Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

PHASE2CompletedINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

January 31, 2007

Study Completion Date

February 28, 2007

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

CC-5013

CC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)

Trial Locations (119)

1211

Hôpitaux Universitaire de Genève - Oncologie, Geneva

2050

Royal Prince Alfred Hospital - Institute of Haematology, Camperdown

2298

Calvary Mater Newcastle - Haematology, Waratah

2500

Wollongong Hospital - Haematology, Wollongong

3000

University Hospital Leuven - Hematology, Leuven

3002

Peter McCallum Cancer Institute - Directorate of Cancer Medecine, East Melbourne

3004

The Alfred Hospital - malignant haematology & stem cell transplantation, Melbourne

3010

Inselspital, Institut für Medizinische Onkologie, Bern

3199

Frankston Hospital-peninsula Health - Oncology Day Unit, Frankston

3690

Border Medical Oncology, Wodonga

4102

Princess Alexandra Hospital - Haematology, Brisbane

4103

Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II, Leipzig

5000

Royal Adelaide Hospital - SA Pathology Haematology, Adelaide

Odense University Hospital, Odense

5530

Cliniques Universitaires ULC de Mont-Godinne - Hematology, Yvoir

7100

Vejle Hospital - Hematology, Vejle

7740

Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie, Jena

8000

Aarhus University Hospital, Aarhus

8091

Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich, Zurich

8916

Hospital Germans Trias i Pujol - Hematology, Badalona

9000

UZ Gent - Hematology, Ghent

Aalborg Sygemus - Haematology, Aalborg

10011

St. Vincents Comprehensive Cancer Center, New York

10021

Memorial Sloan-Kettering Cancer Center, New York

10029

Mt. Sinai Medical Center, New York

10043

Ospedale San Luigi AO Luigi Gonzaga - Hematology, Orbassano

10126

A.O.U. San Giovanni Battista - Hematology, Torino

12808

Charles university Hospital - Internal Medicine, Prague

14152

Karolinska University Hospital Huddinge - Center of hematology, Stockholm

14263

Roswell Park Cancer Institute, Buffalo

14572

University of Athens - Alexandra Hospital; Clinical Therapeutics, Athens

14642

University of Rochester-James P. Wilmot Cancer Center, Rochester

15224

Western Pennsylvania Cancer Institute, Pittsburgh

16132

AO Universitaria San Martino - hematooncology, Genova

17176

Karolinska University Hospital Solna- medicine, Stockholm

19129

Drexel University College of Medicine, Philadelphia

20014

Hospital de Donostia - Hematology, Guipúzcoa

28006

Hospital de La Princesa - Hematology, Madrid

28041

Hospital 12 de Octubre - Hematology, Madrid

29100

Ospedale Guglielmo da Saliceto - hematooncology, Piacenza

30060

Northwest Georgia Oncology - Wellstar Cancer Research, Marietta

32224

Mayo Clinic, Jacksonville

33136

University of Miami- Sylvester Comp Cancer Center, Miami

33604

CHRU - Hôpital du Haut Lévêque - Centre François Magendie, Pessac

33901

Florida Cancer Specialists, Fort Myers

34461

Cancer & Blood Disease Center, Lecanto

35128

Universita degli Studi di Padova - Clinical & Experimental Medicine, Padua

37007

Hospital de Salamanca - Hematology, Salamanca

39008

Hospital Universitario Marqués de Valdecilla - Hematology, Santander

40138

Università degli Studi di Bologna - Policlinico S. Orsola - Hematology, Bologna

42100

Unità di Ematologia Arcispedale S. Maria Nuova - Haematology, Reggio Emilia

44195

The Cleveland Clinic Foundation, Cleveland

45122

Universitätsklinikum Essen, Klinik für Hämatologie, Essen

46009

Hospital La Fe - Hematology, Valencia

48149

Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A, Münster

49033

CHU Angers - Service des maladies du sang, Angers

50005

Fakultní nemocnice Hradec Králové - Hematology, Hradec Králové

54511

CHU Nancy - Hematologie, Vandœuvre-lès-Nancy

