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Ovarian CancerPhase 2NCT06906341

Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers

A Phase 2 study testing Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2 and Bevacizumab 10 mg/kg in people with Ovarian Cancer and Fallopian Tube Cancer, run by Corcept Therapeutics at 49 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2 and Bevacizumab 10 mg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
49 sitesin 8 countries
Study dates
11 Apr 2025to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Arms A and B
  • Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma
  • Arm A Only: Platinum-resistant disease
  • Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor
  • Life expectancy of ≥3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Show all 20Show fewer
  • Able to swallow and retain oral medication
  • 1 to 3 lines of prior systemic anticancer therapy
  • Adequate organ function
  • Negative pregnancy test for patients of childbearing potential
  • Arm C
  • Stage III or IV, recurrent, or metastatic endometrial cancer
  • Life expectancy of ≥3 months
  • ECOG performance status of 0 or 1
  • Able to swallow and retain oral medication
  • Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD[L]1) antibody
  • 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer
  • Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections
  • Adequate organ function
  • Negative pregnancy test for patients of childbearing potential

Who cannot join

  • Arm A and B
  • Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel
  • Prior enrollment in a clinical trial of relacorilant
  • Prior anticancer therapy related toxicities not resolved to grade ≤1
  • Any surgery within 4 weeks prior to enrollment
  • Wide-field radiation to more than 25% of marrow-bearing areas
Show all 31Show fewer
  • Medical conditions requiring chronic or frequent treatment with corticosteroids
  • Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
  • Peripheral neuropathy from any cause >Grade 1
  • Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic
  • Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
  • Bowel obstruction ≤12 weeks prior to study entry
  • Ascites or pleural effusions requiring therapeutic paracentesis
  • Untreated or symptomatic central nervous system metastases
  • History of other malignancy within 3 years prior to enrollment
  • Has received a live vaccine within 30 days prior to the study start date
  • Arm C
  • Has progressed while receiving weekly paclitaxel or nab-paclitaxel
  • Prior enrollment in a clinical trial of relacorilant
  • Prior anticancer therapy related toxicities not resolved to grade ≤1
  • Any surgery within 4 weeks prior to enrollment
  • Wide-field radiation to more than 25% of marrow-bearing areas
  • Medical conditions requiring chronic or frequent treatment with corticosteroids
  • Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
  • Peripheral neuropathy from any cause >Grade 1
  • Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
  • Bowel obstruction ≤12 weeks prior to study entry
  • Ascites or pleural effusions requiring therapeutic paracentesis
  • History of other malignancy within 3 years prior to enrollment
  • Has received a live vaccine within 30 days prior to the study start date
  • Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.

Trial locations and contacts

49 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Corcept Therapeutics contact

