NCT05257408

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Official title

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)

Phase

Phase 3

Status

Active not recruiting

Conditions

Ovarian Neoplasm; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Interventions

Relacorilant 150 mg; Nab-paclitaxel 80 mg/m^2; Nab-paclitaxel 100 mg/m^2

Arms

• Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 · Experimental
• Nab-paclitaxel 100 mg/m^2 · Active comparator

Enrollment

381

Primary outcomes

• Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
• Overall Survival

Sponsor

Corcept Therapeutics with Gynecologic Oncology Group

Start

Jun 29, 2022

Primary completion

Mar 31, 2025

Results posted

Yes

Registry record

NCT05257408 · updated Sep 25, 2026

• Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balazs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagameri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2. PubMed 40473448
• Lorusso D, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Fagotti A, Gilbert L, Mileshkin L, Quesada S, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Clamp A, Prillaman C, Diakos C, Bagameri A, Leiser AL, Salutari V, Monk BJ, Follana P, McClung E, Carbone V, Slomovitz B, Giudice E, Cannizzaro MC, Gavoille L, Devaux A, Scollo P, Scandurra G, Cassani C, Artioli G, Van Gorp T, Santaballa A, Dreiling LK, Kesner-Hays A, Tudor IC, Jubb AM, Colombo N, Olawaiye AB. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026 Apr 18;407(10538):1513-1524. doi: 10.1016/S0140-6736(26)00462-9. Epub 2026 Apr 10. PubMed 41974149
• Olawaiye AB, Kim JW, Bagameri A, Bishop E, Chudecka-Glaz A, Devaux A, Gladieff L, Gordinier ME, Korach J, McCollum ME, Mileshkin L, Monk BJ, Nicum S, Nogueira-Rodrigues A, Oaknin A, O'Malley DM, Orlando M, Dreiling L, Tudor IC, Lorusso D. 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. J Gynecol Oncol. 2024 Jul;35(4):e111. doi: 10.3802/jgo.2024.35.e111. PubMed 39032926
• Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, Olawaiye AB, Nguyen DD, Greenstein AE, Custodio JM, Pashova HI, Tudor IC, Lorusso D. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779-4789. doi: 10.1200/JCO.22.02624. Epub 2023 Jun 26. PubMed 37364223