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Brief Title: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Study ID: NCT02454972
Brief Summary: Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Detailed Description: Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H\&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sarcoma Oncology Research Center, LLC, Santa Monica, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Massachussets General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Centre, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center, San Antonio, Texas, United States
Institut Jules Bordet, Brussels, , Belgium
Hôpital Cochin, Paris, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin - Comprehensive Cancer Center, Berlin, , Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Istituto Clinico Humanitas, Rozzano, Milan, Italy
Istituto Ortopedico Rizzoli, Bologna, , Italy
lstituto Europeo di Oncologia, Milano, , Italy
ASST Monza - Ospedale San Gerardo di Monza Struttura Complessa di Oncologia Medica, Monza, , Italy
AUSL Romagna - Ospedale Santa Maria delle Croci, Ravenna, , Italy
Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hopsital Universitario Donostia - Donostia Unibertsitate Ospitalea, San Sebastián, Guipúzcoa, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Complejo Hospitalario De Navarra, Pamplona, Navarra, Spain
Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain
Hospital de Basurto, Bilbao, Vizcaya, Spain
Complexo Hospitalario Universitario A Coruña, A Coruña, , Spain
Hospital Universitari Vall D' Hebron, Barcelona, , Spain
Complejo Hospitalario Regional Reina Sofía, Cordoba, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Complejo Hospitalario de Especialidades Virgen de la Victoria, Malaga, , Spain
Hospital Universitari i Polotècnic la Fe, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Skane University Hospital, Lund, , Sweden
Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, , Switzerland
UCL Cancer Institute, London, , United Kingdom