Actively Recruiting
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
36
Participants Needed
4
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 mutations in DNA damage response genes
- Disease progressed after at least one standard therapy or no acceptable standard treatment options
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Life expectancy greater than 3 months
- Leukocytes count at least 3,000/mcL
- Absolute neutrophil count at least 1,500/mcL
- Platelet count at least 100,000/mcL
- Hemoglobin level at least 10 g/dL
- Total bilirubin at most 1.5 times the institutional upper limit of normal (up to 3 times with Gilbert's syndrome or liver metastases)
- AST and ALT at most 3 times the institutional upper limit of normal
- Creatinine at most 1.5 times the institutional upper limit of normal or creatinine clearance at least 60 mL/min/1.73m2 (not less than 30 mL/min/1.73m2 with supporting data)
- Measurable disease with at least one lesion of specific minimum size
- Tumor site suitable for biopsy
- Women of child-bearing potential must use highly effective contraception during and for 7 months after study
- Male patients with female partners of reproductive potential must use adequate contraception during and for 4 months after study
- Ability to swallow whole tablets or capsules
- Ability and willingness to sign informed consent
- Recurrent, locally advanced, or metastatic disease
- Disease progression on or after at least one standard-of-care treatment, except if talazoparib is standard
- Specific prior treatments required for ovarian, pancreatic, breast, gastric, and prostate cancer patients as detailed
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks or 5 half-lives (6 weeks for nitrosoureas or mitomycin C)
- Prior treatment with talazoparib
- Monoclonal antibody therapy within 6 weeks (or 3 half-lives), except certain antibodies safe with PARP inhibitors
- Receiving other investigational agents
- Active brain metastases or carcinomatous meningitis
- Uncontrolled illness including infection, heart failure, angina, arrhythmia, or psychiatric illness
- Pregnant women
- Requirement for coumarin-derivative anticoagulants (except low-dose warfarin 1 mg/day or less)
- Currently lactating
- History of prior malignancies within 3 years, except controlled non-melanoma skin cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here