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Recently, GlaxoSmithKline (GSK) and Ivy Brain Tumor Center announced the initiation of a phase 0 clinical trial (NCT05076513) to evaluate Zejula (niraparib) for the treatment of newly diagnosed glioblastoma Efficacy and safety in patients with cell tumor (GBM) and recurrent glioma (Grade II-IV)

According to the announcement, this phase 0 clinical trial will recruit up to 42 patients, divided into 2 groups, group A is newly diagnosed GBM patients, and group B is recurrent glioma patients with IDH mutations and ATRX loss

In the 2 groups, patients were treated with Zejula once a day for 4 days before the planned surgery to detect the drug concentration in the tumor, blood, and cerebrospinal fluid (CSF)

The Ivy Brain Tumor Center is a non-profit translational research project that uses bold early clinical trial strategies to identify new therapies for aggressive brain tumors including GBM.

Nader Sanai, MD, director of the Ivy Brain Tumor Center, pointed out, “By evaluating PK and PD-dependent endpoints in phase 0 clinical trials, patients with brain tumors entering the expansion stage can be confident that there is biological evidence that their tumors can be therapeutically effective.

Zejula is a potentially best-in-class PARP inhibitor due to its differentiated efficacy, once-daily dosage and superior pharmacokinetic characteristics, including its ability to cross the blood-brain barrier Ability

At present, GSK is in a large clinical development project to evaluate the activity of Zejula in the treatment of multiple types of tumors in a number of key clinical trials, including the combination of Zejula and other therapies

Reference source: Ivy Brain Tumor Center Collaborates with GSK on New Phase 0 Clinical Trial to Evaluate Niraparib in Patients with Brain Cancer