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NCT05257408 (Relacorilant in platinum-resistant ovarian cancer): BVCT ex-ante prediction vs. reported outcome

On 14 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 31 Mar 2025 readout is classified on the dashboard as False Negative (FN), a missed prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
ROSELLA
Drug Name
Relacorilant
Drug MoA
oral non-steroidal glucocorticoid receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
platinum-resistant ovarian cancer
Human Patients
381
Sponsor
Corcept Therapeutics
Phase
Phase 3

Prediction of , index 552

Prospective Prediction
Prediction Index
552
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
351 days in advance
Readout Data Interpretation
relacorilant + chemotherapy achieved statistical significance in both PFS improvement (HR=0.70 p=0.008) and OS improvement (HR=0.69 p=0.012) compared with chemotherapy alone
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal indication-specific glucocorticoid receptor modelling that has been permanently improved
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
False Negative (FN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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)
Phase
Phase 3
Status
Active not recruiting
Enrollment
381
Lead sponsor
Corcept Therapeutics
Conditions
Ovarian Neoplasm; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Interventions
DRUG: Nab-paclitaxel 80 mg/m^2; DRUG: Relacorilant 150 mg once daily (QD); DRUG: Nab-paclitaxel 100 mg/m^2
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-06-29
Primary completion
2025-03-24
Completion
2026-03
Primary outcomes
  • Progression-free Survival as Assessed by BICR (Up to 24 months from enrollment of the last patient)
  • Overall survival (Up to 24 months from enrollment of the last patient)

NCT05257408 on ClinicalTrials.gov

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