Niraparib with temozolomide in adults with newly-diagnosed GBM (Glioblastoma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called niraparib is a safe and effective option for people with newly diagnosed GBM. We want to compare how well it works to temozolomide, which is an approved drug that is commonly used to treat GBM.
Newly Diagnosed Glioblastoma (GBM)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are newly diagnosed with GBM
- Have a specific change in the O6-methylguanine methyltransferase (MGMT) gene (called methylation)
- Have an unmethylated MGMT promoter region
- Have had no prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy
- Do not have metastatic or predominant leptomeningeal disease
For more information, contact the study team at 919-684-5301.
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either take the study drug or take temozolomide.
If you are assigned to take the study drug, you will continue your regimen for as long as your cancer does not worsen. If you are assigned to take temozolomide, your treatment period will last for up to 8 months.
No matter your group assignment, you will visit our clinic for radiotherapy sessions during your study drug regimen.
Study Details
