Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

PHASE3CompletedINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

June 17, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

May 23, 2016

Conditions
Colorectal Cancer
Interventions
DRUG

TAS-102

35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

DRUG

Placebo

Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

Trial Locations (115)

4

St. Vincent's University Hospital, Dublin

24

Adelaide and Meath Hospital, Dublin

1090

Universitaet Wien, Vienna

Universitaetsklinik fur Innere Medizin, Vienna

1160

Wilhelminenspital Wien, Vienna

1200

Cliniques Universitaires UCL St. Luc, Brussels

1307

Universitatsklinikum Carl Gustav Carus - Dresden, Dresden

2065

Royal North Shore Hospital, Sydney

2650

Antwerp University Hospital, Edegem

University Hospital Gent, Edegem

3000

Leuven University Hospital - Campus Gasthuiseberg, Leuven

University Hospital Gasthuisberg, Leuven

3050

The Royal Melbourne Hospital, Parkville

3084

Austin Hospital, Heidelberg

4010

Krankenhaus der Barmherzigen Schwestern Linz, Linz

4600

Klinikum Wels-Grieskirchen GmbH, Wels

5011

The Queen Elisabeth Hospital, Woodville South

6000

Grand Hospital de Charleroi, Charleroi

6009

Sir Charles Gairdner Hospital, Perth

6120

Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg, Halle

8035

Hospital Universitario Vall d'Hebrón, Barcelona

8916

Corporacion Sanitaria Parc Tauli, Sabadell

9000

University Hospital Gent, Ghent

10707

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin

16132

"Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria San Martino (Ospedale San Martino)", Genova

17176

Karolinska University Hospital, Stockholm

20133

Fondazione IRCCS Instituto Nazionale dei Tumori Milano, Milan

20162

A.O. Ospedale Niguarda Ca' Granda, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

22408

Hematology/Oncology Associates of Fredericksburg, Fredericksburg

23100

Ospedale di Sondrio, Sondrio

25030

CHU de Becançon, Besançon

25124

Fondazione Poliambulanza, Brescia

25198

Hospital Arnau de Vilanova, Lleida

26133

Klinikum Oldenburg gGmbH, Oldenburg

26204

Institute of Oncology and Rehabilitation Ples, Nová Ves pod Pleší

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Fundacion Jimenez Diaz - Universidad Autonoma de Madrid, Madrid

28041

Hospital 12 de Octubre, Madrid

29010

Hospital Carlos Haya, Málaga

30008

Hospital Universitario Morales Messeguer, Murcia

32806

MD Anderson Cancer Center Orlando, Orlando

33075

University Hospital of Bordeaux, Bordeaux

34298

CRLC Val d'Aurelle, Montpellier

35042

Centre Eugene Marquis, Rennes

41013

Hospital Universitario Virgen del Rocio, Seville

42123

Arcispidale S Maria Nuova, Reggio Emilia

43560

Hickman Cancer Center at Flower Hospital, Sylvania

44718

Gabrail Cancer Center, Canton

46010

Hospital Clínico Universitario de Valencia, Valencia

46014

Hospital General Universitario de Valencia, Valencia

46202

Indiana University Simon Cancer Center, Indianapolis

47923

Ospedale di Rimini, Rimini

48106

St. Joseph Mercy Hospital, Ann Arbor

50005

Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove, Hradec Králové

50937

Uniklinik Koeln, Cologne

53123

Praxiskooperation Bonn-Euskirchen-Rheinbach, Bonn

55131

Johannes Gutenberg Universität Mainz, Mainz

59020

Centre Oscar Lambret, Lille

60488

Medizinische Klinik am Krankenhaus Nordwest GmbH, Frankfurt

61615

Illinois Cancer Care, P.C., Peoria

64111

Saint Luke's Cancer Institute, Kansas City

68167

Interdisziplinaeres Tumorzentrum Mannheim, Mannheim

70809

Mary Bird Perkins Cancer Center, Baton Rouge

75185

Akademiska Sjukhuset, Uppsala

75571

Hopital Saint Antoine, Paris

80131

"A.O. R.N. A.Cardarelli", Naples

Seconda Universita degli Studi de Napoli, Napoli

81377

Klinikum der Universität München - Großhadern, München

81737

Staedtisches Klinikum Muenchen / Klinikum Neuperlach, München

85306

Arizona Center for Cancer Care, Glendale

89081

Universitaetsklinikum Ulm, Ulm

90033

LAC and USC Medical Center, Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles

93401

Coastal Integrative Cancer Care, San Luis Obispo

93720

California Cancer Associates for Research and Excellence, Fresno

94115

Pacific Hematology Oncology Associates, San Francisco

95020

Ronald H. Yanagihara, MD, Gilroy

95124

San Jose Medical Group, San Jose

1010043

AOU San Luidi di Orbassano, Orbassano

1040045

National Cancer Center Hospital, Chuo-ku

1358550

The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku

1608582

Keio University Hospital, Shinjuku-ku

2418515

Kanagawa Cancer Center, Yokohama

2608717

Chiba Cancer Center, Chiba

2778577

National Cancer Center Hospital East, Kashiwa

3058576

Tsukuba University Hospital, Tsukuba

3290498

Jichi Medical University Hospital, Shimotsuke

3620806

Saitama Cancer Center, Kita-adachi-gun

4118777

Shizuoka Cancer Center, Sunto-gun

4648681

Aichi Cancer Center Hospital, Nagoya

5378511

Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka

5698686

Osaka Medical College Hospital, Takatsuki

6500047

Kobe City Medical Center General Hospital, Kobe

6756126

Azienda Ospedaliero, Pisa

7708503

Tokushima University Hospital, Tokushima

7910280

National Hospital Organization Shikoku Cancer Center, Matsuyama

8111395

National Hospital Organization Kyushu Cancer Center, Fukuoka

8608556

Kumamoto University Hospital, Kumamoto

06520

Yale Cancer Center, New Haven

70121-2429

Ochsner Clinic Fndtn, New Orleans

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

65109-6023

Jefferson City Medical Group, Jefferson City

03756

Dartmouth-Hitchcock Medical Center, Lebanon

B-1070

Erasme University Hospital-ULB-Brussels, Brussels

Unknown

Bon Secours Hospital, Cork

277-0882

National Cancer Center Hospital East, Kashiwa

0600001

KKR Sapporo Medical Center TONAN-Hospital, Sapporo

0608648

Hokkaido University Hospital, Sapporo

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

BS2 8ED

University Hospitals Bristol NHS Foundation Trust, Bristol

LS9 7TF

St James' Institute of Oncology, Leeds

NW1 2PG

University College London Hospitals Foundation NHS Trust, London

SM2 5PT

The Royal Marsden NHS Foundation Trust, Surrey

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT01607957 - Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies | Biotech Hunter | Biotech Hunter