Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- <http://hl7.org/fhir/Group/583769> a fhir:Group ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "583769"] ; # fhir:meta [ fhir:versionId [ fhir:v "2" ] ; fhir:lastUpdated [ fhir:v "2026-07-27T13:49:52.712Z"^^xsd:dateTime ] ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Group 583769</b></p><a name=\"583769\"> </a><a name=\"hc583769\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 2; Last updated: 2026-07-27 13:49:52+0000</p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>Artifact Author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>CiteAs</b>: </p><div><p>NCT05327010 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583769. Revised 2026-07-27. Available at: https://fevir.net/resources/Group/583769. Computable resource at: https://fevir.net/resources/Group/583769#json.</p>\n</div><p><b>url</b>: <a href=\"https://fevir.net/resources/Group/583769\">https://fevir.net/resources/Group/583769</a></p><p><b>identifier</b>: FEvIR Object Identifier/583769, FEvIR Linking Identifier/NCT05327010 Eligibility Criteria</p><p><b>name</b>: NCT05327010_Eligibility_Criteria</p><p><b>title</b>: NCT05327010 Eligibility Criteria</p><p><b>status</b>: Active</p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>description</b>: </p><div><p>Inclusion Criteria:</p>\n<ul>\n<li>Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective</li>\n<li>Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable</li>\n<li>Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed\n__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy\n__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy\n__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy\n__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously</li>\n<li>Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy</li>\n<li>Age >= 18 years\n__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients < 18 years of age, children are excluded from this study</li>\n<li>Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =< grade 1) with the exception of alopecia or anorexia</li>\n<li>Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)</li>\n<li>Absolute neutrophil count >= 1,500/mcL</li>\n<li>Platelets >= 150,000/mcL</li>\n<li>Hemoglobin >= 10.0 g/dL (no blood transfusions in the preceding 28 days)</li>\n<li>Total bilirubin 1.5 x =< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels > 1.5 x ULN</li>\n<li>Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN</li>\n<li>Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for subjects with creatinine levels > 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2</li>\n<li>Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial</li>\n<li>Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated</li>\n<li>Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load</li>\n<li>Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability</li>\n<li>Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded</li>\n<li>Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better</li>\n<li>The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately</li>\n<li>Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration</li>\n<li>Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)</li>\n<li>Ability to understand and the willingness to sign a written informed consent document\nExclusion Criteria:</li>\n<li>Patients who are receiving any other investigational agents</li>\n<li>History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib</li>\n<li>Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.</li>\n<li>Patients with uncontrolled intercurrent illness</li>\n<li>Patients with psychiatric illness/social situations that would limit compliance with study requirements</li>\n<li>Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study</li>\n<li>Patients who are involved in the planning and/or conduct of the study</li>\n<li>Patients who are unable or unwilling to swallow pills</li>\n<li>Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization</li>\n<li>Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed</li>\n<li>Patients with radiation to > 25% of the bone marrow</li>\n<li>Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib</li>\n<li>Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor</li>\n<li>Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</li>\n<li>Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib</li>\n<li>Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</li>\n</ul>\n</div><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>\n</div><p><b>membership</b>: Conceptual</p><p><b>combinationMethod</b>: All of</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Age \\>= 18 years</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Age >= 18 years</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients \\< 18 years of age, children are excluded from this study</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients < 18 years of age, children are excluded from this study</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =\\< grade 1) with the exception of alopecia or anorexia</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =< grade 1) with the exception of alopecia or anorexia</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Absolute neutrophil count \\>= 1,500/mcL</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Absolute neutrophil count >= 1,500/mcL</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Platelets \\>= 150,000/mcL</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Platelets >= 150,000/mcL</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Hemoglobin \\>= 10.0 g/dL (no blood transfusions in the preceding 28 days)</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Hemoglobin >= 10.0 g/dL (no blood transfusions in the preceding 28 days)</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Total bilirubin 1.5 x =\\< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels \\> 1.5 x ULN</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Total bilirubin 1.5 x =< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels > 1.5 x ULN</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 60 mL/min/1.73 m\\^2 for subjects with creatinine levels \\> 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\\^2</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for subjects with creatinine levels > 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (\\>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Ability to understand and the willingness to sign a written informed consent document</span></p><p><b>exclude</b>: false</p><p><b>description</b>: </p><div><p>Ability to understand and the willingness to sign a written informed consent document</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients who are receiving any other investigational agents</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients who are receiving any other investigational agents</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with uncontrolled intercurrent illness</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients