FHIRsmith: ResearchStudy/ResearchStudy-583768.json

FHIR IG analytics

Package	hl7.fhir.uv.ebm
Resource Type	ResearchStudy
Id	ResearchStudy-583768.json
FHIR Version	R6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ResearchStudy 583768

version: 2; Last updated: 2026-07-27 13:49:52+0000

Profile: StudyRegistryRecord

ArtifactPublicationStatus: Active

Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

url: https://fevir.net/resources/ResearchStudy/583768

identifier: FEvIR Object Identifier/583768, ClinicalTrials.gov/NCT05327010 (use: official, ), NCI-2022-02915, Registry Identifier/NCI-2022-02915, NCI10486, Other Identifier/10486, Other Identifier/10486, U.S. NIH Grant/Contract/UM1CA186688, FEvIR Linking Identifier/NCT05327010 FHIR Transform

name: NCT05327010_FHIR_Transform

title: Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial

Labels

Type

Value

Official title

Phase 2 Trial of the Combination of the BET Inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients With Molecularly-Selected Solid Tumors (ComBET)

citeAs:

Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 583768. Revised 2026-07-27. Available at: https://fevir.net/resources/ResearchStudy/583768. Computable resource at: https://fevir.net/resources/ResearchStudy/583768#json.

relatesTo
type: Transforms
target: https://clinicaltrials.gov/api/v2/studies/NCT05327010?format=json

relatesTo
type: Transformed With
target: null @ https://fevir.net/ctgovconvert

relatesTo
type: Supported With
target: null @ https://reporter.nih.gov/quickSearch/UM1CA186688

relatesTo
type: Supported With
target: null @ https://grants.nih.gov/policy/sharing.htm

status: Active

phase: Phase 2

studyDesign: Design Masking: None (Open Label), Design Allocation: NA, Uncontrolled cohort design, interventional research

condition: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

descriptionSummary:

This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer.

description:

PRIMARY OBJECTIVE:

I. To evaluate clinical response to the combination of BET bromodomain inhibitor ZEN-3694 (ZEN003694 [ZEN-3694]) and talazoparib using objective response rate (ORR) = (complete response [CR] + partial response [PR]).

SECONDARY OBJECTIVES:

I. To confirm the safety and toxicity profile of the combination of ZEN003694 (ZEN-3694) and talazoparib.

II. To evaluate the clinical benefit rate (stable disease [SD] > 6 months [m]+CR+PR) and progression-free survival (PFS).

III. To assess the pharmacodynamics of the combination of ZEN003694 (ZEN-3694) and talazoparib using pre- and on-treatment tumor biopsies.

IV. To characterize pharmacodynamic changes of exploratory biomarkers to the combination of ZEN003694 (ZEN-3694) and talazoparib in pre- and on-treatment tumor biopsies.

V. To assess putative predictive biomarkers of response and resistance to the combination of ZEN003694 (ZEN-3694) and talazoparib.

OUTLINE:

Patients receive ZEN-3694 orally (PO) once daily (QD) and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study.

After completion of study treatment, patients are followed up 30 days after administration of the last dose of study drug and then every 3 months for up to 2 years.

site:

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ResearchStudy: status = active

classifier: IPDSharing: Yes, IPDSharingDescription: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page., Does not include healthy volunteers, Includes female subjects, Includes male subjects, Minimum Age: 18 Years, Age Group: Adult, Age Group: Older Adult, Has Results: False, Oversight Classifier: oversightHasDmc False, Oversight Classifier: isFdaRegulatedDrug True, Oversight Classifier: isFdaRegulatedDevice False

associatedParty
name: National Cancer Institute (NCI)
role: Sponsor
classifier: NIH

associatedParty
name: National Cancer Institute (NCI)
role: Lead sponsor
classifier: NIH

associatedParty
name: Timothy A Yap
role: Principal investigator
party: University of Texas MD Anderson Cancer Center LAO

progressStatus
state: Recruiting

progressStatus
state: Registration submission
actual: true
period: 2022-04-13 --> (ongoing)

progressStatus
state: Registration submission Quality Check
actual: true
period: 2022-04-13 --> (ongoing)

progressStatus
state: Record Verification
actual: true
period: ?? --> 2026-07

progressStatus
state: Update submission
actual: true
period: ?? --> 2026-07-17

progressStatus
state: Registration posting
actual: true
period: 2022-04-14 --> (ongoing)

