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New treatment option for Ovarian Cancer
Official title Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
ClinicalTrials.gov ID: NCT06906341
What this study is testing
What is Relacorilant 150 mg once daily (QD)?
Relacorilant 150 mg once daily (QD) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as CORT125134.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.