Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
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)
7 other identifiers
interventional
381
14 countries
117
Brief Summary
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2022
Typical duration for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 16, 2025
April 1, 2025
2.7 years
February 4, 2022
April 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival as Assessed by BICR
Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first
Up to 24 months from enrollment of the last patient
Overall survival
Time from randomization to death by any cause
Up to 24 months from enrollment of the last patient
Secondary Outcomes (7)
PFS as Assessed by the Investigator
Up to 24 months from enrollment of the last patient
Objective Response as Assessed by BICR
Up to 24 months from enrollment of the last patient
Best Overall Response as Assessed by BICR
Up to 24 months from enrollment of the last patient
Duration of Response as Assessed by BICR
Up to 24 months from enrollment of the last patient
Clinical benefit rate as assessed by BICR
24 weeks
- +2 more secondary outcomes
Study Arms (2)
Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg
EXPERIMENTALPatients 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 100 mg/m^2
ACTIVE COMPARATORPatients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.
Interventions
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
- 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.
You may not qualify if:
- Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corcept Therapeuticslead
- Gynecologic Oncology Groupcollaborator
Study Sites (117)
Site 318
Phoenix, Arizona, 85016, United States
Site 277
Tucson, Arizona, 85719, United States
Site 350
Irvine, California, 92618, United States
Site 364
La Jolla, California, 92093, United States
Site 150
Palo Alto, California, 94304, United States
Site 278
San Francisco, California, 94109, United States
Site 014
San Francisco, California, 94143, United States
Site 316
Solvang, California, 93463, United States
Site 032
Aurora, Colorado, 80045, United States
Site 335
Miami Beach, Florida, 33140, United States
Site 042
Weston, Florida, 33331, United States
Site 009
Atlanta, Georgia, 30322, United States
Site 272
Atlanta, Georgia, 30342, United States
Site 372
Gainesville, Georgia, 30548, United States
Site 291
Savannah, Georgia, 31405, United States
Site 315
Evanston, Illinois, 60201, United States
Site 314
Hinsdale, Illinois, 60521, United States
Site 346
Urbana, Illinois, 61801, United States
Site 339
Indianapolis, Indiana, 46260, United States
Site 200
Overland Park, Kansas, 66211, United States
Site 334
Overland Park, Kansas, 66211, United States
Site 279
Louisville, Kentucky, 40241, United States
Site 128
Boston, Massachusetts, 02114, United States
Site 288
New Brunswick, New Jersey, 08901, United States
Site 292
Albuquerque, New Mexico, 87131, United States
Site 275
Flushing, New York, 11355, United States
Site 298
Cincinnati, Ohio, 45242, United States
Site 304
Cincinnati, Ohio, 45459, United States
Site 280
Portland, Oregon, 97210, United States
Site 317
Portland, Oregon, 97213, United States
Site 049
Portland, Oregon, 97239, United States
Site 337
Bethlehem, Pennsylvania, 18015, United States
Site 127
Pittsburgh, Pennsylvania, 15213, United States
Site 276
Rapid City, South Dakota, 57701, United States
Site 368
Germantown, Tennessee, 38138, United States
Site 281
Nashville, Tennessee, 37203, United States
Site 229
Austin, Texas, 78731, United States
Site 312
Bedford, Texas, 76022, United States
Site 297
Fort Worth, Texas, 76104, United States
Site 392
San Antonio, Texas, 78240, United States