progressStatus
state: Primary outcome data collection
actual: false
period: ?? --> 2026-12-31

progressStatus
state: Update posting
actual: true
period: ?? --> 2026-07-20

progressStatus
state: Overall study
actual: true
period: 2022-11-14 --> (ongoing)

progressStatus
state: Overall study
actual: false
period: ?? --> 2027-12-31

Recruitments

TargetNumber

Eligibility

NCT05327010 Eligibility Criteria

ComparisonGroups

Eligibility

Treatment (ZEN-3694, talazoparib)

objective
type: Primary
OutcomeMeasures
- Name Type Description Endpoint
* Objective response rate (ORR) Primary
Systemically assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR = complete response + partial response. Complete response is defined as the disappearance of all target or non-target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target or non-target lesions.

Objective response rate (ORR)

objective
type: Secondary
outcomeMeasure
name: Duration of response
type: Secondary
description:
Assessed using RECIST v1.1.

endpoint: Duration of response
outcomeMeasure
name: Clinical benefit rate (CBR)
type: Secondary
description:
Assessed by radiographic disease assessments per RECIST v1.1. CBR = overall response + stable disease > 6 months. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.

endpoint: Clinical benefit rate (CBR)
outcomeMeasure
name: Progression-free survival
type: Secondary
description:
Assessed by radiographic disease assessments per RECIST v1.1.

endpoint: Progression-free survival
outcomeMeasure
name: Overall survival
type: Secondary
description:
Assessed by radiographic disease assessments per RECIST v1.1.

endpoint: Overall survival
outcomeMeasure
name: Incidence of adverse events
type: Secondary
description:
Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type.

endpoint: Incidence of adverse events

objective
type: Exploratory
outcomeMeasure
name: Treatment-induced changes in phospho-protein signaling
type: Exploratory
description:
Reverse phase proteomic array in pre- and on-treatment tumor biopsy samples conducted to assess treatment-induced changes in phospho-protein signaling, to correlate with treatment response and progression, and to assess changes in the levels of cytotoxic T lymphocyte precursor.

endpoint: Treatment-induced changes in phospho-protein signaling
outcomeMeasure
name: Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response
type: Exploratory
description:
Whole exome sequencing conducted on pre-treatment biopsy and at progression to correlate SNV and CNV profiles with treatment response.

endpoint: Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response
outcomeMeasure
name: Gene expression profiling
type: Exploratory
description:
Ribonucleic acid (RNA) sequencing conducted for gene expression profiling.

endpoint: Gene expression profiling
outcomeMeasure
name: Correlate mutation profiles with tumor sequencing
type: Exploratory
description:
Using circulating tumor deoxyribonucleic acid (ctDNA) for correlation.

endpoint: Correlate mutation profiles with tumor sequencing
outcomeMeasure
name: Correlate baseline mutations with treatment response
type: Exploratory
description:
Using ctDNA for correlation.

endpoint: Correlate baseline mutations with treatment response
outcomeMeasure
name: Correlate changes in ctDNA variant allele frequencies with response
type: Exploratory
description:
Using ctDNA for correlation.

endpoint: Correlate changes in ctDNA variant allele frequencies with response
outcomeMeasure
name: Assess emergent resistant mutations
type: Exploratory
description:
Includes BRCA reversion.

endpoint: Assess emergent resistant mutations
outcomeMeasure
name: Analysis of formalin-fixed paraffin-embedded and blood and blood samples
type: Exploratory
description:
DNA, RNA, and protein analysis conducted.

endpoint: Analysis of formalin-fixed paraffin-embedded and blood and blood samples

Generated Narrative: EvidenceVariable #NCT05327010-drug------bet-bromodomain-inhibitor-zen-3694

Profile: VariableDefinition
EvidenceVariableHandlingDetail: boolean variable
name: NCT05327010_drug______bet_bromodomain_inhibitor_zen_3694
title: BET Bromodomain Inhibitor ZEN-3694
status: Active
description:
Given PO

note: , , ,
suggested alternative name: BETi ZEN-3694

suggested alternative name: ZEN 3694

suggested alternative name: ZEN-3694

suggested alternative name: ZEN003694

handling: STATO:0000724
classifier: Intervention Type: DRUG

Generated Narrative: EvidenceVariable #NCT05327010-procedure------biopsy-procedure

