Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
Official Title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
Study ID: NCT03656536
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
Marin Cancer Care, Greenbrae, California, United States
UC Irvine Medical Center, Orange, California, United States
Georgetown University-Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Mayo Clinic-Florida, Jacksonville, Florida, United States
Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci, New Orleans, Louisiana, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Hospital, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Karmanos Cancer Institute, Farmington Hills, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada-Twain, Las Vegas, Nevada, United States
Summit Medical Group, Florham Park, New Jersey, United States
Icahn School of Medicine At Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
White Plains Hospital, White Plains, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Providence Portland Med. Ctr, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Greenville Hospital System University Medical Center Institute For Translational Oncology Research, Greenville, South Carolina, United States
Baylor Scott and White Research Institute, Dallas, Texas, United States
Houston Methodist Research Institute, Houston, Texas, United States
Riverside Regional Medical Center, Newport News, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
West Virginia University Cancer Institute, Morgantown, West Virginia, United States
Aurora Research Institute, Wauwatosa, Wisconsin, United States
Landeskrankenhaus Universitatsklinikum Graz, Graz, , Austria
Innsbruck University Hospital, Innsbruck, , Austria
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz, Linz, , Austria
Salzburger Universitatsklinikum, Salzburg, , Austria
Landeskrankenhaus Steyr, Steyr, , Austria
Allgemeines Krankenhaus Der Stadt Wien, Vienna, , Austria
Ulb Hospital Erasme, Bruxelles, , Belgium
Universitair Ziekenhuis Brussel, Bruxelles, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Hospital de Jolimont, Haine-st-paul, , Belgium
Az Groeninge Campus Kennedylaan, Kortrijk, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven, , Belgium
Chu Ucl Namur University Hospital Mont-Godinne, Yvoir, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cancercare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Health Authority/Qeii Health Sciences Centre, Halifax, Nova Scotia, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
McGill University Health Centre Research Institute, Montreal, Quebec, Canada
Peking Union Medical College Hospital, Beijing, , China
West China Hospital Sichuan University, Chengdu, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangdong, , China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, , China
Shulan Hangzhou Hospital Co Ltd, Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Heilongjiang Province Cancer Hospital, Harbin, , China
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital), Hefei, , China
Kunming 1St People'S Hospital, Kunming, , China
Jiangsu Province Hospital, Nanjing, , China
The Affiliated Hospital of Qingdao University, Shandong, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Xinhua Hospital, SHanghai, , China
Sichuan Cancer Hospital, Sichuan, , China
Tianjin Medical University Cancer Institute Hospital, Tianjin, , China
Tongji Hospital Huazhong University of Science and Technology, Wuhan, , China
Hubei Cancer Hospital, Wuhan, , China
Northern Jiangsu Peoples Hospital, Yangzhou, , China
Herlev Og Gentofte Hospital, Herlev, , Denmark
Docrates Cancer Center, Helsinki, , Finland
Helsinki University Central Hospital, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
Institut Sainte Catherine, Avignon Cedex 9, , France
Chu Besancon Hospital Jean Minjoz, Besançon, , France
Institut Bergonie, Bordeaux Cedex, , France
Hopital Beaujon, Clichy, , France
Chu de Limoges - Hospital Dupuytren, Limoges Cedex, , France
Hopital Prive Jean Mermoz, Lyon Cedex 08, , France
Chu Hopital de La Timone, Marseille Cedex 5, , France
Centre Hospitalier Universitaire de Nantes, Nantes, , France
Centre Antoine Laccassagne, Nice Cedex 02, , France
Hospital Universitaire Pitie-Salpetriere, Paris Cedex 13, , France
Hopital Europeen Georges Pompidou (Hegp), Paris Cedex 15, , France
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque, Pessac Cedex, , France
Hospital de La Miletrie, Poitiers Cedex, , France
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume, Rouen Cedex, , France
University Hospital of Saint Etienne, Saint Etienne, , France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau, Saint Herblain, , France
Chu Toulouse Hopital Rangueil, Toulouse Cedex 9, , France
Chu Vandoeuvre-Les-Nancy Hopital Brabois, Vandoeuvre Les Nancy, , France
Institut Gustave Roussy, Villejuif Cedex, , France
University Medical Center Rwth Aachen, Aachen, , Germany
Charite - Campus Virchow-Klinikum, Berlin, , Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin, , Germany
Universitatsklinikum Bonn Aoer, Bonn, , Germany
Klinikum Bremen-Nord, Bremen, , Germany
University Clinic Carl Gustav Carus Technical University Dresden, Dresden, , Germany
Klinikum Der Johann Wolfgang Goethe University, Frankfurt Am Main, , Germany
University Medical Center Freiburg, Freiburg, , Germany
