Education and Training

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Nab-paclitaxel 80 mg/m^2
  • drug: Relacorilant 150 mg once daily (QD)
  • drug: Nab-paclitaxel 100 mg/m^2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mary Herrera
mhxrrera@stanford.edu
Not Recruiting