Profile: VariableDefinition
EvidenceVariableHandlingDetail: boolean variable
name: NCT05327010_procedure______biopsy_procedure
title: Biopsy Procedure
status: Active
description:
Undergo tumor biopsy

note: , ,
suggested alternative name: Biopsy

suggested alternative name: BIOPSY_TYPE

suggested alternative name: Bx

handling: STATO:0000724
classifier: Intervention Type: PROCEDURE

Generated Narrative: EvidenceVariable #NCT05327010-procedure------biospecimen-collection

Profile: VariableDefinition
EvidenceVariableHandlingDetail: boolean variable
name: NCT05327010_procedure______biospecimen_collection
title: Biospecimen Collection
status: Active
description:
Undergo blood sample collection

note: , , ,
suggested alternative name: Biological Sample Collection

suggested alternative name: Biospecimen Collected

suggested alternative name: Sample Collection

suggested alternative name: Specimen Collection

handling: STATO:0000724
classifier: Intervention Type: PROCEDURE

Generated Narrative: EvidenceVariable #NCT05327010-procedure------diagnostic-imaging-testing

Profile: VariableDefinition
EvidenceVariableHandlingDetail: boolean variable
name: NCT05327010_procedure______diagnostic_imaging_testing
title: Diagnostic Imaging Testing
status: Active
description:
Undergo diagnostic imaging

note: ,
suggested alternative name: Diagnostic Imaging

suggested alternative name: Medical Imaging

handling: STATO:0000724
classifier: Intervention Type: PROCEDURE

Generated Narrative: EvidenceVariable #NCT05327010-drug------talazoparib

Profile: VariableDefinition
EvidenceVariableHandlingDetail: boolean variable
name: NCT05327010_drug______talazoparib
title: Talazoparib
status: Active
description:
Given PO

note: , ,
suggested alternative name: BMN 673

suggested alternative name: BMN-673

suggested alternative name: BMN673

handling: STATO:0000724
classifier: Intervention Type: DRUG

Generated Narrative: Group #NCT05327010-comparison-group-0

Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
identifier: FEvIR Linking Identifier/NCT05327010-comparison-group-0
title: NCT05327010 Comparison Group: Treatment (ZEN-3694, talazoparib)
status: Active
description:
Patients receive ZEN-3694 PO QD and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study.

membership: Conceptual
code: Experimental
combinationMethod: All of
characteristic
code: Exposed to
value: Drug: BET Bromodomain Inhibitor ZEN-3694
exclude: false
characteristic
code: Exposed to
value: Procedure: Biopsy Procedure
exclude: false
characteristic
code: Exposed to
value: Procedure: Biospecimen Collection
exclude: false
characteristic
code: Exposed to
value: Procedure: Diagnostic Imaging Testing
exclude: false
characteristic
code: Exposed to
value: Drug: Talazoparib
exclude: false

Generated Narrative: ResearchStudy #NCT05327010-Location-0-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location City of Hope Comprehensive Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-0

name: City of Hope Comprehensive Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 800-826-4673, becomingapatient@coh.org
* Principal investigator Irene M. Kang
address: Duarte California 91010 United States
Positions
- Longitude Latitude
* -117.97729 34.13945

Generated Narrative: ResearchStudy #NCT05327010-Location-1-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location City of Hope at Irvine Lennar
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-1

name: City of Hope at Irvine Lennar
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 877-467-3411
* Principal investigator Irene M. Kang
address: Irvine California 92618 United States
Positions
- Longitude Latitude
* -117.82311 33.66946

Generated Narrative: ResearchStudy #NCT05327010-Location-2-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UC San Diego Moores Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-2

name: UC San Diego Moores Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 858-822-5354, cancercto@ucsd.edu
* Principal investigator Rana R. McKay
address: La Jolla California 92093 United States
Positions
- Longitude Latitude
* -117.2742 32.84727

Generated Narrative: ResearchStudy #NCT05327010-Location-3-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Keck Medicine of USC Koreatown
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-3

name: Keck Medicine of USC Koreatown
address: Los Angeles California 90020 United States
Positions
- Longitude Latitude
* -118.24368 34.05223

Generated Narrative: ResearchStudy #NCT05327010-Location-4-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Los Angeles General Medical Center
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-4

name: Los Angeles General Medical Center
address: Los Angeles California 90033 United States
Positions
- Longitude Latitude
* -118.24368 34.05223

