Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

February 24, 2016

Primary Completion Date

April 30, 2018

Study Completion Date

December 19, 2019

Conditions
Refractory Metastatic Gastric Cancer
Interventions
DRUG

TAS-102

35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

DRUG

Placebo

35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

Trial Locations (139)

1230

Baskent University Adana Practice and Research Centre Kisla, Adana

6000

Grand Hopital de Charleroi, Charleroi

6100

Ankara University Medical Faculty Cebeci Hospital, Ankara

Hacettepe University, Ankara

6200

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research, Ankara

6330

Diskapi Yildirim Beyazit Training and Research Hospital, Ankara

10016

Laura & Isaac Perlmutter Cancer Center, New York

10043

A.O.U. San Luigi Gonzaga, Orbassano (TO)

10065

Memorial Sloan Kettering Cancer Center, New York

13005

Hopital de La Timone, Marseille

13008

Hôpital Saint Joseph, Marseille

13353

Charite Universitaetsmedizin Berlin, Berlin

14004

Hospital Universitario Reina Sofía, Córdoba

14642

Univeristy of Rochester Medical Center, Rochester

15232

University of Pittsburgh Medical Cancer Center, Pittsburgh

16059

Uludag University Medical Faculty, Bursa

16132

Azienda Ospedaliera San Martino, Genova

20089

Istituto Clinico Humanitas, Rozzano (Mi)

20141

Istituto Europeo di Oncologia (IEO), Milan

20162

A.O. Ospedale 'Niguarda Ca Granda', Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

22030

Trakya University Medical Faculty Hospital, Edirne

23100

A.O. della Valtellina e della Valchiavenna Ospedale di Sondrio, Sondrio

24125

Humanitas Gavazzeni, Bergamo

25124

Fondazione Poliambulanza Istituto Ospedaliero, Brescia

26100

Struttura Complessa di Oncologia, Cremona

27157

Wake Forest Baptist Health, Winston-Salem

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

30008

Hospital Universitario Morales Meseguer, Murcia

30625

Medizinische Hochschule Hannover, Hanover

31096

Rambam healthcare campus, Haifa

32204

21st Century Oncology, Jacksonville

33006

Hospital Universitario Central de Asturias, Oviedo

33081

IRCCS Centro di Riferimento Oncologico - Aviano, Aviano (PN)

33604

Centre medico-chirurgical Magellan, Pessac

34098

Istanbul Üniversitesi, Istanbul

34298

Centre Val D'Aurelle, Montpellier

34722

Bezmialem Vakif Üniversitesi Tip Fakültesi Hastanesi, Istanbul

34890

Marmara University Pendik Training and Research Hospital, Istanbul

35042

Centre Eugène Marquis, Rennes

35340

Dokuz Eylul University Oncology Institute, Izmir

40536

University of Kentucky, Lexington

47014

IRCCS - Istituto Scientifico Romagnolo Per lo Studio e la Cura Dei Tumori (I.R.S.T.), Meldola (FC)

48109

University of Michigan, Ann Arbor

49100

Rabin MC Belinson Hospital, Petah Tikva

49933

ICO Paul Papin, Angers

50005

Faculty Hospital Hradec Kralove, Hradec Králové

50134

Azienda Ospedaliero - Universitaria Careggi, Florence

52520

Sheba Medical Center, Ramat Gan

56126

Azienda Ospedaliero Universitaria Pisana (AOUP), Pisa

60608

Mount Sinai Hospital Medical Center, Chicago

60612

Rush University Medical Center, Chicago

60637

University of Chicago, Chicago

61615

Illinois CancerCare P.C., Peoria

62100

Fakultni Nemocniceu sv. Anny v Brne, Brno

64239

Tel Aviv Sourasky Medical Center, Ramat Gan

66000

Hôpital Saint-Jean, Perpignan

69008

Centre Léon Bérard, Lyon

75015

Hopital Europeen Georges Pompidou, Paris

75651

AP-HP - HU La Pitié-Salpêtrière - Charles-Foix, Paris

77520

Fakultní Nemocnice Olomouc, Olomouc

78404

Coastal Bend Cancer Center, Corpus Christi

80131

A.O.U. Seconda Universita'degli Studi di Napoli, Napoli

81675

Technische Universitaet Muenchen, Munich

81737

Staedtisches Krankenhaus Muenchen Neuperlach, München

85100

A.O.R. San Carlo, Potenza

85234

Banner MD Anderson Cancer Center, Gilbert

89081

Universitaetsklinikum Ulm, Ulm

90017

Los Angeles Cancer Network, Los Angeles

90033

University of Southern California - Keck School of Medicine, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

91120

Hadassah Ein Karem, Jerusalem

92835

St. Jude Heritage Healthcare, Fullerton

94109

California Pacific Medical Center, San Francisco

94704

Alta Bates Summit Comprehensive Cancer Center, Berkeley

97422

Leopoldina-Krankenhaus, Schweinfurt

115478

N.N. Blokhin Russian Cancer Research Center, Moscow

195067

North-Western State Medical University n.a. I.I. Mechnikov, Saint Petersburg

197758

N.N.Petrov Research Institute of Oncology, Saint Petersburg

Saint-Petersburgskiy Oncologic Hospital, Saint Petersburg

200385

"Centrul De Oncologie Sfantul Nectarie", Craiova

220013

Minsk City Clinical Oncology Dispensary, Minsk

223040

Republican center for oncology and medical radiology n.a. Alexandrov, Minsk

246012

Gomel Regional Clinical Oncology Dispensary, Homyel

450054

Republican Oncology Center, Ufa

644013

Budget Institution of Healthcare Omsk Region -Clinical Oncology Dispensary, Omsk

720224

"Spitalul Judetean de Urgenta Sfantul Ioan cel Nou Suceava", Suceava

5822012

Wolfson Medical Center, Holon

8410101

Soroka Medical Centre, Beersheba

03756

Dartmouth-Hitchcock Medical Center (DHMC), Lebanon

02908

Roger Williams Medical Center, Providence

53792-0001

University of Wisconsin, Madison

53226-3522

Medical College of Wisconsin, Milwaukee

Unknown

Clinique universitaire Saint Luc, Brussels

UZ Leuven, Leuven

Nemocnice Na Homolce, Prague

VFN Praha, Prague

Centre René Gauducheau, Saint-Herblain

St James Hospital, Dublin

The Adelaide and Meath Hospital, Dublin, Incorporating The National Children's Hospital, Dublin

Waterford Regional Hospital, Waterford

Nizhegorodsky Regional Oncology Center, Nizhny Novgorod

B-2650

University Hospital Antwerpen, Edegem

H1M 1M1

Recherche GCP Research, Montreal

277-8577

National Cancer Center Hospital East, Kashiwa

373-8550

Gunma Prefectural Cancer Center, Ōta

309-1793

Ibaraki Prefectural Central Hospital, Kasama

540-0006

Osaka National Hospital, Osaka

558-8558

Osaka General Medical Center, Osaka

593-8304

Sakai City Medical Center, Sakai

320-0834

Tochigi Cancer Center, Utsunomiya

930-0194

Toyama University Hospital, Tōyama

020-8505

Iwate Medical University, Morioka

40-635

Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca, Katowice

31-531

Szpital Uniwersytecki w Krakowie, Krakow

93-513

Regionalny Osrodek Onkologiczny, Lodz

10-228

Szpital MSWiA i Warminsko - Mazurskim Centrum Onkologii w Olsztynie, Olsztyn

45-060

Opolskie centrum Onkologii, Opole

02-781

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology, Warsaw

4464-513

Unidade Local de Saúde de Matosinhos E.P.E.- H. Pedro Hispano, Matosinhos Municipality

2805-267

Hospital Garcia de Orta, E.P.E., Almada

4710-243

SNS - Hospital Braga, Braga

1400-038

Fundação Champalimaud, Lisbon

1500-650

Hospital da Luz, S.A., Lisbon

4099-001

Centro Hospitalar do Porto, E.P.E, Porto

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E., Porto

4200-319

Centro Hospitalar de São João, EPE, Porto

5000-259

Centro Hospitalar de Tras-os-Montes e Alto Douro, EPE, Vila Real

08035

Hospital Universitario Vall d'Hebron, Barcelona

08208

Corporacio Parc Tauli, Sabadell

HA6 2RN

East and North Hertfordshire NHS Trust, Northwood

AB25 2ZN

NHS Grampian, Aberdeen

SM2 5NG

Belfast Health and Social Care Trust - Belfast City Hospital, Belfast

LE1 5WW

Leicester Royal Infirmary, Leicester

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

W1G 6AD

Sarah Cannon Research Institute, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT02500043 - Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer | Biotech Hunter | Biotech Hunter