": [
                {
                    "exact_snippets": "No available standard therapy",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Allergy to the the study treatment drugs",
            "criterions": [
                {
                    "exact_snippets": "Allergy to the the study treatment drugs",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable current medical condition",
            "criterions": [
                {
                    "exact_snippets": "Unstable current medical condition",
                    "criterion": "current medical condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence or history of injury to the urinary tract",
            "criterions": [
                {
                    "exact_snippets": "Presence ... of injury to the urinary tract",
                    "criterion": "injury to the urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of injury to the urinary tract",
                    "criterion": "injury to the urinary tract",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior to treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minor surgery within 2 weeks prior to treatment",
            "criterions": [
                {
                    "exact_snippets": "Minor surgery within 2 weeks prior to treatment",
                    "criterion": "minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current acute steroid therapy or taper",
            "criterions": [
                {
                    "exact_snippets": "Current acute steroid therapy",
                    "criterion": "acute steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taper",
                    "criterion": "steroid taper",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Currently pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Substance abuse or condition that may interfere with participation",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "condition that may interfere with participation",
                    "criterion": "condition interfering with participation",
                    "requirements": [
                        {
                            "requirement_type": "potential interference",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received other investigational drugs within 30 days",
            "criterions": [
                {
                    "exact_snippets": "Received other investigational drugs within 30 days",
                    "criterion": "investigational drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Within 4 weeks of their last chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Within 4 weeks of their last chemotherapy",
                    "criterion": "time since last chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last chemotherapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}