Generated Narrative: ResearchStudy #NCT05327010-Location-5-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location USC / Norris Comprehensive Cancer Center
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-5

name: USC / Norris Comprehensive Cancer Center
address: Los Angeles California 90033 United States
Positions
- Longitude Latitude
* -118.24368 34.05223

Generated Narrative: ResearchStudy #NCT05327010-Location-6-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location USC Norris Oncology/Hematology-Newport Beach
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-6

name: USC Norris Oncology/Hematology-Newport Beach
address: Newport Beach California 92663 United States
Positions
- Longitude Latitude
* -117.92895 33.61891

Generated Narrative: ResearchStudy #NCT05327010-Location-7-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of California Davis Comprehensive Cancer Center
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-7

name: University of California Davis Comprehensive Cancer Center
address: Sacramento California 95817 United States
Positions
- Longitude Latitude
* -121.4944 38.58157

Generated Narrative: ResearchStudy #NCT05327010-Location-8-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UC San Diego Medical Center - Hillcrest
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-8

name: UC San Diego Medical Center - Hillcrest
Contacts
- Purpose Name Telecom
* General contact Site Public Contact rhabbaba@health.ucsd.edu
* Principal investigator Rana R. McKay
address: San Diego California 92103 United States
Positions
- Longitude Latitude
* -117.16472 32.71571

Generated Narrative: ResearchStudy #NCT05327010-Location-9-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UCHealth University of Colorado Hospital
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-9

name: UCHealth University of Colorado Hospital
address: Aurora Colorado 80045 United States
Positions
- Longitude Latitude
* -104.83192 39.72943

Generated Narrative: ResearchStudy #NCT05327010-Location-10-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Yale University
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-10

name: Yale University
address: New Haven Connecticut 06520 United States
Positions
- Longitude Latitude
* -72.92816 41.30815

Generated Narrative: ResearchStudy #NCT05327010-Location-11-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Smilow Cancer Hospital Care Center-Trumbull
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-11

name: Smilow Cancer Hospital Care Center-Trumbull
address: Trumbull Connecticut 06611 United States
Positions
- Longitude Latitude
* -73.20067 41.24287

Generated Narrative: ResearchStudy #NCT05327010-Location-12-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UF Health Cancer Institute - Gainesville
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-12

name: UF Health Cancer Institute - Gainesville
address: Gainesville Florida 32610 United States
Positions
- Longitude Latitude
* -82.32483 29.65163

Generated Narrative: ResearchStudy #NCT05327010-Location-13-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Emory University Hospital/Winship Cancer Institute
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-13

name: Emory University Hospital/Winship Cancer Institute
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 404-778-1868
* Principal investigator Ticiana A. Leal
address: Atlanta Georgia 30322 United States
Positions
- Longitude Latitude
* -84.38798 33.749

Generated Narrative: ResearchStudy #NCT05327010-Location-14-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Northwestern University
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-14

name: Northwestern University
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 312-695-1301, cancer@northwestern.edu
* Principal investigator Aparna Kalyan
address: Chicago Illinois 60611 United States
Positions
- Longitude Latitude
* -87.65005 41.85003

Generated Narrative: ResearchStudy #NCT05327010-Location-15-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Clinical Research Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-15

name: University of Kansas Clinical Research Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Fairway Kansas 66205 United States
Positions
- Longitude Latitude
* -94.6319 39.02223

Generated Narrative: ResearchStudy #NCT05327010-Location-16-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-16

name: University of Kansas Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Kansas City Kansas 66160 United States
Positions
- Longitude Latitude
* -94.62746 39.11417

Generated Narrative: ResearchStudy #NCT05327010-Location-17-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Cancer Center-Overland Park
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-17

name: University of Kansas Cancer Center-Overland Park
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Overland Park Kansas 66210 United States
Positions
- Longitude Latitude
* -94.67079 38.98223

Generated Narrative: ResearchStudy #NCT05327010-Location-18-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Hospital-Indian Creek Campus
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-18

name: University of Kansas Hospital-Indian Creek Campus
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Overland Park Kansas 66211 United States
Positions
- Longitude Latitude
* -94.67079 38.98223

Generated Narrative: ResearchStudy #NCT05327010-Location-19-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Hospital-Westwood Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-19

name: University of Kansas Hospital-Westwood Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Westwood Kansas 66205 United States
Positions
- Longitude Latitude
* -94.6169 39.04056

