Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (NCT06906341) | Clinical Trial Compass
RecruitingPhase 2
Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
United States270 participantsStarted 2025-04-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Date of first dose until PD or death, up to 18 months