En studie for å evaluere effektiviteten og sikkerheten til pemigatinib versus kjemoterapi ved uoperabelt eller metastatisk kolangiokarsinom (FIGHT-302)
17. juli 2026 oppdatert av: Incyte Corporation
En fase 3, åpen, randomisert, aktivt kontrollert, multisenterstudie for å evaluere effektiviteten og sikkerheten til Pemigatinib versus Gemcitabine Plus Cisplatin kjemoterapi i førstelinjebehandling av deltakere med ikke-opererbart eller metastatisk kolangiokarsinom med FGFR2-omorganisering (FIGHT-302)
Hensikten med denne studien er å evaluere effektiviteten og sikkerheten til pemigatinib versus gemcitabin pluss cisplatin kjemoterapi i førstelinjebehandling av deltakere med inoperabelt eller metastatisk kolangiokarsinom med FGFR2-omorganisering.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
167
Fase
- Fase 3
Utvidet tilgang
Ikke lenger tilgjengelig utenfor den kliniske utprøvingen.
Se utvidet tilgangspost.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Brussels, Belgia, 01090
- Universitair Ziekenhuis Brussel
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Brussels, Belgia, 01070
- Ulb Hospital Erasme
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Ghent, Belgia, 09000
- Universitair Ziekenhuis Gent
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Haine-st-paul, Belgia, 07100
- Hospital de Jolimont
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Kortrijk, Belgia, 08500
- AZ Groeninge Campus Kennedylaan
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Leuven, Belgia, 03000
- Universitaire Ziekenhuis Leuven - Gasthuisberg
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Yvoir, Belgia, 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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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, Forente stater, 85054
- Mayo Clinic Arizona
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California
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Greenbrae, California, Forente stater, 94904
- Marin Cancer Care
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Orange, California, Forente stater, 92868-3201
- UC Irvine Medical Center
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Georgetown University-Lombardi Comprehensive Cancer Center
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic-Florida
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Miami Beach, Florida, Forente stater, 33140
- Mount Sinai Medical Center Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Winship Cancer Institute of Emory University
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Illinois
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Chicago, Illinois, Forente stater, 60637-1447
- University Of Chicago Medical Center
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Indiana
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Fort Wayne, Indiana, Forente stater, 46845
- Parkview Research Center
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospital and Clinics
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Kansas
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Westwood, Kansas, Forente stater, 66205
- The University of Kansas Cancer Center
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Louisiana
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forente stater, 48201
- Barbara Ann Karmanos Cancer Hospital
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Farmington Hills, Michigan, Forente stater, 48334
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Nevada
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Las Vegas, Nevada, Forente stater, 89169
- Comprehensive Cancer Centers of Nevada-Twain
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New Jersey
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Florham Park, New Jersey, Forente stater, 07932
- Summit Medical Group
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New York
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
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White Plains, New York, Forente stater, 10601
- White Plains Hospital
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
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Portland, Oregon, Forente stater, 97213
- Providence Portland Med. Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Greenville Hospital System University Medical Center Institute For Translational Oncology Research
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Texas
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Dallas, Texas, Forente stater, 75246
- Baylor Scott and White Research Institute
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Houston, Texas, Forente stater, 77030
- Houston Methodist Research Institute
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Virginia
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Newport News, Virginia, Forente stater, 23601
- Riverside Regional Medical Center
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Richmond, Virginia, Forente stater, 23229
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Forente stater, 98101
- Virginia Mason Medical Center
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West Virginia
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Morgantown, West Virginia, Forente stater, 26506
- West Virginia University Cancer Institute
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Wisconsin
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Wauwatosa, Wisconsin, Forente stater, 53226
- Aurora Research Institute
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Avignon, Frankrike, 84918
- Institut Sainte Catherine
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Besançon, Frankrike, 25030
- Chu Besancon Hospital Jean Minjoz
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Bordeaux, Frankrike, 33076
