Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
36
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of talazoparib, an oral PARP inhibitor, in patients with advanced solid tumors that have mutations in DNA damage response genes. This phase II trial includes patients whose cancer has spread locally or to distant parts of the body and who may or may not have been treated previously with other PARP inhibitors. The study aims to understand how talazoparib affects tumors with specific gene aberrations and whether sequential use of different PARP inhibitors could be beneficial. Participants receive talazoparib by mouth once daily for 28-day cycles, continuing as long as the cancer does not progress and side effects are manageable. Throughout the study, patients undergo tumor biopsies, blood sample collections, and imaging scans such as CT or MRI to monitor treatment effects. After finishing treatment, participants are followed up for 30 days to assess outcomes. During the study, researchers measure pharmacodynamic effects in tumor biopsies and evaluate the response rate to talazoparib, including complete and partial responses. Safety and tumor changes are monitored regularly through imaging and blood tests. The primary outcome is the percentage of patients showing Rad51 activation at cycle 2 day 1. This comprehensive monitoring helps assess how talazoparib affects cancer cells with DNA repair gene mutations over the course of treatment and shortly after.
CONDITIONS
Brief Title
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with solid tumors and documented germline or somatic aberrations in DNA damage response genes
- Disease progressed after at least one standard therapy or no acceptable standard treatment options
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than 3 months
- Blood counts within specified safe limits
- Total bilirubin and liver enzymes within institutional normal limits
- Kidney function creatinine clearance of at least 60 mL/min/1.73m2 or acceptable lower
- Measurable disease with at least one lesion suitable for biopsy
- Women of child-bearing potential and men with reproductive partners must agree to use effective contraception
- Ability to swallow whole tablets or capsules
- Recurrent, locally advanced or metastatic disease
- Disease progression on or after at least one line of standard-of-care treatment
- Specific prior therapies required depending on cancer type (e.g., platinum-based therapy for ovarian cancer, anti-HER2 therapy for HER2+ cancers)
- Patients with prostate cancer must meet hormone therapy and mutation criteria
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks or 5 half-lives prior to enrollment
- Prior treatment with talazoparib
- Recent monoclonal antibody therapy not proven safe with PARP inhibitors
- Use of other investigational agents
- Active brain metastases or carcinomatous meningitis
- Uncontrolled illnesses such as active infections or unstable heart conditions
- Pregnant or lactating women
- Use of certain anticoagulants (except low-dose warfarin)
- History of other cancers within past 3 years except controlled non-melanoma skin cancers
- Medications that may affect talazoparib activity without investigator approval
- Psychiatric or social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28-day cycles repeated until disease progression or unacceptable toxicity
Participants receive talazoparib orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants undergo biopsy and blood sample collection, as well as CT scan or MRI throughout the study.
Visits include biopsy, blood sample collection, and imaging scans throughout treatment
Duration - 30 days after last dose
Participants are followed up for safety and response assessments after completion of study treatment.
1 visit (in-person) approximately 30 days after last dose
Trial Site Locations
Total: 4 locations
1
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
2
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
4
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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