USO 22056
A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA) (CORT125134-556)
Disease Types: GYN Cancer Research
Eligibility Requirements:
-Must have confirmed histologic diagnosis of high grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that is platinum resistant with measurable disease
-Received at least one line and not more than 3 lines of prior systemic anticancer therapy, at least one line of platinum therapy and prior treatment with bevacizumab required. Able to swallow and retain oral medication
-No: low-grade endometrioid, clear cell, mucinous, or sarcomatous histology or mixed tumors containing these histologies or low-grade or borderline ovarian tumor; primary platinum refractory disease; requiring treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses; receiving concurrent treatment with mifepristone or other glucocorticoid receptor modulator; peripheral neuropathy ˃ grade 1; unstable angina, myocardial infarction within previous 6 months, uncontrolled or severe concomitant disease such as uncontrolled hypertension, arrhythmia, heart failure, cirrhosis, active infectious disease requiring IV therapy within 2 weeks of first dose, gastric outlet obstruction, small bowel obstruction, carcinomatosis, symptomatic ascites/effusions requiring paracentesis or thoracentesis within 30 days of study entry; current chronic/active with HIV, Hep B, or Hep C; untreated or symptomatic central nervous system metastasis; taking concomitant medication that is either a strong cytochrome P450 inhibitor or strong inducer of CYP3A, or substrate of CYP3A; received a live vaccine within 30 days prior to study start date
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