A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

529

Participants

Timeline

Start Date

April 23, 2009

Primary Completion Date

June 1, 2012

Study Completion Date

February 12, 2014

Conditions
Malignant Melanoma
Interventions
DRUG

ABI-007

Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.

DRUG

Dacarbazine

Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.

Trial Locations (112)

1815

Medisch Centrum Alkmaar, Alkmaar

2065

Royal North Shore Hospital, Sydney

2145

Sydney West Cancer Trials Centre/Westmead Hospital, Westmead

2444

Port Macquarie Base Hospital, Port Macquarie

3004

Alfred Hospital, Melbourne

5000

Royal Adelaide Hospital, Department of Medical Oncology, Adelaide

6000

Royal Perth Hospital, Perth

7000

Royal Hobart Hospital, Hobart

10117

Charite Universitaetsmedizin Berlin, Berlin

16132

IST-Istituto Nazionale per la Ricera sul Cancro, Genova

18015

St. Luke's Hospital & Health Network, Bethlehem

19131

Thomas Jefferson University, Philadelphia

20141

Istituto Europeo di Oncologia, Milan

24105

Universitaetsklinkum Schegwig-Holstein, Keil

27103

Piedmont Hematology, Winston-Salem

30625

Medizinische Hochschuke Hannover, Hanover

32207

Baptist Cancer Institute, Jacksonville

33075

Hopital Saint Andre' CHU de Bordeaux, Bordeaux

33136

University of Miami Hospital and Clincs/SCCC, Miami

33805

Lakeland Regional Cancer Center, Lakeland

34298

Centre Regional Val d' Aurelle Paul Lamarque, Montpellier

35128

IOV-Instituto Oncologico IRCCS, Padua

35243

University of Alabama at Birmingham, Birmingham

38043

Centre Hospitaller Universitaire de Grenoble, Grenoble

43210

OH State University Arthur G. James Cancer Hospital, Columbus

44791

St. Josef-Hospital, Bochum

46202

Indiana University, Indianapolis

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei T, Meldola

48201

Wayne State University, Detroit

52402

IA Blood and Cancer Care, PLC, Cedar Rapids

53100

Azienda Ospedaliera Universitaria Sense, Siena

55455

University of Minnesota, Minneapolis

56100

Ospedale S. Chiara, Pisa

62062

Waren Billhartz Cancer Center, Maryville

63110

Saint Louis University, St Louis

65807

St. John's Medical Research, Springfield

71913

Genesis Cancer Ctr - Hot Springs, Hot Springs

72076

Universitaetsklinkum Tuebingen, Tübingen

72205

University of Arkansa for Medical Sciences, Little Rock

73142

Integris Cancer Institute of OK, Oklahoma City

75018

Hopital Bichat, Paris

75080

Hope Oncology, Richardson

75246

Mary Crowley Research Center, Dallas

77030

Univ of TX MD Anderson Cancer Ctr, Houston

Univ of TX Med School at Houston, Houston

79410

Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center, Lubbock

80045

University of Colorado Cancer Center, Aurora

80131

Ist. Naz. per lo studio e la cura dei tumori G. Pascale, Napoli

84106

Utah Cancer Specialist, Salt Lake City

85258

AZ Cancer Ctr, Scottsdale

85724

Arizona Cancer Center, Tucson

89135

Nevada Cancer Institute, Las Vegas

90033

University of Southern California/Norris Cancer Center, Los Angeles

90095

University of CA Los Angeles, Los Angeles

90211

Tower Cancer Research Foundation, Beverly Hills

92024

San Diego Pacific Oncology and Hematology Associates, Encinitas

92354

Loma Linda University Cancer Center, Loma Linda

94117

St. Mary's Medical Center, San Francisco

94805

Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc, Villejuif

97080

Universitaetsklinkum Wuerzburg PS, Würzburg

98109

Univ. of Washington Medical Center/Seattle Cancer Care Alliance, Seattle

99218

Evergreen Hematology & Oncology, Spokane

02215

Beth Israel Deaconess Medical Center, Boston

07962

Atlantic Melanoma Center, Morristown

Unknown

Sir Charles Gairdner Hospital, Nedlands Perth

CHRU Hopital Claude Huriez, Lile Cedax

Hopital Dypuytren-CHU de Limoges, Limoges

Centre Leon Berad, Lyon

Hopital Sainte Marguerite, Marseille

CHU Hopital Saint Eloi, Montepellier Cedex 5

Groupe hospitalier Cochin-St. Vincent de Paul, Paris

Hopital Saint-Louis, Paris

Universitaetsklinkum Heidelberg, Heidelberg

Universitaetsklinkum Heidelberg, Heidelber

Universitaetsklinkum Hamburg-Eppendorf, Hamburg

Univeritaetsklinkum Goettingen, Gottington

Universitaetklinkum Koeln, Cologne

Universitaetsklinkum Essen, Essen

Universitaetsklinkum Dresden, Dresden

Universitaesklinkum Leipzig, Leipzig

Universitaetsklinkum Mainz, Mainz

"Istituto Tumori Giovanni Paolo II", Bari

Istituto Nazionale Tumori, Milan

"Erasmus MC ae Daniel den Hoed", Rotterdam

H CLINIC I Provincial, Barcelona

H Clinico San Carlos, Madrid

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BCCA Centre for the Southern Interior, Kelowna

BCCA, Centre for the Southern Interior, Kelowna

V3V 1Z2

BC Cancer Agency-Fraser Valley Ctr., Surrey

V5Z4E6

BC Cancer Agency-Vancouver, Vancouver

V8R 6V5

BC Cancer Agency-Vancouver Island Ctr., Victoria

N6A 4L6

London Regional Cancer Program, London

L5M 2N1

Credit Valley Hospital, Missiauga

K1H 8L6

The Ottawa Hospital Regional Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H2W 1S6

McGill University Dept. of Oncology Clinical Research Program, Montreal

06200

Hopital de 1 Archet 2, Nice

07743

UniversitawtsklinKum Jena, Jena

6800TA

Rijnstate ziekenhuis Arnhem, Amhem

08036

H Clinic i Provincial, Barcelona

08208

Corporacion Sanitaria Parc Tauli, Sabadell

CM1 7ET

Broomfield Hospital, Chelmsford

CF14 2TL

Velindre Hospital, Cardiff

SW12 ORE

St. George's Hospital, London

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

SA28QA

Singleton Hospital, Sothwest Wales Inst., Swansea

ST4 6QB

Univ Hospital of North Staffordshire, Stroke on Kent

S10 2SJ

Weston Park Hospital, Sheffield

SV10 0QP

Newcross Hospital, Wolverhampton

SW3 6JJ

Royal Marsden Hospital London, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Arizona

OTHER

lead

Celgene

INDUSTRY