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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Corcept Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

30 May 2025 → ongoing

Decision date (initial)

2025-05-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Corcept Therapeutics Incorporated 101 Redwood Shores Parkway Redwood City, California 94065 USA

External identifiers

EU CT number

2024-517432-21-00

ClinicalTrials.gov

NCT06906341

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Pharmacodynamic

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.

Secondary objectives 1

1. • Objective Response Rate (ORR) • Best Overall Response Rate (BOR) • Duration of Response (DOR) • Clinical Benefit Rate (CBR) • Overall Survival (OS) • Number of patients with one or more adverse events

Conditions and MedDRA coding

Gynecological Cancers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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 • 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
2. 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

Exclusion criteria 2

1. 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 • 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
2. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. 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 • [Time Frame: Date of first dose until PD or death, up to 18 months]
2. BOR: To evaluate the BOR by RECIST version 1.1 recorded from the date of enrollment until PD or death • [Time Frame: Date of first dose until PD or death, up to 18 months]
3. DOR: To evaluate DOR as the time from the first CR or PR to first objectively documented PD or death, whichever comes first. • [Time Frame: Time of first objective response until PD or death, up to 18 months]
4. 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. • [Time Frame: Week 24]
5. OS: To evaluate the probability of OS survival at 6, 12, and 18 months. • [Time Frame: Date of first dose up to 6, 12, and 18 months]
6. Number of patients with one or more adverse events • [Time Frame: Date of first dose up to 30 days after last dose]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Corcept Therapeutics Inc.

Sponsor organisation

Corcept Therapeutics Inc.

Address

101 Redwood Shores Parkway

City

Redwood City

Postcode

94065-1176

Country

United States

Scientific contact point

Organisation

Corcept Therapeutics Inc.

Contact name

Corcept Therapeutics Incorporated

Public contact point

Organisation

Corcept Therapeutics Inc.

Contact name

Corcept Therapeutics Incorporated

Third parties 15

Locations

6 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 80 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications