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Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Sponsor: Corcept Therapeutics
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
381
Start Date
2022-06-29
Completion Date
2026-03
Last Updated
2025-04-16
Healthy Volunteers
No
Interventions
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.
Locations (117)
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