{
    "info": {
        "nct_id": "NCT00999401",
        "official_title": "A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "* Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.\n* Age 18 years or older\n* ECOG 0-2\n* Life expectancy ≥ 3 months\n* Evaluable disease\n* Adequate bone marrow function\n* Adequate renal function\n* Adequate liver function\n* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities\n* Able to swallow capsules\n* At least 3 weeks from major surgery\n* Agree to practice effective contraception\n* Ability to understand and willingness to sign the informed consent form\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previously untreated CNS metastases or progressive CNS metastases\n* Currently receiving radiotherapy, biological therapy, or any other investigational agents\n* Uncontrolled intercurrent illness including\n* Pregnant or lactating women\n* Known to be HIV-positive\n* A history of active hepatitis B and/or hepatitis C infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.",
            "criterions": [
                {
                    "exact_snippets": "Incurable advanced solid tumors",
                    "criterion": "solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "no longer responding to conventional therapy",
                    "criterion": "response to conventional therapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no effective therapy exists",
                    "criterion": "availability of effective therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BRCA mutation carriers",
                    "criterion": "BRCA mutation",
                    "requirements": [
                        {
                            "requirement_type": "mutation status",
                            "expected_value": "carrier"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks from prior systemic treatments",
                    "criterion": "time since prior systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks from ... investigational anti-cancer therapy",
                    "criterion": "time since investigational anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 weeks from ... radiation therapy",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have recovered from prior toxicities",
                    "criterion": "recovery from prior toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to swallow capsules",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow capsules",
                    "criterion": "ability to swallow capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 weeks from major surgery",
            "criterions": [
                {
                    "exact_snippets": "At least 3 weeks from major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to practice effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Agree to practice effective contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign the informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign the informed consent form",
                    "criterion": "willingness to consent",
                    "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": "* Previously untreated CNS metastases or progressive CNS metastases",
            "criterions": [
                {
                    "exact_snippets": "Previously untreated CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "progression status",
                            "expected_value": "progressive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving radiotherapy, biological therapy, or any other investigational agents",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving ... biological therapy",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Currently receiving ... any other investigational agents",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "current treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known to be HIV-positive",
            "criterions": [
                {
                    "exact_snippets": "Known to be HIV-positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of active hepatitis B and/or hepatitis C infection",
            "criterions": [
                {
                    "exact_snippets": "A history of active hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of active ... hepatitis C infection",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}