Marizomib, Temozolomide combination trial expanded to include Optune from Novocure
Celgene Corp. (NASDAQ:CELG) modified an ongoing Phase Ib trial of IV marizomib (NPI-0052) in combination with temozolomide and radiotherapy in about 48 newly diagnosed patients with grade IV malignant gliomas to include a 12-patient cohort evaluating marizomib and temozolomide in combination with Optune (NovoTTF-100A) from Novocure Ltd. (NASDAQ:NVCR).
The open-label trial's primary endpoint is safety; secondary endpoints include preliminary clinical activity, progression-free survival (PFS) and overall survival (OS). The original protocol includes a dose-escalation portion and a dose-expansion portion which called for patients to receive 0.55-1.2 mg/m2 marizomib on days 1, 8, 15, 29 and 36 plus temozolomide and radiotherapy during the 42-day concomitant treatment portion. Patients who complete the concomitant portion move on to receive 0.55-1.2 mg/m2 on days 1, 8, and 15 of each 28-day cycle...