Eligibility Details:
Inclusion Criteria:
- Signed and dated IRB/IEC-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 one line of therapy with evidence of cancer progression within 6
months after the last dose of platinum-based therapy (i.e., having a platinum-free
interval of <6 months [platinum resistant]), or progressive disease during or
immediately after primary platinum-therapy, (i.e.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 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 CT/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] inhibitor). 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/mm3.
- Platelet count ≥ 100,000/mm3.
- Hemoglobin ≥ 9 g/dL.
- AST or 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 m2 (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 IUD, provided that the subject has tolerated its use for at least 3 months
before the first dose of study medication and undertakes not to have it removed
for 1 month after the last dose.
- Abstinence from heterosexual intercourse, when it is in line with the subject's
preferred and usual lifestyle. Periodic abstinence and withdrawal are NOT
acceptable.
- Vasectomized partner provided that the partner is the sole sexual partner of the
trial participant and that the vasectomized partner has received medical
assessment of the surgical success.
- Oral hormonal contraceptives are NOT permitted.
Exclusion Criteria:
- Clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy
that in the opinion of the Investigator has not resolved to Grade 1 or less prior to
randomization.
- Any major surgery within 4 weeks prior to randomization. If subject received major
surgery including (curative or palliative surgery), they must have recovered
adequately from the toxicity and/or complications from the intervention prior to
starting therapy.
- Treatment with the following prior to randomization:
- Concurrent treatment with other anticancer therapy including other chemotherapy,
immunotherapy, radiotherapy, chemoembolization, targeted therapy, an
investigational agent or the non-approved use of a drug or device within 28 days
before the first dose of study drug.
- Hormonal anticancer therapies within 7 days of the first dose of study drug.
- Systemic, inhaled, or prescription strength topical corticosteroids within 21
days of the first dose of study drug. Short courses (≤ 5 days) for
non-cancer-related reasons are allowed if clinically required (such as
prophylaxis for CT).
- Received radiation to more than 25% of marrow-bearing areas.
- Toxicities of prior therapies (except alopecia) that have not resolved to National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 ≤
Grade 1.
- Requirement for treatment with chronic or frequently used oral corticosteroids for
medical conditions or illnesses (e.g., rheumatoid arthritis, immunosuppression after
organ transplantation).
- History of severe hypersensitivity or severe reaction to either study drug.
- 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 nab-paclitaxel, whichever is latest.
- Human immunodeficiency virus or current chronic/active infection with hepatitis C
virus or hepatitis B virus, including:
- Patients with chronic or active hepatitis B as diagnosed by serologic tests are
excluded from the study. In equivocal cases, hepatitis B or C polymerase chain
reaction may be performed and must be negative for enrollment.
- Patient has a clinically significant uncontrolled condition(s) or which in the opinion
of the Investigator may confound the results of the trial or interfere with the
patient's participation, including but not limited to:
- Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
6 months before study entry.
- Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or
diastolic pressure > 100 mmHg despite optimal management). Patients will be
considered eligible if hypertension is treated and controlled during Screening.
- Active infection that requires parenteral antibiotics.
- Bowel obstruction or gastric outlet obstruction.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Untreated parenchymal central nervous system metastases.
- Any other concurrent cancer or a history of another invasive malignancy within the
last 3 years that has a likelihood of recurrence of > 30% within the next 5 years.
Adequately treated non-melanoma skin cancers or non-muscle invasive urothelial cancer
or other tumors curatively treated with no evidence of disease are permissible.
- Are taking a concomitant medication that is a strong CYP3A inhibitor or inducer, or
that is a substrate of CYP3A with a narrow therapeutic window.
- Concurrent treatment with mifepristone or other glucocorticoid receptor (GR)
antagonists.
- Drugs with a narrow therapeutic ratio that are highly dependent on CYP3A for clearance
should be avoided. Caution should be exercised when co-administering known inhibitors
of CYP3A with relacorilant. Medicines/food known to strongly inhibit CYP3A should be
avoided.
- 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 planned start of study therapy. Note:
Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
attenuated vaccines, and are not allowed.
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