{
    "info": {
        "nct_id": "NCT01405391",
        "official_title": "Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients",
        "inclusion_criteria": "1. Voluntarily signed and dated written informed consent\n2. Age ≥ 18 years.\n3. Non or minimally daily activities-interfering disease related symptoms.\n4. Life expectancy ≥ 3 months.\n5. Patients with solid tumor other than CRC.\n6. Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).\n7. Normal cardiac function cardiac function by appropriate image testing.\n8. Women of childbearing potential must have a negative serum pregnancy test before study entry.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Primary colorectal cancer diagnosis\n2. Prior treatment with PM01183.\n3. Concomitant diseases/conditions:\n\n   a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.\n4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases\n5. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.\n6. History of extensive prior pelvic irradiation.\n7. History of previous bone marrow and/or stem cell transplantation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Voluntarily signed and dated written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Non or minimally daily activities-interfering disease related symptoms.",
            "criterions": [
                {
                    "exact_snippets": "Non or minimally daily activities-interfering disease related symptoms",
                    "criterion": "disease related symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "non or minimally daily activities-interfering"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy ≥ 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 3 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with solid tumor other than CRC.",
            "criterions": [
                {
                    "exact_snippets": "solid tumor other than CRC",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than CRC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow ... function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "within normal limits or only minimally altered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "within normal limits or only minimally altered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "within normal limits or only minimally altered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... metabolic function",
                    "criterion": "metabolic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "within normal limits or only minimally altered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment",
                    "criterion": "recovery from adverse event",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "asymptomatic or minimally altered or to baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "mild alteration for alopecia, skin toxicity or fatigue are allowed",
                    "criterion": "mild alteration",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": [
                                "alopecia",
                                "skin toxicity",
                                "fatigue"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Normal cardiac function cardiac function by appropriate image testing.",
            "criterions": [
                {
                    "exact_snippets": "Normal cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate image testing",
                    "criterion": "image testing",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Women of childbearing potential must have a negative serum pregnancy test before study entry.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Primary colorectal cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Primary colorectal cancer diagnosis",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "primary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior treatment with PM01183.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with PM01183",
                    "criterion": "treatment with PM01183",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Concomitant diseases/conditions:",
            "criterions": [
                {
                    "exact_snippets": "Concomitant diseases/conditions",
                    "criterion": "concomitant diseases/conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.",
            "criterions": [
                {
                    "exact_snippets": "History of a clinically relevant cardiac condition",
                    "criterion": "clinically relevant cardiac condition",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known chronic liver disease",
                    "criterion": "chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active uncontrolled infection",
                    "criterion": "uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known human immunodeficiency virus (HIV) infection",
                    "criterion": "human immunodeficiency virus (HIV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Limitation of the patient's ability to comply with the treatment or follow-up protocol",
                    "criterion": "ability to comply with the treatment or follow-up protocol",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic and progressive ... brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progressive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "corticosteroid-requiring documented brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "corticosteroid-requiring",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.",
            "criterions": [
                {
                    "exact_snippets": "Men or women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not using an effective method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of extensive prior pelvic irradiation.",
            "criterions": [
                {
                    "exact_snippets": "History of extensive prior pelvic irradiation.",
                    "criterion": "prior pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of previous bone marrow and/or stem cell transplantation.",
            "criterions": [
                {
                    "exact_snippets": "History of previous bone marrow and/or stem cell transplantation.",
                    "criterion": "bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of previous bone marrow and/or stem cell transplantation.",
                    "criterion": "stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}