NCT00105443 - A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma | Biotech Hunter

Enrollment

602

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions

Carcinoma, Hepatocellular

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

DRUG

Placebo

Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Trial Locations (178)

1023

Auckland

1070

Bruxelles - Brussel

1090

Bruxelles - Brussel

1200

Bruxelles - Brussel

1211

Geneva

1233

Sofia

1431

Sofia

1527

Sofia

2031

Randwick

2050

Camperdown

2145

Westmead

3000

Leuven

3010

Bern

3052

Melbourne

3084

Heidelberg

3165

East Bentleigh

6000

Stara Zagora

6001

Wellington South

7600

Mar del Plata

8000

Bruges

8091

Zurich

9000

Ghent

9007

Sankt Gallen

9010

Varna

10000

Zagreb

10016

New York

10021

New York

10029

New York

10032

New York

12200

Berlin

12462

Haidari

13005

Marseille

14004

Córdoba

14050

México, D.F.

14080

Mexico City

15213

Pittsburgh

19104

Philadelphia

19140

Philadelphia

20089

Rozzano

20122

Milan

20133

Milan

20246

Hamburg

21000

Dijon

23249

Richmond

27100

Pavia

28006

Madrid

28034

Madrid

28041

Madrid

30308

Atlanta

30322

Atlanta

30625

Hanover

31008

Pamplona

32610

Gainesville

33000

Bordeaux

33136

Miami

33612

Tampa

35062

Rennes

35128

Padua

39120

Magdeburg

40138

Bologna

40225

Düsseldorf

40536

Lexington

44718

Canton

44805

Nantes

45122

Essen

45500

Ioannina

46014

Valencia

47100

Forlì

48903

Cruces/Barakaldo

49100

Petah Tikva

53105

Bonn

54500

Vandœuvre-lès-Nancy

54639

Thessaloniki

55131

Mainz

56126

Pisa

56403

Thessaloniki

59020

Lille

60590

Frankfurt am Main

60611

Chicago

60612

Chicago

63104

St Louis

64000

Monterrey

64239

Tel Aviv

66421

Homburg

70300

Zrifin

72076

Tübingen

75020

Paris

79106

Freiburg im Breisgau

81377

München

81675

München

83100

Avellino

84801

Haifa

85724

Tucson

90057

Los Angeles

90127

Palermo

92110

Clichy

93042

Regensburg

93143

Bondy

94121

San Francisco

94305

Stanford

97239

Portland

98104

Seattle

105229

Moscow

115478

Moscow

129110

Moscow

188663

Saint Petersburg

197758

Saint Petersburg

200642

Craiova Dolj

300223

Timișoara

350040

Krasnodar

420012

Kazan'

610002

Kirov

620036

Yekaterinburg

620102

Yekaterinburg

700111

Iași

30180090

Belo Horizonte

30380490

Belo Horizonte

90619900

Porto Alegre

85054-4502

Phoenix

90095-7077

Los Angeles

92668-3298

Orange

06030

Farmington

06510-8019

New Haven

48109-0362

Ann Arbor

48202-2689

Detroit

68198-2000

Omaha

11030-3876

Manhasset

77030-1502

Houston

98195-6174

Seattle

B1629AHJ

Pilar

C1417DTB

Bueno Aires

C1120AAF

Buenos Aires

C1145ADP

Buenos Aires

C1181ACH

Buenos Aires

T4000GTB

San Miguel de Tucumán

T4000HXU

San Miguel de Tucumán

90035-003

Porto Alegre

01246-903

São Paulo

T2N 4N1

Calgary

T6G 2C8

Edmonton

V5Z 1H8

Vancouver

R2H 2A6

Winnipeg

N6A 5A5

London

K1H 1C4

Ottawa

M5G 2N2

Toronto

H3A 1A1

Montreal

833-0024

Santiago

Unknown

Santiago

Santiago Región Metropolitana

Comas Lima

Tolgliatti

06120

Halle

115 27

Athens

540 07

Thessaloniki

00144

Roma

06720

México, D.F.

LIMA 34

Lima

LIMA 1

Lima Cercado

80-952

Gdansk

61-878

Poznan

02-507

Warsaw

02-781

Warsaw

105 203

Moscow

111 020

Moscow

113 811

Moscow

129 010

Moscow

195 067

Saint Petersburg

03010

Alicante

08916

Badalona

08003

Barcelona

08035

Barcelona

08036

Barcelona

BS2 8ED

Bristol

NW3 2QG

London

SE1 9RT

London

OX1 2JD

Oxford

G11 6NT

Glasgow

NE2 4HH

Newcastle upon Tyne