{
    "info": {
        "nct_id": "NCT00975182",
        "official_title": "A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)\n* Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)\n* Adequate organ function as assessed by laboratory tests\n* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Agreement to use an effective form of contraception for the duration of the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment\n* Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)\n* History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication\n* Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)\n* History of clinically significant cardiac or pulmonary dysfunction\n* History of malabsorption syndrome or other condition that would interfere with enteral absorption\n* Clinically significant history of liver disease\n* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents\n* Active autoimmune disease and/or need for corticosteroid therapy\n* Known brain metastases that are untreated, symptomatic, or require therapy\n* Pregnancy, lactation, or breastfeeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)",
            "criterions": [
                {
                    "exact_snippets": "Documented locally advanced or metastatic solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "standard therapy either does not exist or has proven ineffective or intolerable",
                    "criterion": "standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "tolerability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)",
            "criterions": [
                {
                    "exact_snippets": "Documented locally advanced or metastatic NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have failed at least one prior chemotherapy-based regimen for incurable disease",
                    "criterion": "prior chemotherapy-based regimen",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function as assessed by laboratory tests",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed by laboratory tests",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "laboratory tests"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)",
            "criterions": [
                {
                    "exact_snippets": "Evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "per Response Evaluation Criteria in Solid Tumors (RECIST)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agreement to use an effective form of contraception for the duration of the study",
            "criterions": [
                {
                    "exact_snippets": "Agreement to use an effective form of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of the study"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment",
            "criterions": [
                {
                    "exact_snippets": "Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment",
                    "criterion": "anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within a specified timeframe prior to first study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with PI3K pathway-inhibiting agents",
                    "criterion": "prior treatment with PI3K pathway-inhibiting agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication",
            "criterions": [
                {
                    "exact_snippets": "History of Grade >= 3 fasting hyperglycemia",
                    "criterion": "fasting hyperglycemia",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetes requiring regular medication",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "medication requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)",
            "criterions": [
                {
                    "exact_snippets": "clinically significant and uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiovascular",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic",
                    "criterion": "metabolic disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinically significant cardiac or pulmonary dysfunction",
            "criterions": [
                {
                    "exact_snippets": "History of clinically significant cardiac ... dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "History of clinically significant ... pulmonary dysfunction",
                    "criterion": "pulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of malabsorption syndrome or other condition that would interfere with enteral absorption",
            "criterions": [
                {
                    "exact_snippets": "History of malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other condition that would interfere with enteral absorption",
                    "criterion": "condition interfering with enteral absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant history of liver disease",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant history of liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents",
            "criterions": [
                {
                    "exact_snippets": "Any condition requiring full-dose anticoagulants",
                    "criterion": "condition requiring full-dose anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such as warfarin, heparin, or thrombolytic agents",
                    "criterion": "use of anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "warfarin",
                                "heparin",
                                "thrombolytic agents"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active autoimmune disease and/or need for corticosteroid therapy",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need for corticosteroid therapy",
                    "criterion": "corticosteroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known brain metastases that are untreated, symptomatic, or require therapy",
            "criterions": [
                {
                    "exact_snippets": "Known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated",
                    "criterion": "brain metastases treatment status",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic",
                    "criterion": "brain metastases symptoms",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "require therapy",
                    "criterion": "brain metastases therapy requirement",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy, lactation, or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}