Clinical Trial Title A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)
Trial Status Closed to Enrollment
Start Date 01/05/2023
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description 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.
Eligibility Criteria

Inclusion Criteria

  • Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (high-grade endometroid or carcinosarcoma with ≥30% endometroid epithelial tumor component are eligible).
  • Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • 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. At least 1 prior line of platinum therapy is required and prior treatment with bevacizumab is required.

Exclusion Criteria

Patients who meet any of the following criteria will not be permitted entry to the study:

  • Has had any major surgery within 4 weeks prior to randomization. If patient 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.
  • Have not received prior bevacizumab treatment.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer - Full Text View - ClinicalTrials.gov
Principal Investigator Gina Westhoff, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org