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Corcept Completes Enrollment in Pivotal Phase 3 Rosella Trial of Relacorilant in Patients With Platinum-Resistant Ovarian Cancer | ||
By: GlobeNewswire - 08 Apr 2024 | Back to overview list |
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MENLO PARK, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator relacorilant combined with nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. “Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Relacorilant has the potential to become the standard of care for patients with this devastating disease. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year.” The ROSELLA trial has the same design as Corcept's positive Phase 2 study, in which patients who received relacorilant intermittently – the day before, the day of and the day after they received nab-paclitaxel – exhibited improvements in progression-free survival, duration of response and overall survival compared to patients who received nab-paclitaxel alone, without an increased side effect burden. These results were published in the Journal of Clinical Oncology in June 2023. The ROSELLA trial enrolled 381 women at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant dosed intermittently with nab-paclitaxel or nab-paclitaxel monotherapy. ROSELLA’s primary endpoint is progression-free survival. Overall survival is a key secondary endpoint. About Platinum-Resistant Ovarian Cancer About Relacorilant About Corcept’s Oncology Programs Corcept is conducting clinical trials of its proprietary compound, relacorilant, in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. About Corcept Therapeutics Forward-Looking Statements In this press release, forward-looking statements include those concerning the conduct, pace and outcome of our Phase 3 ROSELLA trial in patients with ovarian cancer, as well as the development of relacorilant as a treatment for other solid tumors, Cushing’s syndrome and other indications, including relacorilant’s clinical attributes, regulatory approvals, mandates, oversight, and other requirements; the potential for relacorilant plus nab-paclitaxel to become a standard of care for patients with recurrent, platinum-resistant ovarian cancer or to otherwise meet their unmet medical needs. We disclaim any intention or duty to update forward-looking statements made in this press release. 1 Therapeutic Advances in Medical Oncology (Luvero et al. 2014) CONTACT |
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