with uncontrolled intercurrent illness</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with psychiatric illness/social situations that would limit compliance with study requirements</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients with psychiatric illness/social situations that would limit compliance with study requirements</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients who are involved in the planning and/or conduct of the study</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients who are involved in the planning and/or conduct of the study</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients who are unable or unwilling to swallow pills</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients who are unable or unwilling to swallow pills</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with radiation to \\> 25% of the bone marrow</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients with radiation to > 25% of the bone marrow</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib</p>\n</div></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title=\"Codes:\">Defined by CodeableConcept</span></p><p><b>value</b>: <span title=\"Codes:\">Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</span></p><p><b>exclude</b>: true</p><p><b>description</b>: </p><div><p>Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib</p>\n</div></blockquote></div>"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status> ] ; fhir:value [ a fhir:CodeableConcept ; fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type> ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "Active" ] ] ) ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-author> ] ; fhir:value [ a fhir:ContactDetail ; fhir:name [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as> ] ; fhir:value [ a fhir:Markdown ; fhir:v "NCT05327010 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583769. Revised 2026-07-27. Available at: https://fevir.net/resources/Group/583769. Computable resource at: https://fevir.net/resources/Group/583769#json." ] ] ) ; # fhir:url [ fhir:v "https://fevir.net/resources/Group/583769"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/Group/583769> ] ; # fhir:identifier ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203> ] ; fhir:code [ fhir:v "ACSN" ] ; fhir:display [ fhir:v "Accession ID" ] ] ) ; fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net/FOI"^^xsd:anyURI ; fhir:l <https://fevir.net/FOI> ] ; fhir:value [ fhir:v "583769" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] [ fhir:type [ fhir:text [ fhir:v "FEvIR Linking Identifier" ] ] ; fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ; fhir:l <https://fevir.net/FLI> ] ; fhir:value [ fhir:v "NCT05327010 Eligibility Criteria" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] ) ; # fhir:name [ fhir:v "NCT05327010_Eligibility_Criteria"] ; # fhir:title [ fhir:v "NCT05327010 Eligibility Criteria"] ; # fhir:status [ fhir:v "active"] ; # fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # fhir:contact ( [ fhir:telecom ( [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "support@computablepublishing.com" ] ] ) ] ) ; # fhir:description [ fhir:v "Inclusion Criteria:\n* Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable\n* Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed\n__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy\n__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy\n__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy\n__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously\n* Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy\n* Age \\>= 18 years\n__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients \\< 18 years of age, children are excluded from this study\n* Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =\\< grade 1) with the exception of alopecia or anorexia\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 150,000/mcL\n* Hemoglobin \\>= 10.0 g/dL (no blood transfusions in the preceding 28 days)\n* Total bilirubin 1.5 x =\\< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels \\> 1.5 x ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN\n* Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 60 mL/min/1.73 m\\^2 for subjects with creatinine levels \\> 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability\n* Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better\n* The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration\n* Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (\\>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)\n* Ability to understand and the willingness to sign a written informed consent document\nExclusion Criteria:\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* Patients with uncontrolled intercurrent illness\n* Patients with psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study\n* Patients who are involved in the planning and/or conduct of the study\n* Patients who are unable or unwilling to swallow pills\n* Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization\n* Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed\n* Patients with radiation to \\> 25% of the bone marrow\n* Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib\n* Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor\n* Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib\n* Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib\n* Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib"] ; # fhir:copyright [ fhir:v "Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse)."] ; # fhir:membership [ fhir:v "conceptual"] ; # fhir:combinationMethod [ fhir:v "all-of"] ; # fhir:characteristic ( [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients in cohorts 1, 2, and 4 should have at least one relevant mutation. Patients enrolled in cohorts 1-3 do not require that PARP inhibitor (i) be the immediate prior therapy to be eligible for the trial. Patients should sign a screening consent that will allow the review of local next generation sequencing (NGS) or equivalent Clinical Laboratory Improvement Amendment (CLIA)-certified assay results by MD Anderson's Precision Oncology Decision Support (PODS) team to ensure that the mutations are actionable. No variants of uncertain significance (VUS) will be allowed" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination-therapy" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Patients in Cohort 2 must have: (i) a germline or somatic mutation in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BARD1; FANCA; BRIP1; PALB2; RAD51; RAD51C; RAD51D, with no evidence of mutations in BRCA1 or BRCA2; and (ii) must have received prior PARPi monotherapy or PARPi combination therapy" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Patients in Cohort 3 must be (i) patients who have had PR/CR on prior PARPi monotherapy or PARPi combination treatment; and (ii) patients with no evidence of BRCA1 or BRCA2 mutations or any of the relevant DDR aberrations listed in cohort 2. Patients with ovarian cancer should not have progressed