Status:
RECRUITING
Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
Lead Sponsor:
Corcept Therapeutics
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
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 compris...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06906341
Start Date
April 11 2025
End Date
December 1 2026
Last Update
October 22 2025
Active Locations (45)
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1
150
Palo Alto, California, United States, 94304
2
014
San Francisco, California, United States, 94143
3
544
Fort Myers, Florida, United States, 33901
4
543
West Palm Beach, Florida, United States, 33041