- Institut Bergonie
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Clichy, Frankrike, 92110
- Hopital Beaujon
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Limoges, Frankrike, 87042
- Chu de Limoges - Hospital Dupuytren
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Lyon, Frankrike, 69373
- Hôpital privé Jean Mermoz
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Marseille, Frankrike, 13385
- CHU Hopital de la Timone
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Nantes, Frankrike, 44000
- Centre Hospitalier Universitaire de Nantes
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Nice, Frankrike, 06189
- Centre Antoine Laccassagne
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Paris, Frankrike, 75015
- Hôpital Européen Georges Pompidou (HEGP)
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Paris, Frankrike, 75013
- Hospital Universitaire Pitie-Salpetriere
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Pessac, Frankrike, 336600
- Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrike, 86021
- Hospital de La Miletrie
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Rouen, Frankrike, 76031
- Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
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Saint-Etienne, Frankrike, 42055
- University Hospital of Saint Etienne
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Saint-Herblain, Frankrike, 44800
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Toulouse, Frankrike, 31059
- Chu Toulouse Hopital Rangueil
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Chu Vandoeuvre-Les-Nancy Hopital Brabois
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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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, Italia, 60126
- Azienda Ospedaliero Universitaria Delle Marche
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Bari, Italia, 70124
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
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Bergamo, Italia, 24127
- Ospedale Papa Giovanni Xxiii
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Bologna, Italia, 40138
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
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Candiolo, Italia, 10060
- Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
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Catania, Italia, 95100
- Presidio Ospedaliero Garibaldi Nesima
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Faenza, Italia, 48018
- Ospedale Degli Infermi - Faenza
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Genova, Italia, 16132
- Irccs Azienda Ospedaliera Universitaria San Martino
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Milan, Italia, 20132
- Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
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Milan, Italia, 20141
- European Institute of Oncology
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Milan, Italia, 20162
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Milan, Italia, 20133
- Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
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Modena, Italia, 41124
- A.O.U. Di Modena - Policlinico
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Naples, Italia, 80131
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
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Naples, Italia, 80138
- Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
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Orbassano, Italia, 10043
- Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
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Padova, Italia, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Pescara, Italia, 65124
- Presidio Ospedaliero Pescara
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Pisa, Italia, 56126
- Azienda Ospedaliera Universitaria Pisana
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Roma, Italia, 00144
- Istituto Nazionale Tumori Regina Elena IRCCS
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Roma, Italia, 00137
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rome, Italia, 00152
- Azienda Ospedaliera San Camillo Forlanini
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Rome, Italia, 00128
- Universita Campus Bio Medico Di Roma
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Rozzano, Italia, 20089
- IRCCS Istituto Clinico Humanitas
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Siena, Italia, 53100
- Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
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Verona, Italia, 37134
- Centro Ricerche Cliniche Di Verona (Crc)
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Vicenza, Italia, 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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Amsterdam, Nederland, 1100 DD
- Amsterdam University Medical Centre
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Maastricht, Nederland, 6202 AZ
- Maastricht UMC+
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Rotterdam, Nederland, 3015 CE
- Erasmus Medical Center
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Utrecht, Nederland, 3584 CX
- UMC Utrecht
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Oslo, Norge, 00450
- Oslo University Hospital
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A Coruña, Spania, 15006
- Hospital Materno Teresa Herrera
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Barcelona, Spania, 08026
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spania, 08035
- Hospital General Universitario Vall D Hebron
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Barcelona, Spania, 08036
- Hospital Clinic Barcelona Main
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Córdoba, Spania, 14004
