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

NCT06906341

RecruitingPhase 2

Sponsor: Corcept Therapeutics

Conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms, Endometrial Cancer

Interventions: Relacorilant 150 mg once daily (QD), Nab-paclitaxel 80 mg/m^2, Bevacizumab 10 mg/kg

Countries: United States, Belgium, France, Germany, Italy, Poland, South Korea, Spain

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (49)
  • Birmingham, Alabama, United States
  • Palo Alto, California, United States
  • San Francisco, California, United States
  • Fort Myers, Florida, United States
  • Miami Beach, Florida, United States
  • West Palm Beach, Florida, United States
  • Minneapolis, Minnesota, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • Centerville, Ohio, United States
  • Eugene, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Fairfax, Virginia, United States
  • Norfolk, Virginia, United States
  • Milwaukee, Wisconsin, United States
  • Aalst, Belgium, Belgium
  • Charleroi, Belgium
  • Hasselt, Belgium
  • Leuven, Belgium
  • Lille, France
  • Nancy, France
  • Nice, France
  • Pierre-Bénite, France
  • Plérin, France
  • Toulouse, France
  • Aachen, Germany
  • Berlin, Germany
  • Kempten, Germany
  • Catania, Italy
  • + 19 more on CT.gov