Ovarian cancer is the second most common gynaecologic malignancy. Most patients are asymptomatic until advanced stages of the disease, and for women with distant invasive epithelial ovarian cancer, the five-year survival is approximately 30%.
Despite initial therapy, most women will relapse and require retreatment. Patients who develop a recurrence within 6 months of platinum-based therapy are deemed platinum-refractory. There are few treatment options for platinum-resistant ovarian cancer.
What is ROSELLA?
The ROSELLA study is a Phase III randomised study investigating Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer. Relacorilant is an oral modulator of glucocorticoid receptor, which may reverse the effects of endogenous cortisol and restore the ability of cytotoxic agents to induce tumour cell apoptosis. This is a global study sponsored by Corcept Therapeutics with local sponsor, George Clinical managing the study.
ROSELLA plans to enrol 360 women globally with recurrent, platinum-resistant ovarian cancer, randomised 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. Corcepts phase 2 study demonstrated improvements in progression free survival, duration of response and overall survival without increased side effect burden. Corcept goal with this study is to replicate the positive results shown in the Phase II study.
Prof Linda Mileshkin speaking at ANZGOG’s 2023 ASM
How to participate in ROSELLA
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ROSELLA is open to recruitment at Peter MacCallum Cancer Centre with more sites to open soon. Led by study chair and ANZGOG Member Professor Linda Mileshkin, the study plans to open 6 sites across Australia.
We encourage referrals to this study. Please contact trials@anzgog.org.au.
