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TPS5597 : CORAIL trial: Randomized phase III study of lurbinectedin (PM01183) versus pegylated liposomal doxorubicin (PLD) or topotecan (T) in patients with platinum-resistant ovarian cancer.

Researchers

Presenter

  • Stephanie Gaillard

Principal Investigators

  • Sharad A. Ghamande

  • Beatriz Pardo

  • Domenica Lorusso

  • Ignace Vergote

  • Zsuzsanna Papai

  • D O'Malley

  • Rebecca Sophie Kristeleit

  • Andres Redondo

  • Constanta Timcheva

  • Cristian Fernandez

  • Antonio Nieto

  • Arturo Soto-Matos

  • Keren Rachel Moss

  • Klaus H. Baumann

  • Isabelle Ray-Coquard

  • Ana Oaknin

Medical Centers

  • Duke Cancer Institute, Durham, NC

  • Georgia Regents University, August, GA

  • ICO-Hospital Duran i Reynals, Barcelona, Spain

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  • Universitaire Ziekenhuizen Leuven, Leuven, Belgium

  • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly, Budapest, Hungary

  • Ohio State University Wexner Medical Center, Columbus, OH

  • University College London Hospitals/UCL Cancer Institute, London, United Kingdom

  • Hospital Universitario La Paz, Madrid, Spain

  • MHAT Nadezhda Women Health Hospital, Sofia, Bulgaria

  • PharmaMar, Madrid, Spain

  • INC Reseach, Midreshet Sde Boker, ME, Israel

  • University Medical Center of Giessen and Marburg, Marburg, Germany

  • Centre Leon Berard, Lyon, France

  • Hospital Vall d Hebron, Vall d Hebron Institute of Oncology (VHIO), Barcelona, Spain

Locations

  • Italy

  • Spain

  • Germany

  • United Kingdom

  • United States

  • Bulgaria

  • Israel

  • France

  • Belgium

  • Hungary

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Genetic Disorder

Disease

  • Peritoneal cancer

  • Gynaecological cancer

Biomarkers

  • Cancer antigen 125

Drug/Treatment

  • Doxorubicin Hydrochloride

  • Lurbinectedin

  • Trabectedin

  • Doxorubicin

  • Topotecan Hydrochloride

Outcome

  • N/A


Study Design

  • Randomized

  • Pharmacokinetics

  • Pharmacodynamics

  • Open Label

  • Multinational

  • Multicenteric

  • Prospective

Phase

  • III

Study Id's

  • NCT02421588

Sponsors

  • N/A

Result

  • N/A