Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
NCT ID: NCT05257408
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
381 participants
INTERVENTIONAL
2022-06-29
2026-03-31
Brief Summary
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Detailed Description
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Patients will receive study treatment until confirmed progressive disease (PD) or unacceptable toxicity. All patients will be followed for the collection of study endpoints, inclusive of disease progression and survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel 100 mg/m^2
Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.
Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Interventions
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Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
* Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
* Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression \<6 months from completion of a platinum-containing therapy).
* Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
* Has a life expectancy of ≥3 months.
* At least one lesion that meets the definition of measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Able to comply with protocol requirements.
* Able to swallow and retain oral medication and does not have uncontrolled emesis.
* Received at least 1 but ≤3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
* Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) ≥1500 cells/mm\^3, Platelet count ≥100,000/mm\^3, Hemoglobin ≥9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases, Total bilirubin ≤1.5 × ULN, and Albumin ≥3 g/dL, and creatinine clearance \>40 mL/min/1.73 m\^2 (measured or estimated).
* Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
* Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.
Exclusion Criteria
* Has had any major surgery within 4 weeks prior to randomization.
* Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
* Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy.
* Has not received prior bevacizumab treatment.
* Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before first dose of study drug, radiotherapy not completed at least 2 weeks prior to first dose of study drug, hormonal anticancer therapies within 7 days of first dose of study drug, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
* Has received wide-field radiation to more than 25% of marrow-bearing areas.
* Has toxicities of prior therapies that have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
* Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
* Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
* Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
* Has peripheral neuropathy from any cause \>Grade 1.
* Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the screening visit through at least 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
* Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
* Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
* Has any untreated or symptomatic central nervous system (CNS) metastases.
* Patients with a history of other malignancy within 3 years prior to randomization
* Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
* Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
* Has received a live vaccine within 30 days of prior to the study start date.
18 Years
FEMALE
No
Sponsors
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Gynecologic Oncology Group
NETWORK
Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Sachin Pai, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site 318
Phoenix, Arizona, United States
Site 277
Tucson, Arizona, United States
Site 350
Irvine, California, United States
Site 364
La Jolla, California, United States
Site 150
Palo Alto, California, United States
Site 278
San Francisco, California, United States
Site 014
San Francisco, California, United States
Site 316
Solvang, California, United States
Site 032
Aurora, Colorado, United States
Site 335
Miami Beach, Florida, United States
Site 042
Weston, Florida, United States
Site 009
Atlanta, Georgia, United States
Site 272
Atlanta, Georgia, United States
Site 372
Gainesville, Georgia, United States
Site 291
Savannah, Georgia, United States
Site 315
Evanston, Illinois, United States
Site 314
Hinsdale, Illinois, United States
Site 346
Urbana, Illinois, United States
Site 339
Indianapolis, Indiana, United States
Site 200
Overland Park, Kansas, United States
Site 334
Overland Park, Kansas, United States
Site 279
Louisville, Kentucky, United States
Site 128
Boston, Massachusetts, United States
Site 288
New Brunswick, New Jersey, United States
Site 292
Albuquerque, New Mexico, United States
Site 275
Flushing, New York, United States
Site 298
Cincinnati, Ohio, United States
Site 304
Cincinnati, Ohio, United States
Site 280
Portland, Oregon, United States
Site 317
Portland, Oregon, United States
Site 049
Portland, Oregon, United States
Site 337
Bethlehem, Pennsylvania, United States
Site 127
Pittsburgh, Pennsylvania, United States
Site 276
Rapid City, South Dakota, United States
Site 368
Germantown, Tennessee, United States
Site 281
Nashville, Tennessee, United States
Site 229
Austin, Texas, United States
Site 312
Bedford, Texas, United States
Site 297
Fort Worth, Texas, United States
Site 392
San Antonio, Texas, United States
Site 301
The Woodlands, Texas, United States
Site 300
Norfolk, Virginia, United States
Site 365
Richmond, Virginia, United States
Site 121
Milwaukee, Wisconsin, United States
Site 393
CABA, Buenos Aires, Argentina
Site 381
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Site 415
Córdoba, Córdoba Province, Argentina
Site 401
Córdoba, Córdoba Province, Argentina
Site 395
Córdoba, Córdoba Province, Argentina
Site 404
Mendoza, Mendoza Province, Argentina
Site 391
Rosario, Santa Fe Province, Argentina
Site 412
Rosario, Santa Fe Province, Argentina
Site 426
St Leonards, New South Wales, Australia
Site 417
Benowa, Queensland, Australia
Site 414
Melbourne, Victoria, Australia
Site 419
Melbourne, Victoria, Australia
Site 328
Aalst, , Belgium
Site 109
Brussels, , Belgium
Site 326
Charleroi, , Belgium
Site 325
Hasselt, , Belgium
Site 108
Leuven, , Belgium
Site 327
Liège, , Belgium
Site 424
Brasília, Brasília - DF, Brazil
Site 382
Fortaleza, Ceará, Brazil
Site 384
Salvador, Estado de Bahia, Brazil
Site 383
Belo Horizonte, Minas Gerais, Brazil
Site 390
Natal, Rio Grande do Norte, Brazil
Site 413
São Paulo, São Paulo, Brazil
Site 421
Porto Alegre, , Brazil
Site 380
Rio de Janeiro, , Brazil
Site 376
São Paulo, , Brazil
Site 389
São Paulo, , Brazil
Site 413
São Paulo, , Brazil
Site 374
São Paulo, , Brazil
Site 001
São Paulo, , Brazil
Site 117
Toronto, Ontario, Canada
Site 273
Montreal, Quebec, Canada
Site 306
Lille, , France
Site 347
Montpellier, , France
Site 307
Nancy, , France
Site 310
Nice, , France
Site 289
Paris, , France
Site 323
Plérin, , France
Site 322
Budapest, , Hungary
Site 290
Debrecen, , Hungary
Site 348
Győr, , Hungary
Site 309
Haifa, , Israel
Site 080
Jerusalem, , Israel
Site 203
Tel Aviv, , Israel
Site 321
Catania, , Italy
Site 320
Legnago, , Italy
Site 122
Milan, , Italy
Site 295
Pavia, , Italy
Site 161
Roma, , Italy
Site 124
Rome, , Italy
Site 293
Torino, , Italy
Site 319
Treviso, , Italy
Site 341
Gdynia, , Poland
Site 331
Poznan, , Poland
Site 329
Siedlce, , Poland
Site 397
Gyeonggi-do, , South Korea
Site 399
Seoul, , South Korea
Site 398
Seoul, , South Korea
Site 403
Seoul, , South Korea
Site 400
Seoul, , South Korea
Site 396
Seoul, , South Korea
Site 402
Seoul, , South Korea
Site 409
Seoul, , South Korea
Site 349
Badalona, , Spain
Site 311
San Sebastián, , Spain
Site 330
Valencia, , Spain
Site 367
Brighton, East Sussex, United Kingdom
Site 351
Taunton, Somerset, United Kingdom
Site 366
Cheltenham, , United Kingdom
Site 055
London, , United Kingdom
Site 344
Manchester, , United Kingdom
Site 345
Northwood, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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ROSELLA Study 556
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-3073
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-OV72
Identifier Type: OTHER
Identifier Source: secondary_id
APGOT-Ov10
Identifier Type: OTHER
Identifier Source: secondary_id
LACOG 0223
Identifier Type: OTHER
Identifier Source: secondary_id
ANZGOG2221/2023
Identifier Type: OTHER
Identifier Source: secondary_id
CORT125134-556
Identifier Type: -
Identifier Source: org_study_id
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