{
    "info": {
        "nct_id": "NCT02124148",
        "official_title": "A Phase 1b Trial of LY2606368 in Combination With Chemotherapy or Targeted Agents in Advanced and/or Metastatic Tumors",
        "inclusion_criteria": "* Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed\n* Have adequate organ function\n* Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment\n* All parts except Part B, Part E2, and Part E3 dose expansion: Must have diagnosis of cancer that is advanced or metastatic\n* Part B dose expansion: Must have confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal cancer that is metastatic or recurrent and has failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant of irinotecan or oxaliplatin\n* Part E2 dose expansion: must have cancer that is advanced or metastatic and have prior documentation of a mutation of PIK3CA\n* Part E3 dose expansion: must have advanced or metastatic ER-negative, PR-negative, and HER-2 non-overexpressing breast cancer\n* Must be available during the duration of the study and willing to follow the study procedures\n* Parts A and B: If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug\n* Parts C, D and E: If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug\n* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding\n* Part E: Are able to swallow capsules or tablets\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have received more than 2 previous lines of cytotoxic chemotherapy (if receiving cisplatin, 5-FU or pemetrexed)\n* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment\n* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C\n* Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months\n* Must not have a family history of long QTc syndrome\n* Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome\n* Must not have acute leukemia\n* Part E: Have insulin-dependent (type I) diabetes or a history of gestational diabetes\n* Part E: Prior treatment with a PI3K/mTOR inhibitor",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed",
            "criterions": [
                {
                    "exact_snippets": "appropriate candidate for experimental therapy",
                    "criterion": "candidate for experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "available standard therapies have failed",
                    "criterion": "standard therapies",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment",
            "criterions": [
                {
                    "exact_snippets": "must have discontinued previous systemic treatments for cancer",
                    "criterion": "discontinuation of previous systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from the acute effects of therapy",
                    "criterion": "recovery from acute effects of therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinued mitomycin-C or nitrosourea therapy at least 42 days",
                    "criterion": "discontinuation of mitomycin-C or nitrosourea therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 42,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinued any cytotoxic therapies at least 28 days prior to study enrollment",
                    "criterion": "discontinuation of cytotoxic therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment",
                    "criterion": "completion of radiation therapy and surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All parts except Part B, Part E2, and Part E3 dose expansion: Must have diagnosis of cancer that is advanced or metastatic",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of cancer that is advanced or metastatic",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part B dose expansion: Must have confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal cancer that is metastatic or recurrent and has failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant of irinotecan or oxaliplatin",
            "criterions": [
                {
                    "exact_snippets": "confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal cancer",
                    "criterion": "KRAS status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "wild-type"
                        }
                    ]
                },
                {
                    "exact_snippets": "colorectal cancer that is metastatic or recurrent",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed oxaliplatin- and irinotecan-based chemotherapy",
                    "criterion": "chemotherapy response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant of irinotecan or oxaliplatin",
                    "criterion": "chemotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": "intolerant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E2 dose expansion: must have cancer that is advanced or metastatic and have prior documentation of a mutation of PIK3CA",
            "criterions": [
                {
                    "exact_snippets": "must have cancer that is advanced or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior documentation of a mutation of PIK3CA",
                    "criterion": "PIK3CA mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E3 dose expansion: must have advanced or metastatic ER-negative, PR-negative, and HER-2 non-overexpressing breast cancer",
            "criterions": [
                {
                    "exact_snippets": "advanced or metastatic ER-negative, PR-negative, and HER-2 non-overexpressing breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        },
                        {
                            "requirement_type": "ER status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "PR status",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "HER-2 expression",
                            "expected_value": "non-overexpressing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be available during the duration of the study and willing to follow the study procedures",
            "criterions": [
                {
                    "exact_snippets": "Must be available during the duration of the study",
                    "criterion": "availability during study",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to follow the study procedures",
                    "criterion": "willingness to follow study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parts A and B: If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "participant is of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use medically approved contraceptive precautions",
                    "criterion": "use of contraceptive precautions",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for six months following the last dose of study drug",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for six months following the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Parts C, D and E: If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "participant is of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use medically approved contraceptive precautions",
                    "criterion": "use of contraceptive precautions",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for three months following the last dose of study drug",
                    "criterion": "duration of contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for three months following the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding",
            "criterions": [
                {
                    "exact_snippets": "female of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum or urine pregnancy test within 14 days of the first dose of study drug",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of the first dose of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "must not be breast feeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E: Are able to swallow capsules or tablets",
            "criterions": [
                {
                    "exact_snippets": "able to swallow capsules or tablets",
                    "criterion": "ability to swallow capsules or tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "* Have received more than 2 previous lines of cytotoxic chemotherapy (if receiving cisplatin, 5-FU or pemetrexed)",
            "criterions": [
                {
                    "exact_snippets": "Have received more than 2 previous lines of cytotoxic chemotherapy",
                    "criterion": "previous lines of cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if receiving cisplatin, 5-FU or pemetrexed",
                    "criterion": "current chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "cisplatin",
                                "5-FU",
                                "pemetrexed"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "Must not have taken an unapproved drug as treatment for any indication within the last 28 days",
                    "criterion": "unapproved drug use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C",
            "criterions": [
                {
                    "exact_snippets": "active symptomatic fungal, bacterial or viral infection",
                    "criterion": "active symptomatic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatitis A, B, or C",
                    "criterion": "Hepatitis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months",
            "criterions": [
                {
                    "exact_snippets": "serious heart condition",
                    "criterion": "serious heart condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart attack within the last three months",
                    "criterion": "heart attack",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have a family history of long QTc syndrome",
            "criterions": [
                {
                    "exact_snippets": "family history of long QTc syndrome",
                    "criterion": "family history of long QTc syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome",
            "criterions": [
                {
                    "exact_snippets": "Must not have a serotonin-secreting carcinoid tumor",
                    "criterion": "serotonin-secreting carcinoid tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior history of drug-induced serotonin syndrome",
                    "criterion": "drug-induced serotonin syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must not have acute leukemia",
            "criterions": [
                {
                    "exact_snippets": "Must not have acute leukemia",
                    "criterion": "acute leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E: Have insulin-dependent (type I) diabetes or a history of gestational diabetes",
            "criterions": [
                {
                    "exact_snippets": "insulin-dependent (type I) diabetes",
                    "criterion": "type I diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of gestational diabetes",
                    "criterion": "gestational diabetes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Part E: Prior treatment with a PI3K/mTOR inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a PI3K/mTOR inhibitor",
                    "criterion": "PI3K/mTOR inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}