Site 301
The Woodlands, Texas, 77380, United States
Site 300
Norfolk, Virginia, 23502, United States
Site 365
Richmond, Virginia, 23298, United States
Site 121
Milwaukee, Wisconsin, 53226, United States
Site 393
CABA, Buenos Aires, C1280AEB, Argentina
Site 381
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ANZ, Argentina
Site 415
Córdoba, Córdoba Province, X5004FHP, Argentina
Site 401
Córdoba, Córdoba Province, X5008 HHW, Argentina
Site 395
Córdoba, Córdoba Province, X5016, Argentina
Site 404
Mendoza, Mendoza Province, M5500AYB, Argentina
Site 391
Rosario, Santa Fe Province, 2000, Argentina
Site 412
Rosario, Santa Fe Province, S2000KDS, Argentina
Site 426
St Leonards, New South Wales, 2065, Australia
Site 417
Benowa, Queensland, 4217, Australia
Site 414
Melbourne, Victoria, 3000, Australia
Site 419
Melbourne, Victoria, 3128, Australia
Site 328
Aalst, 9300, Belgium
Site 109
Brussels, B- 1200, Belgium
Site 326
Charleroi, 6000, Belgium
Site 325
Hasselt, 3500, Belgium
Site 108
Leuven, 3000, Belgium
Site 327
Liège, B-4000, Belgium
Site 424
Brasília, Brasília - DF, 70297-400, Brazil
Site 382
Fortaleza, Ceará, 60170-170, Brazil
Site 384
Salvador, Estado de Bahia, 41950-640, Brazil
Site 383
Belo Horizonte, Minas Gerais, 30210-040, Brazil
Site 390
Natal, Rio Grande do Norte, 59062-000, Brazil
Site 413
São Paulo, São Paulo, 01409-002, Brazil
Site 421
Porto Alegre, 90035-001, Brazil
Site 380
Rio de Janeiro, 22250-905, Brazil
Site 376
São Paulo, 01321001, Brazil
Site 389
São Paulo, 01327-001, Brazil
Site 413
São Paulo, 01409-002, Brazil
Site 374
São Paulo, 01509-900, Brazil
Site 001
São Paulo, 01509010, Brazil
Site 117
Toronto, Ontario, M4N 3M5, Canada
Site 273
Montreal, Quebec, H4A 3J1, Canada
Site 306
Lille, 59020, France
Site 347
Montpellier, 34298, France
Site 307
Nancy, 54100, France
Site 310
Nice, 06189, France
Site 289
Paris, 75015, France
Site 323
Plérin, 22190, France
Site 322
Budapest, 1122, Hungary
Site 290
Debrecen, 4032, Hungary
Site 348
Győr, 9024, Hungary
Site 309
Haifa, 3436212, Israel
Site 080
Jerusalem, 911201, Israel
Site 203
Tel Aviv, 6423906, Israel
Site 321
Catania, 95126, Italy
Site 320
Legnago, 37045, Italy
Site 122
Milan, 20141, Italy
Site 295
Pavia, 27100, Italy
Site 161
Roma, 161, Italy
Site 124
Rome, 00168, Italy
Site 293
Torino, 10128, Italy
Site 319
Treviso, 31100, Italy
Site 341
Gdynia, 81-519, Poland
Site 331
Poznan, 61-886, Poland
Site 329
Siedlce, 08-110, Poland
Site 397
Gyeonggi-do, 10408, South Korea
Site 399
Seoul, 03080, South Korea
Site 398
Seoul, 03722, South Korea
Site 403
Seoul, 05505, South Korea
Site 400
Seoul, 06273, South Korea
Site 396
Seoul, 06351, South Korea
Site 402
Seoul, 08308, South Korea
Site 409
Seoul, 42601, South Korea
Site 349
Badalona, 08916, Spain
Site 311
San Sebastián, 20014, Spain
Site 330
Valencia, 46026, Spain
Site 367
Brighton, East Sussex, BN2 1ES, United Kingdom
Site 351
Taunton, Somerset, TA1 5DA, United Kingdom
Site 366
Cheltenham, GL53 7AN, United Kingdom
Site 055
London, NW1 2PG, United Kingdom
Site 344
Manchester, M20 4BX, United Kingdom
Site 345
Northwood, HA6 2RN, United Kingdom
Related Publications (3)
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.
PMID: 40473448DERIVEDOlawaiye 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.
PMID: 39032926DERIVEDColombo 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.
PMID: 37364223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sachin Pai, MD
Corcept Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
February 25, 2022
Study Start
June 29, 2022
Primary Completion
March 24, 2025
Study Completion
March 1, 2026
Last Updated
April 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share