The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0 clinical trial to evaluate niraparib, a novel targeted therapy, in patients with newly diagnosed glioblastoma.
The goal of this Phase 0 study is to confirm that niraparib is capable of crossing the blood-brain barrier. Patients with positive results may advance to an expansion phase that combines therapeutic dosing of niraparib in combination with standard-of-care fractionated radiotherapy.
The expansion phase of this study will examine progression-free survival and monitor safety and tolerability of niraparib in combination with radiation.
PARP (poly ADP ribose polymerase) is a protein that plays an important role in cell survival response to DNA damage.
Niraparib (the treatment agent) is an oral, highly selective PARP inhibitor that blocks the tumor cell survival response.
Niraparib is approved by the FDA for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Click here for information on the study of niraparib for recurrent glioma (grades II-IV) patients.