The Ivy Brain Tumor Center (Phoenix) and University of California, San Francisco will partner on a Phase 0 clinical trial to test GSK’s (NYSE:GSK) Zejula (niraparib) in patients with newly diagnosed glioblastoma (GBM) and recurrent glioma (grades II–IV).
Zejula is a daily oral poly (ADP-ribose) polymerase (PARP) inhibitor.
FDA introduced Phase 0 clinical trials in 2004 to close the gap between initial drug testing and later-phase efficacy studies. If a drug shows promise in a Phase 0 trial, investigators can fast-track it to a Phase 2 study.
“Our mission is to do things differently from what has been done before,” said Shwetal Mehta, chief operating officer of the Ivy Brain Tumor Center, in an interview.
Many drugs tested for brain cancer have trouble crossing the blood-brain barrier, and yet conventional trials don’t tend to be nimble enough to measure near-term efficacy.
“We want to identify drugs that are effective, and we want to do thi…