http://hl7.org/fhir/uv/ebm/Group/583769
type: Group
node role: treeRoot
id:
  v: 583769
meta:
  version id:
    v: 2
  last updated:
    v: 2026-07-27T13:49:52.712Z
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Group 583769 version: 2; Last updated: 2026-07-27 13:49:52+0000 ArtifactPublicationStatus: Active Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: CiteAs: 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. url: https://fevir.net/resources/Group/583769 identifier: FEvIR Object Identifier/583769, FEvIR Linking Identifier/NCT05327010 Eligibility Criteria name: NCT05327010_Eligibility_Criteria title: NCT05327010 Eligibility Criteria status: Active publisher: Computable Publishing LLC contact: support@computablepublishing.com description: Inclusion Criteria: 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 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 __* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable 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…
extension:
  url:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
    l: artifact-publication-status
  value: CodeableConcept
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/cited-artifact-status-type
        l: cited-artifact-status-type
      code:
        v: active
      display:
        v: Active
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/artifact-author
    l: artifact-author
  value: ContactDetail
    name:
      v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
extension:
  url:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as
    l: cite-as
  value: Markdown
    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.
url:
  v: https://fevir.net/resources/Group/583769
  l: https://fevir.net/resources/Group/583769
identifier:
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0203
        l: v2-0203
      code:
        v: ACSN
      display:
        v: Accession ID
    text:
      v: FEvIR Object Identifier
  system:
    v: https://fevir.net/FOI
    l: FOI
  value:
    v: 583769
  assigner:
    display:
      v: Computable Publishing LLC
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT05327010 Eligibility Criteria
  assigner:
    display:
      v: Computable Publishing LLC
name:
  v: NCT05327010_Eligibility_Criteria
title:
  v: NCT05327010 Eligibility Criteria
status:
  v: active
publisher:
  v: Computable Publishing LLC
contact:
  telecom:
    system:
      v: email
description:
  v: Inclusion Criteria: * 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 * 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 __* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable * 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 __* 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 __* 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 __* 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 __* Patients in Cohort 4 must have …
copyright:
  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).
membership:
  v: conceptual
combination method:
  v: all-of
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      v: __* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable
  exclude:
    v: false
  description:
    v: __* Note: Tumor lesions that are situated in a previously irradiated area may or may not be considered measurable
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      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
  exclude:
    v: false
  description:
    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
characteristic:
  code:
    text:
      v: Defined by CodeableConcept
  value: CodeableConcept
    text:
      v: Age \>= 18 years

v: false

v: Age \>= 18 years

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
exclude:
  v: false
description:
  v: Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Absolute neutrophil count \>= 1,500/mcL
exclude:
  v: false
description:
  v: Absolute neutrophil count \>= 1,500/mcL

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Platelets \>= 150,000/mcL
exclude:
  v: false
description:
  v: Platelets \>= 150,000/mcL

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Hemoglobin \>= 10.0 g/dL (no blood transfusions in the preceding 28 days)
exclude:
  v: false
description:
  v: Hemoglobin \>= 10.0 g/dL (no blood transfusions in the preceding 28 days)

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN
exclude:
  v: false
description:
  v: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
exclude:
  v: false
description:
  v: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated
exclude:
  v: false
description:
  v: Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable viral load while on suppressive therapy, if indicated

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: false
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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)
exclude:
  v: false
description:
  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)

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Ability to understand and the willingness to sign a written informed consent document
exclude:
  v: false
description:
  v: Ability to understand and the willingness to sign a written informed consent document

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients who are receiving any other investigational agents
exclude:
  v: true
description:
  v: Patients who are receiving any other investigational agents

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib
exclude:
  v: true
description:
  v: History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or talazoparib

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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.
exclude:
  v: true
description:
  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.

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients with uncontrolled intercurrent illness
exclude:
  v: true
description:
  v: Patients with uncontrolled intercurrent illness

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients with psychiatric illness/social situations that would limit compliance with study requirements
exclude:
  v: true
description:
  v: Patients with psychiatric illness/social situations that would limit compliance with study requirements

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: true
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients who are involved in the planning and/or conduct of the study
exclude:
  v: true
description:
  v: Patients who are involved in the planning and/or conduct of the study

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients who are unable or unwilling to swallow pills
exclude:
  v: true
description:
  v: Patients who are unable or unwilling to swallow pills

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization
exclude:
  v: true
description:
  v: Active infection requiring intravenous (IV) antibiotics, or other uncontrolled intercurrent illness requiring hospitalization

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: true
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients with radiation to \> 25% of the bone marrow
exclude:
  v: true
description:
  v: Patients with radiation to \> 25% of the bone marrow

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib
exclude:
  v: true
description:
  v: Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694 (ZEN-3694) or talazoparib

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor
exclude:
  v: true
description:
  v: Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: true
description:
  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

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    v: Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib
exclude:
  v: true
description:
  v: Patients with impairment of gastrointestinal function that may significantly alter the absorption of ZEN003694 (ZEN-3694) or talazoparib

code:
  text:
    v: Defined by CodeableConcept
value: CodeableConcept
  text:
    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
exclude:
  v: true
description:
  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