En undersøgelse for at evaluere effektiviteten og sikkerheden af pemigatinib versus kemoterapi ved uoperabelt eller metastatisk cholangiocarcinom (FIGHT-302)
17. juli 2026 opdateret af: Incyte Corporation
Et fase 3, åbent, randomiseret, aktivt kontrolleret, multicenter-studie til evaluering af effektiviteten og sikkerheden af Pemigatinib versus Gemcitabine Plus Cisplatin-kemoterapi i førstelinjebehandling af deltagere med uoperabelt eller metastatisk kolangiocarcinom med FGFR2-omlægning (FIGHT-302)
Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af pemigatinib versus gemcitabin plus cisplatin kemoterapi i førstelinjebehandling af deltagere med inoperabelt eller metastatisk kolangiocarcinom med FGFR2-omlejring.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
167
Fase
- Fase 3
Udvidet adgang
Ikke længere tilgængelig uden for det kliniske forsøg.
Se udvidet adgangsregistrering.
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussels, Belgien, 01090
- Universitair Ziekenhuis Brussel
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Brussels, Belgien, 01070
- Ulb Hospital Erasme
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Ghent, Belgien, 09000
- Universitair Ziekenhuis Gent
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Haine-st-paul, Belgien, 07100
- Hospital de Jolimont
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Kortrijk, Belgien, 08500
- AZ Groeninge Campus Kennedylaan
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Leuven, Belgien, 03000
- Universitaire Ziekenhuis Leuven - Gasthuisberg
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Yvoir, Belgien, 05530
- Chu Ucl Namur University Hospital Mont-Godinne
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
- Nova Scotia Health Authority/Qeii Health Sciences Centre
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Ontario
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Toronto, Ontario, Canada, MG5 2M9
- Princess Margaret Cancer Center
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre Research Institute
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Herlev, Danmark, 02730
- Herlev og Gentofte Hospital
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Aberdeen, Det Forenede Kongerige, AB25 2ZN
- Aberdeen Royal Infirmary
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Addenbrookes Hospital
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Cardiff, Det Forenede Kongerige, CF14 2TL
- Velindre Cancer Centre
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Coventry, Det Forenede Kongerige, CV2 2DX
- University Hospital Coventry and Warwickshire
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London, Det Forenede Kongerige, W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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London, Det Forenede Kongerige, SW3 6JJ
- The Royal Marsden Nhs Foundation Trust - Chelsea
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London, Det Forenede Kongerige, WC1E 6BT
- University College London Hospitals (UCLH)
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Maidstone, Det Forenede Kongerige, ME16 9QQ
- Kent Oncology Centre - Maidstone Hospital
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Manchester, Det Forenede Kongerige, M20 4BV
- The Christie NHS Foundation Trust
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Sutton, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden Nhs Foundation Trust - Sutton
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Helsinki, Finland, 00290
- Helsinki University Central Hospital
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Helsinki, Finland, 00180
- Docrates Cancer Center
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Tampere, Finland, 33521
- Tampere University Hospital
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic Arizona
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California
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Greenbrae, California, Forenede Stater, 94904
- Marin Cancer Care
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Orange, California, Forenede Stater, 92868-3201
- UC Irvine Medical Center
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Georgetown University-Lombardi Comprehensive Cancer Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic-Florida
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Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Medical Center Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60637-1447
- University of Chicago Medical Center
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
- Parkview Research Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospital and Clinics
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Kansas
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Westwood, Kansas, Forenede Stater, 66205
- The University of Kansas Cancer Center
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201
- Barbara Ann Karmanos Cancer Hospital
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Farmington Hills, Michigan, Forenede Stater, 48334
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89169
- Comprehensive Cancer Centers of Nevada-Twain
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New Jersey
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Florham Park, New Jersey, Forenede Stater, 07932
- Summit Medical Group
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New York
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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White Plains, New York, Forenede Stater, 10601
- White Plains Hospital
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Med. Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Hospital System University Medical Center Institute For Translational Oncology Research
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Baylor Scott and White Research Institute
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Research Institute
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Virginia
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Newport News, Virginia, Forenede Stater, 23601
- Riverside Regional Medical Center