650-414-2314

corceptstudy557@corcept.com

49 sites in 8 countries

United States16 sites, 16 recruiting

  • 292

    Albuquerque, New Mexico, 97102

    Recruiting

  • 004

    Birmingham, Alabama, 35233

    Recruiting

  • 304

    Centerville, Ohio, 45459

    Recruiting

  • 517

    Eugene, Oregon, 97401

    Recruiting

  • 522

    Fairfax, Virginia, 22031

    Recruiting

  • 544

    Fort Myers, Florida, 33901

    Recruiting

  • 334

    Kansas City, Missouri, 64132

    Recruiting

  • 335

    Miami Beach, Florida, 33140

    Recruiting

  • 121

    Milwaukee, Wisconsin, 53226

    Recruiting

  • 518

    Minneapolis, Minnesota, 55404

    Recruiting

  • 300

    Norfolk, Virginia, 23502

    Recruiting

  • 150

    Palo Alto, California, 94304

    Recruiting

  • 127

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • 014

    San Francisco, California, 94143

    Recruiting

  • 521

    St Louis, Missouri, 63110

    Recruiting

  • 543

    West Palm Beach, Florida, 33041

    Recruiting

Other trials in United States

Italy7 sites, 7 recruiting

  • 321

    Catania, 95126

    Recruiting

  • 122

    Milan, 20141

    Recruiting

  • 516

    Milan, 20159

    Recruiting

  • 295

    Pavia, 27100

    Recruiting

  • 124

    Rome, 00168

    Recruiting

  • 293

    Torino, 10128

    Recruiting

  • 319

    Treviso, 31100

    Recruiting

Other trials in Italy

France6 sites, 6 recruiting

  • 306

    Lille, 59000

    Recruiting

  • 307

    Nancy, 54100

    Recruiting

  • 310

    Nice, 06100

    Recruiting

  • 324

    Pierre-Bénite, 69495

    Recruiting

  • 323

    Plérin, 22190

    Recruiting

  • 308

    Toulouse, 31059

    Recruiting

Other trials in France

South Korea6 sites, 6 recruiting

  • 397

    Gyeonggi-do, Goyang-si, 10408

    Recruiting

  • 396

    Seoul, Gangnam-gu, 06351

    Recruiting

  • 399

    Seoul, Jongno-gu, 03080

    Recruiting

  • 523

    Seoul, Seocho-gu, 06591

    Recruiting

  • 398

    Seoul, Seodaemun-gu, 03722

    Recruiting

  • 403

    Seoul, Songpa-gu, 05505

    Recruiting

Other trials in South Korea

Spain5 sites, 5 recruiting

  • 349

    Badalona, 08916

    Recruiting

  • 115

    Barcelona, 08035

    Recruiting

  • 114

    Madrid, 28034

    Recruiting

  • 558

    Valencia, 46010

    Recruiting

  • 330

    Valencia, 46026

    Recruiting

Other trials in Spain

Belgium4 sites, 4 recruiting

  • 328

    Aalst, Belgium, 9300

    Recruiting

  • 326

    Charleroi, 6000

    Recruiting

  • 325

    Hasselt, 3500

    Recruiting

  • 108

    Leuven, 3000

    Recruiting

Other trials in Belgium

Germany3 sites, 3 recruiting

  • 519

    Aachen, 52074

    Recruiting

  • 255

    Berlin, 10117

    Recruiting

  • 520

    Kempten, 87439

    Recruiting

Other trials in Germany

Poland2 sites, 2 recruiting

  • 341

    Gdynia, 81-519

    Recruiting

  • 329

    Siedlce, 08-MO

    Recruiting

Other trials in Poland

About this study

Official title: An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)

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.

Read the 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.

Being tested
Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2, Bevacizumab 10 mg/kg
Keywords
Genital Neoplasms, Female, Neoplasms by Site, Fallopian Tube Diseases, Ovarian Diseases, Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms, Paclitaxel, Albumin-Bound Paclitaxel, Ovarian, Peritoneal or Advanced Fallopian Tube Cancer, High Grade, Platinum Resistant, Relacorilant, Bella, Nab-paclitaxel, Bevacizumab, Endometrial Neoplasm, Endometrial
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Endometrial Neoplasms, Genital Neoplasms, Female, Neoplasms by Site, Fallopian Tube Diseases, Ovarian Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relacorilant 150 mg once daily (QD)Drug

    Also called CORT125134

    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.

  • Nab-paclitaxel 80 mg/m^2Drug

    Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

  • Bevacizumab 10 mg/kgDrug

    Bevacizumab is administered as IV infusion on Days 1 and 15.

Study groups in NCT06906341
Study groupRoleWhat they receive
Arm A: Relacorilant in Combination with Nab-paclitaxel and BevacizumabExperimentalIn Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.
Receives: Drug: Relacorilant 150 mg once daily (QD); Drug: Nab-paclitaxel 80 mg/m^2; Drug: Bevacizumab 10 mg/kg
Arm B: Relacorilant in Combination with Nab-Paclitaxel and BevacizumabExperimentalIn 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.
Receives: Drug: Relacorilant 150 mg once daily (QD); Drug: Nab-paclitaxel 80 mg/m^2; Drug: Bevacizumab 10 mg/kg
Arm C: Relacorilant in Combination with Nab-PaclitaxelExperimentalIn Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.
Receives: Drug: Relacorilant 150 mg once daily (QD); Drug: Nab-paclitaxel 80 mg/m^2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Date of first dose until PD or death, up to 18 months

Secondary outcomes (9)

  1. 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.

    Measured: Date of first dose until PD or death, up to 18 months

  2. Best Overall Response Rate (BOR)

    To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death.

    Measured: Date of first dose until PD or death, up to 18 months

  3. 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.

    Measured: Time of first objective response until PD or death, up to 18 months

  4. 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.

    Measured: Week 24

  5. Overall Survival (OS)

    To evaluate the probability of OS survival at 6, 12, and 18 months.

    Measured: Date of first dose up to 6, 12, and 18 months

  6. Number of patients with one or more adverse events

    Measured: Date of first dose up to 30 days after last dose

  7. Area under the plasma concentration-time curve (AUC) of relacorilant

    To estimate exposure of relacorilant. This outcome applies to Arms B and C only.

    Measured: On Cycle 1 Day 8 (each cycle is 28 days)

  8. Maximum plasma concentration (Cmax) of relacorilant

    To estimate exposure of relacorilant. This outcome applies to Arms B and C only.

    Measured: On Cycle1 Day 8 (each cycle is 28 days)

  9. Trough plasma concentrations (Cmin) of relacorilant

    To estimate exposure of relacorilant. This outcome applies to Arms B and C only.

    Measured: On Cycle 2 Day 8 through the last cycle (up to 12 cycles, each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start11 Apr 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906341
Sponsor's protocol ID
CORT125134-557
Status last verified
Jul 2026
First submitted
1 Apr 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2 and Bevacizumab 10 mg/kg in people with Ovarian Cancer and Fallopian Tube Cancer, run by Corcept Therapeutics at 49 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Italy, France, South Korea, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Corcept Therapeutics (650-414-2314, corceptstudy557@corcept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Date of first dose until PD or death, up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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