Universitatsklinikum Hamburg Eppendorf, Hamburg, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Hannover Medical School, Hannover, , Germany
Universitaetsklinikum Des Saarlandes, Homburg / Saar, , Germany
Universitatsklinikum Koln, Koln, , Germany
Universitatsklinikum Leipzig Aor, Leipzig, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Otto-Von-Guericke-Universitat Magdeburg, Magdeburg, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
University Hospital Grosshadern Munich, Munich, , Germany
Klinikum Nuernberg, Nuernberg, , Germany
Universitaetsklinikum in Tubingen, Tubingen, , Germany
University Hospital Tuebingen, Tubingen, , Germany
Universitatkinikums Ulm, ULM, , Germany
St. Vincent'S University Hospital, Dublin 4, , Ireland
Soroka University Medical Center, Beer-sheva, , Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah University Hospital, Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Delle Marche, Ancona, , Italy
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, , Italy
Ospedale Papa Giovanni Xxiii, Bergamo, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo, Candiolo, , Italy
Presidio Ospedaliero Garibaldi Nesima, Catania, , Italy
Ospedale Degli Infermi - Faenza, Faenza, , Italy
Irccs Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan, , Italy
European Institute of Oncology, Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, , Italy
A.O.U. Di Modena - Policlinico, Modena, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Napoli, , Italy
Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica, Napoli, , Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano, Orbassano, , Italy
Iov - Istituto Oncologico Veneto Irccs, Padova, , Italy
Presidio Ospedaliero Pescara, Pescara, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs, Roma, , Italy
Istituto Nazionale Tumori Regina Elena Irccs, Roma, , Italy
Universita Campus Bio Medico Di Roma, Rome, , Italy
Azienda Ospedaliera San Camillo Forlanini, Rome, , Italy
Irccs Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte, Siena, , Italy
Centro Ricerche Cliniche Di Verona (Crc), Verona, , Italy
San Bartolo Hospital, Vicenza, , Italy
University of Tokyo Hospital, Bunkyo, , Japan
Chiba Cancer Center, Chiba-shi, , Japan
Chiba University Hospital, Chiba, , Japan
Kyushu University Hospital, Fukuoka-shi, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Hiroshima University Hospital, Hiroshima-shi, , Japan
Hyogo College of Medicine Hospital, Hyogo, , Japan
Kanazawa University Hospital, Ishikawa, , Japan
Teikyo University Hospital, Itabashi-ku, , Japan
Kobe University Hospital, Kobe-shi, , Japan
Cancer Institute Hospital of Jfcr, Koto-ku, , Japan
Kyoto University Hospital, Kyoto-shi, , Japan
Nho Shikoku Cancer Center, Matsuyama-shi, , Japan
Kyorin University Hospital, Mitaka-shi, , Japan
Aichi Cancer Center Hospital, Nagoya-shi, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka-shi, , Japan
Kindai University Hospital, Osakasayama City, , Japan
Saitama Cancer Center, Saitama, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Tohoku University Hospital, Sendai-shi, , Japan
Jichi Medical University Hospital, Shimotsuke-shi, , Japan
Keio University Hospital, Shinjuku-ku, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Osaka University Hospital, Suita-shi, , Japan
Toyama University Hospital, Toyama-shi, , Japan
Yamaguchi University Hospital, UBE, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Yokohama City University Medical Center, Yokohama-shi, , Japan
Kanagawa Cancer Center, Yokohama-shi, , Japan
Oita University Hospital, Yufu-shi, , Japan
Amsterdam University Medical Centre, Amsterdam, , Netherlands
Maastricht Umc+, Maastricht, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Umc Utrecht, Utrecht, , Netherlands
Oslo University Hospital, Oslo, , Norway
Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hospital Clinic Barcelona Main, Barcelona, , Spain
Hospital Clinic Barcelona Main, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Hospital Materno Teresa Herrera, La Coruña, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario Hm Sanchinarro, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Clinica Universidad de Navarra (Cun), Pamplona, , Spain
Hospital Universitari Parc Tauli, Sabadell, , Spain
HOSPITAL UNiVERSITARIO DONOSTIA, San Sebastian, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Sahlgrenska University Hospital, Göteborg, , Sweden
Karolinska Institute Universitetssjukhuset Solna, Solna, , Sweden
Inselspital - Universitaetsspital Bern, Bern, , Switzerland
Universitatsspital Zurich, Zuerich, , Switzerland
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Addenbrookes Hospital, Cambridge, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
University Hospital Coventry and Warwickshire, Coventry, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea, London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital, London, , United Kingdom
University College London Hospitals (Uclh), London, , United Kingdom
Kent Oncology Centre - Maidstone Hospital, Maidstone, , United Kingdom
The Christie Nhs Foundation Trust, Manchester, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton, Sutton, , United Kingdom
Contact Details
Name: Peter Langmuir, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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