55805

St. Luke's Oncology and Hematology Associates, Duluth

55905

Mayo Clinic, Rochester

60077

Midwest Cancer Research Group, Skokie

64019

Centre Hospitalier de la côte basque - Hematologie, Bayonne

69120

Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V, Heidelberg

72076

Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II, Tübingen

75010

Hôpital Saint Louis - Immuno-hematologie, Paris

75185

Overlakare Medocomcentrum - Hematology, Uppsala

77030

MD Anderson Cancer Center, Houston

80131

"Fondazione G. Pascale - Hematology", Napoli

85258

Arizona Cancer Center, Scottsdale

85259

Mayo Clinic, Scottsdale

85925

Centre Hospitalier Départemental Vendée - Onco-hematologie, La Roche-sur-Yon

89081

Universitätsklinikum Ulm - Klinik fur Innere Medizin III, Ulm

92270

Desert Hematology Oncology Medical Group, Inc., Rancho Mirage

94704

Alta Bates Cancer Center, Berkeley

97080

Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II, Würzburg

97201

Oregon Health & Science University, Portland

97227

Kaiser Permanente Northwest Region, Portland

98104

Swedish Cancer Institute, Seattle

125167

Medical Sciences - Hematology & BMT, Moscow

125284

Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology, Moscow

191024

Russian Research Institute of Hematology and Blood Transfusion - Hematology, Saint Petersburg

197341

State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology, Saint Petersburg

85724-5024

Arizona Cancer Center, Tucson

94305-5750

Stanford University Medical Center, Stanford

33612-9497

H. Lee Moffitt Cancer Center and Research Institute, Tampa

60612-3515

Rush Presbyterian-St. Luke's Medical Center, Chicago

60637-1470

University of Chicago Medical Center, Chicago

46202-5149

Indiana University Medical Center, Indianapolis

21287-8963

Johns Hopkins Oncology Center, Baltimore

02115-6084

Dana-Farber Cancer Institute, Boston

48201-2097

Wayne State University School of Medicine, Detroit

68198-7680

University of Nebraska Medical Center, Omaha

11501-3893

Winthrop University Hospital, Mineola

10021-0034

New York Hospital- Cornell, New York

27157-1082

Wake Forest University School of Medicine, Winston-Salem

98109-4417

Fred Hutchinson Cancer Research Center, Seattle

cedex 59037

CHRU de Lille - Service des maladies du sang, Lille

cedex 13009

Institut Paoli Calmette - Hematology 1, Marseille

cedex 01 44093

CHU Hôtel-Dieu - Hematologie, Nantes

cedex 12 75012

CHU Saint Antoine - Service des maladies du sang, Paris

cedex 69495

Centre Hospitalier Lyon sud - Hematologie, Pierre-Bénite

cedex 9 31059

CHRU Hôpital Purpan - Hematologie, Toulouse

cedex 37044

Hôpital Bretonneau - Hématologie & Thérapie cellulaire, Tours

00161

"Policlinico Umberto I, Università La Sapienza di Roma - Hematology", Roma

1081 HV

VUMC - Hematology, Amsterdam

3015 CE

Erasmus Medical Center - Hematology, Rotterdam

3584-CX

University Medical Center - Hematology, Utrecht

08036

Hospital Clinic i Provincial de Barcelona - Hematology, Barcelona

S-41345

Sahlgrenska Hospital, University of Goteborg - Hematology, Gothenburg

BH7 7DW

Royal Bournemouth Hospital - Haematology, Bournemouth

LS9 7TF

St James's University Hospital - Haematology, Leeds

EC1A 7BE

St Bartholomew's Hospital - Medical Oncology, London

SE5 9RS

King's College Hospital - Haematology Clinical Trials, London

NE7 7DN

Freeman Hospital - Northern Centre for Cancer Care, Newcastle upon Tyne

NG5 1PB

Nottingham City Hospital - Centre for Clinical Haematology, Nottingham

PL6 8DH

Derriford Hospital - Haematology, Plymouth

S10 2JF

Royal hallamshire Hospital - Haematology, Sheffield

SM2 5PT

Royal Marsden NHS Foundation Trust - Haematology, Surrey

WV10 OQP

Royal Wolverhampton hospitals trust - Research and development, Wolverhampton

Sponsors
All Listed Sponsors
lead

Celgene Corporation

INDUSTRY