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Richmond, Virginia, Forenede Stater, 23229
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Cancer Institute
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Wisconsin
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Wauwatosa, Wisconsin, Forenede Stater, 53226
- Aurora Research Institute
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Avignon, Frankrig, 84918
- Institut Sainte Catherine
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Besançon, Frankrig, 25030
- Chu Besancon Hospital Jean Minjoz
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Bordeaux, Frankrig, 33076
- Institut Bergonie
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Clichy, Frankrig, 92110
- Hôpital Beaujon
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Limoges, Frankrig, 87042
- Chu de Limoges - Hospital Dupuytren
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Lyon, Frankrig, 69373
- Hôpital Privé Jean Mermoz
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Marseille, Frankrig, 13385
- Chu Hopital de La Timone
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Nantes, Frankrig, 44000
- Centre Hospitalier Universitaire de Nantes
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Nice, Frankrig, 06189
- Centre Antoine Laccassagne
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Paris, Frankrig, 75015
- Hôpital Européen Georges Pompidou (HEGP)
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Paris, Frankrig, 75013
- Hospital Universitaire Pitie-Salpetriere
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Pessac, Frankrig, 336600
- Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrig, 86021
- Hospital de La Miletrie
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Rouen, Frankrig, 76031
- Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
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Saint-Etienne, Frankrig, 42055
- University Hospital of Saint Etienne
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Saint-Herblain, Frankrig, 44800
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Toulouse, Frankrig, 31059
- Chu Toulouse Hopital Rangueil
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Vandœuvre-lès-Nancy, Frankrig, 54511
- Chu Vandoeuvre-Les-Nancy Hopital Brabois
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Villejuif, Frankrig, 94805
- Institut Gustave Roussy
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Amsterdam, Holland, 1100 DD
- Amsterdam University Medical Centre
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Maastricht, Holland, 6202 AZ
- Maastricht UMC+
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Rotterdam, Holland, 3015 CE
- Erasmus Medical Center
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Utrecht, Holland, 3584 CX
- UMC Utrecht
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Dublin, Irland, D04 Y8V0
- St. Vincent's University Hospital
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Beersheba, Israel, 84001
- Soroka University Medical Center
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Haifa, Israel, 3109601
- Rambam Health Care Campus
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Jerusalem, Israel, 9112001
- Hadassah University Hospital
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Petah Tikva, Israel, 4941492
- Rabin Medical Center - Beilinson Hospital
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Ancona, Italien, 60126
- Azienda Ospedaliero Universitaria delle Marche
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Bari, Italien, 70124
- Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
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Bergamo, Italien, 24127
- Ospedale Papa Giovanni Xxiii
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Bologna, Italien, 40138
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
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Candiolo, Italien, 10060
- Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
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Catania, Italien, 95100
- Presidio Ospedaliero Garibaldi Nesima
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Faenza, Italien, 48018
- Ospedale Degli Infermi - Faenza
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Genova, Italien, 16132
- IRCCS Azienda Ospedaliera Universitaria San Martino
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Milan, Italien, 20132
- Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
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Milan, Italien, 20141
- European Institute of Oncology
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Milan, Italien, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Milan, Italien, 20133
- Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
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Modena, Italien, 41124
- A.O.U. Di Modena - Policlinico
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Naples, Italien, 80131
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
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Naples, Italien, 80138
- Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
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Orbassano, Italien, 10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
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Padova, Italien, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Pescara, Italien, 65124
- Presidio Ospedaliero Pescara
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Pisa, Italien, 56126
- Azienda Ospedaliera Universitaria Pisana
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Roma, Italien, 00144
- Istituto Nazionale Tumori Regina Elena IRCCS
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Roma, Italien, 00137
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rome, Italien, 00152
- Azienda Ospedaliera San Camillo Forlanini
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Rome, Italien, 00128
- Universita Campus Bio Medico Di Roma
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Rozzano, Italien, 20089
- Irccs Istituto Clinico Humanitas
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Siena, Italien, 53100
- Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
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Verona, Italien, 37134
- Centro Ricerche Cliniche Di Verona (Crc)
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Vicenza, Italien, 36100
- San Bartolo Hospital
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Bunkyō City, Japan, 113-8655
- University of Tokyo Hospital
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Chiba, Japan, 260-8717
- Chiba cancer center
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Chiba, Japan, 260-8677
- Chiba University Hospital
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hyōgo, Japan, 663-8501
- Hyogo College of Medicine Hospital
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Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
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Itabashi-ku, Japan, 173-8606
- Teikyo University Hospital
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Kobe, Japan, 650-0017
- Kobe University Hospital
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Kyoto, Japan, 606-8507
- Kyoto University hospital
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Kōtoku, Japan, 135-8550
- Cancer Institute Hospital of Jfcr
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Matsuyama, Japan, 791-0280
- NHO Shikoku Cancer Center
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Mitaka-shi, Japan, 181-8611
- Kyorin University Hospital
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Nagoya, Japan, 464-8681
- Aichi Cancer Center Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Sayama, Japan, 589-8511
- Kindai University Hospital
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Sendai, Japan, 980-8574
- Tohoku University Hospital
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Shimotsuke-shi, Japan, 329-0498
- Jichi Medical University Hospital
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Shinjuku-ku, Japan, 160-8582
- Keio University Hospital
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Suita-shi, Japan, 565-0871
- Osaka University Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Ube, Japan, 755-8505
- Yamaguchi University Hospital
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Wakayama, Japan, 641-8509
- Wakayama Medical University Hospital
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Yokohama, Japan, 232-0024
- Yokohama City University Medical Center
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Yokohama, Japan, 241-8515
- Kanagawa Cancer Center
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Yufu-shi, Japan, 879-5593
- Oita University Hospital
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Beijing, Kina, 100032
- Peking Union Medical College Hospital
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Chengdu, Kina, 610041
- West China Hospital Sichuan University
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Fuzhou, Kina, 350005
- Fujian Cancer Hospital
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Guangdong, Kina, 510000
- Sun Yat-sen Memorial Hospital Sun Yat-sen University
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Guangzhou, Kina, 510000
- Sun Yat-sen Memorial Hospital Sun Yat-sen University
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Hangzhou, Kina, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Hangzhou, Kina, 310000
- Shulan Hangzhou Hospital Co Ltd
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Harbin, Kina, 150081
- Heilongjiang Province Cancer Hospital
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Hefei, Kina, 230001
- University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
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Kunming, Kina, 650032
- Kunming 1St People'S Hospital
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Nanjing, Kina, 210029
- Jiangsu Province Hospital
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Shandong, Kina, 266071
- The Affiliated Hospital Of Qingdao University
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Shanghai, Kina, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Kina, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Kina, 200092
- Xinhua Hospital
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Sichuan, Kina, 610041
- Sichuan Cancer Hospital
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Tianjin, Kina, 300060
- Tianjin Medical University Cancer Institute Hospital
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Wuhan, Kina, 430079
- Hubei Cancer Hospital
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Wuhan, Kina, 430030
- Tongji Hospital Huazhong University of Science and Technology
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Yangzhou, Kina, 225001
- Northern Jiangsu Peoples Hospital
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Oslo, Norge, 00450
- Oslo University Hospital
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Bern, Schweiz, 03010
- Inselspital - Universitaetsspital Bern
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Zurich, Schweiz, 08091
- Universitätsspital Zürich
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A Coruña, Spanien, 15006
- Hospital Materno Teresa Herrera
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Barcelona, Spanien, 08026
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spanien, 08035
- Hospital General Universitario Vall D Hebron
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Barcelona, Spanien, 08036
- Hospital Clinic Barcelona Main
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Córdoba, Spanien, 14004
- Hospital Universitario Reina Sofia
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Donostia / San Sebastian, Spanien, 20014
- Hospital Universitario Donostia
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Madrid, Spanien, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spanien, 28050
- Hospital Universitario HM Sanchinarro
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Málaga, Spanien, 29010
- Hospital Regional Universitario de Málaga
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Pamplona, Spanien, 31008
- Clinica Universidad de Navarra (Cun)