on platinum-therapy within six months of therapy" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Patients in Cohort 4 must have KRAS mutated advanced solid tumors. Prior treatments with KRAS inhibitors are permitted. Patients with KRAS G12C mutations must have already had KRAS G12C targeted therapy (e.g., sotorasib) previously" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options, and subjects who have declined standard of care therapy prior to study introduction, are also eligible. Patients with ovarian cancer in cohort 3 should not have progressed on platinum within six months of therapy" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Age \\>= 18 years" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Age \\>= 18 years" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients \\< 18 years of age, children are excluded from this study" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "__* Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with talazoparib in patients \\< 18 years of age, children are excluded from this study" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =\\< grade 1) with the exception of alopecia or anorexia" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients must be greater than 4 weeks (6 weeks for nitrosoureas or mitomycin C) beyond treatment with any chemotherapy or other investigational therapy including hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities =\\< grade 1) with the exception of alopecia or anorexia" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Absolute neutrophil count \\>= 1,500/mcL" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Absolute neutrophil count \\>= 1,500/mcL" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Platelets \\>= 150,000/mcL" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Platelets \\>= 150,000/mcL" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Hemoglobin \\>= 10.0 g/dL (no blood transfusions in the preceding 28 days)" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Hemoglobin \\>= 10.0 g/dL (no blood transfusions in the preceding 28 days)" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Total bilirubin 1.5 x =\\< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels \\> 1.5 x ULN" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Total bilirubin 1.5 x =\\< institutional upper limit of normal (ULN) OR direct bilirubin = ULN for subjects with total bilirubin levels \\> 1.5 x ULN" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 60 mL/min/1.73 m\\^2 for subjects with creatinine levels \\> 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\\^2" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Creatinine 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 60 mL/min/1.73 m\\^2 for subjects with creatinine levels \\> 1.5 x institutional ULN, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\\^2" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Patients with known symptomatic brain metastases requiring steroids are excluded. Of note, patients who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout. Follow-up brain imaging after central nervous system (CNS)-directed therapy must show no evidence of progression and patient should be clinically stable for at least 1 month. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients 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 are eligible for this trial. However, patients with concurrent malignancy that is progressing or requiring active treatment are excluded" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be of class 2B or better" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "The effects of the combination ZEN003694 (ZEN-3694) and talazoparib on the developing human fetus are unknown. For this reason, and because BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 7 months after completion of study drug administration" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (\\>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (\\>/= 1 year before screening), total hysterectomy, or menopause (defined as 12 consecutive months of amenorrhea)" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Ability to understand and the willingness to sign a written informed consent document" ] ] ; fhir:exclude [ fhir:v false ] ; fhir:description [ fhir:v "Ability to understand and the willingness to sign a written informed consent document" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients who are receiving any other investigational agents" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients who are receiving any other investigational agents" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product." ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or P-gp, strong inhibitors of BCRP, sensitive substrates of CYP1A2, proton-pump-inhibitors (H2 antagonists are allowed), and herbal medications/preparations (vitamins are allowed) are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694 (ZEN-3694). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product." ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with uncontrolled intercurrent illness" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients with uncontrolled intercurrent illness" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with psychiatric illness/social situations that would limit compliance with study requirements" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients with psychiatric illness/social situations that would limit compliance with study requirements" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is a BET inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of the study drug. These potential risks may also apply to other agents used in this study" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients who are involved in the planning and/or conduct of the study" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients who are involved in the planning and/or conduct of the study" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients who are unable or unwilling to swallow pills" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients who are unable or unwilling to swallow pills" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients receiving any medications or substances that are factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with radiation to \\> 25% of the bone marrow" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients with radiation to \\> 25% of the bone marrow" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib" ] ] [ fhir:code [ fhir:text [ fhir:v "Defined by CodeableConcept" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] ; fhir:exclude [ fhir:v true ] ; fhir:description [ fhir:v "Patients that have had major surgery other than diagnostic surgery, dental surgery, or stenting within 4 weeks prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib" ] ] ) . #
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Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot5.
Generated
2026-08-17
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