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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

And 115 more locations on ClinicalTrials.gov