Generated Narrative: ResearchStudy #NCT05327010-Location-20-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kentucky/Markey Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-20

name: University of Kentucky/Markey Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 859-257-3379
* Principal investigator Rachel W. Miller
address: Lexington Kentucky 40536 United States
Positions
- Longitude Latitude
* -84.47772 37.98869

Generated Narrative: ResearchStudy #NCT05327010-Location-21-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Ochsner Medical Center Jefferson
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-21

name: Ochsner Medical Center Jefferson
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 504-842-8084, Elisemarie.curry@ochsner.org
* Principal investigator Daniel Johnson
address: New Orleans Louisiana 70121 United States
Positions
- Longitude Latitude
* -90.07507 29.95465

Generated Narrative: ResearchStudy #NCT05327010-Location-22-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location National Cancer Institute Developmental Therapeutics Clinic
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-22

name: National Cancer Institute Developmental Therapeutics Clinic
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 800-411-1222
* Principal investigator A P. Chen
address: Bethesda Maryland 20892 United States
Positions
- Longitude Latitude
* -77.10026 38.98067

Generated Narrative: ResearchStudy #NCT05327010-Location-23-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location National Institutes of Health Clinical Center
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-23

name: National Institutes of Health Clinical Center
address: Bethesda Maryland 20892 United States
Positions
- Longitude Latitude
* -77.10026 38.98067

Generated Narrative: ResearchStudy #NCT05327010-Location-24-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Cancer Center - North
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-24

name: University of Kansas Cancer Center - North
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Kansas City Missouri 64154 United States
Positions
- Longitude Latitude
* -94.57857 39.09973

Generated Narrative: ResearchStudy #NCT05327010-Location-25-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Cancer Center - Lee's Summit
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-25

name: University of Kansas Cancer Center - Lee's Summit
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 913-588-3671, KUCC_Navigation@kumc.edu
* Principal investigator Joaquina C. Baranda
address: Lee's Summit Missouri 64064 United States
Positions
- Longitude Latitude
* -94.38217 38.91084

Generated Narrative: ResearchStudy #NCT05327010-Location-26-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Kansas Cancer Center at North Kansas City Hospital
ProgressStatuses
- State
* Temporarily Closed to Accrual

Generated Narrative: Location #NCT05327010-Location-26

name: University of Kansas Cancer Center at North Kansas City Hospital
address: North Kansas City Missouri 64116 United States
Positions
- Longitude Latitude
* -94.56218 39.13

Generated Narrative: ResearchStudy #NCT05327010-Location-27-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UNC Lineberger Comprehensive Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-27

name: UNC Lineberger Comprehensive Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 877-668-0683, cancerclinicaltrials@med.unc.edu
* Principal investigator Shetal Patel
address: Chapel Hill North Carolina 27599 United States
Positions
- Longitude Latitude
* -79.05584 35.9132

Generated Narrative: ResearchStudy #NCT05327010-Location-28-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Pittsburgh Cancer Institute (UPCI)
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-28

name: University of Pittsburgh Cancer Institute (UPCI)
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 412-647-8073
* Principal investigator Leonard J. Appleman
address: Pittsburgh Pennsylvania 15232 United States
Positions
- Longitude Latitude
* -79.99589 40.44062

Generated Narrative: ResearchStudy #NCT05327010-Location-29-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Texas at Austin
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-29

name: University of Texas at Austin
address: Austin Texas 78712 United States
Positions
- Longitude Latitude
* -97.74306 30.26715

Generated Narrative: ResearchStudy #NCT05327010-Location-30-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Texas Medical Branch
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-30

name: University of Texas Medical Branch
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 409-772-1950, clinical.research@utmb.edu
* Principal investigator Maurice Willis
address: Galveston Texas 77555-0565 United States
Positions
- Longitude Latitude
* -94.7977 29.30135

Generated Narrative: ResearchStudy #NCT05327010-Location-31-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location UT MD Anderson Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-31

name: UT MD Anderson Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 866-632-6789, askmdanderson@mdanderson.org
* Principal investigator Timothy A. Yap
address: Houston Texas 77030 United States
Positions
- Longitude Latitude
* -95.36327 29.76328

Generated Narrative: ResearchStudy #NCT05327010-Location-32-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Texas Health Science Center at San Antonio
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-32

name: University of Texas Health Science Center at San Antonio
Contacts
- Purpose Name Telecom
* General contact John Sarantopoulos ph: 210-450-1785, sarantopoulo@uthscsa.edu
* Principal investigator John Sarantopoulos
address: San Antonio Texas 78229 United States
Positions
- Longitude Latitude
* -98.49363 29.42412

