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Brief Title: A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma
Study ID: NCT02451943
Brief Summary: The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
UCLA Medical Center, Los Angeles, California, United States
Stanford University, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Georgia Cancer Specialists PC, Atlanta, Georgia, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University Medical School, Saint Louis, Missouri, United States
Nebraska Methodist Cancer Center, Omaha, Nebraska, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Oncology Hematology Care Inc, Fairfield, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
The West Clinic, Germantown, Tennessee, United States
Oncology Hematology Care Inc, Nashville, Tennessee, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Utah School of Medicine, Salt Lake City, Utah, United States
Fairfax Northern Virginia Hematology Oncology, PC, Fairfax, Virginia, United States
Alexander Fleming, Caba, BS, Argentina
CENIT Centro de Neurociencias, Investigación y Tratamiento, Caba, Buenos Aires, Argentina
Hospital Provincial del Centenario, Rosario, Santa Fe, Argentina
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
AKH, Wien, , Austria
Cliniques universitaires Saint-Luc, Bruxelles, Brussel, Belgium
Universitair Ziekenhuis Gent, Gent, Oost-Vlaanderen, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
INCA Hospital do Câncer III, Rio de Janeiro, RJ, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo, Sao Paulo, São Paulo, Brazil
Tom Baker Cancer Center, Calgary, Alberta, Canada
BC Cancer Vancouver, Vancouver, British Columbia, Canada
Princess Margaret Hospital (Ontario), Lai Chi Kok, Kowloon, Canada
Royal Victoria Hospital-Montreal, Montreal, Quebec, Canada
Herlev and Gentofte Hospital, Herlev, , Denmark
Tampereen yliopistollinen sairaala, Tampere, Pirkanmaa, Finland
Turku University Central Hospital, Turku, , Finland
Centre Georges François Leclerc, Dijon, Côte-d'Or, France
Centre Leon Berard, Lyon, Rhône-Alpes, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, , France
CHU Hopital d'enfants de la Timone, Marseille CEDEX 05, , France
Institut Curie, Paris, , France
Institut Claudius Regaud, Toulouse cedex 9, , France
Gustave Roussy, Villejuif Cedex, , France
Klinikum Mannheim gGmbH Universitätsmedizin, Mannheim, Baden-Württemberg, Germany
Universitätsklinikum Tübingen, Tubingen, Baden-Württemberg, Germany
Klinikum der Universität München Großhadern, Munchen, Bayern, Germany
Universitaetsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv Jaffa, , Israel
Istituto Nazionale dei Tumori, Milano, Lombardie, Italy
Istituto Clinico Humanitas, Rozzano, Milano, Italy
Università degli Studi di Catania - Azienda Policlinico, Catania, Sicilia, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia, Candiolo, Torino, Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Osaka University Hospital, Suita, Osaka, Japan
Saitama Medical University International Medical Center, Hidaka, Saitama, Japan
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan
Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Okayama University Hospital, Okayama, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Asan Medical Center, Seoul, Korea, Korea, Republic of
Seoul St. Mary's Hospital, Seoul, Korea, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Angeles, Tijuana, Baja California, Mexico
Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Consultorio Dr. Reinoso, Monterrey, Nuevo Leon, Mexico
Centro de Atención E Investigación Clínica En Oncología, Merida, Yucatán, Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC, San Luis Potosi, , Mexico
Maastricht UMC+, Maastricht, Limburg, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Universitair Medisch Centrum St Radboud Nijmegen, Nijmegen, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Kazan Oncology Dispensary, Kazan, Tatarstan Republic, Russian Federation
Blokhin Cancer Research Center, Moscow, , Russian Federation
St-Petersburg scientifical practical cente spec medical care, St. Petersburg, , Russian Federation
Hospital Universitario Virgen Del Rocio, Sevilla, Andalucía, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Duran I Reynals, Barcelona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Fe de Valencia, Valencia, , Spain
Skånes universitetssjukhus Lund, Lund, , Sweden
Cantonal Hospital St.Gallen, St Gallen, Sankt Gallen, Switzerland
Inselspital Bern, Bern, , Switzerland
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan Hsien, , Taiwan
University College Hospital - London, London, Greater London, United Kingdom
Royal Marsden NHS Trust, London, Greater London, United Kingdom
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
The Clatterbridge Cancer Centre, Bebbington, Merseyside, United Kingdom
Weston Park Hospital, Sheffield, South Yorkshire, United Kingdom
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR