RecruitingPhase 2NCT04550494

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

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response


Sponsor

National Cancer Institute (NCI)

Enrollment

36 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing talazoparib — a PARP inhibitor that blocks cancer cells from repairing their DNA — in adult patients with advanced solid tumors who have specific inherited or acquired mutations in DNA repair genes. **You may be eligible if...** - You are an adult with a confirmed solid tumor that has progressed after at least one prior standard treatment (or for whom no standard treatment exists) - Your tumor or blood has a documented mutation in a gene involved in DNA damage repair (such as BRCA1, BRCA2, PALB2, ATM, or related genes) - The mutation was identified through a recognized genetic testing laboratory - Your organ function is adequate to tolerate the study drug **You may NOT be eligible if...** - You do not have a qualifying DNA repair gene mutation - You have had prior treatment with a PARP inhibitor - You have active brain metastases that are not stable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGTalazoparib

Given PO


Locations(4)

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

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NCT04550494


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