Generated Narrative: ResearchStudy #NCT05327010-Location-33-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location Huntsman Cancer Institute/University of Utah
ProgressStatuses
- State
* Active, not recruiting

Generated Narrative: Location #NCT05327010-Location-33

name: Huntsman Cancer Institute/University of Utah
address: Salt Lake City Utah 84112 United States
Positions
- Longitude Latitude
* -111.89105 40.76078

Generated Narrative: ResearchStudy #NCT05327010-Location-34-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location University of Virginia Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-34

name: University of Virginia Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
* Principal investigator Linda R. Duska
address: Charlottesville Virginia 22908 United States
Positions
- Longitude Latitude
* -78.47668 38.02931

Generated Narrative: ResearchStudy #NCT05327010-Location-35-ResearchStudy

Profile: ResearchStudySite
partOf: ResearchStudy Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial
status: Active
site: Location VCU Massey Comprehensive Cancer Center
ProgressStatuses
- State
* Recruiting

Generated Narrative: Location #NCT05327010-Location-35

name: VCU Massey Comprehensive Cancer Center
Contacts
- Purpose Name Telecom
* General contact Site Public Contact ph: 804-628-6430, CTOclinops@vcu.edu
* Principal investigator Emily N. Kinsey
address: Richmond Virginia 23298 United States
Positions
- Longitude Latitude
* -77.46026 37.55376

