RECRUITING

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

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Conditions

Ovarian CancerFallopian Tube CancerPeritoneal NeoplasmsEndometrial CancerGenital Neoplasms, FemaleNeoplasms by SiteFallopian Tube DiseasesOvarian DiseasesNeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsPaclitaxelAlbumin-Bound PaclitaxelOvarianPeritoneal or Advanced Fallopian Tube CancerHigh GradePlatinum ResistantRelacorilantBellaNab-paclitaxelBevacizumabEndometrial NeoplasmEndometrial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-04-11
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06906341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma
  2. * Arm A Only: Platinum-resistant disease
  3. * Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor
  4. * Life expectancy of ≥3 months
  5. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. * Able to swallow and retain oral medication
  7. * 1 to 3 lines of prior systemic anticancer therapy
  8. * Adequate organ function
  9. * Negative pregnancy test for patients of childbearing potential
  10. * Stage III or IV, recurrent, or metastatic endometrial cancer
  11. * Life expectancy of ≥3 months
  12. * ECOG performance status of 0 or 1
  13. * Able to swallow and retain oral medication
  14. * Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\[L\]1) antibody
  15. * 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer
  16. * Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections
  17. * Adequate organ function
  18. * Negative pregnancy test for patients of childbearing potential
  1. * Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel
  2. * Prior enrollment in a clinical trial of relacorilant
  3. * Prior anticancer therapy related toxicities not resolved to grade ≤1
  4. * Any surgery within 4 weeks prior to enrollment
  5. * Wide-field radiation to more than 25% of marrow-bearing areas
  6. * Medical conditions requiring chronic or frequent treatment with corticosteroids
  7. * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
  8. * Peripheral neuropathy from any cause \>Grade 1
  9. * Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic
  10. * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
  11. * Bowel obstruction ≤12 weeks prior to study entry
  12. * Ascites or pleural effusions requiring therapeutic paracentesis
  13. * Untreated or symptomatic central nervous system metastases
  14. * History of other malignancy within 3 years prior to enrollment
  15. * Has received a live vaccine within 30 days prior to the study start date
  16. * Has progressed while receiving weekly paclitaxel or nab-paclitaxel
  17. * Prior enrollment in a clinical trial of relacorilant
  18. * Prior anticancer therapy related toxicities not resolved to grade ≤1
  19. * Any surgery within 4 weeks prior to enrollment
  20. * Wide-field radiation to more than 25% of marrow-bearing areas
  21. * Medical conditions requiring chronic or frequent treatment with corticosteroids
  22. * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators
  23. * Peripheral neuropathy from any cause \>Grade 1
  24. * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation
  25. * Bowel obstruction ≤12 weeks prior to study entry
  26. * Ascites or pleural effusions requiring therapeutic paracentesis
  27. * History of other malignancy within 3 years prior to enrollment
  28. * Has received a live vaccine within 30 days prior to the study start date
  29. * 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.

Contacts and Locations

Study Contact

Corcept Therapeutics
CONTACT
650-684-0171
corceptstudy557@corcept.com

Principal Investigator

Sachin Pai, MD, MS
STUDY_DIRECTOR
Corcept Therapeutics

Study Locations (Sites)

150
Palo Alto, California, 94304
United States
014
San Francisco, California, 94143
United States
544
Fort Myers, Florida, 33901
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

Collaborators and Investigators

Sponsor: Corcept Therapeutics

  • Sachin Pai, MD, MS, STUDY_DIRECTOR, Corcept Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-11
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-04-11
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Endometrial Cancer