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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 36 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo biopsy
• PROCEDURE: Biospecimen Collection — Undergo blood sample collection
• PROCEDURE: Computed Tomography — Undergo CT scan
• PROCEDURE: Magnetic Resonance Imaging — Undergo MRI
• DRUG: Talazoparib — Given PO

Primary Outcomes

• Percent of patients who demonstrate simultaneous Rad51 activation (At cycle 2 day 1)

Secondary Outcomes

• Overall response rate (Up to 30 days after last dose)

Trial Locations

• 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

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