{
    "info": {
        "nct_id": "NCT01021748",
        "official_title": "A Phase I Study of Oral MK-2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors",
        "inclusion_criteria": "* Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist\n* Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years\n* At least 18 years of age\n* Participant is able to swallow oral medications\n* For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study\n* Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1\n* Participant has known central nervous system metastases and/or carcinomatous meningitis\n* Participant has a primary central nervous system tumor or spinal cord compression\n* Participant is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse\n* Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study\n* Participant is human immunodeficiency virus (HIV) positive\n* Participant is has history of hepatitis B or C or active hepatitis A\n* Participant has a history or current evidence of heart disease\n* Participant has uncontrolled high blood pressure\n* Participant has poorly controlled diabetes",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist",
            "criterions": [
                {
                    "exact_snippets": "confirmed metastatic or locally advanced solid tumor",
                    "criterion": "solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to respond to standard therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed despite standard therapy",
                    "criterion": "progression despite standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapies known to provide clinical benefit",
                    "criterion": "therapies known to provide clinical benefit",
                    "requirements": [
                        {
                            "requirement_type": "existence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years",
            "criterions": [
                {
                    "exact_snippets": "Participant has no history of prior cancer",
                    "criterion": "history of prior cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except certain cervical, skin, or prostate cancers",
                    "criterion": "history of cervical, skin, or prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone potentially curative therapy with no evidence of disease for 5 years",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is able to swallow oral medications",
            "criterions": [
                {
                    "exact_snippets": "Participant is able to swallow oral medications",
                    "criterion": "ability to swallow oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator",
            "criterions": [
                {
                    "exact_snippets": "must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC)",
                    "criterion": "KRAS tumor-type non small-cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "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": "* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study",
            "criterions": [
                {
                    "exact_snippets": "Participant has had chemotherapy ... within 4 weeks of entering the study",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... radiotherapy ... within 4 weeks of entering the study",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has had ... biological therapy within 4 weeks of entering the study",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1",
            "criterions": [
                {
                    "exact_snippets": "Participant is currently participating in or has participated in a study of an investigational compound or device",
                    "criterion": "participation in investigational study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days or 5x the compound's half-life of Cycle 1, Day 1",
                    "criterion": "time since last investigational study",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x the compound's half-life"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has known central nervous system metastases and/or carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": "known central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a primary central nervous system tumor or spinal cord compression",
            "criterions": [
                {
                    "exact_snippets": "primary central nervous system tumor",
                    "criterion": "primary central nervous system tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse",
            "criterions": [
                {
                    "exact_snippets": "Participant is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs",
                    "criterion": "illicit drug use",
                    "requirements": [
                        {
                            "requirement_type": "regular use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had a recent history (within the last year) of drug or alcohol abuse",
                    "criterion": "drug or alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "recent history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study",
            "criterions": [
                {
                    "exact_snippets": "Participant is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "expecting to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "father children within the projected duration of the study",
                    "criterion": "expecting to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is human immunodeficiency virus (HIV) positive",
            "criterions": [
                {
                    "exact_snippets": "Participant is human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is has history of hepatitis B or C or active hepatitis A",
            "criterions": [
                {
                    "exact_snippets": "history of hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis A",
                    "criterion": "hepatitis A",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has a history or current evidence of heart disease",
            "criterions": [
                {
                    "exact_snippets": "history or current evidence of heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has uncontrolled high blood pressure",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled high blood pressure",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has poorly controlled diabetes",
            "criterions": [
                {
                    "exact_snippets": "poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}