{
    "info": {
        "nct_id": "NCT01192165",
        "official_title": "An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors",
        "inclusion_criteria": "* The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.\n* Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.\n* The subject has a radiographically measurable tumor.\n* The subject is able to carry out daily life activities without difficulty.\n* The subject is able to swallow and retain oral medication.\n* The subject does not have significant side effects from previous anti-cancer treatment.\n* The subject has adequate organ and blood cell counts.\n* Sexually active subjects must use medically acceptable methods of contraception during the course of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.\n* The subject has a brain tumor.\n* Current severe, uncontrolled systemic disease.\n* History of clinically significant heart, lung, or eye/vision problems.\n* The subject has high blood pressure that is not well-controlled with medication.\n* The subject has a permanent pacemaker.\n* The subject is pregnant or breastfeeding.\n* Positive for Hepatitis B, Hepatitis C, or HIV.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.",
            "criterions": [
                {
                    "exact_snippets": "The subject has a solid tumor.",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Expansion cohorts are limited to non-small cell lung cancer",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Expansion cohorts are limited to ... pancreatic cancer",
                    "criterion": "pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without a KRAS mutation",
                    "criterion": "KRAS mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "optional"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.",
            "criterions": [
                {
                    "exact_snippets": "Tumor progression following at least one prior standard therapy",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "prior standard therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the subject refuses standard therapy",
                    "criterion": "refusal of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard therapy exists",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a radiographically measurable tumor.",
            "criterions": [
                {
                    "exact_snippets": "radiographically measurable tumor",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "radiographically measurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is able to carry out daily life activities without difficulty.",
            "criterions": [
                {
                    "exact_snippets": "able to carry out daily life activities without difficulty",
                    "criterion": "ability to carry out daily life activities",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is able to swallow and retain oral medication.",
            "criterions": [
                {
                    "exact_snippets": "able to swallow",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "retention of oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject does not have significant side effects from previous anti-cancer treatment.",
            "criterions": [
                {
                    "exact_snippets": "The subject does not have significant side effects from previous anti-cancer treatment.",
                    "criterion": "side effects from previous anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has adequate organ and blood cell counts.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... blood cell counts",
                    "criterion": "blood cell counts",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active subjects must use medically acceptable methods of contraception during the course of the study.",
            "criterions": [
                {
                    "exact_snippets": "Sexually active subjects must use medically acceptable methods of contraception",
                    "criterion": "contraception use",
                    "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": [
        {
            "line": "* The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.",
            "criterions": [
                {
                    "exact_snippets": "The subject has had major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received certain types of cancer therapy within 2-3 weeks",
                    "criterion": "cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a brain tumor.",
            "criterions": [
                {
                    "exact_snippets": "The subject has a brain tumor.",
                    "criterion": "brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current severe, uncontrolled systemic disease.",
            "criterions": [
                {
                    "exact_snippets": "Current severe, uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinically significant heart, lung, or eye/vision problems.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant heart ... problems",
                    "criterion": "heart problems",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... lung ... problems",
                    "criterion": "lung problems",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ... eye/vision problems",
                    "criterion": "eye/vision problems",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has high blood pressure that is not well-controlled with medication.",
            "criterions": [
                {
                    "exact_snippets": "high blood pressure",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "not well-controlled with medication",
                    "criterion": "blood pressure control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has a permanent pacemaker.",
            "criterions": [
                {
                    "exact_snippets": "The subject has a permanent pacemaker.",
                    "criterion": "permanent pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "The subject is pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Positive for Hepatitis B, Hepatitis C, or HIV.",
            "criterions": [
                {
                    "exact_snippets": "Positive for Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive for Hepatitis C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive for ... HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}