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Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer

ROSELLA: Phase 3 Clinical Trial for Ovarian Cancer

Key Findings and Practical Solutions

Ovarian cancer is often diagnosed late and becomes resistant to chemotherapy. The ROSELLA study aims to improve outcomes for women with platinum-resistant ovarian cancer by using relacorilant, a selective GR modulator, in combination with nab-paclitaxel.

The study includes women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer who have received prior systemic anticancer therapy. Participants are randomized to receive relacorilant with nab-paclitaxel or nab-paclitaxel alone, with the primary goal of assessing progression-free survival (PFS).

Secondary endpoints include overall survival (OS), objective response rate, and safety evaluations. The study also evaluates patient-reported outcomes and clinical benefit rate at 24 weeks.

Value and Applications

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