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

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.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Castration-Resistant Prostate Carcinoma
• Clinical Stage III Gastric Cancer AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• HER2-Positive Breast Carcinoma
• Locally Advanced Breast Carcinoma
• Locally Advanced Gastric Carcinoma
• Locally Advanced Malignant Solid Neoplasm
• Locally Advanced Ovarian Carcinoma
• Locally Advanced Pancreatic Carcinoma
• Locally Advanced Prostate Carcinoma
• Metastatic Breast Carcinoma
• Metastatic Gastric Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Ovarian Carcinoma
• Metastatic Pancreatic Carcinoma
• Metastatic Prostate Carcinoma
• Platinum-Sensitive Ovarian Carcinoma
• Recurrent Breast Carcinoma
• Recurrent Gastric Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Pancreatic Carcinoma
• Recurrent Prostate Carcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• A P Chen · National Cancer Institute LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-26

Primary Completion

2026-12-01

Completion

2026-12-01

FDA Drug

Yes

Countries

• United States

Study Locations