Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Summary
This is a Phase 2, open-label, randomized, 3-arm study to evaluate progression-free survival (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer treated with intermittent or continuous regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.
Timeline
- Start
- 2019-04-05
- Primary completion
- 2021-03-16
- Completion
- 2023-07-12
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper On the basis of protocol-prespecified Hochberg step-up multiplicity adjustment, the primary end point did not reach statistical significance (P < .025). reads as missed primary endpoint PMID 37364223 ↗
release “Women with platinum resistant ovarian cancer experienced longer progression free survival with relacorilant plus nab-paclitaxel than with nab-paclitaxel alone” reads as met primary endpoint corcept.com ↗
release “Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival” reads as met primary endpoint corcept.com ↗
release “women with recurrent, platinum-resistant ovarian cancer who were administered relacorilant at the time they received nab-paclitaxel exhibited meaningful improvements in progression free survival” reads as met primary endpoint corcept.com ↗
release “the improvement in the higher dose Intermittent arm was statistically significant (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: <0.05).” reads as met primary endpoint corcept.com ↗
Publications
- Zhou Y, Tong F, Jin B, Pan J, Ren N, Ren L, Xu Q. Relacorilant plus nab-paclitaxel for recurrent, platinum-resistant ovarian cancer: a cost-effectiveness study. J Gynecol Oncol. 2025 Jul;36(4):e63. doi: 10.3802/jgo.2025.36.e63. Epub 2025 Feb 20.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Relacorilant | Small molecule | 150 mg | Oral |