- Hospital Universitario Reina Sofia
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Donostia / San Sebastian, Spania, 20014
- Hospital Universitario Donostia
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Madrid, Spania, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, Spania, 28007
- Hospital General Universitario Gregorio Marañón
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Madrid, Spania, 28050
- Hospital Universitario HM Sanchinarro
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Málaga, Spania, 29010
- Hospital Regional Universitario de Málaga
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Pamplona, Spania, 31008
- Clinica Universidad de Navarra (Cun)
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Sabadell, Spania, 08208
- Hospital Universitari Parc Tauli
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Santander, Spania, 39008
- Hospital Universitario Marqués de Valdecilla
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Valencia, Spania, 46014
- Hospital General Universitario de Valencia
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Aberdeen, Storbritannia, AB25 2ZN
- Aberdeen Royal Infirmary
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Cambridge, Storbritannia, CB2 0QQ
- Addenbrookes Hospital
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Cardiff, Storbritannia, CF14 2TL
- Velindre Cancer Centre
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Coventry, Storbritannia, CV2 2DX
- University Hospital Coventry and Warwickshire
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London, Storbritannia, W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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London, Storbritannia, SW3 6JJ
- The Royal Marsden Nhs Foundation Trust - Chelsea
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London, Storbritannia, WC1E 6BT
- University College London Hospitals (UCLH)
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Maidstone, Storbritannia, ME16 9QQ
- Kent Oncology Centre - Maidstone Hospital
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Manchester, Storbritannia, M20 4BV
- The Christie NHS Foundation Trust
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Sutton, Storbritannia, SM2 5PT
- The Royal Marsden Nhs Foundation Trust - Sutton
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Bern, Sveits, 03010
- Inselspital - Universitaetsspital Bern
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Zurich, Sveits, 08091
- Universitätsspital Zürich
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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
- Universitatsklinikum 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, Østerrike, 08036
- Landeskrankenhaus Universitatsklinikum Graz
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Innsbruck, Østerrike, A-6020
- Innsbruck University Hospital
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Linz, Østerrike, 04010
- Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
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Salzburg, Østerrike, 05020
- Salzburger Universitätsklinikum
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Steyr, Østerrike, 04400
- Landeskrankenhaus Steyr
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Vienna, Østerrike, 01090
- Allgemeines Krankenhaus der Stadt Wien
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Mannlige og kvinnelige deltakere minst 18 år på tidspunktet for undertegning av informert samtykkeskjema (ICF).
- Histologisk eller cytologisk bekreftet kolangiokarsinom som tidligere er ubehandlet og ansett som ikke-opererbart og/eller metastatisk (stadium IV i henhold til American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
- Radiografisk målbar eller evaluerbar sykdom ved CT eller MR i henhold til RECIST v1.1 kriterier.
- Eastern Cooperative Oncology Group ytelsesstatus 0 til 1.
- Dokumentert FGFR2-omorganisering.
- Vilje til å unngå graviditet eller far til barn.
Ekskluderingskriterier:
- Fikk tidligere systemisk behandling mot kreft for ikke-opererbar og/eller metastatisk sykdom (ikke inkludert adjuvant/neo-adjuvant behandling fullført minst 6 måneder før påmelding, og deltakere som har mottatt behandling for lokalt avansert sykdom med transarteriell kjemoembolisering eller selektiv intern strålebehandling , hvis klare bevis på radiologisk progresjon observeres før registrering, eller registrert fra og med Amendment 6 (eller Amendment 5-JP2) og deltakeren mottok 1 syklus gemcitabin pluss cisplatin [starten av studiemedikamentet {syklus 1 dag 1} må være kl. minst 14 dager og ≤ 4 uker {28 dager} fra siste dose gemcitabin pluss cisplatin]).
- Child-Pugh B og C.
- Toksisitet relatert til tidligere behandling(er) må være vanlige terminologikriterier for bivirkninger (CTCAE) v5.0 ≤ grad 1 på tidspunktet for screening.
- Samtidig kreftbehandling, annet enn terapiene som testes i denne studien.
- Deltaker er en kandidat for potensielt kurativ kirurgi.
- Nåværende bevis på klinisk signifikant hornhinne (inkludert, men ikke begrenset til bulløs/båndkeratopati, hornhinneavslitning, betennelse/ulcerasjon og keratokonjunktivitt) eller retinal lidelse (inkludert men ikke begrenset til sentral serøs retinopati, makulær/retinal degenerasjon, diabetisk retinopati, netthinneløsning ) som bekreftet ved oftalmologisk undersøkelse.
- Strålebehandling administrert innen 4 uker etter registrering/randomisering/første dose studiebehandling.
- Kjente metastaser i sentralnervesystemet (CNS) eller historie med ukontrollerte anfall.
- Kjent ytterligere malignitet som utvikler seg eller krever aktiv behandling (unntak: basalcellekarsinom i huden, plateepitelkarsinom i huden eller in situ livmorhalskreft som har gjennomgått potensielt kurativ behandling).
- Laboratorieverdier ved screening utenfor det protokolldefinerte området.