Source1

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  "title": "Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial",
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  "condition": [
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  "descriptionSummary": "This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Another aim of this study is to find out if, and how, patients' genes influence their response to this specific drug combination. For this part of the study, investigators will run tests using samples of patients' tumor tissue and blood that will be collected during the study. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Genes are pieces of the DNA code that individuals inherit from their parents. Some genes work to protect against cancer by correcting damage that can occur in the DNA when cells divide. BRCA1 and BRCA2 are two examples of these types of genes, and they are called tumor-suppressor genes. For example, if a person has a mutation in a BRCA1/2 gene they have a greatly increased risk of developing breast and ovarian cancer because their cells may no longer be able to completely repair damaged DNA. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Other genes are also involved in this process, and these are called DNA damage repair genes. The KRAS mutation is a change in a protein in normal cells. Normally KRAS serves as an information hub for signals in the cell that lead to cell growth, but when there is a mutation in KRAS it signals too much and cells grow without being told to, which causes cancer. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer.",
  "description": "PRIMARY OBJECTIVE:\n\nI. To evaluate clinical response to the combination of BET bromodomain inhibitor ZEN-3694 (ZEN003694 \\[ZEN-3694\\]) and talazoparib using objective response rate (ORR) = (complete response \\[CR\\] + partial response \\[PR\\]).\n\nSECONDARY OBJECTIVES:\n\nI. To confirm the safety and toxicity profile of the combination of ZEN003694 (ZEN-3694) and talazoparib.\n\nII. To evaluate the clinical benefit rate (stable disease \\[SD\\] \\> 6 months \\[m\\]+CR+PR) and progression-free survival (PFS).\n\nIII. To assess the pharmacodynamics of the combination of ZEN003694 (ZEN-3694) and talazoparib using pre- and on-treatment tumor biopsies.\n\nIV. To characterize pharmacodynamic changes of exploratory biomarkers to the combination of ZEN003694 (ZEN-3694) and talazoparib in pre- and on-treatment tumor biopsies.\n\nV. To assess putative predictive biomarkers of response and resistance to the combination of ZEN003694 (ZEN-3694) and talazoparib.\n\nOUTLINE:\n\nPatients receive ZEN-3694 orally (PO) once daily (QD) and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging, blood sample collection, and tumor biopsy throughout the study.\n\nAfter completion of study treatment, patients are followed up 30 days after administration of the last dose of study drug and then every 3 months for up to 2 years.",
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      "reference": "#NCT05327010-Location-21-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-22-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-23-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-24-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-25-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-26-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-27-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-28-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-29-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-30-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-31-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-32-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-33-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-34-ResearchStudy",
      "type": "ResearchStudy"
    },
    {
      "reference": "#NCT05327010-Location-35-ResearchStudy",
      "type": "ResearchStudy"
    }
  ],
  "classifier": [
    {
      "text": "IPDSharing: Yes"
    },
    {
      "text": "IPDSharingDescription: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."
    },
    {
      "coding": [
        {
          "system": "https://fevir.net/resources/CodeSystem/419455",
          "code": "does-not-include-healthy-volunteers",
          "display": "Does not include healthy volunteers"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "https://fevir.net/resources/CodeSystem/419455",
          "code": "includes-females",
          "display": "Includes female subjects"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "https://fevir.net/resources/CodeSystem/419455",
          "code": "includes-males",
          "display": "Includes male subjects"
        }
      ]
    },
    {
      "text": "Minimum Age: 18 Years"
    },
    {
      "text": "Age Group: Adult"
    },
    {
      "text": "Age Group: Older Adult"
    },
    {
      "text": "Has Results: False"
    },
    {
      "text": "Oversight Classifier: oversightHasDmc False"
    },
    {
      "text": "Oversight Classifier: isFdaRegulatedDrug True"
    },
    {
      "text": "Oversight Classifier: isFdaRegulatedDevice False"
    }
  ],
  "associatedParty": [
    {
      "name": "National Cancer Institute (NCI)",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "sponsor",
            "display": "Sponsor"
          }
        ]
      },
      "classifier": [
        {
          "text": "NIH"
        }
      ]
    },
    {
      "name": "National Cancer Institute (NCI)",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "lead-sponsor",
            "display": "Lead sponsor"
          }
        ]
      },
      "classifier": [
        {
          "text": "NIH"
        }
      ]
    },
    {
      "name": "Timothy A Yap",
      "role": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
            "code": "primary-investigator",
            "display": "Principal investigator"
          }
        ]
      },
      "party": {
        "display": "University of Texas MD Anderson Cancer Center LAO"
      }
    }
  ],
  "progressStatus": [
    {
      "state": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-status",
            "code": "recruiting",
            "display": "Recruiting"
          }
        ]
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "registration-submission",
            "display": "Registration submission"
          }
        ]
      },
      "actual": true,
      "period": {
        "start": "2022-04-13"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "registration-submission-qc",
            "display": "Registration submission Quality Check"
          }
        ]
      },
      "actual": true,
      "period": {
        "start": "2022-04-13"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "record-verification",
            "display": "Record Verification"
          }
        ]
      },
      "actual": true,
      "period": {
        "end": "2026-07"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "update-submission",
            "display": "Update submission"
          }
        ]
      },
      "actual": true,
      "period": {
        "end": "2026-07-17"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "registration-posting",
            "display": "Registration posting"
          }
        ]
      },
      "actual": true,
      "period": {
        "start": "2022-04-14"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "primary-outcome-data-collection",
            "display": "Primary outcome data collection"
          }
        ]
      },
      "actual": false,
      "period": {
        "end": "2026-12-31"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/research-study-registration-activity",
            "code": "update-posting",
            "display": "Update posting"
          }
        ]
      },
      "actual": true,
      "period": {
        "end": "2026-07-20"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-status",
            "code": "overall-study",
            "display": "Overall study"
          }
        ]
      },
      "actual": true,
      "period": {
        "start": "2022-11-14"
      }
    },
    {
      "state": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-status",
            "code": "overall-study",
            "display": "Overall study"
          }
        ]
      },
      "actual": false,
      "period": {
        "end": "2027-12-31"
