The trial is being conducted in collaboration with the Dana-Farber/Partners Cancer Care (DFPCC), a joint venture non-profit consortium established by Massachusetts General Hospital, The Brigham and Women’s Hospital, and Dana-Farber Cancer Institute.
The primary objective of the single-arm phase II trial is to determine the tumor response rate in a cohort of women with platinum-resistant ovarian cancer after treatment with NOV-002 and carboplatin. Up to 25 women will be enrolled in the trial, and may receive up to six cycles of NOV-002 and carboplatin. Interim results are expected in early 2007.
“Ovarian cancer patients who do not respond to therapy with platinum-based drugs or who relapse soon after a response are in need of new, more effective therapies. Based on overseas clinical data, NOV-002 added to the treatment regimen holds promise for these women,” said Dr Michael Seiden, associate professor in medicine at Massachusetts General Hospital, who oversees the clinical research program for the gynecologic cancer program at DFPCC.