A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

PHASE3CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

September 30, 2006

Study Completion Date

January 31, 2009

Conditions
Melanoma
Interventions
DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19

DRUG

Carboplatin/Paclitaxel

Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1

DRUG

Placebo

Placebo, 2 tablets bid Study Days 2-19

Trial Locations (66)

2050

Camperdown

2145

Westmead

2300

Warartah

3002

East Melbourne

3004

Melbourne

3084

Heidelberg

3144

Malvern

4101

Brisbane

6009

Nedlands

10065

New York

12200

Berlin

14263

Buffalo

15232

Pittsburgh

22908

Charlottesville

24105

Kiel

29285

Brest

33000

Bordeaux

33612

Tampa

34298

Montpellier

35243

Birmingham

39373

Lyon

40202

Louisville

43221

Columbus

45122

Essen

54290

Trier

60068

Park Ridge

60488

Frankfurt am Main

60590

Frankfurt am Main

60612

Chicago

63110

St Louis

66421

Homburg

68114

Omaha

68135

Mannheim

69112

Heidelberg

72076

Tübingen

75010

Paris

75634

Paris

77030

Houston

80045

Aurora

81675

München

85724

Tucson

90025

Los Angeles

92104

Boulogne-Billancourt

94805

Villejuif

07042

Montclair

37232-6307

Nashville

98109-1023

Seattle

T2N 4N2

Calgary

T6G 1Z2

Edmonton

N6A 4L6

London

M4N 3M5

Toronto

M5G 2M9

Toronto

H3T 1E2

Montreal

1066 CX

Amsterdam

3075 EA

Rotterdam

3584 CX

Utrecht

SO16 6YD

Southampton

LE1 5WW

Leicester

SE1 9RT

London

SW3 6JJ

London

M20 4BX

Manchester

CH63 4JY

Bebington

NG5 1PB

Nottingham

SM2 5PT

Sutton

LS9 7TF

Leeds

SA2 8QA

Swansea

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Bayer

INDUSTRY