Jul 20, 2013 - 3:07 pm
New trial NCT01847274, sponsored by Tesaro, Inc. not yet recruiting.
Niraparib, formerly known as MK-4827, is an orally active and potent poly (ADP-ribose) polymerase, or PARP inhibitor. A Phase 1/2 monotherapy study has been completed in more than 100 patients with advanced solid tumors. Based upon the results of the Phase 1/2 study and published data from other trials of PARP inhibitors, TESARO plans to further evaluate niraparib at a dose of 300 milligrams once daily in each of two Phase 3 studies as a maintenance therapy in patients with platinum sensitive ovarian cancer and in germline BRCA breast cancer.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle.
I emailed Tesaro today and received reply within minutes. I'm waiting for the list of local investigators, which I will post here once available.