The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
381
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
Relacorilant is administered as capsules for oral dosing.
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Site 318
Phoenix, Arizona, United States
Site 277
Tucson, Arizona, United States
Site 350
Irvine, California, United States
Site 364
La Jolla, California, United States
Site 150
Palo Alto, California, United States
Site 278
San Francisco, California, United States
Progression-free Survival as Assessed by BICR
Time from randomization until the time of first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first
Time frame: Up to 24 months from enrollment of the last patient
Overall survival
Time from randomization to death by any cause
Time frame: Up to 24 months from enrollment of the last patient
PFS as Assessed by the Investigator
Time from randomization until the time of first documented progressive disease (PD) by RECIST v1.1, or death due to any cause, whichever occurs first
Time frame: Up to 24 months from enrollment of the last patient
Objective Response as Assessed by BICR
Proportion of patients with measurable disease at baseline who attain CR or PR by RECIST v1.1.
Time frame: Up to 24 months from enrollment of the last patient
Best Overall Response as Assessed by BICR
Proportion of patients with measurable disease at baseline who attain CR or PR as best response by RECIST v1.1.
Time frame: Up to 24 months from enrollment of the last patient
Duration of Response as Assessed by BICR
Time from when response (CR or PR per RECIST v1.1) is first documented to first objectively documented PD or death (whichever occurs first)
Time frame: Up to 24 months from enrollment of the last patient
Clinical benefit rate as assessed by BICR
Proportion of patients who attain CR, PR, or stable disease (SD) per RECIST v1.1.
Time frame: 24 weeks
Cancer Antigen (CA)-125 Response
Cancer antigen (CA)-125 response will be assessed per Gynecologic Cancer Intergroup (GCIG) criteria defined as ≥50% reduction in CA-125 from a pre-treatment sample and maintained for ≥28 days in patients with a pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level falls to within the reference range will be classified as CA-125 complete responders.
Time frame: Up to 24 months from enrollment of the last patient
Combined Response According to RECIST v1.1 and GCIG Criteria
Combined response will be assessed for PD per RECIST v1.1 and for CA-125 response per GCIG criteria
Time frame: Up to 24 months from enrollment of the last patient
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Site 014
San Francisco, California, United States
Site 316
Solvang, California, United States
Site 032
Aurora, Colorado, United States
Site 335
Miami Beach, Florida, United States
...and 107 more locations