Talazoparib for Advanced Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that might affect the activity of talazoparib, the principal investigator will review your case to determine eligibility. Patients on certain anticoagulants like warfarin are excluded, but low-dose warfarin is allowed.
Is Talazoparib safe for humans?
How is the drug Talazoparib unique for treating advanced cancer?
Talazoparib is unique because it is an oral drug that specifically targets and inhibits PARP enzymes, which are crucial for repairing damaged DNA in cancer cells. This mechanism, known as synthetic lethality, is particularly effective in patients with BRCA mutations, offering better outcomes compared to traditional chemotherapy.12467
Research Team
A P Chen
Principal Investigator
National Cancer Institute LAO
Eligibility Criteria
Adults with advanced cancer and specific DNA repair gene mutations, who have progressed after standard therapy or lack treatment options. They must be able to swallow pills, have a life expectancy over 3 months, acceptable blood counts and organ function, and women must use contraception. Excluded are those with HIV, recent chemotherapy or radiotherapy, lactating women, pregnant women, prior talazoparib treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talazoparib orally once daily on days 1-28 of each cycle, with cycles repeating 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.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days post-treatment.
Treatment Details
Interventions
- Talazoparib
Talazoparib is already approved in United States, European Union for the following indications:
- Deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer
- Monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor