Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 11:46 AM
Study NCT ID:
NCT04550494
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: