HelpAcademyLoginJoin us as a Member

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

NCT05257408Phase 3Active, not recruiting

Lead sponsor
Corcept Therapeutics (Industry)
Enrollment
381 (actual)
Start date
29 Jun 2022
Primary completion
31 Mar 2025 (actual)
Study completion
1 Dec 2026
Last update posted
25 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • Relacorilant 150 mg Drug
  • Nab-paclitaxel 80 mg/m^2 Drug
  • Nab-paclitaxel 100 mg/m^2 Drug

Conditions and primary outcome

  • Ovarian Neoplasm
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Primary outcome

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (Up to 20 months); Overall Survival (Up to 32 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT05257408 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

    Time frame
    Up to 20 months
    Measure
    Median
    Unit
    months

    • Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 vs Nab-paclitaxel 100 mg/m^2Superiority

      Analysis of PFS stratified by factors used for randomization.

      Estimate
      0.70Hazard Ratio (HR)
      95% CI, two-sided
      0.54 to 0.91
      p-value
      0.0076
      Method
      Log Rank

  2. Overall Survival

    Time frame
    Up to 32 months
    Measure
    Median
    Unit
    months

    • Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2 vs Nab-paclitaxel 100 mg/m^2Superiority

      Analysis of OS stratified by factors used for randomization.

      Estimate
      0.65Hazard Ratio (HR)
      95% CI, two-sided
      0.51 to 0.83
      p-value
      0.0004
      Method
      Log Rank

Serious adverse events

Time frame: All-cause Mortality: up to 32 months; Adverse Events: up to 25 months

Participants with serious adverse events per group for NCT05257408, as posted
GroupAffectedAt risk
Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^266188
Nab-paclitaxel 100 mg/m^245190

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

4 on PubMed

  1. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial.

    Lancet (London, England) · 2026 Apr 18

    PubMed 41974149 (opens in a new tab)DOI 10.1016/S0140-6736(26)00462-9 (opens in a new tab)

  2. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.

    Lancet (London, England) · 2025 Jun 21

    PubMed 40473448 (opens in a new tab)DOI 10.1016/S0140-6736(25)01040-2 (opens in a new tab)

  3. Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer.

    Journal of gynecologic oncology · 2024 Jul

    PubMed 39032926 (opens in a new tab)DOI 10.3802/jgo.2024.35.e111 (opens in a new tab)

  4. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Oct 20

    PubMed 37364223 (opens in a new tab)DOI 10.1200/JCO.22.02624 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

About CT-VCA

Loading CT-VCA scores…

Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.