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NCT04550494 · ClinicalTrials.gov registry record · Phase 2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
36
Enrollment target
4
Study locations

NCT04550494 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT04550494, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
36 participants
Enrollment target
4
Study locations

Study Summary

This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • DRUG Talazoparib

Study Locations (4)

Maryland

  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2021-04-26
Est. Completion 2026-12-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04550494

The ClinicalTrials.gov registry entry for NCT04550494 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (88% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04550494 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Maryland, Florida, Oklahoma.

Frequently Asked Questions

What is clinical trial NCT04550494 about?

NCT04550494 is a clinical study titled "Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations". This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been ...

What is the current status of trial NCT04550494?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2021-04-26. Estimated completion is 2026-12-01.

What conditions does trial NCT04550494 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8.

What interventions are being tested in trial NCT04550494?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Talazoparib (DRUG).

Who is sponsoring clinical trial NCT04550494?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04550494 being conducted?

This trial has 4 study locations across Florida, Maryland, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.