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Clinical Trial Summary

This phase II trial studies if talazoparib works in patients with cancer that has spread to other places in 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.

Clinical Trial 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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and blood sample collection throughout the study. Patients undergo 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 Design

Related Conditions & MeSH terms

  • Advanced Pancreatic Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Castration-Resistant Prostate Carcinoma
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Locally Advanced Breast Carcinoma
  • Locally Advanced Gastric Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • 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
  • Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Platinum-Sensitive Ovarian Carcinoma
  • Prostatic Neoplasms
  • 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
  • Stomach Neoplasms

NCT number NCT04550494
Study type Interventional
Source National Cancer Institute (NCI)
Status Recruiting
Phase Phase 2
Start date April 26, 2021
Completion date December 1, 2024

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