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RecruitingNCT04550494

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the pharmacodynamic (PD) effect of talazoparib in tumor biopsies for patients with aberrations in deoxyribonucleic acid (DNA) damage response genes who have or have not received prior PARP inhibitor treatment (separately). SECONDARY OBJECTIVE: I. Determine the response rate (complete response \[CR\] + partial response \[PR\]) of treatment with talazoparib in patients with aberrations in DNA damage response genes. EXPLORATORY OBJECTIVE: I. Investigate tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib. OUTLINE: Patients receive talazoparib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and blood sample collection, as well as computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up at 30 days.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiopsy ProcedureUndergo biopsy
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREComputed TomographyUndergo CT scan
PROCEDUREMagnetic Resonance ImagingUndergo MRI
DRUGTalazoparibGiven PO

Timeline

Start date
2021-04-26
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2020-09-16
Last updated
2026-04-13

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04550494. Inclusion in this directory is not an endorsement.