NCT06906341 Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
| NCT ID | NCT06906341 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Corcept Therapeutics |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 270 participants in total. It began in 2025-04-11 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Contact & Investigator
Sachin Pai, MD, MS
STUDY DIRECTOR
Corcept Therapeutics
Frequently Asked Questions
Who can join the NCT06906341 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06906341 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06906341 currently recruiting?
Yes, NCT06906341 is actively recruiting participants. Contact the research team at corceptstudy557@corcept.com for enrollment information.
Where is the NCT06906341 trial being conducted?
This trial is being conducted at Birmingham, United States, Palo Alto, United States, San Francisco, United States, Fort Myers, United States and 11 additional locations.
Who is sponsoring the NCT06906341 clinical trial?
NCT06906341 is sponsored by Corcept Therapeutics. The principal investigator is Sachin Pai, MD, MS at Corcept Therapeutics. The trial plans to enroll 270 participants.
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