ROSELLA
Research type
Research Study
Full 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)
IRAS ID
1006742
Contact name
Shibani Nicum, Dr
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Eudract number
2022-000662-18
Clinicaltrials.gov Identifier
Research summary
This clinical study involves an experimental drug called relacorilant (also called CORT125134). The drug will be tested on female participants who have ovarian, primary peritoneal, or fallopian tube cancer that has progressed or spread to other areas of the body after treatment with anti-cancer therapies. Relacorilant is a type of drug known as a glucocorticoid receptor (GR) modulator, which acts to block the action of cortisol in the body which may help prevent chemotherapy resistance.
Sometimes cancer tumours develop resistance to chemotherapy and the body stops responding to the drug and the cancer grows or spreads. The tumour may use cortisol, a steroid hormone naturally produced in the body, to develop chemotherapy resistance. Cortisol plays a role in controlling different processes throughout the body, including the body’s immune response (the reaction of the cells and fluids in the body to the presence of a foreign substance, such as a virus, an infection or cancer).
The main purpose of the study is to determine if the combination of relacorilant and nab-paclitaxel (a chemotherapy drug also known as Abraxane) controls the cancer better than nab-paclitaxel alone. Chemotherapy drugs are thought to interfere with the cell’s ability to divide and reproduce. Chemotherapy kills cells that divide rapidly, which includes most cancer cells.
Participants will be enrolled into 1 of 2 treatment arms (Arm A & B) and will have an equal chance of being assigned to each treatment arm: Arm A will be nab-paclitaxel + relacorilant; Arm B will be nab-paclitaxel.
Relacorilant has not been approved or authorised for use outside of a clinical trial by any authority that regulates new medicines, including the UK MHRA.
The study will take place at approx 125 study sites globally. 360 participants who are aged at least 18 years are expected to take part.
The average duration of participation is expected to be 12-18 months.
The study sponsor is Corcept Therapeutics USA.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0054
Date of REC Opinion
23 Aug 2023
REC opinion
Further Information Favourable Opinion