Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Nab-paclitaxel 80 mg/m^2Relacorilant 150 mg once daily (QD)Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel 80 mg/m^2: Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant 150 mg once daily (QD): Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel 100 mg/m^2: Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Study summary
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
* Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
* Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression \<6 months from completion of a platinum-containing therapy).
* Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
* Has a life expectancy of ≥3 months.
* At least one lesion that meets the definition of measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Able to comply with protocol requirements.
* Able to swallow and retain oral medication and does not have uncontrolled emesis.
* Received at least 1 but ≤3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
* Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) ≥1500 cells/mm\^3, Platelet count ≥100,000/mm\^3, Hemoglobin ≥9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases, Total bilirubin ≤1.5 × ULN, and Albumin ≥3 g/dL, and creatinine clearance \>40 mL/min/1.73 m\^2 (measured or estimated).
* Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
* Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.
Exclusion Criteria:
* Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
* Has had any major surgery within 4 weeks prior to randomization.
* Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
* Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy.
* Has not received prior bevacizumab treatment.
* Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before first dose of study drug, radiotherapy not completed at least 2 weeks prior to first dose of study drug, hormonal anticancer therapies within 7 days of first dose of study drug, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
* Has received wide-field radiation to more than 25% of marrow-bearing areas.
* Has toxicities of prior therapies that have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
* Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
* Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
* Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
* Has peripheral neuropathy from any cause \>Grade 1.
* Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the screening visit through at least 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
* Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
* Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
* Has any untreated or symptomatic central nervous system (CNS) metastases.
* Patients with a history of other malignancy within 3 years prior to randomization
* Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
* Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
* Has received a live vaccine within 30 days of prior to the study start date.
Primary outcome measure(s)
Progression-free Survival as Assessed by BICR — Up to 24 months from enrollment of the last patient Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first
Overall survival — Up to 24 months from enrollment of the last patient Time from randomization to death by any cause
Trial sites (117)
Facility
City
Region
Status
Site 318
Phoenix
Arizona
Site 277
Tucson
Arizona
Site 350
Irvine
California
Site 364
La Jolla
California
Site 150
Palo Alto
California
Site 278
San Francisco
California
Site 014
San Francisco
California
Site 316
Solvang
California
Site 032
Aurora
Colorado
Site 335
Miami Beach
Florida
Site 042
Weston
Florida
Site 009
Atlanta
Georgia
Site 272
Atlanta
Georgia
Site 372
Gainesville
Georgia
Site 291
Savannah
Georgia
Site 315
Evanston
Illinois
Site 314
Hinsdale
Illinois
Site 346
Urbana
Illinois
Site 339
Indianapolis
Indiana
Site 200
Overland Park
Kansas
Site 334
Overland Park
Kansas
Site 279
Louisville
Kentucky
Site 128
Boston
Massachusetts
Site 288
New Brunswick
New Jersey
Site 292
Albuquerque
New Mexico
Site 275
Flushing
New York
Site 298
Cincinnati
Ohio
Site 304
Cincinnati
Ohio
Site 280
Portland
Oregon
Site 317
Portland
Oregon
Site 049
Portland
Oregon
Site 337
Bethlehem
Pennsylvania
Site 127
Pittsburgh
Pennsylvania
Site 276
Rapid City
South Dakota
Site 368
Germantown
Tennessee
Site 281
Nashville
Tennessee
Site 229
Austin
Texas
Site 312
Bedford
Texas
Site 297
Fort Worth
Texas
Site 392
San Antonio
Texas
+ 77 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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