Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab | Experimental | In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab. |
|
| Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab | Experimental | In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab. |
|
| Arm C: Relacorilant in Combination with Nab-Paclitaxel | Experimental | In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant 150 mg once daily (QD) | Drug | Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first. | Date of first dose until PD or death, up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | To evaluate the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST version 1.1. | Date of first dose until PD or death, up to 18 months |
| Best Overall Response Rate (BOR) |
Not provided
Inclusion Criteria:
Arms A and B
Arm C
Exclusion Criteria:
Arm A and B
Arm C
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corcept Therapeutics | Contact | 650-684-0171 | corceptstudy557@corcept.com |
| Name | Affiliation | Role |
|---|---|---|
| Sachin Pai, MD, MS | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 004 | Recruiting | Birmingham | Alabama | 35233 | United States | |
| 150 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nab-paclitaxel 80 mg/m^2 | Drug | Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle. |
|
| Bevacizumab 10 mg/kg | Drug | Bevacizumab is administered as IV infusion on Days 1 and 15. |
|
To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death. |
| Date of first dose until PD or death, up to 18 months |
| Duration of Response (DOR) | To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first. | Time of first objective response until PD or death, up to 18 months |
| Clinical Benefit Rate (CBR) | To evaluate CBR as the proportion of patients who attain CR, PR, or stable disease (SD) at Week 24 as per RECIST version 1.1. | Week 24 |
| Overall Survival (OS) | To evaluate the probability of OS survival at 6, 12, and 18 months. | Date of first dose up to 6, 12, and 18 months |
| Number of patients with one or more adverse events | Date of first dose up to 30 days after last dose |
| Area under the plasma concentration-time curve (AUC) of relacorilant | To estimate exposure of relacorilant. This outcome applies to Arms B and C only. | On Cycle 1 Day 8 (each cycle is 28 days) |
| Maximum plasma concentration (Cmax) of relacorilant | To estimate exposure of relacorilant. This outcome applies to Arms B and C only. | On Cycle1 Day 8 (each cycle is 28 days) |
| Trough plasma concentrations (Cmin) of relacorilant | To estimate exposure of relacorilant. This outcome applies to Arms B and C only. | On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days) |
| Recruiting |
| Palo Alto |
| California |
| 94304 |
| United States |
| 014 | Recruiting | San Francisco | California | 94143 | United States |
| 544 | Recruiting | Fort Myers | Florida | 33901 | United States |
| 335 | Recruiting | Miami Beach | Florida | 33140 | United States |
| 543 | Recruiting | West Palm Beach | Florida | 33041 | United States |
| 518 | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| 334 | Recruiting | Kansas City | Missouri | 64132 | United States |
| 521 | Recruiting | St Louis | Missouri | 63110 | United States |
| 292 | Recruiting | Albuquerque | New Mexico | 97102 | United States |
| 304 | Recruiting | Centerville | Ohio | 45459 | United States |
| 517 | Recruiting | Eugene | Oregon | 97401 | United States |
| 127 | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| 522 | Recruiting | Fairfax | Virginia | 22031 | United States |
| 300 | Recruiting | Norfolk | Virginia | 23502 | United States |
| 121 | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| 328 | Recruiting | Aalst | 9300 | Belgium |
| 326 | Recruiting | Charleroi | 6000 | Belgium |
| 325 | Recruiting | Hasselt | 3500 | Belgium |
| 108 | Recruiting | Leuven | 3000 | Belgium |
| 306 | Recruiting | Lille | 59000 | France |
| 307 | Recruiting | Nancy | 54100 | France |
| 310 | Recruiting | Nice | 06100 | France |
| 324 | Recruiting | Pierre-Bénite | 69495 | France |
| 323 | Recruiting | Plérin | 22190 | France |
| 308 | Recruiting | Toulouse | 31059 | France |
| 519 | Recruiting | Aachen | 52074 | Germany |
| 255 | Recruiting | Berlin | 10117 | Germany |
| 520 | Recruiting | Kempten | 87439 | Germany |
| 321 | Recruiting | Catania | 95126 | Italy |
| 122 | Recruiting | Milan | 20141 | Italy |
| 516 | Recruiting | Milan | 20159 | Italy |
| 295 | Recruiting | Pavia | 27100 | Italy |
| 124 | Recruiting | Rome | 00168 | Italy |
| 293 | Recruiting | Torino | 10128 | Italy |
| 319 | Recruiting | Treviso | 31100 | Italy |
| 341 | Recruiting | Gdynia | 81-519 | Poland |
| 329 | Recruiting | Siedlce | 08-MO | Poland |
| 396 | Recruiting | Seoul | Gangnam-gu | 06351 | South Korea |
| 397 | Recruiting | Gyeonggi-do | Goyang-si | 10408 | South Korea |
| 399 | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
| 523 | Recruiting | Seoul | Seocho-gu | 06591 | South Korea |
| 398 | Recruiting | Seoul | Seodaemun-gu | 03722 | South Korea |
| 403 | Recruiting | Seoul | Songpa-gu | 05505 | South Korea |
| 349 | Recruiting | Badalona | 08916 | Spain |
| 115 | Recruiting | Barcelona | 08035 | Spain |
| 114 | Recruiting | Madrid | 28034 | Spain |
| 558 | Recruiting | Valencia | 46010 | Spain |
| 330 | Recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D009371 | Neoplasms by Site |
| D005184 | Fallopian Tube Diseases |
| D010049 | Ovarian Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000633444 | relacorilant |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided