Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

• Signed and dated Investigational Review Board/Independent Ethics Committee-approved informed consent form (ICF) prior to study-specific screening procedures.
• Female patients aged ≥18 years old at time of consent
• Histologic diagnosis of high grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer or ovarian carcinosarcoma. Clear cell, mucinous and borderline histologic subtypes are excluded.
• Received at least 1 line of therapy with evidence of cancer progression within 6 months after the last dose of platinum-based therapy (ie, having a platinum-free interval of ≤6 months [platinum resistant]), or progressive disease during or immediately after primary platinum-therapy, (ie, platinum refractory). Patients with primary platinum resistance (progression within 6 months of the last dose of first-line platinum-containing chemotherapy) are considered eligible.

Notes: For the calculation of the platinum-free interval, cancer progression must be defined by clear evidence of progression, such as radiographic progression per RECIST v1.1. Calculating the platinum-free interval on the basis of increased Cancer Antigen (CA-125) is not allowed.

• Measurable or non-measurable disease by RECIST v1.1:
• Previously irradiated lesions are not allowed as measurable disease, unless there is documented evidence of progression in the lesions.
• To be eligible with non-measurable disease, patients must have evaluable disease with CA 125 at least twice the upper limit of reference range (of CA-125 ≥70 U/mL), along with radiographically evaluable disease by computerized tomography (CT)/magnetic resonance imaging (MRI).
• Availability and consent to provide tumor tissue for biomarker assays (archival or recent biopsy).
• No more than 4 prior chemotherapeutic or myelosuppressive regimens (not including maintenance therapy such as single-agent bevacizumab or poly (ADP-ribose) polymerase [PARP] inhibitors). Patients with platinum-refractory cancer cannot have had more than 2 prior lines of treatment for refractory disease.
• Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Adequate organ and bone marrow function meeting the following criteria at the Screening Visit:
• Absolute neutrophil count (ANC) ≥1,500 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 the context of liver metastasis).
• Total bilirubin ≤1.5 × ULN.
• Creatinine clearance ≥45 mL/min/1.73 m^2 (measured or estimated).
• Albumin ≥3 g/dL (≥30 g/L) .
• If patient has undergone surgery of the gastrointestinal or hepatobiliary tract, adequate absorption as evidenced by: albumin ≥3.0 g/dL, controlled pancreatic insufficiency (if present), and lack of malabsorption.
• Able to swallow and retain oral medication and does not have uncontrolled emesis.
• Able to comply with protocol requirements.
• Negative pregnancy test for patients of childbearing potential. Patients of childbearing potential must use appropriate precautions to avoid pregnancy, defined as of non-childbearing potential (ie, postmenopausal or permanently sterilized) or using highly effective contraception with low user-dependency, for at least 3 months after the last dose of relacorilant, or per the duration indicated in the product label for nab-paclitaxel, whichever is latest. A woman is postmenopausal if it is more than 12 months since her last menstruation, without an alternative medical cause. Accepted methods of permanent sterilization methods are hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. Accepted methods of highly effective contraception with low-user-dependency are:
• An intrauterine device (IUD), provided that the subject has tolerated its use for at least 3 months before the first dose of stu