West Cancer Center

OVARIAN: METASTATIC: Plat Resistant: HIGH GRADE: 2nd Line: ROSELLA

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)

Title

Corcept CORT1251344-556 (Ovarian relacorilant)

Study Title

Site Link

NCT05257408

Malignancy

Ovary, Ovarian, Primary peritoneal, fallopian tube

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line

Investigational Agent

Relacorilant

Drug Class

Glucocoricoid receptor antagonist

Todd Tillmanns, MD

Sponsor

Corcept Therapeutics

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

High grade (grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
Platinum resistant disease (defined progression <6 monhths from completion of a platinum containing therapy)
Measurable disease
ECOG PS 0-1
Received at least 1 but < or = 3 lines of prior systemic anticancer therapy.
Prior treatment with bevacizumab is required
No low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies
No primary platinnum refractory disease
No requirement of treatment with chronic or frequent use of oral steroids
No concurrent treatment with mifepristone or other GR modulators
No peripheral neuropathy
No symptomatic CNS disease

Objective

Primary
- PFS
Secondary
- OS
- ORR
- BOR
- DoR
- CBR
- CA-125 response

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

High risk epithelial

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes