Summary:
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0/2 clinical trial to evaluate pamiparib (a PARP inhibitor) in patients with newly diagnosed or recurrent glioblastoma. If the research shows that pamiparib is reaching the tumor tissue, we will compare it with olaparib, another PARP inhibitor, which is currently in Phase 2 trials for newly diagnosed and recurrent glioblastoma.
The goal of this study is to confirm that the drug (treatment agent) is capable of crossing the blood-brain barrier. Patients with positive results may continue to receive treatment in Phase 2 while receiving standard of care radiation therapy. We will also confirm if the study drug is hitting the molecular targets.
- PARP is a protein that plays an important role in cell survival response to DNA damage.
- Pamiparib (BGB-290) is an investigational small molecule PARP inhibitor that blocks the DNA repair process.
- Pamiparib is currently in global clinical development for a variety of solid tumor malignancies.
- Olaparib is an FDA-approved drug currently used to treat advanced ovarian and breast cancer in adults. It is not approved to treat brain tumors.
Criteria:- You are 18 years or older
- You have a suspected newly diagnosed glioblastoma and plan to follow the standard treatment regimen
-OR-
- You are 18 years or older
- You have had prior resection (surgical removal) of a histologically diagnosed glioblastoma (WHO grade IV)
- You have been treated with radiation and a chemotherapy drug called temozolomide
- Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed) and you require resection with radiation therapy as part of your post-surgical treatment plan
Qualified Participants May Receive:
As part of a clinical trial at the Ivy Brain Tumor Center, the study drugs will be provided free of charge, however, the patient and/or their health plan/insurance company will be responsible for some or all of the costs of treating the tumor in the study, including any standard medical care such as surgical resection.