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Sabadell, Spanien, 08208
- Hospital Universitari Parc Tauli
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Santander, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, Spanien, 46014
- Hospital General Universitario de Valencia
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Solna, Sverige, 171 64
- Karolinska Institute Universitetssjukhuset Solna
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Aachen, Tyskland, 52074
- University Medical Center Rwth Aachen
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Berlin, Tyskland, 13353
- Charité - Campus Virchow-Klinikum
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Berlin, Tyskland, 13353
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
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Bonn, Tyskland, 53127
- Universitatsklinikum Bonn Aoer
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Bremen, Tyskland, 28755
- Klinikum Bremen-Nord
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Cologne, Tyskland, 50937
- Universitätsklinikum Köln
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Dresden, Tyskland, 01307
- University Clinic Carl Gustav Carus Technical University Dresden
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Frankfurt am Main, Tyskland, 60590
- Klinikum Der Johann Wolfgang Goethe University
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Freiburg im Breisgau, Tyskland, 79106
- University Medical Center Freiburg
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Hamburg, Tyskland, 22763
- Asklepios Klinik Altona
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Hamburg, Tyskland, 20246
- Universitätsklinikum Hamburg Eppendorf
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Hanover, Tyskland, 30625
- Hannover Medical School
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Homburg / SAAR, Tyskland, 66421
- Universitaetsklinikum des Saarlandes
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Leipzig, Tyskland, 04103
- Universitätsklinikum Leipzig AöR
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Ludwigsburg, Tyskland, 71640
- Klinikum Ludwigsburg
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Magdeburg, Tyskland, 39120
- Otto-von-Guericke-Universität Magdeburg
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Mainz, Tyskland, 55131
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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Munich, Tyskland, 81377
- University Hospital Grosshadern Munich
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Nuremberg, Tyskland, 90419
- Klinikum Nuernberg
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Tübingen, Tyskland, 72076
- University Hospital Tuebingen
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Tübingen, Tyskland, 72076
- Universitaetsklinikum in Tubingen
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Ulm, Tyskland, 89081
- Universitatkinikums Ulm
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Graz, Østrig, 08036
- Landeskrankenhaus Universitatsklinikum Graz
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Innsbruck, Østrig, A-6020
- Innsbruck University Hospital
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Linz, Østrig, 04010
- Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
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Salzburg, Østrig, 05020
- Salzburger Universitätsklinikum
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Steyr, Østrig, 04400
- Landeskrankenhaus Steyr
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Vienna, Østrig, 01090
- Allgemeines Krankenhaus der Stadt Wien
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Mandlige og kvindelige deltagere er mindst 18 år på tidspunktet for underskrivelsen af den informerede samtykkeformular (ICF).
- Histologisk eller cytologisk bekræftet cholangiocarcinom, som tidligere er ubehandlet og anses for inoperabelt og/eller metastatisk (stadium IV i henhold til American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
- Radiografisk målbar eller evaluerbar sygdom ved CT eller MR i henhold til RECIST v1.1 kriterier.
- Eastern Cooperative Oncology Groups præstationsstatus 0 til 1.
- Dokumenteret FGFR2 omarrangering.
- Vilje til at undgå graviditet eller far til børn.
Ekskluderingskriterier:
- Modtaget tidligere anticancer systemisk behandling for inoperabel og/eller metastatisk sygdom (ikke inklusive adjuverende/neo-adjuverende behandling afsluttet mindst 6 måneder før indskrivning, og deltagere, der har modtaget behandling for lokalt fremskreden sygdom med transarteriel kemoembolisering eller selektiv intern strålebehandling , hvis der observeres klare tegn på radiologisk progression før tilmelding, eller tilmeldt fra ændring 6 (eller ændring 5-JP2), og deltageren modtog 1 cyklus gemcitabin plus cisplatin [starten af undersøgelseslægemidlet {cyklus 1 dag 1} skal være kl. mindst 14 dage og ≤ 4 uger {28 dage} fra den sidste dosis gemcitabin plus cisplatin]).
- Child-Pugh B og C.
- Toksicitet relateret til tidligere behandling(er) skal være almindelige terminologikriterier for bivirkninger (CTCAE) v5.0 ≤ grad 1 på screeningstidspunktet.
- Samtidig anticancerterapi, bortset fra de terapier, der testes i denne undersøgelse.
- Deltageren er en kandidat til potentielt helbredende kirurgi.
- Aktuel evidens for klinisk signifikant hornhinde (herunder, men ikke begrænset til bulløs/båndkeratopati, hornhindeafskrabning, inflammation/ulceration og keratoconjunctivitis) eller retinal lidelse (herunder, men ikke begrænset til central serøs retinopati, makulær/retinal degeneration, diabetisk retinopati, nethindeløsning ) som bekræftet ved oftalmologisk undersøgelse.
- Strålebehandling administreret inden for 4 uger efter tilmelding/randomisering/første dosis af undersøgelsesbehandling.
- Kendte metastaser i centralnervesystemet (CNS) eller historie med ukontrollerede anfald.
- Kendt yderligere malignitet, der skrider frem eller kræver aktiv behandling (undtagelser: basalcellekarcinom i huden, pladecellekræft i huden eller in situ livmoderhalskræft, der har gennemgået potentielt helbredende behandling).
- Laboratorieværdier ved screening uden for det protokoldefinerede interval.
- Anamnese med calcium- og fosfathæmostaseforstyrrelser eller systemisk mineralubalance med ektopisk forkalkning af blødt væv (undtagelse: almindeligt observerede forkalkninger i blødt væv, såsom hud, nyrer, sener eller kar på grund af skade, sygdom og aldring, i fravær af systemisk mineralubalance).
- Betydelige gastrointestinale lidelser, der kan interferere med absorption, metabolisme eller udskillelse af pemigatinib.
- Klinisk signifikant eller ukontrolleret hjertesygdom.
- Anamnese eller tilstedeværelse af et unormalt EKG, som efter investigators mening er klinisk meningsfuldt.
- Kronisk eller aktuel aktiv infektionssygdom, der kræver systemisk antibiotika eller svampedræbende eller antiviral behandling inden for 2 uger før indskrivning (deltagere med asymptomatiske kroniske infektioner på profylaktisk behandling er tilladt). Bemærk: HIV-positive deltagere er tilladt, hvis alle følgende kriterier er opfyldt: CD4+-tal ≥ 300/µL, upåviselig viral belastning, modtager antiretroviral behandling, der ikke interagerer med undersøgelseslægemidlet, og ingen HIV/AIDS-associeret opportunistisk infektion i sidste 12 måneder.
- Brug af potente CYP3A4-hæmmere eller -inducere eller moderate CYP3A4-induktorer inden for 14 dage eller 5 halveringstider (alt efter hvad der er længst) før den første dosis af undersøgelsesbehandlingen. Bemærk: Moderate CYP3A4-hæmmere er ikke forbudt
- Kendt overfølsomhed eller alvorlig reaktion på pemigatinib, gemcitabin, cisplatin eller deres hjælpestoffer.
- Utilstrækkelig genopretning fra toksicitet og/eller komplikationer fra en større operation, før behandlingen påbegyndes.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pemigatinib
|
Pemigatinib i den protokoldefinerede dosis administreret oralt én gang dagligt som kontinuerlig behandlingsplan (en cyklus er 3 uger).
Andre navne:
|
|
Aktiv komparator: Gemcitabin + Cisplatin
Deltagere, der oplever sygdomsprogression, mens de får gemcitabin + cisplatin eller i opfølgningsperioden og før påbegyndelse af en ny kræftbehandling, vil være berettiget til at krydse over og modtage pemigatinib.
|
Gemcitabin 1000 mg/m^2 indgivet som en intravenøs infusion på dag 1 og 8 i hver 3-ugers cyklus i op til 8 cyklusser.
Cisplatin 25 mg/m^2 indgivet som en intravenøs infusion på dag 1 og 8 i hver 3-ugers cyklus i op til 8 cyklusser.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Randomized Treatment Period: Progression-free Survival (PFS)
Tidsramme: up to 1422 days
|
PFS was defined as the time from the date of randomization until the date of disease progression (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] and assessed by an Independent Central Review [ICR]) or death, whichever occurs first.
|
up to 1422 days
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
Tidsramme: up to 1422 days
|
PFS was defined as the time from the date of randomization until the date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first.
Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
|
up to 1422 days
|
|
Transition Period: PFS
Tidsramme: up to 1496 days
|
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
|
up to 1496 days
|
|
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
Tidsramme: up to 1496 days
|
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
|
up to 1496 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Randomized Treatment Period: Objective Response Rate (ORR)
Tidsramme: up to 1422 days
|
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm).
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
|
up to 1422 days
|
|
Transition Period: ORR
Tidsramme: up to 1496 days
|
ORR was defined as the percentage of participants with a best overall response of CR or PR per RECIST v1.1 as assessed by an ICR.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
|
up to 1496 days
|
|
Randomized Treatment Period: Overall Survival
Tidsramme: up to 1422 days
|
Overall survival was defined as the time from the date of randomization until death due to any cause.
|
up to 1422 days
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
Tidsramme: up to 1422 days
|
Overall survival was defined as the time from the date of randomization until death due to any cause.
Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
|
up to 1422 days
|
|
Randomized Treatment Period: Duration of Response (DOR)
Tidsramme: up to 1422 days
|
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
|
up to 1422 days
|
|
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
Tidsramme: up to 1422 days
|
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
|
up to 1422 days
|
|
Transition Period: DOR
Tidsramme: up to 1496 days
|
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
|
up to 1496 days
|
|
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
Tidsramme: up to 1496 days
|
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurred first.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
|
up to 1496 days
|
|
Randomized Treatment Period: Disease Control Rate (DCR)
Tidsramme: up to 1422 days
|
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
SD: no change in target lesions to qualify for CR, PR, or PD.
|
up to 1422 days
|
|
Transition Period: DCR
Tidsramme: up to 1496 days
|
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR.
