{
    "info": {
        "nct_id": "NCT04703920",
        "official_title": "A Phase 1 Dose-Escalation Trial of Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer",
        "inclusion_criteria": "* One of the following disease types: Men or women with histologically confirmed metastatic or unresectable breast cancer that is HER2 negative as assessed by 2018 ASCO-CAP guidelines. Trial participants with hormone receptor positive disease must have progression on at least one hormonal therapy and a CDK inhibitor AND be considered a candidate for chemotherapy; OR, Men with metastatic castration resistant prostate cancer with progression on androgen deprivation therapy and at least one additional agent in the metastatic setting; OR, Women with metastatic high grade serous ovarian cancer with progression on at least one chemotherapy agent; OR, men or women with metastatic or unresectable pancreatic adenocarcinoma with progression on at least one chemotherapy regimen in the metastatic/unresectable setting\n* Measurable disease as defined by RECIST 1.1 criteria.\n* Trial participants must be at least 21 days from last dose of chemotherapy and recovered from all chemotherapy-related reversible toxicity to Grade 0 or 1, with the exception of alopecia and neuropathy.\n* The last radiation therapy (including palliative radiation) must have occurred ≥3 weeks prior to study registration.\n* Trial participants must have experienced disease progression at the time of study enrollment.\n* ECOG performance status of 0 or 1.\n* Adequate organ and marrow function per protocol.\n* Trial participants with treated brain metastases are eligible provided the metastases are recently treated and/or clinically stable and greater than 4 weeks has elapsed from time of treatment and date of initiation of study drug.\n* Trial participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* Males and females of reproductive potential must use two forms of effective contraception during the duration of the trial and for minimum of 7 months after last dose of study drug. A woman of reproductive potential is defined as a premenopausal female with intact uterus and ovaries. For women, non-childbearing potential is defined as:\n\n  * ≥45 years of age and has not had menses for >2 years.\n  * Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n  * Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n* Ability to understand and the willingness to sign a written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous or current treatment with a histone deacetylase inhibitor (HDACi)S.\n* Participation in other investigational studies concurrently if these therapies include a therapeutic intervention.\n* Treatment with any investigational agent within 30 days (or 5 serum half-lives of the investigational drug, whichever is longer) of enrollment.\n* Evidence of current serious uncontrolled concomitant cardiovascular nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:\n\n  * Myocardial infarction or arterial thromboembolic events within 6 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 450 msec.\n  * Uncontrolled hypertension or diabetes mellitus.\n  * Another known malignancy that is progressing or requires active treatment.\n  * Active infection requiring systemic therapy.\n  * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Any contraindication to oral agents or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption.\n* Allergy to talazoparib, belinostat or to the inactive components of talazoparib or belinostat formulations.\n* Pregnancy or breastfeeding.\n* QTc ≥ 450 ms or congenital long QT syndrome given potential for prolongation with belinostat.\n* Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study of drugs which are moderate or strong inhibitors of UGT1A1 per protocol.\n* Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study, of strong P-gp inhibitors per protocol.\n* Subjects homozygous for UGT1A1*28 allele; this will be determined via clinical testing by polymerase chain reaction with capillary electrophoresis by the University of Michigan Molecular Diagnostics laboratory.\n* Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* One of the following disease types: Men or women with histologically confirmed metastatic or unresectable breast cancer that is HER2 negative as assessed by 2018 ASCO-CAP guidelines. Trial participants with hormone receptor positive disease must have progression on at least one hormonal therapy and a CDK inhibitor AND be considered a candidate for chemotherapy; OR, Men with metastatic castration resistant prostate cancer with progression on androgen deprivation therapy and at least one additional agent in the metastatic setting; OR, Women with metastatic high grade serous ovarian cancer with progression on at least one chemotherapy agent; OR, men or women with metastatic or unresectable pancreatic adenocarcinoma with progression on at least one chemotherapy regimen in the metastatic/unresectable setting",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed metastatic or unresectable breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative as assessed by 2018 ASCO-CAP guidelines",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone receptor positive disease",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on at least one hormonal therapy",
                    "criterion": "hormonal therapy progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "at least one hormonal therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on ... a CDK inhibitor",
                    "criterion": "CDK inhibitor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "CDK inhibitor"
                        }
                    ]
                },
                {
                    "exact_snippets": "considered a candidate for chemotherapy",
                    "criterion": "chemotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": "candidate for chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic castration resistant prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic castration resistant"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "androgen deprivation therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on ... at least one additional agent in the metastatic setting",
                    "criterion": "additional agent progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "at least one additional agent in the metastatic setting"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic high grade serous ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic high grade serous"
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on at least one chemotherapy agent",
                    "criterion": "chemotherapy agent progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "at least one chemotherapy agent"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic or unresectable pancreatic adenocarcinoma",
                    "criterion": "pancreatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression on at least one chemotherapy regimen in the metastatic/unresectable setting",
                    "criterion": "chemotherapy regimen progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "at least one chemotherapy regimen in the metastatic/unresectable setting"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as defined by RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined by RECIST 1.1 criteria.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST 1.1 criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trial participants must be at least 21 days from last dose of chemotherapy and recovered from all chemotherapy-related reversible toxicity to Grade 0 or 1, with the exception of alopecia and neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "at least 21 days from last dose of chemotherapy",
                    "criterion": "time since last chemotherapy dose",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from all chemotherapy-related reversible toxicity to Grade 0 or 1",
                    "criterion": "chemotherapy-related reversible toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Grade 0",
                                "Grade 1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of ... neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The last radiation therapy (including palliative radiation) must have occurred ≥3 weeks prior to study registration.",
            "criterions": [
                {
                    "exact_snippets": "The last radiation therapy (including palliative radiation) must have occurred ≥3 weeks prior to study registration.",
                    "criterion": "time since last radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trial participants must have experienced disease progression at the time of study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "experienced disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of study enrollment",
                    "criterion": "time of study enrollment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of study enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and marrow function per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trial participants with treated brain metastases are eligible provided the metastases are recently treated and/or clinically stable and greater than 4 weeks has elapsed from time of treatment and date of initiation of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Trial participants with treated brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastases are recently treated and/or clinically stable",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment recency",
                            "expected_value": "recently treated"
                        },
                        {
                            "requirement_type": "clinical stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than 4 weeks has elapsed from time of treatment and date of initiation of study drug",
                    "criterion": "time elapsed since treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Trial participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.",
            "criterions": [
                {
                    "exact_snippets": "prior or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "natural history or treatment does not have the potential to interfere with the safety or efficacy assessment",
                    "criterion": "interference with safety or efficacy assessment",
                    "requirements": [
                        {
                            "requirement_type": "potential to interfere",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males and females of reproductive potential must use two forms of effective contraception during the duration of the trial and for minimum of 7 months after last dose of study drug. A woman of reproductive potential is defined as a premenopausal female with intact uterus and ovaries. For women, non-childbearing potential is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Males and females of reproductive potential must use two forms of effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": ">= 2"
                        }
                    ]
                },
                {
                    "exact_snippets": "during the duration of the trial and for minimum of 7 months after last dose of study drug",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and for minimum of 7 months after last dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "A woman of reproductive potential is defined as a premenopausal female with intact uterus and ovaries",
                    "criterion": "reproductive potential (women)",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "premenopausal female with intact uterus and ovaries"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥45 years of age and has not had menses for >2 years.",
            "criterions": [
                {
                    "exact_snippets": "≥45 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not had menses for >2 years",
                    "criterion": "menstrual history",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": "menses"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.",
            "criterions": [
                {
                    "exact_snippets": "Amenorrheic for <2 years",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without a hysterectomy",
                    "criterion": "hysterectomy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without a ... oophorectomy",
                    "criterion": "oophorectomy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle-stimulating hormone value in the postmenopausal range",
                    "criterion": "follicle-stimulating hormone level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.",
            "criterions": [
                {
                    "exact_snippets": "Post hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "Post ... oophorectomy",
                    "criterion": "oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "Post ... tubal ligation",
                    "criterion": "tubal ligation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented hysterectomy ... confirmed with medical records of the actual procedure or confirmed by an ultrasound",
                    "criterion": "hysterectomy documentation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "medical records",
                                "ultrasound"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Documented ... oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound",
                    "criterion": "oophorectomy documentation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "medical records",
                                "ultrasound"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Tubal ligation must be confirmed with medical records of the actual procedure",
                    "criterion": "tubal ligation documentation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "medical records"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "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": "* Previous or current treatment with a histone deacetylase inhibitor (HDACi)S.",
            "criterions": [
                {
                    "exact_snippets": "Previous or current treatment with a histone deacetylase inhibitor (HDACi)",
                    "criterion": "treatment with a histone deacetylase inhibitor (HDACi)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in other investigational studies concurrently if these therapies include a therapeutic intervention.",
            "criterions": [
                {
                    "exact_snippets": "Participation in other investigational studies concurrently",
                    "criterion": "participation in other investigational studies",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if these therapies include a therapeutic intervention",
                    "criterion": "therapies in investigational studies",
                    "requirements": [
                        {
                            "requirement_type": "inclusion of therapeutic intervention",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with any investigational agent within 30 days (or 5 serum half-lives of the investigational drug, whichever is longer) of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any investigational agent within 30 days (or 5 serum half-lives of the investigational drug, whichever is longer) of enrollment.",
                    "criterion": "treatment with investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "serum half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of current serious uncontrolled concomitant cardiovascular nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease.",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrolled concomitant cardiovascular ... disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... nervous system ... disease",
                    "criterion": "nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... pulmonary (including obstructive pulmonary disease) ... disease",
                    "criterion": "pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... renal ... disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... hepatic ... disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... endocrine (include uncontrolled diabetes mellitus) ... disease",
                    "criterion": "endocrine disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled concomitant ... gastrointestinal disease",
                    "criterion": "gastrointestinal disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "History or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction or arterial thromboembolic events within 6 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 450 msec.",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction ... within 6 months prior to screening",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arterial thromboembolic events within 6 months prior to screening",
                    "criterion": "arterial thromboembolic events",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe or unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "unstable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) Class III or IV disease",
                    "criterion": "New York Heart Association (NYHA) class",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval > 450 msec",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension or diabetes mellitus.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Another known malignancy that is progressing or requires active treatment.",
            "criterions": [
                {
                    "exact_snippets": "Another known malignancy that is progressing",
                    "criterion": "known malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Another known malignancy that ... requires active treatment",
                    "criterion": "known malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "active treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "Known active central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any contraindication to oral agents or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption.",
            "criterions": [
                {
                    "exact_snippets": "contraindication to oral agents",
                    "criterion": "contraindication to oral agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant nausea and vomiting",
                    "criterion": "nausea and vomiting",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption",
                    "criterion": "malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant small bowel resection",
                    "criterion": "small bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy to talazoparib, belinostat or to the inactive components of talazoparib or belinostat formulations.",
            "criterions": [
                {
                    "exact_snippets": "Allergy to talazoparib",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "talazoparib"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy to ... belinostat",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "belinostat"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy to ... inactive components of talazoparib",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "inactive components of talazoparib"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergy to ... inactive components of ... belinostat formulations",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": "inactive components of belinostat formulations"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTc ≥ 450 ms or congenital long QT syndrome given potential for prolongation with belinostat.",
            "criterions": [
                {
                    "exact_snippets": "QTc ≥ 450 ms",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study of drugs which are moderate or strong inhibitors of UGT1A1 per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study of drugs which are moderate or strong inhibitors of UGT1A1",
                    "criterion": "use of drugs which are moderate or strong inhibitors of UGT1A1",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "current or anticipated use within 7 days prior to enrollment or during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study, of strong P-gp inhibitors per protocol.",
            "criterions": [
                {
                    "exact_snippets": "Current or anticipated use within 7 days prior to enrollment, or anticipated use during the study, of strong P-gp inhibitors",
                    "criterion": "use of strong P-gp inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "current or anticipated use within 7 days prior to enrollment or during the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects homozygous for UGT1A1*28 allele; this will be determined via clinical testing by polymerase chain reaction with capillary electrophoresis by the University of Michigan Molecular Diagnostics laboratory.",
            "criterions": [
                {
                    "exact_snippets": "Subjects homozygous for UGT1A1*28 allele",
                    "criterion": "UGT1A1*28 allele",
                    "requirements": [
                        {
                            "requirement_type": "homozygosity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.",
            "criterions": [
                {
                    "exact_snippets": "Any medical or psychological condition",
                    "criterion": "medical or psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "interference with safe completion of the trial",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}