This is a Phase 3 study. Phase 3 studies can involve testing a study drug in hundreds to thousands of people over several years. The main purpose of this study is to see if the study drug, Niraparib, works better than the comparator drug in people who have just been diagnosed with glioblastoma. The comparator drug is a type of chemotherapy commonly used to treat newly diagnosed glioblastoma.
This study includes:
• Phase 1, where subjects will take either the study drug or comparator drug. All participants will also receive radiotherapy in this phase. In this phase, there will be about 45 visits to the study center. The duration for this phase will last as long as the cancer does not get worse.
• Phase 2, where subjects will continue with the same drug given in Phase 1 without radiotherapy. In this phase there will be about 53 visits to the study center and participation in the study will last for 42 weeks.
There are four periods of the study, the screening period (last about 1 month), study treatment period (as long as desired or up to 8 months), safety follow-up period (1 month), and long-term follow up period (up to 5 years).
Some procedures in this study are blood tests, memory, speech and thinking test, ECG, tissue sample, bone marrow biopsy, and imaging test. Some risks include the cancer could get worse and there are risks associated with the study drugs (for example, low appetite, difficulty speaking, headaches, vomiting, nausea, diarrhea, etc.)