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TERMINATED
NCT03656536
PHASE3

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

167

Start Date

2019-06-03

Completion Date

2025-07-07

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

Pemigatinib

Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.

DRUG

Cisplatin

Cisplatin 25 mg/m\^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.

Locations (215)

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 D.C., 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

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

Brussels, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, 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, France

Chu Besancon Hospital Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Hopital Beaujon

Clichy, France

Chu de Limoges - Hospital Dupuytren

Limoges, France

Hopital Prive Jean Mermoz

Lyon, France

Chu Hopital de La Timone

Marseille, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Centre Antoine Laccassagne

Nice, France

Hospital Universitaire Pitie-Salpetriere

Paris, France

Hopital Europeen Georges Pompidou (Hegp)

Paris, France

Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

Pessac, France

Hospital de La Miletrie

Poitiers, France

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

Rouen, 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, France

Chu Vandoeuvre-Les-Nancy Hopital Brabois

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, 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

Universitatsklinikum Koln

Cologne, 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 im Breisgau, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Asklepios Klinik Altona

Hamburg, Germany

Hannover Medical School

Hanover, Germany

Universitaetsklinikum Des Saarlandes

Homburg / SAAR, 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

Nuremberg, Germany

Universitaetsklinikum in Tubingen

Tübingen, Germany

University Hospital Tuebingen

Tübingen, Germany

Universitatkinikums Ulm

Ulm, Germany

St. Vincent'S University Hospital

Dublin, Ireland

Soroka University Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital

Jerusalem, Israel

Rabin Medical Center - Beilinson Hospital

Petah 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

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

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

Milan, Italy

A.O.U. Di Modena - Policlinico

Modena, Italy

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, Italy

Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica

Naples, 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

Bunkyō City, Japan

Chiba University Hospital

Chiba, Japan

Chiba Cancer Center

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hyogo College of Medicine Hospital

Hyōgo, Japan

Kanazawa University Hospital

Ishikawa, Japan

Teikyo University Hospital

Itabashi-ku, Japan

Kobe University Hospital

Kobe, Japan

Cancer Institute Hospital of Jfcr

Kōtoku, Japan

Kyoto University Hospital

Kyoto, Japan

Nho Shikoku Cancer Center

Matsuyama, Japan

Kyorin University Hospital

Mitaka-shi, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka International Cancer Institute

Osaka, Japan

Saitama Cancer Center

Saitama, Japan

Hokkaido University Hospital

Sapporo, Japan

Kindai University Hospital

Sayama, Japan

Tohoku University Hospital

Sendai, 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, Japan

Yamaguchi University Hospital

Ube, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Yokohama City University Medical Center

Yokohama, Japan

Kanagawa Cancer Center

Yokohama, 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 Materno Teresa Herrera

A Coruña, Spain

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 Universitario Reina Sofia

Córdoba, Spain

HOSPITAL UNiVERSITARIO DONOSTIA

Donostia / San Sebastian, 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 Marques de Valdecilla

Santander, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Karolinska Institute Universitetssjukhuset Solna

Solna, Sweden

Inselspital - Universitaetsspital Bern

Bern, Switzerland

Universitatsspital Zurich

Zurich, 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