Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

PHASE3TerminatedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 27, 2019

Primary Completion Date

March 2, 2023

Study Completion Date

March 2, 2023

Conditions
Advanced CholangiocarcinomaFGFR2 Gene Mutation
Interventions
DRUG

BGJ398

Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

DRUG

Cisplatin

Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

Trial Locations (116)

333

Chang Gung Memorial Hospital, Linkou, Taoyuan

632

National Taiwan University Hospital - YunLin Branch, Huwei

704

National Cheng Kung University Hospital, Tainan City

833

Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung City

1200

Cliniques Universitaires Saint-Luc, Brussels

2650

Universitair Ziekenhuis Antwerpen, Edegem

6000

Grand Hopital de Charleroi, Charleroi

10016

NYU Langone Medical Center, New York

10021

Memorial Sloan Kettering Cancer Center, New York

10330

Chulalongkorn University, Bangkok

11217

Taipei Veterans General Hospital, Taipei

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21000

CHRU Dijon, Dijon

21079

Centre Georges-Francois Leclerc, Dijon

21702

Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute, Frederick

25200

Hopital Nord Franche-Comte, Montbéliard

26100

Azienda Socio Sanitaria Territoriale di Cremona (ASST), Cremona

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario HM Sanchinarro - CIOCC, Madrid

28204

Levine Cancer Institute - Charlotte, Charlotte

29414

Charleston Oncology, Charleston

32804

Florida Hospital Medical Group, Orlando

32806

UF Health Cancer Center at Orlando Health, Orlando

35128

Istituto Oncologico Veneto - I.R.C.C.S., Padua

37007

Complejo Asistencial Universitario de Salamanca - Hospital Clinico, Salamanca

40447

China Medical University Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

43202

Ohio State University Comprehensive Cancer Center, Columbus

44137

Klinikum Dortmund gGmbH, Dortmund

45267

University of Cincinnati Medical Center, Cincinnati

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST, Meldola

48073

William Beaumont Hospital, Royal Oak

48201

Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center, Detroit

49503

Cancer and Hematology Centers of Western Michigan, Grand Rapids

50009

Hospital Universitario Miguel Servet, Zaragoza

50200

Maharaj Nakorn Chiang Mai Chiang Mai University, Chiang Mai

59000

Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille, Lille

60611

Northwestern Memorial Hospital, Chicago

69120

University Clinic Heidelberg, Heidelberg

69437

Groupement Hospitalier Edouard Herriot, Lyon

70112

University Medical Center - New Orleans, New Orleans

72076

Universitätsklinikum Tübingen, Tübingen

72205

University of Arkansas for Medical Sciences, Little Rock

73657

Chi Mei Hospital, Liouying, Tainan City

75014

Hopital Cochin, Paris

75343

Parkland Health and Hospital System, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75571

Hôpital Saint Antoine, Paris

75674

L'Institut Mutualiste Montsouris, Paris

77030

University of Texas MD Anderson Cancer Center, Houston

77096

Baylor College of Medicine, Houston

81675

Klinikum rechts der Isar der Technischen Universität München, München

85234

Banner MD Anderson Cancer Center, Gilbert

85724

University of Arizona, Tucson

90033

USC Norris Cancer Center, Los Angeles

90095

University of California Los Angeles, Los Angeles

90110

Songklanagarind Hospital, Prince of Songkla University, Hat Yai

92835

St. Joseph Heritage Healthcare, Fullerton

94000

Hopital Henri Mondor, Créteil

100033

Peking University People's Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

100191

Peking University Third Hospital, Beijing

110042

Liaoning Cancer Hospital & Institute, Shenyang

410006

Hunan Cancer Hospital, Changsha

430079

Hubei Cancer Hospital, Hubei

510060

The First Affiliated Hospital, Sun Yat-sen University, Zhongshan

510080

Guangzhou First People's Hospital, Guangzhou

02114

Massachusetts General Hospital, Boston

Unknown

Chris O'Brien Lifehouse Hospital, Camperdown

Blacktown Hospital, Darlinghurst

Royal Adelaide Hospital, Adelaide

Monash Medical Centre, Bentleigh East

Peninsula & South Eastern Haematology and Oncology Group, Frankston

St John of God Hospital Subiaco, Subiaco

Cross Cancer Institute, Edmonton

St. Josephs Health Centre, Toronto

Pusan National University Hospital, Pusan

Seoul National University Bundang Hospital, Seongnam-si

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital Yonsei University Health System, Seoul

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

Ajou University Hospital, Suwon

National Taiwan University Hospital, Taipei

Ramathibodi Hospital Mahidol University, Bangkok

Srinagarind Hospital, Khon Kaen

Naresuan University, Phitsanulok

K1H 8L6

Ottawa Hospital, Ottawa

H3T 1E2

Jewish General Hospital, Montreal

06202

Groupe Hospitalier Archet I Et II, Nice

00128

Policlinico Universitario Campus Biomedico Di Roma, Roma

2674-514

Hospital Beatriz Angelo, Loures

2801-951

Hospital Garcia de Orta, Almada

3000-075

Centro Hospitalar E Universitário de Coimbra EPE, Coimbra

Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE, Coimbra

1099-023

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon

1649-035

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

1998-018

Hospital CUF Descobertas, Lisbon

4099-001

Centro Hospitalar do Porto - Hospital de Santo António, Porto

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto

4200-319

Centro Hospitalar de São João, E.P.E., Porto

00935

Hospital Oncologico, Puerto Rico Medical Center, Rio Piedras

07061

SMG - SNU Boramae Medical Center, Seoul

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08907

Instituto Catalan de Oncologio ICO I'Hospitalet, Barcelona

08035

Hospital Universitario Vall d'Hebrón - PPDS, Barcelona

NG5 1PB

Nottingham City Hospital, Nottingham

SM2 5PT

Royal Marsden Hospital, Sutton

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

SE1 9RT

Guys Hospital, London

M20 4BX

The Christie NHS Foundation Trust - PPDS, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Helsinn Healthcare SA

INDUSTRY

lead

QED Therapeutics, Inc., a Bridgebio company

INDUSTRY