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Spots Global Cancer Trial Database for Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma

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Trial Identification

Brief Title: Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma

Official Title: Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma

Study ID: NCT06088290

Conditions

Leiomyosarcoma

Study Description

Brief Summary: The primary objective of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Hospital - Phoenix, Phoenix, Arizona, United States

Sarcoma Oncology Center, Los Angeles, California, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

University of Michigan, Ann Arbor, Michigan, United States

Mayo Clinic - Rochester, Rochester, Minnesota, United States

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States

Cleveland Clinic Main Campus, Cleveland, Ohio, United States

University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin, Graz, , Austria

Institut Jules Bordet, Anderlecht, , Belgium

Institut de Cancérologie de l'Ouest - Angers, Angers cedex 02, Pays De La Loire, France

Centre Antoine Lacassagne, Nice Cedex 2, Provence Alpes Cote D-Azur, France

Centre Léon Bérard, Lyon, Rhone-Alpes, France

Institut Bergonié, Bordeaux, , France

Centre de Lutte contre le Cancer - Centre Oscar Lambre, Lille, , France

Centre Hospitalier Universitaire Dupuytren 1, Limoges, , France

Hôspital de la Timone, Marseille Cedex 5, , France

Centre Eugène Marquis, Rennes Cedex, , France

Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau, Saint-Herblain, , France

Helios Klinikum Bad Saarow, Bad Saarow, , Germany

Universitätsklinikum Münster, Münster, , Germany

Universitätsklinikum Tübingen, Tübingen, , Germany

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Naples, Italy

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia, Candiolo, , Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, , Italy

Università Campus Bio-Medico di Roma, Roma, , Italy

Account Istituto Nazionale Tumori Regina Elena, Roma, , Italy

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Universitari Vall d'Hebrón, Barcelona, , Spain

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain

Hospital Universitario de Canarias, La Laguna, , Spain

Hospital General Universitario Gregorio Marañón, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

START Madrid - CIOCC - HM Sanchinarro, Madrid, , Spain

Hospital Universitario Virgen del Rocío, Sevilla, , Spain

Hospital Clínico Universitario de Valencia, Valencia, , Spain

Hospital Universitario Miguel Servet, Zaragoza, , Spain

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom

University College London Hospitals NHS Foundation Trust, London, , United Kingdom

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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