- Anamnese med kalsium- og fosfathemostaseforstyrrelse eller systemisk mineralubalanse med ektopisk forkalkning av bløtvev (unntak: ofte observerte forkalkninger i bløtvev, som hud, nyre, sener eller kar på grunn av skade, sykdom og aldring, i fravær av systemisk mineralubalanse).
- Betydelige gastrointestinale lidelser som kan forstyrre absorpsjon, metabolisme eller utskillelse av pemigatinib.
- Klinisk signifikant eller ukontrollert hjertesykdom.
- Anamnese eller tilstedeværelse av et unormalt EKG, som etter etterforskerens mening er klinisk meningsfullt.
- Kronisk eller pågående aktiv infeksjonssykdom som krever systemisk antibiotika eller soppdrepende eller antiviral behandling innen 2 uker før påmelding (deltakere med asymptomatiske kroniske infeksjoner på profylaktisk behandling er tillatt). Merk: HIV-positive deltakere er tillatt hvis alle følgende kriterier er oppfylt: CD4+-tall ≥ 300/µL, upåviselig virusmengde, mottar antiretroviral terapi som ikke interagerer med studiemedikamentet, og ingen HIV/AIDS-assosiert opportunistisk infeksjon i siste 12 måneder.
- Bruk av potente CYP3A4-hemmere eller -induktorer eller moderate CYP3A4-induktorer innen 14 dager eller 5 halveringstider (den som er lengst) før den første dosen av studiebehandlingen. Merk: Moderate CYP3A4-hemmere er ikke forbudt
- Kjent overfølsomhet eller alvorlig reaksjon på pemigatinib, gemcitabin, cisplatin eller deres hjelpestoffer.
- Utilstrekkelig utvinning fra toksisitet og/eller komplikasjoner fra en større operasjon før behandlingsstart.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Pemigatinib
|
Pemigatinib i den protokolldefinerte dosen administrert oralt én gang daglig som kontinuerlig behandlingsplan (en syklus er 3 uker).
Andre navn:
|
|
Aktiv komparator: Gemcitabin + Cisplatin
Deltakere som opplever sykdomsprogresjon mens de får gemcitabin + cisplatin eller i løpet av oppfølgingsperioden og før oppstart av en ny kreftbehandling vil være kvalifisert til å krysse over og få pemigatinib.
|
Gemcitabin 1000 mg/m^2 administrert som en intravenøs infusjon på dag 1 og 8 i hver 3-ukers syklus i opptil 8 sykluser.
Cisplatin 25 mg/m^2 administrert som en intravenøs infusjon på dag 1 og 8 i hver 3-ukers syklus i opptil 8 sykluser.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Peter Langmuir, MD, Incyte Corporation
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. juni 2019
Primær fullføring (Faktiske)
7. juli 2025
Studiet fullført (Faktiske)
7. juli 2025
Datoer for studieregistrering
Først innsendt
29. august 2018
Først innsendt som oppfylte QC-kriteriene
30. august 2018
Først lagt ut (Faktiske)
4. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Karsinom
- Kolangiokarsinom
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Platinumforbindelser
- Gemcitabin
- Cisplatin
- pemigatinib
Andre studie-ID-numre
- INCB 54828-302
- 2018-002894-23 (EudraCT-nummer)
- 2024-513513-12-00 (Registeridentifikator: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Incyte deler data med kvalifiserte eksterne forskere etter at et forskningsforslag er sendt inn. Disse forespørslene vurderes og godkjennes av et granskingspanel på grunnlag av vitenskapelig fortjeneste. Alle data som oppgis er anonymisert for å respektere personvernet til pasienter som har deltatt i forsøket i tråd med gjeldende lover og forskrifter.
Tilgjengeligheten av prøvedata er i henhold til kriteriene og prosessen beskrevet på https://www.incyte.com/our-company/compliance-and-transparency
IPD-delingstidsramme
Data vil bli delt etter primærpublisering eller 2 år etter at studien er avsluttet for markedsautoriserte produkter og indikasjoner.
Tilgangskriterier for IPD-deling
Data fra kvalifiserte studier vil bli delt med kvalifiserte forskere i henhold til kriteriene og prosessen beskrevet i delen for datadeling på www.incyteclinicaltrials.com
nettsted.
For godkjente forespørsler vil forskerne få tilgang til anonymiserte data under vilkårene i en datadelingsavtale.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .