Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

PHASE3CompletedINTERVENTIONAL
Enrollment

512

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2013

Conditions
Renal Cell Carcinoma
Interventions
DRUG

Sorafenib

Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).

DRUG

temsirolimus (Torisel)

Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Trial Locations (128)

1090

Pfizer Investigational Site, Vienna

1221

Pfizer Investigational Site, Geneva

2065

Pfizer Investigational Site, St Leonards

2145

Pfizer Investigational Site, Westmead

2217

Pfizer Investigational Site, Kogarah

2730

Pfizer Investigational Site, Herlev

4031

Pfizer Investigational Site, Basel

4101

Pfizer Investigational Site, South Brisbane

5000

Pfizer Investigational Site, Adelaide

5011

Pfizer Investigational Site, Woodville South

5020

Pfizer Investigational Site, Salzburg

5112

Pfizer Investigational Site, Elizabeth Vale

6000

Pfizer Investigational Site, Lucerne

8000

Pfizer Investigational Site, Aarhus C

10065

Pfizer Investigational Site, New York

10117

Pfizer Investigational Site, Berlin

13273

Pfizer Investigational Site, Marseille

14076

Pfizer Investigational Site, Caen

20817

Pfizer Investigational Site, Bethesda

21079

Pfizer Investigational Site, Dijon

21201

Pfizer Investigational Site, Baltimore

23538

Pfizer Investigational Site, Lübeck

25000

Pfizer Investigational Site, Besançon

27100

Pfizer Investigational Site, Pavia

28007

Pfizer Investigational Site, Madrid

28041

Pfizer Investigational Site, Madrid

33006

Pfizer Investigational Site, Oviedo

33075

Pfizer Investigational Site, Bordeaux

34125

Pfizer Investigational Site, Kassel

34298

Pfizer Investigational Site, Montpellier

38801

Pfizer Investigational Site, Tupelo

40202

Pfizer Investigational Site, Louisville

41013

Pfizer Investigational Site, Seville

41464

Pfizer Investigational Site, Neuss

44195

Pfizer Investigational Site, Cleveland

44805

Pfizer Investigational Site, Saint Herlain/Nantes Cedex

46010

Pfizer Investigational Site, Valencia

47303

Pfizer Investigational Site, Municie

49100

Pfizer Investigational Site, Angers

50134

Pfizer Investigational Site, Florence

54511

Pfizer Investigational Site, Vandœuvre-lès-Nancy

59000

Pfizer Investigational Site, Lille

63011

Pfizer Investigational Site, Clermont-Ferrand

66013

Pfizer Investigational Site, Chieti

67091

Pfizer Investigational Site, Strasbourg

69120

Pfizer Investigational Site, Heidelberg

69373

Pfizer Investigational Site, Lyon

70006

Pfizer Investigational Site, Metairie

73120

Pfizer Investigational Site, Oklahoma City

74104

Pfizer Investigational Site, Tulsa

75226

Pfizer Investigational Site, Dallas

75246

Pfizer Investigational Site, Dallas

75908

Pfizer Investigational Site, Paris

78229

Pfizer Investigational Site, San Antonio

78731

Pfizer Investigational Site, Austin

80131

Pfizer Investigational Site, Napoli

81675

Pfizer Investigational Site, München

84412

Pfizer Investigational Site, Salt Lake City

86021

Pfizer Investigational Site, Poitiers

89081

Pfizer Investigational Site, Ulm

90095

Pfizer Investigational Site, Los Angeles

91010

Pfizer Investigational Site, Duarte

92037

Pfizer Investigational Site, La Jolla

92093

Pfizer Investigational Site, La Jolla

92103

Pfizer Investigational Site, San Diego

92505

Pfizer Investigational Site, Riverside

92868

Pfizer Investigational Site, Orange

94805

Pfizer Investigational Site, Villejuif

98101

Pfizer Investigational Site, Seattle

169610

Pfizer Investigational Site, Singapore

90095-6984

Pfizer Investigational Site, Los Angeles

06451

Pfizer Investigational Site, Meriden

84112-5550

Pfizer Investigational Site, Salt Lake City

C1426ANZ

Pfizer Investigational Site, Buenos Aires

S2000KZE

Pfizer Investigational Site, Rosario

C1122AAL

Pfizer Investigational Site, Buenos Aires

C1437JCP

Pfizer Investigational Site, Buenos Aires

X5006HBF

Pfizer Investigational Site, Nueva Cordoba

T4000 IAK

Pfizer Investigational Site, San Miguel de Tucumán

T6G 1Z2

Pfizer Investigational Site, Edmonton

V1Y 5L3

Pfizer Investigational Site, Kelowna

V5Z 4E6

Pfizer Investigational Site, Vancouver

V8R 6V5

Pfizer Investigational Site, Victoria

B3H 1V7

Pfizer Investigational Site, Halifax

B3H 2Y9

Pfizer Investigational Site, Halifax

B3H 3A7

Pfizer Investigational Site, Halifax

K6R 5S5

Pfizer Investigational Site, Cornwall

L8N 4A6

Pfizer Investigational Site, Hamilton

N6A 4G5

Pfizer Investigational Site, London

N6A 4L6

Pfizer Investigational Site, London

K1H 8L6

Pfizer Investigational Site, Ottawa

K1Y 4K7

Pfizer Investigational Site, Ottawa

M4N 3M5

Pfizer Investigational Site, Toronto

M5G 2M9

Pfizer Investigational Site, Toronto

H3G 1A4

Pfizer Investigational Site, Montreal

Unknown

Pfizer Investigational Site, Providencia

Pfizer Investigational Site, Hong Kong

Pfizer Investigational Site, Kleinriehenstrasse 30

Pfizer Investigational Site, Basel

Pfizer Investigational Site, Bruderholz

Pfizer Investigational Site, Rheinstrasse 26

33 521

Pfizer Investigational Site, Tampere

20 520

Pfizer Investigational Site, Turku

01307

Pfizer Investigational Site, Dresden

H-1122

Pfizer Investigational Site, Budapest

00144

Pfizer Investigational Site, Roma

00152

Pfizer Investigational Site, Roma

0144

Pfizer Investigational Site, Roma

3318 AT

Pfizer Investigational Site, Dordrecht

8934 AD

Pfizer Investigational Site, Leeuwarden

8025 AB

Pfizer Investigational Site, Zwolle

110-744

Pfizer Investigational Site, Seoul

120-752

Pfizer Investigational Site, Seoul

135-710

Pfizer Investigational Site, Seoul

138-736

Pfizer Investigational Site, Seoul

08916

Pfizer Investigational Site, Badalona

08025

Pfizer Investigational Site, Barcelona

08208

Pfizer Investigational Site, Sabadell

SE-413 45

Pfizer Investigational Site, Gothenburg

221 85

Pfizer Investigational Site, Lund

205 02

Pfizer Investigational Site, Malmo

B5 7UG

Pfizer Investigational Site, Edgbaston

CB2 0QQ

Pfizer Investigational Site, Cambridge

M20 4BX

Pfizer Investigational Site, Withington

B15 2TH

Pfizer Investigational Site, Birmingham

SE1 9RT

Pfizer Investigational Site, London

M23 9LT

Pfizer Investigational Site, Manchester

NE4 6BE

Pfizer Investigational Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY