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

PHASE3TerminatedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

June 3, 2019

Primary Completion Date

July 7, 2025

Study Completion Date

July 7, 2025

Conditions
Unresectable CholangiocarcinomaMetastatic Cholangiocarcinoma
Interventions
DRUG

Pemigatinib

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

DRUG

Gemcitabine

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

DRUG

Cisplatin

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

Trial Locations (215)

10029

Icahn School of Medicine At Mount Sinai, New York

10043

Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano, Orbassano

10060

Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo, Candiolo

10601

White Plains Hospital, White Plains

13353

Charite - Campus Virchow-Klinikum, Berlin

Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

13385

Chu Hopital de La Timone, Marseille

14004

Hospital Universitario Reina Sofia, Córdoba

15006

Hospital Materno Teresa Herrera, A Coruña

16132

Irccs Azienda Ospedaliera Universitaria San Martino, Genova

19111

Fox Chase Cancer Center, Philadelphia

20007

Georgetown University-Lombardi Comprehensive Cancer Center, Washington D.C.

20014

HOSPITAL UNiVERSITARIO DONOSTIA, Donostia / San Sebastian

20089

Irccs Istituto Clinico Humanitas, Rozzano

20132

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan

20133

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milan

20141

European Institute of Oncology, Milan

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

20246

Universitatsklinikum Hamburg Eppendorf, Hamburg

21287

Johns Hopkins Oncology Center, Baltimore

22763

Asklepios Klinik Altona, Hamburg

23229

Virginia Commonwealth University, Richmond

23601

Riverside Regional Medical Center, Newport News

24127

Ospedale Papa Giovanni Xxiii, Bergamo

25030

Chu Besancon Hospital Jean Minjoz, Besançon

26506

West Virginia University Cancer Institute, Morgantown

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28050

Hospital Universitario Hm Sanchinarro, Madrid

28755

Klinikum Bremen-Nord, Bremen

29010

Hospital Regional Universitario de Malaga, Málaga

29605

Greenville Hospital System University Medical Center Institute For Translational Oncology Research, Greenville

30322

Winship Cancer Institute of Emory University, Atlanta

30625

Hannover Medical School, Hanover

31008

Clinica Universidad de Navarra (Cun), Pamplona

31059

Chu Toulouse Hopital Rangueil, Toulouse

32224

Mayo Clinic-Florida, Jacksonville

33076

Institut Bergonie, Bordeaux

33140

Mount Sinai Medical Center Comprehensive Cancer Center, Miami Beach

33521

Tampere University Hospital, Tampere

35128

Iov - Istituto Oncologico Veneto Irccs, Padua

36100

San Bartolo Hospital, Vicenza

37134

Centro Ricerche Cliniche Di Verona (Crc), Verona

39008

Hospital Universitario Marques de Valdecilla, Santander

39120

Otto-Von-Guericke-Universitat Magdeburg, Magdeburg

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

41124

A.O.U. Di Modena - Policlinico, Modena

42055

University Hospital of Saint Etienne, Saint-Etienne

44000

Centre Hospitalier Universitaire de Nantes, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44800

Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau, Saint-Herblain

46014

Hospital General Universitario de Valencia, Valencia

46845

Parkview Research Center, Fort Wayne

48018

Ospedale Degli Infermi - Faenza, Faenza

48201

Barbara Ann Karmanos Cancer Hospital, Detroit

48202

Henry Ford Hospital, Detroit

48334

Karmanos Cancer Institute, Farmington Hills

50937

Universitatsklinikum Koln, Cologne

52074

University Medical Center Rwth Aachen, Aachen

52242

University of Iowa Hospital and Clinics, Iowa City

53100

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte, Siena

53127

Universitatsklinikum Bonn Aoer, Bonn

53226

Aurora Research Institute, Wauwatosa

54511

Chu Vandoeuvre-Les-Nancy Hopital Brabois, Vandœuvre-lès-Nancy

55131

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz

55905

Mayo Clinic, Rochester

56126

Azienda Ospedaliera Universitaria Pisana, Pisa

60126

Azienda Ospedaliero Universitaria Delle Marche, Ancona

60590

Klinikum Der Johann Wolfgang Goethe University, Frankfurt am Main

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65124

Presidio Ospedaliero Pescara, Pescara

66205

The University of Kansas Cancer Center, Westwood

66421

Universitaetsklinikum Des Saarlandes, Homburg / SAAR

69373

Hopital Prive Jean Mermoz, Lyon

70121

Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci, New Orleans

70124

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari

71640

Klinikum Ludwigsburg, Ludwigsburg

72076

Universitaetsklinikum in Tubingen, Tübingen

University Hospital Tuebingen, Tübingen

75013

Hospital Universitaire Pitie-Salpetriere, Paris

75015

Hopital Europeen Georges Pompidou (Hegp), Paris

75246

Baylor Scott and White Research Institute, Dallas

76031

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume, Rouen

77030

Houston Methodist Research Institute, Houston

79106

University Medical Center Freiburg, Freiburg im Breisgau

80131

Istituto Nazionale Tumori Irccs Fondazione Pascale, Napoli

80138

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

81377

University Hospital Grosshadern Munich, Munich

84001

Soroka University Medical Center, Beersheba

84918

Institut Sainte Catherine, Avignon

85054

Mayo Clinic Arizona, Phoenix

86021

Hospital de La Miletrie, Poitiers

87042

Chu de Limoges - Hospital Dupuytren, Limoges

89081

Universitatkinikums Ulm, Ulm

89169

Comprehensive Cancer Centers of Nevada-Twain, Las Vegas

90419

Klinikum Nuernberg, Nuremberg

92110

Hopital Beaujon, Clichy

94805

Institut Gustave Roussy, Villejuif

94904

Marin Cancer Care, Greenbrae

95100

Presidio Ospedaliero Garibaldi Nesima, Catania

97213

Providence Portland Med. Ctr, Portland

97239

Oregon Health & Science University, Portland

98101

Virginia Mason Medical Center, Seattle

100032

Peking Union Medical College Hospital, Beijing

150081

Heilongjiang Province Cancer Hospital, Harbin

200032

Zhongshan Hospital Fudan University, Shanghai

200092

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

Xinhua Hospital, Shanghai

210029

Jiangsu Province Hospital, Nanjing

225001

Northern Jiangsu Peoples Hospital, Yangzhou

230001

University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital), Hefei

266071

The Affiliated Hospital of Qingdao University, Shandong

300060

Tianjin Medical University Cancer Institute Hospital, Tianjin

310000

Shulan Hangzhou Hospital Co Ltd, Hangzhou

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

336600

Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque, Pessac

350005

Fujian Cancer Hospital, Fuzhou

430030

Tongji Hospital Huazhong University of Science and Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

510000

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangdong

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou

610041

West China Hospital Sichuan University, Chengdu

Sichuan Cancer Hospital, Sichuan

650032

Kunming 1St People'S Hospital, Kunming

3109601

Rambam Health Care Campus, Haifa

4941492

Rabin Medical Center - Beilinson Hospital, Petah Tikva

9112001

Hadassah University Hospital, Jerusalem

92868-3201

UC Irvine Medical Center, Orange

60637-1447

University of Chicago Medical Center, Chicago

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07932

Summit Medical Group, Florham Park

08036

Landeskrankenhaus Universitatsklinikum Graz, Graz

Hospital Clinic Barcelona Main, Barcelona

A-6020

Innsbruck University Hospital, Innsbruck

04010

Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz, Linz

05020

Salzburger Universitatsklinikum, Salzburg

04400

Landeskrankenhaus Steyr, Steyr

01090

Allgemeines Krankenhaus Der Stadt Wien, Vienna

Universitair Ziekenhuis Brussel, Brussels

01070

Ulb Hospital Erasme, Brussels

09000

Universitair Ziekenhuis Gent, Ghent

07100

Hospital de Jolimont, Haine-st-paul

08500

Az Groeninge Campus Kennedylaan, Kortrijk

03000

Universitaire Ziekenhuis Leuven - Gasthuisberg, Leuven

05530

Chu Ucl Namur University Hospital Mont-Godinne, Yvoir

T2N 4N2

Tom Baker Cancer Centre, Calgary

R3E 0V9

Cancercare Manitoba, Winnipeg

B3H 4K4

Nova Scotia Health Authority/Qeii Health Sciences Centre, Halifax

MG5 2M9

Princess Margaret Cancer Center, Toronto

H4A 3J1

McGill University Health Centre Research Institute, Montreal

02730

Herlev Og Gentofte Hospital, Herlev

00180

Docrates Cancer Center, Helsinki

00290

Helsinki University Central Hospital, Helsinki

06189

Centre Antoine Laccassagne, Nice

01307

University Clinic Carl Gustav Carus Technical University Dresden, Dresden

04103

Universitatsklinikum Leipzig Aor, Leipzig

D04 Y8V0

St. Vincent'S University Hospital, Dublin

00137

Fondazione Policlinico Universitario Agostino Gemelli Irccs, Roma

00144

Istituto Nazionale Tumori Regina Elena Irccs, Roma

00128

Universita Campus Bio Medico Di Roma, Rome

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

113-8655

University of Tokyo Hospital, Bunkyō City

260-8677

Chiba University Hospital, Chiba

260-8717

Chiba Cancer Center, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

812-8582

Kyushu University Hospital, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

663-8501

Hyogo College of Medicine Hospital, Hyōgo

920-8641

Kanazawa University Hospital, Ishikawa

173-8606

Teikyo University Hospital, Itabashi-ku

650-0017

Kobe University Hospital, Kobe

135-8550

Cancer Institute Hospital of Jfcr, Kōtoku

606-8507

Kyoto University Hospital, Kyoto

791-0280

Nho Shikoku Cancer Center, Matsuyama

181-8611

Kyorin University Hospital, Mitaka-shi

464-8681

Aichi Cancer Center Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, Niigata

541-8567

Osaka International Cancer Institute, Osaka

362-0806

Saitama Cancer Center, Saitama

060-8648

Hokkaido University Hospital, Sapporo

589-8511

Kindai University Hospital, Sayama

980-8574

Tohoku University Hospital, Sendai

329-0498

Jichi Medical University Hospital, Shimotsuke-shi

160-8582

Keio University Hospital, Shinjuku-ku

411-8777

Shizuoka Cancer Center, Shizuoka

565-0871

Osaka University Hospital, Suita-shi

930-0194

Toyama University Hospital, Toyama

755-8505

Yamaguchi University Hospital, Ube

641-8509

Wakayama Medical University Hospital, Wakayama

232-0024

Yokohama City University Medical Center, Yokohama

241-8515

Kanagawa Cancer Center, Yokohama

879-5593

Oita University Hospital, Yufu-shi

1100 DD

Amsterdam University Medical Centre, Amsterdam

6202 AZ

Maastricht Umc+, Maastricht

3015 CE

Erasmus Medical Center, Rotterdam

3584 CX

Umc Utrecht, Utrecht

00450

Oslo University Hospital, Oslo

08026

Hospital de La Santa Creu I Sant Pau, Barcelona

08035

Hospital General Universitario Vall D Hebron, Barcelona

08208

Hospital Universitari Parc Tauli, Sabadell

171 64

Karolinska Institute Universitetssjukhuset Solna, Solna

03010

Inselspital - Universitaetsspital Bern, Bern

08091

Universitatsspital Zurich, Zurich

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

CB2 0QQ

Addenbrookes Hospital, Cambridge

CF14 2TL

Velindre Cancer Centre, Cardiff

CV2 2DX

University Hospital Coventry and Warwickshire, Coventry

SW3 6JJ

The Royal Marsden Nhs Foundation Trust - Chelsea, London

W12 0HS

Imperial College Healthcare Nhs Trust - Hammersmith Hospital, London

WC1E 6BT

University College London Hospitals (Uclh), London

ME16 9QQ

Kent Oncology Centre - Maidstone Hospital, Maidstone

M20 4BV

The Christie Nhs Foundation Trust, Manchester

SM2 5PT

The Royal Marsden Nhs Foundation Trust - Sutton, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY