{
    "info": {
        "nct_id": "NCT00997360",
        "official_title": "A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors",
        "inclusion_criteria": "1. Male or female subjects age 18 years or older.\n2. Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor. Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.\n3. Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides for exploratory biomarker analysis.\n4. Incurable cancer, with disease progression following at least 1 conventional, standard, or investigational therapy with no further standard treatment available in the opinion of the investigator.\n5. At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\n6. Eastern Cooperative Oncology Group (ECOG) 0 to 2.\n7. Acceptable laboratory values, including fasting serum glucose.\n8. All male and female subjects who are biologically capable of having children, must agree to use a medically acceptable method of birth control for the duration of the study (e.g., condom with a spermicide) and for 12 weeks after the last dose of investigational product. All female subjects who are biologically capable of having children must have a negative serum pregnancy test result before first dose of investigational product. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the active treatment phase of the study or for 12 weeks after the last dose of investigational product.\n\nExclusion criteria:\n\n1. Major surgery, chemotherapy, radiotherapy, investigational therapy, or other cancer therapy within 2 weeks prior to first dose of investigational product.\n2. Lack of recovery from any prior surgery, chemotherapy, radiotherapy, or other cancer therapy.\n3. Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks before first dose of PKI-179 (no significant change in anticonvulsant doses, mental status, or clinical symptoms related to the CNS tumors).\n4. Subjects with known diabetes.\n5. QTc interval > 470 ms.\n6. Pregnant or breastfeeding women.\n7. Evidence of significant medical illness or abnormal laboratory finding that in the opinion of the investigator would substantially increase the risk associated with the subject's participation in the study or impact the assessment of safety and/or efficacy. Examples include, but are not limited to: uncontrolled seizures, serious ongoing active infection requiring treatment, significant uncontrolled cardiac disease, such as congestive heart failure, myocardial infarction within past 6 months, angina requiring treatment, or other clinically significant or uncontrolled conditions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male or female subjects age 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Male or female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor. Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.",
            "criterions": [
                {
                    "exact_snippets": "Part 1/MTD Estimation Phase: Pathologic diagnosis of any solid tumor.",
                    "criterion": "pathologic diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "tumor type",
                            "expected_value": "any solid tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 2/MTD Confirmation Phase: Pathologic diagnosis of one of the following tumor types: breast, non-small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma.",
                    "criterion": "pathologic diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "tumor type",
                            "expected_value": [
                                "breast",
                                "non-small cell lung",
                                "ovarian",
                                "endometrial",
                                "colorectal cancer",
                                "glioblastoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides for exploratory biomarker analysis.",
            "criterions": [
                {
                    "exact_snippets": "Availability of either formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "formalin-fixed paraffin-embedded (FFPE) tumor tissue block",
                                "unstained slides"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Incurable cancer, with disease progression following at least 1 conventional, standard, or investigational therapy with no further standard treatment available in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Incurable cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": "incurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression following at least 1 conventional, standard, or investigational therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": "following at least 1 conventional, standard, or investigational therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "no further standard treatment available in the opinion of the investigator",
                    "criterion": "standard treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
            "criterions": [
                {
                    "exact_snippets": "At least 1 evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
                    "criterion": "evaluable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) 0 to 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0 to 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Acceptable laboratory values, including fasting serum glucose.",
            "criterions": [
                {
                    "exact_snippets": "Acceptable laboratory values",
                    "criterion": "laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "acceptable"
                        }
                    ]
                },
                {
                    "exact_snippets": "fasting serum glucose",
                    "criterion": "fasting serum glucose",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "acceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. All male and female subjects who are biologically capable of having children, must agree to use a medically acceptable method of birth control for the duration of the study (e.g., condom with a spermicide) and for 12 weeks after the last dose of investigational product. All female subjects who are biologically capable of having children must have a negative serum pregnancy test result before first dose of investigational product. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the active treatment phase of the study or for 12 weeks after the last dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "All male and female subjects who are biologically capable of having children",
                    "criterion": "biological capability of having children",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use a medically acceptable method of birth control for the duration of the study",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All female subjects who are biologically capable of having children must have a negative serum pregnancy test result before first dose of investigational product",
                    "criterion": "serum pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any pregnancy that occurs in the female partner of a male subject in the trial must be reported",
                    "criterion": "reporting of pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Major surgery, chemotherapy, radiotherapy, investigational therapy, or other cancer therapy within 2 weeks prior to first dose of investigational product.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery ... within 2 weeks prior to first dose of investigational product.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy ... within 2 weeks prior to first dose of investigational product.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy ... within 2 weeks prior to first dose of investigational product.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "investigational therapy ... within 2 weeks prior to first dose of investigational product.",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer therapy within 2 weeks prior to first dose of investigational product.",
                    "criterion": "other cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Lack of recovery from any prior surgery, chemotherapy, radiotherapy, or other cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Lack of recovery from any prior surgery",
                    "criterion": "recovery from prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lack of recovery"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from any prior ... chemotherapy",
                    "criterion": "recovery from prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lack of recovery"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from any prior ... radiotherapy",
                    "criterion": "recovery from prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lack of recovery"
                        }
                    ]
                },
                {
                    "exact_snippets": "Lack of recovery from any prior ... other cancer therapy",
                    "criterion": "recovery from prior other cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lack of recovery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks before first dose of PKI-179 (no significant change in anticonvulsant doses, mental status, or clinical symptoms related to the CNS tumors).",
            "criterions": [
                {
                    "exact_snippets": "Clinically unstable primary or metastatic central nervous system (CNS) tumors",
                    "criterion": "CNS tumor stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "progression of CNS tumors ... clinically stable for at least 4 weeks before first dose of PKI-179",
                    "criterion": "CNS tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no significant change in anticonvulsant doses",
                    "criterion": "anticonvulsant dose change",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no significant change in ... mental status",
                    "criterion": "mental status change",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no significant change in ... clinical symptoms related to the CNS tumors",
                    "criterion": "CNS tumor-related clinical symptoms change",
                    "requirements": [
                        {
                            "requirement_type": "change",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects with known diabetes.",
            "criterions": [
                {
                    "exact_snippets": "Subjects with known diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. QTc interval > 470 ms.",
            "criterions": [
                {
                    "exact_snippets": "QTc interval > 470 ms",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Pregnant or breastfeeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Evidence of significant medical illness or abnormal laboratory finding that in the opinion of the investigator would substantially increase the risk associated with the subject's participation in the study or impact the assessment of safety and/or efficacy. Examples include, but are not limited to: uncontrolled seizures, serious ongoing active infection requiring treatment, significant uncontrolled cardiac disease, such as congestive heart failure, myocardial infarction within past 6 months, angina requiring treatment, or other clinically significant or uncontrolled conditions.",
            "criterions": [
                {
                    "exact_snippets": "significant medical illness",
                    "criterion": "significant medical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal laboratory finding",
                    "criterion": "abnormal laboratory finding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled seizures",
                    "criterion": "uncontrolled seizures",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious ongoing active infection requiring treatment",
                    "criterion": "serious ongoing active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant uncontrolled cardiac disease",
                    "criterion": "significant uncontrolled cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "angina requiring treatment",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other clinically significant or uncontrolled conditions",
                    "criterion": "other clinically significant or uncontrolled conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}