Corcept Therapeutics (NASDAQ:CORT) has initiated pivotal Phase 3 clinical trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.
ROSELLA study is a pivotal Phase 3 clinical trial designed to evaluate relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer. The study has a target of enrolling 360 women subjects with recurrent, platinum-resistant ovarian cancer.
The primary endpoint of this study will be progression-free survival, with overall survival as a key secondary endpoint.
Bill Guyer, Chief Development Officer, said, "We are excited that our ROSELLA study is now open. Our Phase 2 study demonstrated improvements in progression free survival, duration of response and overall survival without increased side effect burden. Our goal in Phase 3 is to replicate these positive results, which would be of unprecedented benefit to women with platinum-resistant ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care."
Ovarian cancer is the most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having platinum-resistant disease.
Corcept shares closed Wednesday’s trading up 2 percent at $24.74