Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

773

Participants

Timeline

Start Date

December 24, 2019

Primary Completion Date

March 2, 2022

Study Completion Date

April 5, 2022

Conditions
Biliary Tract Cancer
Interventions
DRUG

NUC-1031

IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes

DRUG

Gemcitabine

IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert

DRUG

Cisplatin

IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

Trial Locations (125)

1083

Semmelweis Egyetem, Budapest

1097

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

2050

Chris O'Brien Lifehouse, Camperdown

2145

Westmead Hospital, Westmead

2217

St George Hospital, Kogarah

2305

Newcastle Private Hospital, Newcastle

3004

The Alfred Hospital, Melbourne

3084

Warringal Medical Centre, Heidelberg

3526

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Miskolc

3722

Severance Hospital, Yonsei University, Seoul

4032

Debreceni Egyetem, Debrecen

4814

Townsville Cancer Centre, Townsville

5004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

5505

Asan Medical Center, Seoul

6009

Sir Charles Gairdner Hospital, Nedlands

6150

Fiona Stanley Hospital, Murdoch

10016

National Taiwan University Hospital, Taipei

10449

MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

12351

Vivantes Klinikum Neukoelln, Berlin

13496

CHA Bundang Medical Center, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14642

University of Rochester Medical Center - Strong Memorial Hospital, Rochester

16132

Ospedale Policlinico San Martino, Genova

19104

Corporal Michael J. Crescenz VA Medical Center, Philadelphia

20141

IEO Istituto Europeo di Oncologia, Milan

21079

Centre Georges François Leclerc, Dijon

22030

Trakya University Medical Faculty, Edirne

27157

Wake Forest University Health Sciences, Winston-Salem

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28050

Hospital Universitario HM Madrid Sanchinarro, Madrid

29605

Prisma Health Upstate, Greenville

30625

Medizinische Hochschule Hannover, Hanover

31904

IACT Health, Columbus

32806

Orlando Health, Inc., Orlando

33176

Baptist Health Medical Group Oncology, LLC, Miami

34098

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul

35128

IOV - Istituto Oncologico Veneto IRCCS, Padua

37124

Centro Ricerche Cliniche di Verona S.r.l, Verona

38043

CHU de Grenoble - Hôpital Nord, Grenoble

40022

RCI Sumy Regional Clinical Oncological Dispensary, Sumy

40217

Norton Cancer Institute, Louisville

40447

China Medical University Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

43018

Treatment-Prevention Institution Volyn Regional Oncological Dispensary, Lutsk

43210

The Ohio State University James Cancer Hospital and Solove Research Institute, Columbus

44280

Inonu University Medical Facility, Malatya

44805

ICO - Site René Gauducheau, Saint-Herblain

48202

Henry Ford Medical Group, Detroit

50004

Changhua Christian Medical Foundation Changhua Christian Hospital, Changhua

53226

The Medical College of Wisconsin, Inc., Milwaukee

55404

Minnesota Oncology Hemtology, Minneapolis

55455

Regents of the University of Minnesota, Minneapolis

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

58013

CI Chernivtsi RC Oncological Dispensary, Chernivtsi

58128

Chonnam National University Hwasun Hospital, Hwasun

60415

Affiliated Oncologists LLC, Chicago Ridge

61070

Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU, Kharkiv

61166

CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection, Kharkiv

65025

Communal Institution Odesa Regional Clinical Hospital, Odesa

66205

University of Kansas Medical Center Research Institute, Inc., Westwood

69120

Universitaetsklinikum Heidelberg, Heidelberg

72076

Universitaetsklinikum Tuebingen, Tübingen

75246

Baylor Charles A. Sammons Cancer Center, Dallas

75679

Hôpital Cochin, Paris

75702

Texas Oncology, P.A. - Tyler, Tyler

78705

Texas Oncology, P.A. - Austin, Austin

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80012

Rocky Mountain Cancer Centers, LLP- Aurora, Aurora

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

85711

Arizona Oncology Associates , PC - HOPE, Tucson

85719

University of Arizona Cancer Center, Tucson

92300

Institut Hospitalier Franco-Britannique, Levallois-Perret

98101

Virginia Mason Medical Center, Seattle

98684

Northwest Cancer Specialists, P.C.-Vancouver, Vancouver

98801

Wenatchee Valley Hospital and Clinics, Wenatchee

115478

"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow

FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin, Moscow

129515

"VitaMed LLC", Moscow

191104

"State Budget Institution of Healthcare Leningrad Regional Clinical Oncology Dispensary", Saint Petersburg

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

"SPb SBIH City Clinical Oncological Dispensary", Saint Petersburg

625041

Medicinskiy gorod, Tyumen

90602-3171

The Oncology Institute of Hope and Innovation, Whittier

02114

Massachusetts General Hospital, Boston

02215-5400

Beth Israel Deaconess Medical Center, Boston

11794-3369

The Research Foundation for The State University of New York, Stony Brook

T2N 4N2

Tom Baker Cancer Centre, Calgary

B3H1V7

Nova Scotia Health Authority, Halifax

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G 1X6

Princess Margaret Cancer Centre, Toronto

H2X 0A9

CHUM Centre de Recherche, Montreal

H3T 1E2

SMBD Jewish General Hospital, Montreal

625 00

Fakultní nemocnice Brno, Brno

500 05

Fakultní nemocnice Hradec Králové, Hradec Králové

775 20

Fakultní nemocnice Olomouc, Olomouc

140 59

Thomayerova nemocnice, Prague

150 30

Nemocnice Na Homolce, Prague

602-715

Dong-A University Hospital, Pusan

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

08308

Korea University Guro Hospital, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08908

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

01130

Acibadem Adana Hospital, Adana

01220

Baskent University Adana Application and Research Center, Adana

07058

Akdeniz University Medical Faculty, Antalya

06105

Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Malatya

03115

Kyiv City Clinical Oncological Center, Kyiv

03126

"SI Shalimov's National Institute of Surgery and Transplantation of NAMSU", Kyiv

SE1 9RY

Guy's Hospital, London

M20 4BX

The Christie, Manchester

EH4 2XU

Western General Hospital, Edinburgh

G12 OYN

Beatson West of Scotland Cancer Centre, Glasgow

CH63 4JY

The Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

TQ2 7AA

Torbay Hospital, Torquay

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NuCana plc

OTHER