Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
Recruiting now · Phase 2
Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms, Endometrial Cancer
In brief
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.
Key facts
- Study ID
- NCT06906341
- Run by
- Corcept Therapeutics
- People needed
- 270
- Starts
- 2025-04-11
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- 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
- 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
Where it is running
- 004 — Birmingham, Alabama, United States (enrolling)
- 150 — Palo Alto, California, United States (enrolling)
- 014 — San Francisco, California, United States (enrolling)
- 544 — Fort Myers, Florida, United States (enrolling)
- 335 — Miami Beach, Florida, United States (enrolling)
- 543 — West Palm Beach, Florida, United States (enrolling)
- 518 — Minneapolis, Minnesota, United States (enrolling)
- 334 — Kansas City, Missouri, United States (enrolling)
- 521 — St Louis, Missouri, United States (enrolling)
- 292 — Albuquerque, New Mexico, United States (enrolling)
- 304 — Centerville, Ohio, United States (enrolling)
- 517 — Eugene, Oregon, United States (enrolling)
- 127 — Pittsburgh, Pennsylvania, United States (enrolling)
- 522 — Fairfax, Virginia, United States (enrolling)
- 300 — Norfolk, Virginia, United States (enrolling)
- 121 — Milwaukee, Wisconsin, United States (enrolling)
- 328 — Aalst, Belgium, Belgium (enrolling)
- 326 — Charleroi, Belgium (enrolling)
- 325 — Hasselt, Belgium (enrolling)
- 108 — Leuven, Belgium (enrolling)
- 306 — Lille, France (enrolling)
- 307 — Nancy, France (enrolling)
- 310 — Nice, France (enrolling)
- 324 — Pierre-Bénite, France (enrolling)
- 323 — Plérin, France (enrolling)
Full record on ClinicalTrials.gov
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