{
    "info": {
        "nct_id": "NCT02431260",
        "official_title": "A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies",
        "inclusion_criteria": "* Confirmed diagnosis of advanced malignancy:\n\n  * Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas\n  * Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)\n  * Treatment Group C (TGC): Multiple myeloma\n* Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Inadequate hematopoietic, liver, endocrine or renal function\n* Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:\n\n  * < 6 weeks for mitomycin-C or nitrosoureas\n  * < 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)\n  * < 28 days for any antibodies or biological therapies\n  * < 5 half-lives for all other anticancer medications, or sponsor approval\n* Prior radiotherapy within 2 weeks prior to first dose of study drug\n* Untreated brain or central nervous system (CNS) metastases\n* Type 1 diabetes or uncontrolled Type 2 diabetes\n* Any sign of clinically significant bleeding",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Confirmed diagnosis of advanced malignancy:",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of advanced malignancy",
                    "criterion": "advanced malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas",
            "criterions": [
                {
                    "exact_snippets": "Part 1 and Part 2: Any advanced solid tumor or lymphoma",
                    "criterion": "advanced solid tumor or lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Part 3: Histologically confirmed disease in specific solid tumors and lymphomas",
                    "criterion": "histologically confirmed disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "specificity",
                            "expected_value": "specific solid tumors and lymphomas"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)",
            "criterions": [
                {
                    "exact_snippets": "Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only)",
                    "criterion": "acute leukemia",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "acute myeloid leukemia (AML)"
                        }
                    ]
                },
                {
                    "exact_snippets": "myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myelodysplastic /myeloproliferative neoplasms (MDS/MPN)",
                    "criterion": "myelodysplastic/myeloproliferative neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myelofibrosis (MF)",
                    "criterion": "myelofibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment Group C (TGC): Multiple myeloma",
            "criterions": [
                {
                    "exact_snippets": "Multiple myeloma",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)",
            "criterions": [
                {
                    "exact_snippets": "Progressed following at least 1 line of prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no further approved therapy available that has been demonstrated to prolong survival",
                    "criterion": "approved therapy availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects who are intolerant to the approved therapy",
                    "criterion": "therapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of ... 0, 1, 2 in Part 3 dose expansion",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "allowed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Inadequate hematopoietic, liver, endocrine or renal function",
            "criterions": [
                {
                    "exact_snippets": "Inadequate hematopoietic ... function",
                    "criterion": "hematopoietic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... endocrine ... function",
                    "criterion": "endocrine function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Inadequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:",
            "criterions": [
                {
                    "exact_snippets": "Receipt of anticancer medications",
                    "criterion": "anticancer medications",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Receipt of ... investigational drugs",
                    "criterion": "investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 6 weeks for mitomycin-C or nitrosoureas",
            "criterions": [
                {
                    "exact_snippets": "< 6 weeks for mitomycin-C",
                    "criterion": "time since mitomycin-C treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "< 6 weeks for ... nitrosoureas",
                    "criterion": "time since nitrosoureas treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)",
            "criterions": [
                {
                    "exact_snippets": "< 5 half-lives or 14 days, whichever is longer, for any investigational agent",
                    "criterion": "washout period for investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 28 days for any antibodies or biological therapies",
            "criterions": [
                {
                    "exact_snippets": "< 28 days for any antibodies or biological therapies",
                    "criterion": "antibodies or biological therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* < 5 half-lives for all other anticancer medications, or sponsor approval",
            "criterions": [
                {
                    "exact_snippets": "< 5 half-lives for all other anticancer medications",
                    "criterion": "time since last anticancer medication",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sponsor approval",
                    "criterion": "sponsor approval",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiotherapy within 2 weeks prior to first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy within 2 weeks prior to first dose of study drug",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Untreated brain or central nervous system (CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": "Untreated brain or central nervous system (CNS) metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Untreated brain or central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Type 1 diabetes or uncontrolled Type 2 diabetes",
            "criterions": [
                {
                    "exact_snippets": "Type 1 diabetes",
                    "criterion": "Type 1 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled Type 2 diabetes",
                    "criterion": "Type 2 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any sign of clinically significant bleeding",
            "criterions": [
                {
                    "exact_snippets": "clinically significant bleeding",
                    "criterion": "clinically significant bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}