Ovarian CancerFallopian Tube CancerPeritoneal NeoplasmsEndometrial Cancer
Investigational drug(s) / intervention(s)
Relacorilant 150 mg once daily (QD)Nab-paclitaxel 80 mg/m^2Bevacizumab 10 mg/kg
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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-Free Survival (PFS) — Date of first dose until PD or death, up to 18 months To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever occurs first.
Trial sites (49)
Facility
City
Region
Status
004
Birmingham
Alabama
Recruiting
150
Palo Alto
California
Recruiting
014
San Francisco
California
Recruiting
544
Fort Myers
Florida
Recruiting
335
Miami Beach
Florida
Recruiting
543
West Palm Beach
Florida
Recruiting
518
Minneapolis
Minnesota
Recruiting
334
Kansas City
Missouri
Recruiting
521
St Louis
Missouri
Recruiting
292
Albuquerque
New Mexico
Recruiting
304
Centerville
Ohio
Recruiting
517
Eugene
Oregon
Recruiting
127
Pittsburgh
Pennsylvania
Recruiting
522
Fairfax
Virginia
Recruiting
300
Norfolk
Virginia
Recruiting
121
Milwaukee
Wisconsin
Recruiting
328
Aalst
Belgium
Recruiting
326
Charleroi
Belgium
Recruiting
325
Hasselt
Belgium
Recruiting
108
Leuven
Belgium
Recruiting
306
Lille
France
Recruiting
307
Nancy
France
Recruiting
310
Nice
France
Recruiting
324
Pierre-Bénite
France
Recruiting
323
Plérin
France
Recruiting
308
Toulouse
France
Recruiting
519
Aachen
Germany
Recruiting
255
Berlin
Germany
Recruiting
520
Kempten
Germany
Recruiting
321
Catania
Italy
Recruiting
122
Milan
Italy
Recruiting
516
Milan
Italy
Recruiting
295
Pavia
Italy
Recruiting
124
Rome
Italy
Recruiting
293
Torino
Italy
Recruiting
319
Treviso
Italy
Recruiting
341
Gdynia
Poland
Recruiting
329
Siedlce
Poland
Recruiting
396
Seoul
Gangnam-gu
Recruiting
397
Gyeonggi-do
Goyang-si
Recruiting
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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