      }
    }
  ],
  "recruitment": {
    "targetNumber": 88,
    "eligibility": {
      "reference": "Group/583769",
      "type": "Group",
      "identifier": {
        "type": {
          "text": "FEvIR Linking Identifier"
        },
        "system": "https://fevir.net/FLI",
        "value": "NCT05327010 Eligibility Criteria",
        "assigner": {
          "display": "Computable Publishing LLC"
        }
      },
      "display": "NCT05327010 Eligibility Criteria"
    }
  },
  "comparisonGroup": [
    {
      "eligibility": {
        "reference": "#NCT05327010-comparison-group-0",
        "type": "Group",
        "display": "Treatment (ZEN-3694, talazoparib)"
      }
    }
  ],
  "objective": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "primary",
            "display": "Primary"
          }
        ]
      },
      "outcomeMeasure": [
        {
          "name": "Objective response rate (ORR)",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "primary",
                "display": "Primary"
              }
            ]
          },
          "description": "Systemically assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR = complete response + partial response. Complete response is defined as the disappearance of all target or non-target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target or non-target lesions.",
          "endpoint": {
            "reference": "EvidenceVariable/583770",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-primaryOutcome-0",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Objective response rate (ORR)"
          }
        }
      ]
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
          }
        ]
      },
      "outcomeMeasure": [
        {
          "name": "Duration of response",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "description": "Assessed using RECIST v1.1.",
          "endpoint": {
            "reference": "EvidenceVariable/583771",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-secondaryOutcome-0",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Duration of response"
          }
        },
        {
          "name": "Clinical benefit rate (CBR)",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "description": "Assessed by radiographic disease assessments per RECIST v1.1. CBR = overall response + stable disease \\> 6 months. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.",
          "endpoint": {
            "reference": "EvidenceVariable/583772",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-secondaryOutcome-1",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Clinical benefit rate (CBR)"
          }
        },
        {
          "name": "Progression-free survival",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "description": "Assessed by radiographic disease assessments per RECIST v1.1.",
          "endpoint": {
            "reference": "EvidenceVariable/583773",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-secondaryOutcome-2",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Progression-free survival"
          }
        },
        {
          "name": "Overall survival",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "description": "Assessed by radiographic disease assessments per RECIST v1.1.",
          "endpoint": {
            "reference": "EvidenceVariable/583774",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-secondaryOutcome-3",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Overall survival"
          }
        },
        {
          "name": "Incidence of adverse events",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "secondary",
                "display": "Secondary"
              }
            ]
          },
          "description": "Incidence and severity of adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Includes significant changes in laboratory parameters, electrocardiograms, and vital signs. Summarized by grade and type.",
          "endpoint": {
            "reference": "EvidenceVariable/583775",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-secondaryOutcome-4",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Incidence of adverse events"
          }
        }
      ]
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "exploratory",
            "display": "Exploratory"
          }
        ]
      },
      "outcomeMeasure": [
        {
          "name": "Treatment-induced changes in phospho-protein signaling",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Reverse phase proteomic array in pre- and on-treatment tumor biopsy samples conducted to assess treatment-induced changes in phospho-protein signaling, to correlate with treatment response and progression, and to assess changes in the levels of cytotoxic T lymphocyte precursor.",
          "endpoint": {
            "reference": "EvidenceVariable/583776",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-0",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Treatment-induced changes in phospho-protein signaling"
          }
        },
        {
          "name": "Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Whole exome sequencing conducted on pre-treatment biopsy and at progression to correlate SNV and CNV profiles with treatment response.",
          "endpoint": {
            "reference": "EvidenceVariable/583777",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-1",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Correlation of single nucleotide variant (SNV) and copy number variant (CNV) profiles with treatment response"
          }
        },
        {
          "name": "Gene expression profiling",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Ribonucleic acid (RNA) sequencing conducted for gene expression profiling.",
          "endpoint": {
            "reference": "EvidenceVariable/583778",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-2",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Gene expression profiling"
          }
        },
        {
          "name": "Correlate mutation profiles with tumor sequencing",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Using circulating tumor deoxyribonucleic acid (ctDNA) for correlation.",
          "endpoint": {
            "reference": "EvidenceVariable/583779",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-3",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Correlate mutation profiles with tumor sequencing"
          }
        },
        {
          "name": "Correlate baseline mutations with treatment response",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Using ctDNA for correlation.",
          "endpoint": {
            "reference": "EvidenceVariable/583780",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-4",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Correlate baseline mutations with treatment response"
          }
        },
        {
          "name": "Correlate changes in ctDNA variant allele frequencies with response",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Using ctDNA for correlation.",
          "endpoint": {
            "reference": "EvidenceVariable/583781",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-5",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Correlate changes in ctDNA variant allele frequencies with response"
          }
        },
        {
          "name": "Assess emergent resistant mutations",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "Includes BRCA reversion.",
          "endpoint": {
            "reference": "EvidenceVariable/583782",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-6",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Assess emergent resistant mutations"
          }
        },
        {
          "name": "Analysis of formalin-fixed paraffin-embedded and blood and blood samples",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "exploratory",
                "display": "Exploratory"
              }
            ]
          },
          "description": "DNA, RNA, and protein analysis conducted.",
          "endpoint": {
            "reference": "EvidenceVariable/583783",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT05327010-otherOutcome-7",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "Analysis of formalin-fixed paraffin-embedded and blood and blood samples"
          }
        }
      ]
    }
  ]
}