Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
Start Date
4/11/2025
Completion Date
12/1/2026
Summary
This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.
Detailed Description
This study is designed with the goal to add additional arms as new treatments become available. All arms will follow an independent and parallel design. For Arms A and B, study treatment will comprise relacorilant combined with nab-paclitaxel, and bevacizumab and will begin on Cycle 1 Day 1 (C1D1). Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before, the day of, and the day after nab-paclitaxel infusion (in Cycle 1 relacorilant is only given on 2 consecutive days, starting on C1D1), in combination with nab-paclitaxel (80 mg/m\^2 intravenously \[IV\]) administered on Days 1, 8, and 15 of each 28-day cycle. Bevacizumab (10 mg/kg IV once every 2 weeks \[Q2W\]) will be administered on Days 1 and 15 of each 28-day cycle. Study treatment for Arm C will be similar to Arm A but does not include bevacizumab. Patients will receive treatment until they reach a protocol-defined event of progressive disease (PD), experience an unmanageable toxicity, or until other treatment discontinuation criteria are met.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Relacorilant 150 mg once daily (QD)
Nab-paclitaxel 80 mg/m^2
Bevacizumab 10 mg/kg
Conditions
Locations
004
Birmingham, Alabama 35233
United States
150
Palo Alto, California 94304
United States
014
San Francisco, California 94143
United States
544
Fort Myers, Florida 33901
United States
335
Miami Beach, Florida 33140
United States
543
West Palm Beach, Florida 33041
United States
518
Minneapolis, Minnesota 55404
United States
334
Kansas City, Missouri 64132
United States
521
St Louis, Missouri 63110
United States
292
Albuquerque, New Mexico 97102
United States
304
Centerville, Ohio 45459
United States
517
Eugene, Oregon 97401
United States
127
Pittsburgh, Pennsylvania 15213
United States
522
Fairfax, Virginia 22031
United States
300
Norfolk, Virginia 23502
United States
121
Milwaukee, Wisconsin 53226
United States
328
Aalst, Belgium 9300
Belgium
326
Charleroi, 6000
Belgium
325
Hasselt, 3500
Belgium
108
Leuven, 3000
Belgium
306
Lille, 59000
France
307
Nancy, 54100
France
310
Nice, 06100
France
324
Pierre-Bénite, 69495
France
323
Plérin, 22190
France
308
Toulouse, 31059
France
519
Aachen, 52074
Germany
255
Berlin, 10117
Germany
520
Kempten, 87439
Germany
321
Catania, 95126
Italy
122
Milan, 20141
Italy
516
Milan, 20159
Italy
295
Pavia, 27100
Italy
124
Rome, 00168
Italy
293
Torino, 10128
Italy
319
Treviso, 31100
Italy
341
Gdynia, 81-519
Poland
329
Siedlce, 08-MO
Poland
396
Seoul, Gangnam-gu 06351
South Korea
397
Gyeonggi-do, Goyang-si 10408
South Korea
399
Seoul, Jongno-gu 03080
South Korea
523
Seoul, Seocho-gu 06591
South Korea
398
Seoul, Seodaemun-gu 03722
South Korea
403
Seoul, Songpa-gu 05505
South Korea
349
Badalona, 08916
Spain
115
Barcelona, 08035
Spain
114
Madrid, 28034
Spain
558
Valencia, 46010
Spain
330
Valencia, 46026
Spain