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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to evaluate progression-free survival (PFS) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with Investigator's choice of chemotherapy (liposomal doxorubicin, paclitaxel, topotecan, or nab-paclitaxel).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Topotecan

Criteria

Inclusion Criteria:

• Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.

• Confirmed diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

• Patients must have platinum-resistant disease (defined as progression within 6 months from completion of their platinum-containing therapy).

• Must be willing to provide an archival tumor-tissue block or slides, or to undergo procedure to obtain a new biopsy using a low risk, medically routine procedure.

• 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 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.

• Negative pregnancy test for patients of childbearing potential.

• 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 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.

• For Arm A only (intermittent relacorilant + nab-paclitaxel): 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 3 months after the last dose of relacorilant, or per the duration indicated in the product label for chemotherapy, whichever is latest.

• 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 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.

• Has been assigned to liposomal doxorubicin: left-ventricular ejection fraction (LVEF) <55% by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA).

• 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 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.