Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Gynecologic Cancers
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Female
CORT125134-556 (primary)
NCI-2022-07960
GOG-3073
Summary
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.
Objectives
As there are no currently approved therapies or effective standard of care for heavily
pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy
and/or bevacizumab, the combination of intermittently administered relacorilant and
nab-paclitaxel may demonstrate a substantial improvement without increased toxicity
compared with nab-paclitaxel.
Patients will receive study treatment until confirmed progressive disease (PD) or
unacceptable toxicity. All patients will be followed for the collection of study
endpoints, inclusive of disease progression and survival.
Eligibility
- 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 â?¥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 â?¤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) â?¥1500 cells/mm^3, Platelet count â?¥100,000/mm^3, Hemoglobin â?¥9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) â?¤2.5 Ã? upper limit of normal (ULN), or â?¤5 Ã? ULN in context of liver metastases, Total bilirubin â?¤1.5 Ã? ULN, and Albumin â?¥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.
Treatment Sites in Georgia
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