CR: disappearance of all target and non-target lesions and no appearance of any new lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm.
PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
PD: progression of a target or non-target lesion or presence of a new lesion.
SD: no change in target lesions to qualify for CR, PR, or PD.
|
up to 1496 days
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Tidsramme: up to 1457 days
|
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib.
For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
|
up to 1457 days
|
|
Number of Participants With Any Treatment-related TEAE
Tidsramme: up to 1457 days
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib.
For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
|
up to 1457 days
|
|
Transition Period: Number of Participants With Any TEAE
Tidsramme: up to 1531 days
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
|
up to 1531 days
|
|
Transition Period: Number of Participants With Any Treatment-related TEAE
Tidsramme: up to 1531 days
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.
A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
|
up to 1531 days
|
|
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
Tidsramme: Baseline; up to 1422 days
|
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures.
These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial).
All scales and single-item measures range in score from 0 to 100.
A high scale score represents a higher response level.
Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL.
A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
|
Baseline; up to 1422 days
|
|
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
Tidsramme: Baseline; up to 1422 days
|
The EORTC QLQ-BIL21 assessed QoL across 8 scales: eating, jaundice, tiredness, pain, anxiety, treatment side effects, drains, and weight loss.
The raw score of each scale is the mean of the item values that contribute to the scale, and the standardized score is a linear transformation of the raw score so that the range is from 0 to 100.
A high score for a symptom scale represents a high level of symptomatology/problems.
The BIL21 questionnaire was only be administered to participants for whom the questionnaire is validated in that language.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
|
Baseline; up to 1422 days
|
|
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
Tidsramme: Baseline; up to 1422 days
|
The EQ-5D (3L) is the descriptive system that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 3 levels: no problems, some problems, extreme problems.
|
Baseline; up to 1422 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Peter Langmuir, MD, Incyte Corporation
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.
- Bekaii-Saab TS, Melisi D, Wilmink H, Garufi C, Tran N, Tortora G, De Braud F, Frodin JE, Lonardi S, Lin E, Babiker H, Lin B, Fornaro L, Munoz Martin A, Bridgewater J, Knox JJ, De Vos-Geelen J, Scott-Brown M, Veronese L, Ioannidis S, Gilmartin A, Janik JE, Guo Y, Furuse J, Ioka T, Rimassa L, Vogel A. Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase III FIGHT-302 Trial. J Clin Oncol. 2026 Jun 1:JCO2600788. doi: 10.1200/JCO-26-00788. Online ahead of print.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. juni 2019
Primær færdiggørelse (Faktiske)
7. juli 2025
Studieafslutning (Faktiske)
7. juli 2025
Datoer for studieregistrering
Først indsendt
29. august 2018
Først indsendt, der opfyldte QC-kriterier
30. august 2018
Først opslået (Faktiske)
4. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Karcinom
- Cholangiocarcinom
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Deoxycytidin
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Platinforbindelser
- Gemcitabin
- Cisplatin
- Pemigatinib
Andre undersøgelses-id-numre
- INCB 54828-302
- 2018-002894-23 (EudraCT nummer)
- 2024-513513-12-00 (Registry Identifier: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Incyte deler data med kvalificerede eksterne forskere, efter at et forskningsforslag er indsendt. Disse anmodninger gennemgås og godkendes af et bedømmelsespanel på grundlag af videnskabelig fortjeneste. Alle opgivne data er anonymiseret for at respektere privatlivets fred for patienter, der har deltaget i forsøget i overensstemmelse med gældende love og regler.
Tilgængeligheden af forsøgsdata er i overensstemmelse med kriterierne og processen beskrevet på https://www.incyte.com/our-company/compliance-and-transparency
IPD-delingstidsramme
Data vil blive delt efter den primære offentliggørelse eller 2 år efter undersøgelsen er afsluttet for markedsgodkendte produkter og indikationer.
IPD-delingsadgangskriterier
Data fra kvalificerede undersøgelser vil blive delt med kvalificerede forskere i henhold til kriterierne og processen beskrevet i afsnittet om datadeling på www.incyteclinicaltrials.com
internet side.
For godkendte anmodninger vil forskerne få adgang til anonymiserede data i henhold til en datadelingsaftale.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .