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

Author:

Olawaiye Alexander B.1ORCID,Kim Jae-Weon2ORCID,Bagameri Andrea3ORCID,Bishop Erin4ORCID,Chudecka-Głaz Anita5ORCID,Devaux Alix6ORCID,Gladieff Laurence7ORCID,Gordinier Mary E.8ORCID,Korach Jacob9ORCID,McCollum Michael E.10ORCID,Mileshkin Linda11ORCID,Monk Bradley J.12ORCID,Nicum Shibani13ORCID,Nogueira-Rodrigues Angélica14ORCID,Oaknin Ana15ORCID,O’Malley David M.16ORCID,Orlando Mauro17ORCID,Dreiling Lyndah18ORCID,Tudor Iulia C.18ORCID,Lorusso Domenica19ORCID

Affiliation:

1. University of Pittsburgh School of Medicine and Magee-Womens Hospital, Gynecologic Oncology Group, Pittsburgh, PA, USA.

2. Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.

3. National Institute of Oncology, Budapest, Hungary.

4. Medical College of Wisconsin, Gynecologic Oncology Group, Milwaukee, WI, USA.

5. Pomeranian Medical University, Polish Gynecologic Oncology Group, Szczecin, Poland.

6. Oncology Department of Grand Hôpital de Charleroi, Charleroi, Belgium.

7. Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse Oncopole, Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Toulouse, France.

8. Norton Cancer Institute, Louisville, KY, USA.

9. Sheba Medical Center, School of Medicine, Tel Aviv University, Israeli Society of Gynecologic Oncology, Tel Aviv, Israel.

10. Virginia Oncology Associates, Norfolk, VA, USA.

11. Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.

12. Gynecologic Oncology Group Foundation; Florida Cancer Specialists and Research Institute, West Palm Beach, FL, USA.

13. University College London Cancer Institute, National Cancer Research Institute, London, UK.

14. Federal University of Minas Gerais, Dom Oncologia and Oncoclinicas - Brazil, Belo Horizonte, Brazil.

15. Medical Oncology Service, Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain.

16. The Ohio State University and the James Cancer Center, Gynecologic Oncology Group, Columbus, OH, USA.

17. Instituto Alexander Fleming, Buenos Aires, Argentina.

18. Corcept Therapeutics Incorporated, Menlo Park, CA, USA.

19. Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico and Catholic University of the Sacred Heart, Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies, Rome, Italy.

Funder

Corcept Therapeutics, Inc.

Publisher

XMLink

Reference28 articles.

1. Cancer statistics, 2022

2. National Cancer Institute. SEER cancer stat facts: ovarian cancer [Internet]. Bethesda, MD. National Cancer Institute. 2023. cited 2024 Feb 23. Available from: https://seer.cancer.gov/statfacts/html/ovary.html

3. Ovarian cancer statistics, 2018

4. Predicting Prognosis and Platinum Resistance in Ovarian Cancer: Role of Immunohistochemistry Biomarkers

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