The Phase 2 study will enroll approximately 20 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
Stanford Cancer Institute professor of neurology and neurosurgery, principle investigator of the study Lawrence Recht said the patients with bevacizumab-resistant high-grade glioma currently have little to no treatment options to help them manage their disease.
"We know that the mechanism of topoisomerase I inhibition has resulted in anti-tumor activity in gliomas in the past," Dr. Recht added.
"As a result, we are interested in evaluating etirinotecan pegol, this new targeted topoisomerase I inhibitor, which provides sustained exposure of drug metabolite to tumor cells."
The six-week progression free survival (PFS) rate is the primary endpoint of the open label, single-arm trial, while the secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date of pathologic diagnosis or confirmation of high-grade glioma, and the safety profile of etirinotecan pegol in patients with bevacizumab-resistant high-grade glioma.