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

RecruitingPhase 2Ages 18 Years - anyFemaleCorcept Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Relacorilant 150 mg once daily (QD)
  • Nab-paclitaxel 80 mg/m^2
  • Bevacizumab 10 mg/kg
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Where

49 sites
004
Birmingham, United States
150
Palo Alto, United States
014
San Francisco, United States
544
Fort Myers, United States
335
Miami Beach, United States
543
West Palm Beach, United States
518
Minneapolis, United States
334
Kansas City, United States

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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