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ACTIVE NOT RECRUITING
NCT05257408
PHASE3

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Sponsor: Corcept Therapeutics

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Relacorilant 150 mg once daily (QD)

Relacorilant is administered as capsules for oral dosing.

DRUG

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