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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04550494
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 26, 2021
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (talazoparib)
    Patients receive talazoparib PO 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 CT scan or MRI throughout the study.

Primary Outcome Measure

Percent of patients who demonstrate simultaneous Rad51 activation [ Time Frame: At cycle 2 day 1 ]

Locations (4)

FacilityCityStateZIPSite coordinators
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610
Site Public Contact
[email protected]
352-273-8010
Thomas J. George (PRINCIPAL_INVESTIGATOR)
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)
National Institutes of Health Clinical CenterBethesdaMaryland20892-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Abdul Rafeh Naqash (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
UF Health Cancer Institute - Gainesville· Gainesville, FLNational Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MDUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

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