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Brief Title: A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Official Title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer
Study ID: NCT02711553
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The University of Arizona Cancer Center, Tucson, Arizona, United States
UCSF Medical Center at Mission Bay, San Francisco, California, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Florida School of Medicine, Gainesville, Florida, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University Medical School, Creve Coeur, Missouri, United States
Washington University Medical School, Saint Louis, Missouri, United States
Washington University Medical School, Saint Louis, Missouri, United States
Washington University Medical School, Saint Peters, Missouri, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Florida Cancer Specialists, Nashville, Tennessee, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
Alexander Fleming, Caba, BS, Argentina
Hospital de Gastroenterologia Udaondo, Capital Federal, Buenos Aires, Argentina
Fundacion Ars Medica, San Salvador de Jujuy, Jujuy, Argentina
Clinica Viedma, Viedma, Río Negro, Argentina
Centro Medico San Roque, San Miguel de Tucumán, Tucumán, Argentina
Fundacion Favaloro, Ciudad de Buenos Aires, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer, La Rioja, , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan, San Juan, , Argentina
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
Landesklinikum Wr. Neustadt, Wiener Neustadt, Niederösterreich, Austria
Universitätsklinikum Salzburg, Salzburg, , Austria
KH der Barmherzigen Brüder Wien, Wien, , Austria
Cliniques universitaires Saint-Luc, Bruxelles, Brussel, Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, , Belgium
Masarykuv onkologicky ustav, Brno, Brno-město, Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni Nemocnice v Motole, Praha 5, , Czechia
Aarhus Universitetshospital, Aarhus Sygehus, Aarhus C, , Denmark
Odense Universitetshospital, Odense C, , Denmark
CHU de Bordeaux Hop St ANDRE, Bordeaux, Gironde, France
Centre Leon Berard, Lyon, Rhône-Alpes, France
CHU de Besancon Hopital Jean Minjoz, Besancon Cedex, , France
Hôpital C. HURIEZ, Lille, , France
CHRU de Montpellier-Hopital St Eloi, Montpellier Cedex 5, , France
Centre Antoine-Lacassagne, Nice, , France
Gustave Roussy, Villejuif Cedex, , France
Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
Medizinische Hochschule Hanover, Hannover, Niedersachsen, Germany
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek, Debrecen, Hajdu-Bihar, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Asan Medical Center, Seoul, Korea, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Arke Estudios Clinicos S.A. de C.V., Mexico, DF, Mexico
Instituto Nacional de Ciencias Medicas y Nutrici Salva Zubir, Mexico City, , Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC, San Luis Potosi, , Mexico
Russian Scientific Center of Radiology and Surgical Technologies, St. Petersburg, Sankt-Peterburg, Russian Federation
Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk, , Russian Federation
Blokhin Cancer Research Center, Moscow, , Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
Hospital Duran I Reynals, Hospitalet De Llobregat, Barcelona, Spain
Hospital Clínico Universitario de Valencia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Clinico de San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Skåne universitetssjukhus, Malmö, , Sweden
Karolinska Universitetssjukhuset i Solna, Stockholm, , Sweden
Chang Gung Memorial Hospital - Kaohsiung Branch, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng-Kung Uni. Hosp., Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou, Taoyuan City, , Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center, Adana, , Turkey
Hacettepe University Faculty of Medicine, Ankara, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Trakya University, Edirne, , Turkey
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi, Istanbul, , Turkey
University College Hospital - London, London, Greater London, United Kingdom
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
Hammersmith Hospital, Acton, London, United Kingdom
The Clatterbridge Cancer Centre, Bebbington, Merseyside, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, 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