Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
NCT ID: NCT06906341
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
270 participants
INTERVENTIONAL
2025-04-11
2026-12-31
Brief Summary
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Detailed Description
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For Arms A and B, study treatment will comprise relacorilant combined with nab-paclitaxel, and bevacizumab and will begin on Cycle 1 Day 1 (C1D1). Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before, the day of, and the day after nab-paclitaxel infusion (in Cycle 1 relacorilant is only given on 2 consecutive days, starting on C1D1), in combination with nab-paclitaxel (80 mg/m\^2 intravenously \[IV\]) administered on Days 1, 8, and 15 of each 28-day cycle. Bevacizumab (10 mg/kg IV once every 2 weeks \[Q2W\]) will be administered on Days 1 and 15 of each 28-day cycle. Study treatment for Arm C will be similar to Arm A but does not include bevacizumab. Patients will receive treatment until they reach a protocol-defined event of progressive disease (PD), experience an unmanageable toxicity, or until other treatment discontinuation criteria are met.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab
In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 10 mg/kg
Bevacizumab is administered as IV infusion on Days 1 and 15.
Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab
In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 10 mg/kg
Bevacizumab is administered as IV infusion on Days 1 and 15.
Arm C: Relacorilant in Combination with Nab-Paclitaxel
In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.
Relacorilant 150 mg once daily (QD)
Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Interventions
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Relacorilant 150 mg once daily (QD)
Relacorilant is administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion.
Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Bevacizumab 10 mg/kg
Bevacizumab is administered as IV infusion on Days 1 and 15.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Sachin Pai, MD, MS
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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150
Palo Alto, California, United States
014
San Francisco, California, United States
544
Fort Myers, Florida, United States
543
West Palm Beach, Florida, United States
518
Minneapolis, Minnesota, United States
334
Kansas City, Missouri, United States
521
St Louis, Missouri, United States
292
Albuquerque, New Mexico, United States
304
Centerville, Ohio, United States
517
Eugene, Oregon, United States
127
Pittsburgh, Pennsylvania, United States
522
Fairfax, Virginia, United States
300
Norfolk, Virginia, United States
121
Milwaukee, Wisconsin, United States
328
Aalst, , Belgium
326
Charleroi, , Belgium
325
Hasselt, , Belgium
108
Leuven, , Belgium
306
Lille, , France
307
Nancy, , France
310
Nice, , France
324
Pierre-Bénite, , France
323
Plérin, , France
308
Toulouse, , France
519
Aachen, , Germany
255
Berlin, , Germany
520
Kempten, , Germany
321
Catania, , Italy
122
Milan, , Italy
516
Milan, , Italy
295
Pavia, , Italy
124
Rome, , Italy
293
Torino, , Italy
319
Treviso, , Italy
341
Gdynia, , Poland
329
Siedlce, , Poland
396
Seoul, Gangnam-gu, South Korea
397
Gyeonggi-do, Goyang-si, South Korea
399
Seoul, Jongno-gu, South Korea
523
Seoul, Seocho-gu, South Korea
398
Seoul, Seodaemun-gu, South Korea
403
Seoul, Songpa-gu, South Korea
349
Badalona, , Spain
115
Barcelona, , Spain
330
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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CORT125134-557
Identifier Type: -
Identifier Source: org_study_id
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